Introduction to the Responsible Conduct of Research

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1 ORI Introduction to the Resonsible Conduct of Research Nicholas H. Steneck illustrations by David Zinn


3 ORI Introduction to the Resonsible Conduct of Research Nicholas H. Steneck illustrations by David Zinn Revised Edition August 2007

4 US GOVERNMENT OFFICIAL EDITION NOTICE Legal Status and Use of Seals and Logos The seal of the U.S. Deartment of Health and Human Services (HHS) authenticates this ublication as the Official U.S. Government edition of the ORI Introduction to the Resonsible Conduct of Research. Under the rovisions of 42 U.S.C. 132b-10, the unauthorized use of this seal in a ublication is rohibited and subject to a civil enalty of u to $5,000 for each unauthorized coy of it that is rerinted or distributed. USE of ISBN Prefix This is the Official U.S. Government edition of this ublication and is herein identified to certify its authenticity. Use of the ISBN is for this U.S. Government Printing Office Official Edition only. The Suerintendent of Documents of the U.S. Government Printing Office requests that any rerinted edition be labeled clearly as a coy of the authentic work with a new ISBN. Disclaimer The ORI Introduction to the Resonsible Conduct of Research is not an official olicy statement or guideline and should not be viewed as such. While every effort has been made to resent an accurate descrition of Federal rules and the ractices acceted by the research community for the resonsible conduct of research, any statement in this ORI Introduction to RCR that is inconsistent with Federal law or regulation or official olicy or guidance is suerseded thereby. This document is also not intended to create any right or benefit, substantive or rocedural, enforceable at law by a arty against the United States, its agencies, officers, or emloyees or any PHS-funded research institution or its officers, emloyees, or research staff. Coyright and Acknowledgment Notice ORI requests that any re-use or re-ublication of any of the materials contained within the ORI Introduction to the Resonsible Conduct of Research acknowledge the source. Coyright for the illustrations aearing herein is held by the artist, David Zinn. Limited ersonal and educational use of these illustrations is ermitted with aroriate attribution to the artist. Inquiries regarding other uses of the illustrations should be addressed to the artist at Other questions about re-use and re-ublication should be addressed to

5 Message from the Secretary of Health and Human Services Advances in scientific knowledge have rovided the foundation for imrovements in ublic health and have led to enhanced health and quality of life for all Americans. Many of these advances can be traced to the work of the U.S. Deartment of Health and Human Services (HHS), which suorts the world s largest medical research effort. Research conducted with suort from HHS also hels to assure the safety of foods and health care roducts, is vital in the fight against drug and alcohol abuse, and in many other ways fosters the Deartment s mission to imrove health and to hel those in need of assistance. As the custodian of the largest share of our Nation s resources devoted to biomedical and behavioral research, HHS takes seriously the challenge of ensuring these resources are used resonsibly. Secial rograms already exist to oversee the rotection of human and animal subjects in research, to review conflicts of interest, and to assure laboratory safety and resonsible grants management. With this ublication, we hoe to encourage researchers and research institutions to make a secial effort to understand, discuss, and teach others about the resonsible conduct of research. Tommy G. Thomson Secretary U.S. Deartment of Health and Human Services iii


7 Foreword The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services and the American ublic. This resonsibility extends to around $30 billion in Federal research suort, devoted rimarily to the biomedical and behavioral sciences through intramural and extramural rograms, and to the thousands of researchers, research staff, and research administrators who work on PHS-funded research. As art of its efforts to romote integrity in PHS-funded research, ORI is authorized to undertake activities and to suort rograms that enhance education in the resonsible conduct of research (RCR). The ORI Introduction to the Resonsible Conduct of Research is being issued to further this imortant mission. The imortance of formal RCR education was first exlicitly recognized in the 1989 Institute of Medicine Reort, The Resonsible Conduct of Research in the Health Sciences, and has since been endorsed by other grous and members of the research community. Thanks to this suort, researchers who want to learn about or hel others understand resonsible conduct in research have many resources available, from formal courses to web-based instruction rograms, a growing array of challenging books, and the exerience of established researchers conveyed through mentoring. The ORI Introduction to RCR seeks to sulement existing resources by making a comrehensive overview of basic rules of the road for resonsible research available to all PHS-funded researchers. It has been reared with the needs of small and mid-size research institutions and beginning researchers in mind, since we have often been asked to rovide resources for this community, but it may find use in other settings. In issuing this ublication, it needs to be stressed that ORI is not establishing or even recommending how RCR ought to be taught. We understand that resonsible conduct in research can be and is learned in different ways, that the standards for resonsible conduct can vary from field to field, and that in many situations two or more resonses to a question about resonsible research may be considered accetable research ractice. We hoe the ORI Introduction to RCR will therefore be seen as the beginning and not the end of learning about this imortant asect of rofessional life. Chris B. Pascal, J.D. Director Office of Research Integrity v


9 Contents Message from the Secretary of Health and Human Services... iii Foreword...v Preface...xi Part I. Shared Values Rules of the Road a. Professional self-regulation...6 1b. Government regulation...9 1c. Institutional olicies d. Personal resonsibility Research Misconduct a. Federal research misconduct definition and olicies b. Institutional research misconduct olicies c. Putting research misconduct into ersective...26 Part II. Planning Research The Protection of Human Subjects a. Federal regulations b. Definitions c. IRB membershi and deliberations d. Training e. Continuing resonsibility f. Ethical issues...45 vii

10 4. The Welfare of Laboratory Animals a. Rules, olicies, and guidelines b. Definitions c. Institutional organization d. Federal and voluntary oversight e. Princiles for the resonsible use of animals in research f. Broader resonsibilities Conflicts of Interest a. Financial conflicts b. Conflicts of commitment c. Personal and intellectual conflicts d. Reorting and managing significant conflicts...78 Part III. Conducting Research Data Management Practices a. Data ownershi b. Data collection c. Data rotection d. Data Sharing e. Future considerations Mentor and Trainee Resonsibilities a. Basic resonsibilities b. Research environment c. Suervision and review d. Transition to indeendent researcher viii

11 8. Collaborative Research a. Roles and Relationshis b. Management c. Different research settings Part IV. Reorting and Reviewing Research Authorshi and Publication a. Authorshi b. Elements of a resonsible ublication c. Practices that should be avoided Peer review a. Meeting deadlines b. Assessing quality c. Judging imortance d. Preserving confidentiality Part V. Safe Driving and Resonsible Research ix


13 Preface Surred by a growing belief in the imortance of science and technology, ublic suort for research increased dramatically over the course of the 20 th century. A century ago, research did not lay a major role in the average erson s life. Today, few asects of life are not touched in one way or another by the information and technologies generated through research. With growing ublic suort for research has come an understandable concern about the way it is conducted. Public funds suort roughly one-third of all research and develoment (R&D) in the U.S. and half of all basic research. Many researchers, therefore, send a significant ortion of their time working for the ublic. As ublic servants and also rofessionals, researchers have clear obligations to conduct their research in a resonsible manner. In general terms, resonsible conduct in research is simly good citizenshi alied to rofessional life. In general terms, resonsible conduct in research is simly good citizenshi alied to rofessional life. Researchers who reort their work honestly, accurately, efficiently, and objectively are on the right road when it comes to resonsible conduct. Anyone who is dishonest, knowingly reorts inaccurate results, wastes funds, or allows ersonal bias to influence scientific findings is not. However, the secifics of good citizenshi in research can be a challenge to understand and ut into ractice. Research is not an organized rofession in the same way as law or medicine. Researchers learn best ractices in a number of ways and in different settings. The norms for resonsible conduct can vary from field to field. Add to this the growing body of local, state, and Federal regulations and you have a situation that can test the rofessional savvy of any researcher. xi

14 Researchers learn best ractices in a number of ways and in different settings. The norms for resonsible conduct can vary from field to field. The ORI Introduction to the Resonsible Conduct of Research has been written rimarily for researchers and research staff engaged in research suorted by the Public Health Service but is alicable to scholarly research in general. As an introduction, it seeks to rovide a ractical overview of the rules, regulations, and rofessional ractices that define the resonsible conduct of research. The coverage is not exhaustive and leaves room for continued reading and discussion in the laboratory and classroom, at rofessional meetings, and in any other setting where researchers gather to discuss their work. The content is organized around two ways of thinking about research. The main sections follow the normal flow of research, from a consideration of shared values to lanning, conducting, reorting, and reviewing. The chaters within the main sections cover nine core instructional areas that have been widely recognized as central to the resonsible conduct of research. An oening chater on rules of the road and a brief eilogue on resonsible research round out the coverage. Although designed to follow the normal flow of research, the chaters in this volume are all more-or-less self-contained and can be read in any order. Each oens with a short case in which students and researchers are faced with making decisions about the resonsible conduct of research. Throughout xii

15 i the chaters, imortant oints are summarized in bulleted lists ( ) or noted in the margins (see left). Each chater ends with a set of closing questions for further discussion ( 1, 2...) and resources for reference and additional reading. The Web addresses given for the resources and elsewhere in this work were current at the time of rinting. While written with all researchers in mind, secial consideration has been given to the needs of students, ostdocs, and researchers who do not have easy access to resonsible conduct of research materials or to colleagues who can exlain the intricacies of resonsible conduct in research to them. Two or three hours with this book should rovide anyone in this osition with a better understanding of the reasons for and the scoe of the most imortant resonsibilities researchers have. Many colleagues have generously rovided comments on arts or all of this work as it took shae over several drafts, including Ruth Bulger, Tony Demsey, Peggy Fischer, Carolyn Fassi, Nelson Garnett, Shirley Hicks, Erich Jensen, Mike Kalichman and his students, Nell Kriesberg, John Krueger, Tony Mazzaschi, Judy Nowack, Chris Pascal, Ken Pimle, Larry Rhoades, Fran Sanden, Mary Scheetz, Joan Schwartz, David Shore, Peggy Sundermeyer, and Carol Wigglesworth. Co-creator, artist David Zinn, atiently roduced multile versions of his drawings as we worked together to turn serious dilemmas into lighter but thought-rovoking illustrations. ORI Director, Chris Pascal, and Associate Director, Larry Rhoades, deserve credit for initiating and carrying through on this roject. If through romoting integrity and resonsible conduct in research this work hels reserve the lace of research in society today, it will have been a roject well worth undertaking. Nicholas H. Steneck Ann Arbor, MI xiii

16 Part I.

17 Shared Values

18 ORI Introduction to the Resonsible Conduct of Research Part I: Shared Values There is no one best way to undertake research, no universal method that alies to all scientific investigations. Acceted ractices for the resonsible conduct of research can and do vary from disciline to disciline and even from laboratory to laboratory. There are, however, some imortant shared values for the resonsible conduct of research that bind all researchers together, such as: 2

19 Part I: Shared Values HONESTY conveying information truthfully and honoring commitments, accuracy reorting findings recisely and taking care to avoid errors, efficiency using resources wisely and avoiding waste, and objectivity letting the facts seak for themselves and avoiding imroer bias. At the very least, resonsible research is research that is built on a commitment to these and other imortant values that define what is meant by integrity in research. The oening chaters of the ORI Introduction to RCR rovide a framework for thinking about basic values in the context of the day-to-day ractice of research. Chater 1, Rules of the Road, resents a brief overview of the different ways research resonsibilities are defined, ranging from formal regulations to informal codes and common ractices. Chater 2, Research Misconduct, describes research ractices that must be avoided and the obligation researchers have to reort misconduct. 3

20 Setting off on the road to the resonsible conduct of research

21 Chater 1: Rules of the Road Chater 1. Rules of the Road How should you conduct your research? What ractices should you follow? The ublic and their rofessional colleagues exect researchers to follow many rules and commonly acceted ractices as they go about their work advancing knowledge and utting knowledge to work. Resonsible conduct in research is conduct that meets this exectation. Society s exectations for the resonsible conduct of research are comlex and not always well defined. Becoming a resonsible researcher is not like becoming a resonsible driver. Resonsible driving is clearly defined through laws and written down in drivers manuals. Before individuals are allowed to drive, they are tested on both their knowledge of the rules of the road and their skills. Then, licensed drivers are constantly reminded of their resonsibilities by signs, traffic signals, and road markings. They also know that their behavior as drivers is monitored and that there are secific enalties for imroer behavior. Guidance for the resonsible conduct of research is not this well organized. Some resonsible ractices are defined through law and institutional olicies that must be followed. Others are set out in non-binding codes and guidelines that should be followed. Still other resonsible ractices are commonly acceted by most researchers but not written down. Instead, they are transmitted informally through mentoring, based on the understandings and values of each mentor. This situation is further comlicated by the fact that researchers are not routinely tested on their knowledge of resonsible ractices or licensed. Moreover, their behavior as researchers is inconsistently monitored and the enalties for irresonsible behavior vary considerably. Researchers do, of course, care deely about resonsible behavior in research and ay a great deal of attention to best research ractices. The fact remains, however, that it can take 5

22 ORI Introduction to the Resonsible Conduct of Research some effort to find out what these ractices are and how to act when the comlex rules for resonsible ractice seem to conflict with one another. This chater describes the four basic sources of rules of the road for the resonsible conduct of research: rofessional codes, government regulations, institutional olicies, and ersonal convictions. If you are rimarily interested in learning more about your resonsibilities rather than understanding their origin, ski ahead to the substantive chaters that follow, returning to this chater later, when it might have more relevance. Case Study Katherine, a ostdoc in Dr. Susan B. s laboratory, has just had a manuscrit acceted for ublication in a restigious research journal, conditional on a few imortant changes. Most imortantly, the editor has requested that she significantly shorten the methods section to save sace. If she makes the requested changes, other researchers may not be able to relicate her work. Asked about the situation, Dr. B. recommends that Katherine go ahead with the changes. After all, if other researchers want more information they can always get in touch. She remains concerned that an inadequate exlanation of her methods could lead other researchers to waste time and valuable research dollars attemting to relicate her work. Should Katherine make the requested changes? Should she be concerned about roviding inadequate information to colleagues? Is reducing detail in methods sections a reasonable way to go about saving valuable sace in journals? How can Katherine get definitive answers to these and other questions about the resonsible conduct of research? 1a. Professional self-regulation Prior to World War II, society rovided little ublic suort for research and did not exect much from researchers in return. Researchers were more or less left alone to run their own affairs, excet when they assumed other roles, as teachers, hysicians, or engineers. 6

23 Chater 1: Rules of the Road As rofessionals, researchers have not been articularly concerned about rules for self-regulation. Since the goal of research is to advance knowledge through critical inquiry and scientific exerimentation, it has commonly been assumed that the normal checking that goes on in testing new ideas is sufficient to kee researchers honest. Based on this assumtion, research arguably does not need secific rules for self-regulation because it is, by definition, an activity that routinely monitors itself. The lack of a erceived need for secific rules oses roblems for researchers who want guidance on resonsible research ractices. Intellectually and rofessionally researchers organize their lives around fields of study. They are biologists, chemists, and hysicists, increasingly working in secialized areas, such as biohysics, biochemistry, molecular biology, and so on. However, the societies that reresent fields of study for the most art have not develoed comrehensive guidelines for resonsible research ractices. Many do have codes of ethics, but most codes of ethics are simly general statements about ideals and do not contain the secific guidance researchers need to work resonsibly in comlex research settings. Fortunately, there are a few imortant excetions to this last generalization. Comrehensive descritions of resonsible research ractices can be found in (see the resources listed at the end of this chater for references): National Academy of Sciences, On Being a Scientist (1995) The scientific research enterrise, like other human activities, is built on a foundation of trust. Scientists trust that the results reorted by others are valid. Society trusts that the results of research reflect an honest attemt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationshi with society has contributed to a eriod of unaralleled scientific roductivity. But this trust will endure only if the scientific community devotes itself to exemlifying and transmitting the values associated with ethical scientific conduct. htt:// 7

24 ORI Introduction to the Resonsible Conduct of Research i reorts and olicy statements issued by the National Academy of Sciences, the American Association for the Advancement of Science, the Association of American Medical Colleges, and Sigma Xi; guidance on resonsible ublication ractices ublished in journals; and a few comrehensive rofessional codes. When alicable, the guidance rovided by rofessional societies is a good lace to begin learning about resonsible research ractices. American Chemical Society The Chemist s Code of Conduct (1994) Chemists Acknowledge Resonsibilities To: The Public. Chemists have a rofessional resonsibly to serve the ublic interest and welfare and to further knowledge of science. The Science of Chemistry. The Profession. The Emloyer. Emloyees. Students. Associates. Chemists should seek to advance chemical science, understand the limitations of their knowledge, and resect the truth. Chemists should remain current with develoments in their field, share ideas and information, kee accurate and comlete laboratory records, maintain integrity in all conduct and ublications, and give due credit to the contributions of others. Conflicts of interest and scientific misconduct, such as fabrication, falsification, and lagiarism, are incomatible with this Code. Chemists should romote and rotect the legitimate interests of their emloyers, erform work honestly and cometently, fulfill obligations, and safeguard rorietary information. Chemists, as emloyers, should treat subordinates with resect for their rofessionalism and concern for their well-being. Chemists should regard the tutelage of students as a trust conferred by society for the romotion of the student s learning and rofessional develoment. Chemists should treat associates with resect, regardless of the level of their formal education, encourage them, learn with them, share ideas honestly, and give credit for their contributions. htt:// 8

25 Chater 1: Rules of the Road 1b. Government regulation As ublic suort for research grew after World War II, the ublic, through its elected officials, became more interested in the way research is racticed. Over time, concerns began to surface about some of these ractices, focusing initially on the use of animals and humans in research and later on research misconduct. When it aeared that the research community was not doing enough to address these concerns, government turned to regulation. Government regulations usually begin in Congress. When a otential roblem is identified, Congress calls hearings to learn more about the roblem and then asses legislation to fix it. The regulations covering the use of humans and animals in research as well as research misconduct stem from three acts assed by Congress: the 1966 Animal Welfare Act (PL ), the 1974 National Research Act (PL ), and the 1985 Health Research Extension Act (PL ). These and other research-related acts give the Federal Government the authority to regulate the research it funds. Along with the authority to address roblems, Congress usually rovides guidance on general objectives, but it seldom drafts detailed regulations. This job falls to the Federal agencies in the Executive Branch of government, which are resonsible for carrying out the law. Federal agencies translate Congressional directives into regulations (also called rules), olicies, and guidelines. i In 1989, the Deartment of Health and Human Services (HHS) established the Office of Scientific Integrity (OSI) and the Office of Scientific Integrity Review (OSIR), in resonse to the 1985 Health Research Extension Act. The Office of Research Integrity (ORI) was established in 1992 and assumed the resonsibilities reviously assigned to 9

26 ORI Introduction to the Resonsible Conduct of Research i OSI and OSIR. In addition to resonding to misconduct, ORI undertook a number of stes to romote integrity and resonsible research ractices. The ORI Introduction to RCR is a result of that effort. Regulations. When Federal agencies translate Congressional directives into regulations, they must follow rovisions set out in the Federal Administrative Procedure Act (5 USC ). As its name imlies, this act establishes rocedures for develoing new regulations, including stes for getting ublic inut. Before establishing a new regulation, an agency must issue a draft regulation, obtain and consider ublic comment, and then issue the final regulation. Each ste must be ublished in the Federal Register the official daily ublication for rules, roosed rules, and notices of Federal agencies and organizations, as well as executive orders and other residential documents (htt:// Objections raised during the ublic comment eriod must be addressed before the final regulation is adoted. After it is adoted, the final regulation is incororated into the Code of Federal Regulations and becomes official government regulatory olicy that must be followed. Agency olicies and guidelines. Executive Branch agencies have the authority to issue some olicies as art of their normal oeration. The National Institutes of Health (NIH), for examle, has the authority to establish olicies for grant awards. From time to time, it changes these olicies to assure that its research funds are sent wisely and resonsibly. It is in this caacity that NIH issued a secial RCR Training Grant Requirement in 1989 and the more recent Required Education in the Protection of Human Research Particiants (discussed in Chater 3). Federal agencies also issue Guidelines, which recommend but do not require a articular course of action. To hel research institutions handle allegations of research 10

27 Chater 1: Rules of the Road Required Education in the Protection of Human Research Particiants June 5, 2000 (Revised August 25, 2000) National Institutes of Health Policy: Background: Beginning on October 1, 2000, the NIH will require education on the rotection of human research articiants for all investigators submitting NIH alications for grants or roosals for contracts or receiving new or non-cometing awards for research involving human subjects. To bolster the Federal commitment to the rotection of human research articiants, several new initiatives to strengthen government oversight of medical research were announced by HHS Secretary Shalala on May 30, This announcement also reminds institutions of their resonsibility to oversee their clinical investigators and institutional review boards (IRBs). One of the new initiatives addresses education and training. This NIH announcement is develoed in resonse to the Secretary s directive. htt:// html misconduct (see Chater 2), ORI issued as guidelines a Model Policy and Procedures for Resonding to Allegations of Scientific Misconduct (htt:// olicy.shtml). In this case, the model olicy is intended to rovide guidance and does not imose binding requirements on institutions. The lethora of Federal regulations, olicies, and guidelines that affect research can be confusing. They do not always seak with one voice. The same asect of a research roject can be subject to regulations by more than one Federal agency, as for examle the use of human or animal subjects. Common Federal regulations, such as the Federal Policy on Research Misconduct (discussed in Chater 2) and the Common Rule for human subjects research (discussed in Chater 3), are not truly common regulations until they have been adoted by all agencies. In addition, distinctions between regulations, olicies, requirements, guidelines, and recommended ractices can be difficult to understand. 11

28 ORI Introduction to the Resonsible Conduct of Research i Researchers are well advised to seek hel when it comes to understanding Federal and state research regulations. The Federal agencies that regulate research have comrehensive Web ages that list and exlain their olicies and regulations and readily answer questions. For local advice, your institutional research administrators may be the best lace to begin. 1c. Institutional olicies Research institutions (universities, hositals, rivate research comanies, and so on) are required by law to have olicies that cover various asects of their research rograms if they accet Federal funds. They must have committees to review human and animal research (discussed in Chaters 3 and 4). They must have rocedures for investigating and reorting research misconduct (Chater 2) and conflicts of interest (Chater 5). They must arove and manage all research budgets, ensure that laboratory safety rules are followed, and follow established ractices for the resonsible use of hazardous substances in research. They must also rovide training for researchers who use animal or human subjects in their research and for individuals suorted on NIH training grants. To hel manage their resonsibilities, most research institutions have research offices/officers and institutional research olicies. Both rovide excellent sources of guidance for resonsible conduct in research, since both are the roducts of the institution s efforts to clarify its own resonsibilities. In addition, institutional olicies are often more comrehensive than Federal and state olicies since they must encomass the full anoly of institutional resonsibilities. So, for examle, many research institutions have more comrehensive definitions of research misconduct than the Federal Government to cover other ractices that can undermine the integrity of research, such as the 12

29 Chater 1: Rules of the Road deliberate violation of research regulations, abuses of confidentiality, and even the failure to reort misconduct (discussed in Chater 2). Most also require institutional review for more human subjects research than is required by Federal regulation. Large research institutions usually have Web sites that contain some or all of the following information: coies of institutional research olicies, links to state and Federal olicies, required forms and instructions for comleting them, resonsible conduct of research training rograms, and lists of key ersonnel. There is, of course, little or no coordination across different research institutions, so the information on an institution s Web site ertains only to that institution. But if you are looking for a comrehensive set of rules of the road for resonsible research, check your home institution s research administration Web site or one from a comarable institution. i Stanford University - Research Policy Handbook Document 2.1 Title: Originally issued: Dec 8, 1971 Current version: Dec 8, 1971 Classification: Summary: Princiles Concerning Research Stanford University Policy Presents broad rinciles to guide the research enterrise and assure the integrity of scholarly inquiry at Stanford University. htt:// 13

30 ORI Introduction to the Resonsible Conduct of Research 1d. Personal resonsibility As imortant as rules of the road are for the resonsible conduct of research, they have two imortant limitations. First, rules generally set minimum standards for behavior rather than strive for the ideal. The rules say that you can drive at 65 miles er hour over a stretch of road, but there may be times or circumstances when 55 would be better. If you use human subjects in research, you must follow secific rules, but there may be situations in which you should strive for a higher standard of conduct. Resonsible research requires more than simly following rules. i Second, rules will not resolve some of the ersonal conflicts and moral dilemmas that arise in research. Journals have rules against listing undeserving authors on aers (individuals who have not made significant contributions to the research described in the aer). These same rules do not tell you what to do if the undeserving author can have a significant influence on your career. Rules also cannot relace the critical reasoning skills needed to assess ethically controversial human or animal exeriments or conflicts of interest. Researchers will face ethical dilemmas in research. They should be able to recognize these dilemmas and know how to resolve them (discussed in Chater 11). The rules of the road for research therefore need to be sulemented with good judgment and a strong sense of ersonal integrity. When meeting deadlines, you can cut corners by filling in a few missing data oints without actually running the exeriments or adding a few references to your notes that you have not read. You can resist sharing data with colleagues or leave some information on method out of a ublication to slow down the cometition. You can ignore your resonsibilities to students or a mentor in order to get your own work done. You can do all of these things and more, but should you? 14

31 Chater 1: Rules of the Road In the final analysis, whatever decision you make when you confront a difficult decision about resonsibility in research, you are the one who has to live with the consequences of that decision. If you are uncertain whether a articular course of action is resonsible, subject it to one simle test. Imagine what you are rearing to do will be reorted the next day on the front age of your local newsaer. If you are comfortable having colleagues, friends, and family know what you did, chances are you acted resonsibly, rovided, of course, you also understand your resonsibilities as a researcher, as described in the rules of the road covered in the rest of the ORI Introduction to RCR. Questions for discussion 1 Is research a rofession? 2 How do researchers learn about the resonsible conduct of research? 3 How should researchers learn about the resonsible conduct of research? 4 What factors influence researchers attitudes toward the resonsible conduct of research? 5 How is integrity in research monitored? Is self-regulation of integrity in research effective? 15

32 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Association of American Medical Colleges. Develoing a Code of Ethics in Research: A Guide for Scientific Societies, Washington, DC: AAMC, (available at: htts:// Publications/index.cfm?fuseaction=Product.dislayForm&rd_ id=28&rv_id=17&cfid=1&cftoken=28c bcc- 92A8B871AE78AE22/) Institute of Medicine. The Resonsible Conduct of Research in the Health Sciences, Washington, DC: National Academies of Science, (available at: htt:// National Academy of Sciences. Committee on the Conduct of Science. On Being a Scientist: Resonsible Conduct in Research, 2nd ed. Washington, DC: National Academy Press, (available at: htt:// National Institutes of Health. Guidelines for the Conduct of Research in the Intramural Research Programs at NIH, (available at: htt:// Sigma Xi. Honor in Science, New Haven, CN: Sigma Xi, (available at: htt:// General Information Web Sites American Association for the Advancement of Science. Integrity in Scientific Research. htt:// (Information on five videos on integrity in research.) Bird, S, Sier, R, eds. Science and Engineering Ethics, 1995 ff. htt:// 0&changeHeade/ (Includes articles on the resonsible conduct of research.) Collaborative Institutional Training Initiative (CITI), Course in the Resonsible Conduct of Research. Home Page. htts://www. National Institutes of Health. Research Conduct and Ethics Instruction Materials. htt:// ResEthicsCases/cases-toc.htm North Carolina State University. Research & Professional Ethics Program. htt:// Office of Research Integrity. Home Page. htt:// Online Ethics Center for Engineering and Science. Home Page. htt:// 16

33 Chater 1: Rules of the Road RCR Education Consortium. Home Page. htt:// Shamoo, AE, ed. Accountability in Research: Policies and Quality Assurance, 1994 ff. htt:// titles/ html (Includes articles on research integrity and related issues.) Additional Reading Barnbaum, DR, Byron, M. Research Ethics: Text and Readings, Uer Saddle River, NJ: Prentice Hall, Beach, D. The Resonsible Conduct of Research, New York: VCH Publishers, Bulger, RE, Heitman, E, Reiser, SJ. The Ethical Dimensions of the Biological and Health Sciences, 2nd ed. Cambridge, UK; New York: Cambridge University Press, Elliott, D, Stern, JE. Research Ethics: A Reader, Hanover, NH: Published by University Press of New England for the Institute for the Study of Alied and Professional Ethics at Dartmouth College, Frankel, M, Bird, S. eds. The Role of Scientific Societies in Promoting Research Integrity, Science and Engineering Ethics 9, 2 (2003). Grinnell, F. The Scientific Attitude, 2nd ed. New York: The Guilford Press, Korenman, SG, Shi, AC. Teaching the Resonsible Conduct of Research through a Case Study Aroach: A Handbook for Instructors, Washington, DC: Association of American Medical Colleges, Macrina, FL. Scientific Integrity: An Introductory Text with Cases, 2nd ed. Washington, DC: ASM Press, Penslar, RL. Research Ethics: Cases and Materials, Bloomington: Indiana University Press, Resnik, DB. The Ethics of Science : An Introduction, Philosohical Issues in Science, London; New York: Routledge, Shamoo, AE, Resnik, DB. Resonsible Conduct of Research, New York: Oxford University Press, Sigma Xi. The Resonsible Researcher: Paths and Pitfalls, Stern, JE, Elliott, D. The Ethics of Scientific Research: A Guidebook for Course Develoment, Hanover, NH: University Press of New England, Whitbeck, C. Ethics in Engineering Practice and Research, Cambridge; New York: Cambridge University Press,

34 When research misconduct becomes ublic

35 Chater 2: Research Misconduct Chater 2. Research Misconduct Public concern about misconduct in research first surfaced in the early 1980 s following reorts of cases of egregious misbehavior. One researcher reublished under his own name dozens of articles reviously ublished by others. Other researchers in one way or another falsified or fabricated research results. To make matters worse, it seemed as if research institutions sometimes ignored or deliberately covered u roblems rather than investigate them. Eventually Congress steed in and required Federal agencies and research institutions to develo research misconduct olicies. Research misconduct olicies rovide guidance on resonsible conduct in three areas. They: establish definitions for misconduct in research, outline rocedures for reorting and investigating misconduct, and rovide rotection for whistleblowers (ersons who reort misconduct) and ersons accused of misconduct. Together, the definitions of and rocedures for handling allegations of misconduct in research form an initial foundation for effective self-regulation in research. Although Federal olicies technically aly only to federally funded research, many research institutions aly Federal research misconduct olicies to all research. Many research institutions have also broadened the basic Federal definitions to include other inaroriate ractices. In combination, Federal and institutional research misconduct olicies define research ractices that researchers must avoid. Failure to do so can result in the termination of emloyment or ineligibility to receive Federal funding. 19

36 ORI Introduction to the Resonsible Conduct of Research Case Study Dr. José M. is beginning his fifth year as an indeendent researcher. His work is going well. He has ublished a number of imortant articles and secured a large grant for future work. Based on this rogress, he exects his ending romotion review to roceed without roblems. Late one afternoon a graduate student hands José two aers written by a senior colleague in his deartment. She has circled grahs in each of the aers that are clearly the same but reorted as reresenting two different exeriments. After checking the grahs carefully and reviewing the suorting data, José agrees that something is wrong. The senior colleague, who will almost certainly be a member of his romotion review, has either made a careless mistake or falsified information in a ublication. What should he do? Ask the senior colleague about the grahs? Bring the ublications to the attention of his deartment chair? Reort the roblem anonymously to a research administrator? Encourage the graduate student to reort the roblem? Nothing, at least until after the romotion review is comleted? 2a. Federal research misconduct definition and olicies After a decade of sometimes sirited debate, in December 2000 the Office of Science and Technology Policy (OSTP) in the Executive Office of the President adoted a Federal Policy on Research Misconduct. The OSTP Policy is in most resects similar to earlier ones adoted by the Public Health Service (PHS) and the National Science Foundation (NSF), but it did recommend some significant changes to the definition of research misconduct. When it is finally imlemented by all government research agencies (the target date of December 2001 was not met), all federally funded researchers will be subject to a uniform definition of research misconduct. Definition. The OSTP Policy defines research misconduct as fabrication, falsification, or lagiarism in roosing, erforming, or reviewing research, or in reorting research results (see accomanying box for details). It also sets the legal threshold for roving charges of misconduct. 20

37 Chater 2: Research Misconduct To be considered research misconduct, actions must: reresent a significant dearture from acceted ractices ; have been committed intentionally, or knowingly, or recklessly ; and be roven by a reonderance of evidence. These further stiulations limit the Federal Government s role in research misconduct (fabrication, falsification, or lagiarism) to well-documented, serious deartures from acceted research ractices. When using the common Federal definition to discuss research misconduct, it is imortant to understand that it establishes a minimum standard for measuring accetable behavior, not a standard for judging all research behavior. In articular, it does not imly that all other behaviors are accetable. It also does not encomass criminal behavior, ersonal disutes, violations of grant management olicies or other unaccetable behaviors not unique to research, such as discrimination or harrassment. The government s main concern in establishing this definition is to assure that ublicly funded research is accurate and aroriately reresented by clearly stating that three ractices, commonly referred to as FFP, are wrong. i Federal Research Misconduct Policy. I. Research Misconduct Defined. Research misconduct is defined as fabrication, falsification, or lagiarism in roosing, erforming, or reviewing research, or in reorting research results. Fabrication is making u data or results and recording or reorting them. Falsification is maniulating research materials, equiment, or rocesses, or changing or omitting data or results such that the research is not accurately reresented in the research record. Plagiarism is the aroriation of another erson s ideas, rocesses, results, or words without giving aroriate credit. Research misconduct does not include differences of oinion. htt:// 21

38 ORI Introduction to the Resonsible Conduct of Research i Reorting and investigation. Federal misconduct olicy assumes that researchers and research institutions bear the rimary resonsibility for reorting and investigating allegations of misconduct. This assumtion is consistent with the osition, strongly suorted by most researchers, that research is a rofession and should regulate its own conduct (see Chater 1). Successful rofessional self-regulation deends on conscientious community articiation. For individual researchers, this means they must assume resonsibility for their own actions, take misconduct seriously, and reort aarent misconduct by other researchers. Every institution that receives PHS funding must have rocedures in lace for receiving and investigating reorts of research misconduct. These rocedures must include: the designation of individuals who are authorized to receive and investigate allegations of misconduct, rovisions for an initial inquiry to determine whether the allegations have any merit, rovisions for a formal investigation to reach conclusions about the truth of the allegations, the designation of an individual who is authorized to weigh (adjudicate) the conclusions reached in the investigation and imose administrative actions to redress the misconduct (sanctions) or take stes to vindicate the erson charged, and rovisions for reorting findings to ORI. Researchers should be familiar with these rocedures and their institution s definition of research misconduct (discussed below). Basic rotections. Researchers who commit misconduct lace their careers at risk. The Federal Government can debar researchers who commit misconduct from receiving Federal funds for a secified eriod of time. In most 22

39 Chater 2: Research Misconduct instances, research institutions also take their own actions, such as terminating a researcher s emloyment or requiring suervision of future research activities. By like token, making allegations of misconduct blowing the whistle can sometimes lace a whistleblower s career at risk. Although by law institutions must not retaliate against whistleblowers who reort in good faith, they sometimes do. The new common Federal olicy rovides guidelines for rotecting both arties the whistleblower and the resondent in research misconduct investigations. As a general rule, research misconduct allegations must not be made ublic until they have been fully investigated and confirmed. There are, however, excetions to this rule. If the misconduct could ose a threat to ublic health or safety, such as misconduct in a clinical trial, it must immediately be brought to the attention of the erson heading the trial, the erson with oversight authority, or both. ORI and the Federal sonsor must also be notified immediately. In such cases, the names of the ersons charged should remain confidential, but stes must be taken to safeguard the subjects in the trial. Similarly, research institutions and researchers must not in any way enalize or take action against individuals who reort research misconduct in good faith. Even if accusations are not sustained, as long as they are brought in good faith, informants must be rotected and given suort since they lay a vital role in rofessional self-regulation. 2b. Institutional research misconduct olicies Institutional research misconduct olicies generally follow the attern recommended by the Federal Government, but almost always include some additional elements that for one reason or another are assumed to have local imortance. This is articularly true for the definition of research misconduct. Institutional definitions must include some 23

40 ORI Introduction to the Resonsible Conduct of Research University Research Misconduct Policies Rice University. Research misconduct may include the fabrication/ falsification of data, lagiarism, or other ractices that seriously deviate from those that are commonly acceted within the scientific community for roosing, conducting, reviewing, or reorting research. It also encomasses the failure to comly with federal requirements for rotecting researchers, human and animal subjects, and the ublic. In general, gross negligence of research standards and any action taken with the intent to defraud are considered forms of research misconduct. It does not, however, include honest error or honest differences in interreting or judging data. htt:// University of New Mexico. A researcher commits research misconduct under UNM s olicy if he or she fabricates or falsifies data or research results or lagiarizes another erson s ideas or work. Research misconduct also occurs if a researcher wantonly disregards truth or objectivity or fails to comly or attemt to comly with legal requirements governing the research; however, other University olicies and rocedures will be followed in resolving such cases. It is imortant to understand that research misconduct is not a mistake in reasoning, disagreeing with recognized authorities, misinterreting results, an error in lanning or carrying out an exeriment, or an oversight in attribution. htt:// version of FFP, but then sometimes add other ractices that also constitute misconduct in the articular local setting. Thus, deending on where a researcher works, any of the following ractices could be reorted as misconduct in research. Violation of Federal rules. As will be discussed in later chaters, research is subject to many rules or regulations other than research misconduct olicies. Although the violation of a research rule or regulation is not considered misconduct under the common Federal definition of research misconduct, many research institutions exlicitly state that the violation of any research regulation is research misconduct. Abuse of confidentiality. Confidentiality lays a number of imortant roles in research. Most eer review is done confidentially (see Chater 10). Researchers also share ideas 24

41 Chater 2: Research Misconduct with colleagues with the understanding that they will not be used or made ublic without ermission (see Chater 8). Federal regulations, such as the Health Insurance Portability and Accountability Act of 1996 (see Chater 3), imose confidentiality requirements on human subjects research. The abuse of confidentiality may not undermine the validity of research data, but it can undermine the integrity of the research rocess. Therefore, some institutions include such abuses under their definition of research misconduct. Authorshi and ublication violations. As will be discussed in Chater 9, there are well-established guidelines for getting credit for work done (authorshi) and making research results known (ublication). Some violations of these guidelines do not rise to the level of FFP, as defined in Federal olicy. For examle, the Federal Government usually does not get involved in disutes over authorshi or investigate charges of trivial ublication (dividing the results of a single exeriment into multile ublications so that there are more to list on a résumé). However, given the imortance of the integrity of the research record, some research institutions include authorshi and ublication violations in their misconduct olicies. Failure to reort misconduct. Failure to reort many crimes can be considered a crime and result in enalties. This is articularly true if failure to reort a crime uts other individuals or society at risk. Research misconduct can ut individuals at risk, if, for examle, the misconduct affects information that is used for making medical or ublic decisions. Failure to reort research misconduct also undermines rofessional self-regulation. Therefore, some research institutions include failure to reort misconduct in their research misconduct olicies. Obstruction of investigations and retaliation. To emhasize the imortance of research misconduct investigations, some institutions also include obstruction 25

42 ORI Introduction to the Resonsible Conduct of Research i of investigations and retaliation against whistleblowers under research misconduct. Other ractices. Early in the evolution of Federal research misconduct olicies, the National Science Foundation (NSF) and the Public Health Service (PHS) included a broad rovision in their definitions to catch other ractices that seriously deviate from commonly acceted ractices. NSF in articular felt that FFP left out behaviors that could undermine the integrity of the research it funded. While the serious deviations clause no longer exists in the common Federal definition, excet as a standard for judging FFP, it can still be found in some institutional olicies. Researchers therefore need to be aware of the fact that in some settings, actions that seriously deviate from commonly acceted ractices can be considered research misconduct. 2c. Putting research misconduct into ersective Research misconduct has understandably received considerable ublic attention. Researchers who act dishonestly waste ublic funds, harm the research record, distort the research rocess, undermine ublic trust, and can even adversely imact ublic health and safety. Research misconduct olicies, whether Federal, state, institutional, or rofessional, identify seriously inaroriate behaviors and establish rocedures for dealing with them. Judged on the basis of the number of confirmed cases, misconduct aarently is not common in research. Over the last decade, PHS and NSF combined have averaged no more than 20 to 30 misconduct findings a year. This uts the annual rate of misconduct in research at or below 1 case for every 10,000 researchers. However, before making too much of this assessment, two imortant cautions need to be ket in mind. First, the number of confirmed cases is robably less than the number of actual cases. Underreorting is to be 26

43 Chater 2: Research Misconduct exected, as it is in criminal and other tyes of inaroriate behavior. Moreover, several studies have suggested that researchers do not reort susected misconduct, even though they should (see Korenman, Additional Reading). Since every case of misconduct can otentially undermine ublic suort for research, researchers should take their resonsibility to look out for and reort research misconduct seriously. Second, the resonsibility to avoid misconduct in research is a minimum standard for the resonsible conduct of research, so the fact that most researchers do not engage in research misconduct does not necessarily imly that the level of integrity in research overall is high. Resonsible research requires careful attention to many other exectations for aroriate ractice, as discussed in the remainder of the ORI Introduction to RCR. Questions for discussion 1 Should other ractices besides fabrication, falsification, and lagiarism be considered misconduct in research? 2 Is it fair to use significant dearture from acceted ractices to make judgments about a researcher s behavior? 3 Should researchers reort misconduct if they are concerned that doing so could adversely imact their career? 4 What evidence is needed to demonstrate that a researcher committed misconduct intentionally, or knowingly, or recklessly? 5 What are aroriate enalties for different tyes of misconduct? 27

44 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Deartment of Health and Human Services. Commission on Research Integrity. Integrity and Misconduct in Research, Washington, DC: Health and Human Services, (available at: htt://ori.hhs. gov/documents/reort_commission.df) Deartment of Health and Human Services. Public Health Service Policies on Research Misconduct; Final Rule, 42 CFR Parts 50 and 93, (2005). (available at: htt:// shtml) National Academy of Science. Committee on Science Engineering and Public Policy. Panel on Scientific Resonsibility and the Conduct of Research. Resonsible Science: Ensuring the Integrity of the Research Process, Washington, DC: National Academy Press, Office of the President. Office of Science and Technology Policy. Federal Policy on Research Misconduct, Federal Register 65 (6 December 2000): (available at: htt:// olicies/fed_research_misconduct.shtml) Office of Research Integrity, ORI Model Policy and Procedures for Resonding to Allegations of Scientific Misconduct, 1995, revised (available at: htt:// National Science Foundation. Research Misconduct, 45 CFR 689 (2002). (available at: htt:// United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight. Fraud in Biomedical Research, Washington, DC: GPO, Wells, FO, Lock, S, Farthing, MJG. Fraud and Misconduct in Biomedical Research, London: BMJ Books, General Information Web Sites National Science Foundation, Office of Insector General. Home Page. htt:// Office of Research Integrity. Handling Misconduct. htt://ori.hhs. gov/misconduct/ 28

45 Chater 2: Research Misconduct Additional Reading Braxton, JM, Bayer, AE. Percetions of Research Misconduct and an Analysis of their Correlates. In Persectives on Scholarly Misconduct in the Sciences, edited by John M. Braxton, Columbus, OH: Ohio State University Press, 1999, Korenman, SG, Berk, R, Wenger, NS, Lew, V. Evaluation of the Research Norms of Scientists and Administrators Resonsible for Academic Research Integrity, Journal of the American Medical Association 279, 1 (1998): Parrish, DM. Scientific Misconduct and Correcting the Scientific Literature, Academic Medicine 74, 3 (1999): Pascal, CB. Scientific Misconduct and Research Integrity for the Bench Scientist, Proceedings of the Society for Exerimental Biology and Medicine 224, 4 (2000): Price, AR. Anonymity and Pseudonymity in Whistleblowing to the U.S. Office of Research Integrity, Academic Medicine 73, 5 (1998): Rhoades, LR. The American Exerience: Lessons Learned, Science and Engineering Ethics 6,1 (2000): School of Education. University of Indiana. Understanding Plagiarism, (available at: htt://education.indiana. edu/~frick/lagiarism) United States. President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Whistleblowing in Biomedical Research: Policies and Procedures for Resonding to Reorts of Misconduct: Proceedings of a Worksho, Setember 21-22, 1981, Washington, DC: GPO,

46 Part II.

47 Planning Research

48 ORI Introduction to the Resonsible Conduct of Research Part II: Planning Research Research begins with ideas, questions and hyotheses. What causes this articular henomenon? What would haen if? How can I find out? Researchers think first about roblems and ways to solve them and about the resources they will need to erform exeriments. 32

49 Part II: Planning Research Planning for any roject should include the consideration of resonsibilities. In some cases, work cannot begin until it has been aroved. In other cases, confronting otential roblems before they arise can hel ensure that they do not turn into real roblems later. The chaters in this section cover three areas where aroriate lanning and aroval are essential: Chater 3, The Protection of Human Subjects, describes the regulations covering the use of humans in research. Chater 4, The Welfare of Laboratory Animals, describes similar regulations for animals used in research. Chater 5, Conflicts of Interest, discusses what researchers should do when their interests are or aear to be in conflict. Planning is essential in other areas as well. Resonsible research administration, the safe use of hazardous materials, and the fair treatment of students and emloyees should be addressed early in any roject. However, with the use of humans and animals and, increasingly, the otential influence of conflicting interests, there is no choice. These resonsibilities must be fully addressed before the first subject is contacted, the first animal urchased, or any agreement signed. 33

50 Designing a resonsible informed consent form

51 Chater 3: The Protection of Human Subjects Chater 3. The Protection of Human Subjects The use of human subjects in research benefits society in many ways, from contributing to the develoment of new drugs and medical rocedures to understanding how we think and act. It also can and has imosed unaccetable risks on research subjects. To hel ensure that the risks do not outweigh the benefits, human subjects research is carefully regulated by society. Case Study Two weeks into the new semester, the rofessor in Mary s course on family health gives the class a secial assignment that was not on the course syllabus. Over the next week, everyone in the class is to talk with three classmates who are not in the course about the way their families deal with medical emergencies and chronic illness. Next week they should come to class reared to reort on their interviews. The Professor warns them, however, that in talking about their conversations they should not mention any names to rotect the rivacy of their classmates. The assignment makes Mary uneasy. In her basic sychology course last semester she learned about some of the rules ertaining to the use of human subjects in research. However, when she raises her concerns with her rofessor, he assures her that her informal conversations with classmates are not research and therefore not subject to regulation. Moreover, since she will not be mentioning any names, there are no rivacy issues to worry about. Should Mary be content with these assurances and conduct the interviews? If she still has concerns, where should she turn for advice? Did the rofessor act roerly in giving this assignment to the class? Investigators who conduct research involving humans that is subject to regulation must comly with all relevant Federal regulations as well as any alicable state and local laws, regulations, and olicies related to the rotection of human subjects. They are also exected to follow other relevant codes that have been formulated by rofessional grous. To meet these resonsibilities requires, among other things: knowing what research is subject to regulation, understanding and following the rules for roject aroval, 35

52 ORI Introduction to the Resonsible Conduct of Research i getting aroriate training, and acceting continuing resonsibility for comliance through all stages of a roject. If you exect to use or study living humans in your research, no matter how harmless that use may seem, and receive Federal funding, familiarize yourself with your resonsibilities and check with someone in a osition of authority before making any contacts or undertaking any work. 3a. Federal regulations Society rotects the welfare of individuals in many ways, but it did not secifically address the issue of the welfare of research subjects until after World War II. Following the War, widesread concerns about atrocities committed during the War in the name of research led to the formulation of a code for human subjects research known as the Nuremberg Code (1947). Although not binding on researchers, the Nuremberg Code and the later Declaration of Helsinki (1964; latest revision and clarification, 2002) rovided the first exlicit international guidelines for the ethical treatment of human subjects in research. The Nuremberg Code and Declaration of Helsinki did not ut an end to unethical human subjects research. During the Cold War, U.S. researchers tested the effects of radiation on hosital atients, children, and soldiers without obtaining informed consent or ermission to do so. Through the 1950 s and 1960 s, well after antibiotics effective for the treatment of syhilis were discovered, scores of African-American males in a long-term syhilis study (conducted by the U.S. Public Health Service in Tuskegee, Alabama) were not offered treatment with the new drugs so that researchers could continue to track the course of the disease. These and other questionable ractices raised serious ublic concern and led eventually to government regulation. 36

53 Chater 3: The Protection of Human Subjects Excerts, Nuremberg Code (1947) 1. The voluntary consent of the human subject is absolutely essential. 2. The exeriment should be such as to yield fruitful results for the good of society. 3. The exeriment should be so designed and based on the results of animal exerimentation and a knowledge of the natural history of the disease. 4. The exeriment should be so conducted as to avoid all unnecessary hysical and mental suffering and injury. 5. No exeriment should be conducted where there is an a riori reason to believe that death or disabling injury will occur. 6. The degree of risk to be taken should never exceed that determined by the humanitarian imortance of the roblem to be solved by the exeriment. 7. Proer rearations should be made and adequate facilities rovided to rotect the exerimental subject against even remote ossibilities of injury, disability, or death. 8. The exeriment should be conducted only by scientifically qualified ersons. 9. During the course of the exeriment the human subject should be at liberty to bring the exeriment to an end. 10. During the course of the exeriment the scientist in charge must be reared to terminate the exeriment at any stage, if he has robable cause to believe, in the exercise of the good faith, suerior skill and careful judgment required of him that a continuation of the exeriment is likely to result in injury, disability, or death to the exerimental subject. htt:// To revent these and similar abuses from continuing, in 1974 Congress required the Deartment of Health, Education and Welfare (HEW, currently Health and Human Services HHS) to clarify its rules for the use of human subjects in research. With this mandate in hand, HEW codified its rocedures under Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46). (At roughly the same time, the FDA codified its rules for human subjects research under 21 CFR 50 and 56.) Congress also called in 1974 for the creation of a National Commission for the Protection of Human Subjects of 37

54 ORI Introduction to the Resonsible Conduct of Research i Biomedical and Behavioral Research. During the 4 years it met, the Commission issued a number of reorts on the rotection of research subjects and recommended rinciles for judging the ethics of human subjects research (discussed below). In 1991 most Federal deartments and agencies that conduct or suort human subjects research adoted a common set of regulations for the rotection of human subjects referred to as the Common Rule (45 CFR 46, Subart A). Additional requirements on three sensitive research areas are also included in 45 CFR 46: Subart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research. Subart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. Subart D Additional Protections for Children Involved as Subjects in Research. Together, 45 CFR 46, Subarts A-D, rovide a comrehensive articulation of society s exectations for the resonsible use of human subjects in research. i Authority for enforcing the HHS regulations for the rotection of human subjects who articiate in research conducted or suorted by HHS now rests with the Office for Human Research Protections (OHRP) in the Office of Public Health and Science (OPHS). If you have secific questions about the Federal requirements for the rotection of human subjects, contact your local institutional officials, OHRP (for research conducted or suorted by HHS), or aroriate officials at the deartment or agency conducting or suorting the research. 38

55 Chater 3: The Protection of Human Subjects 3b. Definitions Researchers are resonsible for obtaining aroriate aroval before conducting research involving human subjects. The need for aroval rests on three seemingly obvious but not always easy-to-interret considerations: 1) whether the work qualifies as research, 2) whether it involves human subjects, and 3) whether it is exemt. All three considerations are discussed in the Common Rule and guide decisionmaking about the use of human subjects in research. The authority to make decisions about the need for aroval rests with the Institutional Review Board (IRB, discussed below) or other aroriate institutional officials. Research. The Common Rule defines research as systematic investigation, including research develoment, testing and evaluation, designed to develo or contribute to generalizable knowledge ( (d), see box, next age, for full definition). This means that a roject or study is research if it: is conducted with the intention of drawing conclusions that have some general alicability and uses a commonly acceted scientific method. The random collection of information about individuals that has no general alicability is not research. Scientific investigation that leads to generalizable knowledge is. Human subjects. Human subjects are living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable rivate information ( (f), see box, next age, for full definition). Humans are considered subjects and covered by Federal regulations if the researcher: interacts or intervenes directly with them, or collects identifiable rivate information. 39

56 ORI Introduction to the Resonsible Conduct of Research 45 CFR Protection of Human Subjects Definitions (d) Research means a systematic investigation, including research develoment, testing and evaluation, designed to develo or contribute to generalizable knowledge. Activities which meet this definition constitute research for uroses of this olicy, whether or not they are conducted or suorted under a rogram which is considered research for other uroses. For examle, some demonstration and service rograms may include research activities (f) Human subject means a living individual about whom an investigator (whether rofessional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable rivate information. Intervention includes both hysical rocedures by which data are gathered (for examle, veniuncture) and maniulations of the subject or the subject s environment that are erformed for research uroses. Interaction includes communication or interersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably exect that no observation or recording is taking lace, and information which has been rovided for secific uroses by an individual and which the individual can reasonably exect will not be made ublic (for examle, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. htt:// i If one of these two conditions alies and if the roject or study qualifies as research, then institutional aroval is needed before any work is undertaken. Exemt research. Some studies that involve humans may be exemt from the requirements in the Federal regulations. Studies that fall into the following categories could qualify for exemtions, including: research conducted in established or commonly acceted educational settings; research involving the use of educational tests; 40

57 Chater 3: The Protection of Human Subjects research involving the collection or study of existing data, documents, records, athological secimens, or diagnostic secimens, if unidentifiable or ublicly available; research and demonstration rojects which are conducted by or subject to the aroval of deartment or agency heads; or taste and food quality evaluation and consumer accetance studies. It is critically imortant to note, however, that decisions about whether studies are exemt from the requirements of the Common Rule must be made by an IRB or an aroriate institutional official and not by the investigator. i 3c. IRB membershi and deliberations Federally funded research that uses human subjects must be reviewed and aroved by an indeendent committee called an Institutional Review Board or IRB. The IRB rovides an oortunity and lace for individuals with different backgrounds to discuss and make judgments about the accetability of rojects, based on criteria set out in the Common Rule. Under the Common Rule, IRBs must have at least five members and include at least one scientist, one nonscientist, and one member who is not otherwise affiliated with the institution and who is not art of the immediate family of a erson who is affiliated with the institution ( (d)). IRBs have authority to arove, require modification of (in order to secure aroval), and disarove all research activities covered by the Common Rule. They also are resonsible for conducting continuing review of research at least once er year and for ensuring that roosed changes in aroved research are not initiated 41

58 ORI Introduction to the Resonsible Conduct of Research without IRB review and aroval, excet when necessary to eliminate aarent immediate hazards to the subject. IRBs weigh many factors before aroving roosals. Their main concern is to determine whether ( (a)): risks to subjects are minimized; risks to subjects are reasonable in relation to anticiated benefits, if any, to subjects, and the imortance of the knowledge that may reasonably be exected to result; selection of subjects is equitable; informed consent will be sought from each rosective subject or the subject s legally authorized reresentative; informed consent will be aroriately documented; when aroriate, the research lan makes adequate rovision for monitoring the data collected to ensure the safety of subjects; and when aroriate, there are adequate rovisions to rotect the rivacy of subjects and to maintain the confidentiality of data. Researchers should consider each of these issues before comleting their research lan and submitting it to an IRB for aroval. Making decisions about whether human subjects will be treated fairly and aroriately or given adequate information requires judgments about right and wrong (moral judgments). In the 1979 Belmont Reort, the National Commission recommended three rinciles for making these judgments: resect for ersons and their right to make decisions for and about themselves without undue influence or coercion from someone else (the researcher in most cases); beneficence or the obligation to maximize benefits and reduce risks to the subject; and 42

59 Chater 3: The Protection of Human Subjects The Belmont Reort (1979) Ethical Princiles and Guidelines for the Protection of Human Subjects of Research SUMMARY: On July 12, 1974, the National Research Act (Pub. L ) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical rinciles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develo guidelines which should be followed to assure that such research is conducted in accordance with those rinciles. htt:// justice or the obligation to distribute benefits and risks equally without rejudice to articular individuals or grous, such as the mentally disadvantaged or members of a articular race or gender. While this list does not exhaust the rinciles that can be used for judging the ethics of human subjects research, it has nonetheless been acceted as a common standard for most IRB deliberations. Knowing this, researchers should send time considering whether their work does rovide adequate resect for ersons, aroriately balances risks and benefits, and is just. i 3d. Training To hel assure that researchers understand their resonsibilities to research subjects, the National Institutes of Health (NIH) currently requires education on the rotection of human research articiants for all investigators submitting NIH alications for grants or roosals for contracts or receiving new or non-cometing awards for research involving human subjects. (htt:// guide/notice-files/not-od html) 43

60 ORI Introduction to the Resonsible Conduct of Research Many institutions, including NIH, rovide this training through secial Web-based rograms that summarize essential information and in some cases require some evidence of mastery. A descrition of the education rogram and who was trained must be included in alications for grants and contracts before they will be considered. 3e. Continuing resonsibility Once a roject has been aroved by an IRB, researchers must adhere to the aroved rotocol and follow any additional IRB instructions. This, unfortunately, is where a few researchers and institutions have occasionally run into roblems and temorarily had their assurance (FWA - Federalwide Assurance) susended. The continuing resonsibilities that researchers have include: enrolling only those subjects that meet IRB aroved inclusion and exclusion criteria, Federalwide Assurance (FWA) The Federal Policy (Common Rule) for the rotection of human subjects at Section 103(a) requires that each institution engaged in Federally suorted human subject research file an Assurance of rotection for human subjects. The Assurance formalizes the institution s commitment to rotect human subjects. The requirement to file an Assurance includes both awardee and collaborating erformance site institutions. Under the Federal Policy (Common Rule) at Section 102(f) awardees and their collaborating institutions become engaged in human subject research whenever their emloyees or agents (i) intervene or interact with living individuals for research uroses; or (ii) obtain, release, or access individually identifiable rivate information for research uroses. In addition, awardee institutions are automatically considered to be engaged in human subject research whenever they receive a direct HHS award to suort such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears ultimate resonsibility for rotecting human subjects under the award. The awardee is also resonsible for ensuring that all collaborating institutions engaged in the research hold an OHRP aroved Assurance rior to their initiation of the research. htt:// 44

61 Chater 3: The Protection of Human Subjects roerly obtaining and documenting informed consent, obtaining rior aroval for any deviation from the aroved rotocol, keeing accurate records, and romtly reorting to the IRB any unanticiated roblems involving risks to subjects or others. While research institutions are increasingly monitoring the rogress of human subjects research, the rimary resonsibility for conducting exeriments as aroved still lies with the individual researchers and staff who conduct the exeriments. i 3f. Ethical issues Desite the many rules governing research with humans, tough choices continually arise that have no easy answers. Informed consent. It is widely agreed that research subjects should be fully informed about exeriments in which they may articiate and give their consent before they enroll. However, some subjects, such as children, some adults with imaired decisionmaking caacity, and some critically ill atients, cannot give informed consent, either because they are not old enough to understand the information being conveyed or because they have lost their ability to understand. These and other roblems could be eliminated by forbidding researchers to do studies that raise difficult questions about resect for ersons, beneficence, and justice, but this would make it difficult or even imossible to get some crucial information needed to make informed decisions about medicine and ublic health. Since children do not resond to medicines in the same way as adults, it is imortant to include children in some clinical trials. However, it is not easy to decide when they should be included and how consent can/should be obtained. 45

62 ORI Introduction to the Resonsible Conduct of Research i Right to withdraw. It is widely agreed that research subjects should have the right to withdraw from exeriments at any time, but in some cases they cannot. In the final stages of develoment, mechanical hearts are tested on atients whose own heart is about to fail. But if it has not failed, and once the mechanical heart relaces the weakened heart, there is no turning back. The atient can technically withdraw from the exeriment and undergo no further testing, but he or she cannot withdraw from the conditions imosed by the exeriment, no matter how distressing living with the mechanical heart might be. Knowing this, under what conditions should these exeriments be allowed? Risk without benefit. In one recent exeriment, researchers wanted to test whether a common surgical rocedure used to relieve arthritis ain had any benefits. To gather information about benefits they designed a clinical trial in which subjects in the control grou received sham surgery. An oeration was erformed, but the common surgical rocedure was not erformed. The researchers in this case comlied with all regulations, which included thorough IRB review. None of the atients exerienced any adverse effects, and the study concluded that the common surgical rocedure did not rovide significant benefits. However, since surgery always involves some risk, the subjects in the control grou were laced at risk without any exectation that they would benefit. Should this be allowed, and if so, under what circumstances? These and other questions must ultimately be answered by IRBs during the review rocess. Researchers who serve on IRBs need additional training to hel them deal with the growing comlexities of biomedical, social, and behavioral research. Researchers who use human subjects in research should seriously consider having some formal training in bioethics so that they can articiate in the critical reasoning rocess needed to resond to the comlex moral issues raised by the use of human subjects in research. 46

63 Chater 3: The Protection of Human Subjects Questions for discussion 1 Why should some research on humans be exemted from regulation? 2 What other criteria could be used to identify necessary members for IRBs? 3 What should subjects know about roosed research and their rotection before they enroll as subjects? 4 What other rinciles could be used for evaluating the ethics of human subjects research besides resect for ersons, beneficence, and justice? 5 Should subjects be allowed to enroll in exeriments that either romise no direct benefit to them or cannot rovide them with the oortunity to withdraw comletely? 47

64 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Directives for Human Exerimentation: Nuremberg Code (available at: htt:// Federal Policy for the Protection of Human Subjects, 45 CFR 46, Subart A (2005). (available at: htt:// humansubjects/guidance/45cfr46.htm) National Institutes of Health. Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health, (available at: htt:// guidelines/graybook.html). Required Education in the Protection of Human Research Particiants, National Institutes of Health, (available at: htt:// html) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Reort: Ethical Princiles and Guidelines for the Protection of Human Subjects of Research, Washington, DC: DHHS, (available at: htt:// World Medical Association. Declaration of Helsinki: Ethical Princiles for Medical Research Involving Human Subjects, Helsinki, Finland: World Medical Association, 1964, (available at: htt:// General Information Web Sites Food and Drug Administration. Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators, htt:// National Institutes of Health. Standards for Clinical Research within the NIH Intramural Research Program, htt:// gov/ccc/clinicalresearch/index.html National Institutes of Health. Bioethics Resources on the Web, htt:// OHSR Infosheets/Forms, nd. htt:// html National Institutes of Health, Office of Human Subjects Research. Home Page. htt:// Office for Human Research Protections, HHS. Home Page. htt:// 48

65 Chater 3: The Protection of Human Subjects Additional Reading Eckstein, S, King s College (University of London). Centre of Medical Law and Ethics. Manual for Research Ethics Committees, 6th ed. Cambridge, UK; New York: Cambridge University Press, Federman, DD, Hanna, KE, Rodriguez, LL. Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Particiants. Resonsible Research: A Systems Aroach to Protecting Research Particiants, Washington, D.C.: National Academies Press, Gallin, JI. Princiles and Practice of Clinical Research, San Diego, CA: Academic Press, Jensen, E. Not Just Another GCP Handbook: A Practical Guide to FDA/DHHS Requirements, New York, NY: PJB Publications Ltd., (available at: htt:// &reortid=626) Loue, S. Textbook of Research Ethics: Theory and Practice, New York, N.Y.: Kluwer Academic/Plenum Pub. Cor., Penslar, RL, National Institutes of Health (U.S.). Office for Protection from Research Risks. Protecting Human Research Subjects: Institutional Review Board Guidebook, 2nd ed. Bethesda, MD; Washington, DC: GPO, Shamoo, AE, Khin-Maung-Gyi, FA. Ethics of the Use of Human Subjects in Research: Practical Guide, London; New York: Garland Science,

66 How do researchers decide which animals are used in research?

67 Chater 4: The Welfare of Laboratory Animals 4. The Welfare of Laboratory Animals Animal research is as carefully regulated as human research, but for different reasons. With humans, regulation stems from the need to assure that the benefits all humans gain from human research do not imose unaccetable burdens on some research articiants. Animals may benefit from the information gained through animal exerimentation and some research with animals is conducted secifically for the urose of imroving animal health (veterinary medicine and animal husbandry research). But most animal research is conducted rimarily for the benefit of humans, not animals. Moreover, unlike humans, animals cannot consent to articiate in exeriments or comment on their treatment, creating secial needs that should be taken into consideration in their care and use. The secial needs of animals have evolved over time into olicies for the aroriate care and use of all animals Case Study After many years using fish and frogs to study brain function, Dr. Ruth Q. encountered some roblems that can be exlored only using new animal models. For the near future, she lans to turn to mice or rats, but eventually may have to do some research using cats or dogs. To hel reare the way for this new research, she decides to ut a note about her lans in the rogress reort for her current research grant, which runs out next year. The day after she gave a draft of the rogress reort to her long-time research assistant, he came to her with a troubled look on his face. Although he never told her, the main reason he alied for the job in her laboratory many years ago was the fact that she did not use warm-blooded animals in her research. If she changed her animal models as lanned, he would have to quit his job and had no rosects for getting another osition that aid as well and was as rewarding. Does Dr. Q. have any obligation to consider her research assistant's views before she redirects his research? Why are objections raised to the use of some animals in research and how can those objections be answered? Why are there more objections to using some animals in research comared to others? 51

68 ORI Introduction to the Resonsible Conduct of Research i involved in research, research training, and biological testing activities. Researchers can meet their resonsibilities by: knowing what activities are subject to regulation, understanding and following the rules for roject aroval, obtaining aroriate training, and acceting continuing resonsibility for comliance through all stages of a roject. If you exect to use or study living animals in your research, regardless of the level of invasiveness, familiarize yourself with your resonsibilities and check with someone in a osition of authority before making any lans or undertaking any work. 4a. Rules, olicies, and guidelines The current rules, olicies, and rofessional guidelines for the resonsible use of animals in research are the roduct of roughly 50 years of ongoing discussion between government, the ublic, animal care rofessionals, and Animal Welfare Act as Amended (7 USC, ) Section 1. (a) This Act may be cited as the Animal Welfare Act. (b) The Congress finds that animals and activities which are regulated under this Act are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and that regulation of animals and activities as rovided in this Act is necessary to revent and eliminate burdens uon such commerce and to effectively regulate such commerce, in order (1) to insure that animals intended for use in research facilities or for exhibition uroses or for use as ets are rovided humane care and treatment; (2) to assure the humane treatment of animals during transortation in commerce; and (3) to rotect the owners of animals from the theft of their animals by reventing the sale or use of animals which have been stolen. htt:// 52

69 Chater 4: The Welfare of Laboratory Animals PHS Policy on Humane Care and Use of Laboratory Animals (Amended, August 2002) II. Alicability This Policy is alicable to all PHS-conducted or suorted activities involving animals, whether the activities are erformed at a PHS agency, an awardee institution, or any other institution and conducted in the United States, the Commonwealth of Puerto Rico, or any territory or ossession of the United States. htt:// researchers. The conclusions reached through these discussions are laid out in two key sources of information for researchers who use animals in their work: Federal regulations and rofessional guidelines. Federal regulations. Over the last 50 years, Congress has addressed the resonsible use of animals in research on a number of occasions and drafted two imortant statutes: the 1966 Animal Welfare Act (revised 1970, 1976, 1985, and 1990) and the 1985 Health Research Extension Act, Sec The former broadly assigns authority for the resonsible transortation, care, and use of animals to the United States Deartment of Agriculture (USDA), as imlemented by Title 9 of the Code of Federal Regulations. It covers animals used in research facilities or for exhibition uroses or for use as ets. The latter law delegates authority for the resonsible use of animals in biomedical and behavioral research to the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH) and the Office of Laboratory Animal Welfare (OLAW), NIH. Researchers who use animals in research, including observational research, or teaching, can come under the jurisdiction of the USDA animal welfare regulations and/or i 53

70 ORI Introduction to the Resonsible Conduct of Research the PHS Policy on Humane Care and Use of Laboratory Animals (hereafter, PHS Policy), which carries out the rovisions of the 1985 Health Research Extension Act. They therefore should be familiar with both. Guidelines. In the late 1950 s, a grou of animal-care rofessionals formed the Animal Care Panel (ACP) secifically for the urose of establishing a rofessional standard for laboratory animal care and facilities. Their work led to the ublication of a comrehensive and influential Guide for Laboratory Animal Facilities and Care (1963, revised 1965, 1968, 1972, 1978, 1985, and 1996). The current edition, now called the Guide for the Care and Use of Laboratory Animals, or Guide, as it is commonly referenced, was reared by a committee aointed by the National Research Council of the National Academy of Sciences and rovides guidance on: Institutional Policies and Resonsibilities; Animal Environment, Housing, and Management; Guide for the Care and Use of Laboratory Animals (1996) The Guide for the Care and Use of Laboratory Animals (the Guide) was first ublished in 1963 under the title Guide for Laboratory Animal Facilities and Care and was revised in 1965, 1968, 1972, 1978, and More than 400,000 coies have been distributed since it was first ublished, and it is widely acceted as a rimary reference on animal care and use. The changes and new material in this seventh edition are in keeing with the belief that the Guide is subject to modification with changing conditions and new information. The urose of the Guide, as exressed in the charge to the Committee to Revise the Guide for the Care and Use of Laboratory Animals, is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely aroriate. The Guide is also intended to assist investigators in fulfilling their obligation to lan and conduct animal exeriments in accord with the highest scientific, humane, and ethical rinciles. The recommendations are based on ublished data, scientific rinciles, exert oinion, and exerience with methods and ractices that have roved to be consistent with high-quality, humane animal care and use. htt:// 54

71 Chater 4: The Welfare of Laboratory Animals Veterinary Medical Care; and Physical Plant. The Guide is widely acceted by both government and research institutions as the most authoritative source of information on most animal care and use questions. The PHS Policy requires that PHS-funded institutions use the Guide as a basis for develoing and imlementing an institutional rogram for animal care and use. i 4b. Definitions The term animal is defined differently in the statutes, codes, olicies, and guidelines that govern animal research. Federally funded research is guided by two key definitions: The PHS Policy, which alies to all PHS-funded activities involving animals, defines animals as any live, vertebrate animals used or intended for use in research, research training, exerimentation, or biological testing or for related uroses. The Federal Code that imlements the Animal Welfare Act (Title 9) covers warm-blooded animals but excludes [b]irds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research uroses and other farm animals. Many institutions aly uniform and consistent standards to all activities involving animals regardless of the source of funding or legal requirements as a way of ensuring broad comliance with all regulations covering the care and use of animals in research. Researchers are not authorized to make decisions about covered or excluded research themselves. Therefore, anyone who lans to use animals in research, teaching, testing and other covered activities is well advised to assume a broad definition and to consult with their institutional committee (see below) before ordering animals or beginning work. i 55

72 ORI Introduction to the Resonsible Conduct of Research 4c. Institutional organization The task of assuring that researchers adhere to the regulations and guidelines for the resonsible care and use of animals is generally recognized to be an institutional resonsibility. Institutions vest authority for animal care and use in an institutional official (IO), who in turn aoints the Congressionally mandated Institutional Animal Care and Use Committee (IACUC), administers institutional care and use units at institutions that are large enough to have such, and handles other general matters relating to the care and use of animals at that institution. IACUCs. Following the rovisions of the 1985 Health Research Extension Act, PHS Policy, USDA regulations, the Guide, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) require research institutions to establish an IACUC. IACUCs oversee and evaluate all asects of the institution s animal rogram, rocedures, and facilities. Its members must include a doctor of veterinary medicine, one researcher who uses animals in research, and one erson who is not affiliated with the institution. Many IACUCs also have a researcher who does not use animals or a member who has some grounding in ethics. IACUC Members are aointed by their institution, but they have considerable indeendent authority. Their resonsibilities include: reviewing and aroving all animal use research roosals, reviewing the institution s animal care rogram, insecting (at least twice a year) the institution s animal facilities, receiving and reviewing concerns raised about the care and use of animals, and submitting reorts to the Institutional Official. IACUCs also have indeendent authority to susend rojects if they determine that they are not being conducted 56

73 Chater 4: The Welfare of Laboratory Animals in accordance with alicable requirements. This authority comes directly from Congress through the Health Research Extension Act and can be exercised indeendent of any other institutional administrative authority. Animal care and use units. Research institutions with large animal research rograms generally have centralized animal care and use units that rovide veterinary suort, training in rocedures, and advice on analgesics, anesthesia, euthanasia, and occuational health and safety. While the staff emloyed in these units cannot arove research rotocols for the institution or make decisions secifically assigned to the institutional IACUC, as animal care rofessionals they are an excellent local source of information about the resonsible care and use of animals in research. i 4d. Federal and voluntary oversight OLAW, USDA, and a voluntary accreditation rogram (Association for Assessment and Accreditation of Laboratory Animal Care AAALAC) are charged with or assume the task of assuring that research institutions live u to their resonsibilities for the care and use of animals in research. OLAW. OLAW relies on an assurance mechanism to monitor institutional comliance with the PHS Policy. An Assurance is a signed agreement submitted by a research institution confirming that it will: comly with alicable rules and olicies for animal care and use, rovide a descrition of the institution s rogram for animal care and use, maintain an aroriate IACUC, and aoint a resonsible IO for comliance. The Assurance is considered the cornerstone of a trust relationshi between the institution and the PHS and grants considerable authority to institutions for self-regulation. i 57

74 ORI Introduction to the Resonsible Conduct of Research Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International AAALAC International is a rivate, nonrofit organization that romotes the humane treatment of animals in science through voluntary accreditation and assessment rograms.... More than 700 comanies, universities, hositals, government agencies and other research institutions in 29 countries have earned AAALAC accreditation, demonstrating their commitment to resonsible animal care and use. These institutions volunteer to articiate in AAALAC s rogram, in addition to comlying with the local, state and federal laws that regulate animal research. htt:// i An OLAW-aroved Assurance and comliance with PHS olicy are considered terms and conditions of receiving PHS funds. Comliance is monitored by OLAW through annual mandatory institutional reorting to OLAW and in the event of noncomliance, serious deviations from the Guide, or IACUC susensions. OLAW conducts limited site visits and reviews, and if necessary conducts investigations of reorted noncomliance. Institutions that fail to submit an Assurance or to live u to the terms of their Assurance can have their aroval to use animals in research, teaching, and testing susended. USDA. The animal welfare regulations also have mandatory reorting requirements, but USDA is an insection-based system carried out by USDA Veterinary Medical Officers. Rather than allowing institutions to assure their own comliance, USDA visits sites, either announced or unannounced, to check whether institutions are in comliance. If violations are found, the institution is then subject to administrative fines and enalties. Accreditation rograms. Animal use rograms can be, and most large ones are, accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. AAALAC is a rivate nonrofit organization that romotes the humane treatment of animals in science through a voluntary accreditation 58

75 Chater 4: The Welfare of Laboratory Animals rogram. It is governed by a Board of Trustees reresenting scientific, rofessional, and educational organizations. Its Council on Accreditation is comosed of animal care and use rofessionals and researchers who conduct the rogram evaluations that determine which institutions are awarded accreditation. AAALAC relies on widely acceted guidelines, such as the Guide, and other eer-reviewed resources when evaluating an institution s animal research rogram. During the accreditation rocess, AAALAC accreditors evaluate all asects of an institution s animal research rogram. If an institution meets AAALAC s standards, it receives an accreditation for a secified eriod of time and can use this accreditation to demonstrate its commitment to high standards for the care and use of animals. 4e. Princiles for the resonsible use of animals in research There is a range of views about the morality of animal exerimentation. Antivivisectionists hold that humans have no right to lace their own welfare above the welfare of animals and therefore all animal exerimentation is immoral. Many animal welfare organizations find that some scientifically necessary exerimentation is accetable, but that it should be ket to a minimum and conducted on animals low on the hylogenetic scale, in ways that minimize ain and suffering. Many scientists feel that extensive animal exerimentation is necessary and moral, rovided it is based on sound scientific ractices and utilizes quality animal care, along with minimization of ain and distress. To hel researchers and IACUCs make decisions about the resonsible and aroriate use of animals in research, the Federal government has adoted nine Princiles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training (see box, next age). These rinciles secify requirements for lanning and conducting research and are useful to investigators and IACUCs. When questions i 59

76 ORI Introduction to the Resonsible Conduct of Research arise, PHS olicy and USDA regulations rovide further criteria for researchers and IACUCs to consider in assessing rotocols. Further ractical advice on ways to assure aroriate resect for animals can be found in the three Rs of alternatives devised by Russell and Burch in 1959: Relacement using non-animal models such as microorganisms or cell culture techniques, comuter simulations, or secies lower on the hylogenetic scale. Reduction using methods aimed at reducing the numbers of animals such as minimization of variability, aroriate selection of animal model, minimization of animal loss, and careful exerimental design. Refinement the elimination or reduction of unnecessary ain and distress. US Government Princiles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training [Researchers should:] 1. follow the rules and regulations for the transortation, care, and use of animals; 2. design and erform research with consideration of relevance to human or animal health, the advancement of knowledge, or the good of society; 3. use aroriate secies, quality, and the minimum number of animals to obtain valid results, and consider non-animal models; 4. avoid or minimize ain, discomfort, and distress when consistent with sound scientific ractices; 5. use aroriate sedation, analgesia, or anesthesia; 6. ainlessly kill animals that will suffer severe or chronic ain or distress that cannot be relieved; 7. feed and house animals aroriately and rovide veterinary care as indicated; 8. assure that everyone who is resonsible for the care and treatment of animals during the research is aroriately qualified and trained; and 9. defer any excetions to these rinciles to the aroriate IACUC. htt:// 60

77 Chater 4: The Welfare of Laboratory Animals Although PHS Policy is not exlicit in addressing refinements, the requirements to use aroriate animal models and numbers of animals and to avoid or minimize ain and distress are, for all ractical uroses, synonymous with requirements to consider alternative methods that reduce, refine, or relace the use of animals. USDA animal welfare regulations require a written narrative of the methods used and sources consulted to determine the availability of alternatives. Knowing the concerns society has about the use of animals in research, researchers should be reared to exlain why they are using a articular secies in their research; why ain or discomfort cannot be avoided; why it may be necessary to sacrifice the animals; and why non-animal otions cannot be used to gather the same information or to achieve the same ends, based on the rinciles set out in the U.S. Government Princiles and other sources of guidance. i 4f. Broader resonsibilities Even with all of the care and review that currently is used to assure the resonsible use of animals in research, animal research is still controversial and raises concerns that cannot easily be set aside. Pain and suffering. Some exerimental information cannot be gained without subjecting animals to ain and suffering. Researchers who study the effects of severe trauma, such as child abuse, can learn a great deal about hysiological change by subjecting animals to different levels of ain and suffering. This can be done by administering mild electric shocks, forcing animals such as rats to swim until they reach exhaustion, or subjecting them to other traumatic treatments. How much ain and suffering is accetable in exeriments is not easily determined. Concern for different secies. There is widesread agreement that some animals, such as rimates and 61

78 ORI Introduction to the Resonsible Conduct of Research household ets, deserve more rotection than other animals, such as worms and clams. There is less agreement about the relative rotection that is needed for secies within general grous of animals, such as cats, dogs, igs, rabbits, mice, and rats. What moral considerations set one secies aart from another when making decisions about the use to which it can be ut in exeriments? Unnecessary exeriments. Members of the ublic disagree about the use to which animals can reasonably be ut in research, testing, and teaching. Animals are used to test the safety of exerimental drugs, but should they also be used to test the toxicity of chemicals or cosmetics (as once was common, but has largely been abandoned)? Should they be used to train surgeons to do elective surgery? Do researchers sometimes use more animals in an exeriment than is absolutely necessary or use animals when other means of testing would rovide the same information? i Discussions about the resonsible use of animals in research are not likely to dissiate in the near future. If animals are essential to your research and cannot be relaced; if you cannot reduce the number without comromising the exeriment; and if you cannot further refine your methods to reduce ain and suffering, then resumably you have done all you can to meet your resonsibility. However, do not forget that society does not have to ermit the use of animals in research. It can seek to rotect animals through comlex and exensive regulations if it loses confidence in the research community s ability to regulate itself. 62

79 Chater 4: The Welfare of Laboratory Animals Questions for discussion 1 Should all animals used in research be treated the same or are there reasons to treat some animals differently than others? 2 Are there some animals that should not be used in research? 3 What circumstances justify ain and suffering of exerimental animals? 4 How should research animals be rocured? How should they be housed and treated during exeriments? 5 How should members of IACUCs be selected? What constituencies should be reresented on IACUCs? 63

80 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements National Academy of Sciences. Institute of Laboratory Animal Resources Commission of Life Sciences. Guide for the Care and Use of Laboratory Animals, Washington, DC: National Academy Press, (available at: htt:// labrats/) National Institutes of Health. U.S. Government Princiles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Bethesda, MD: National Institutes of Health, nd. (available at: htt:// references/hsol.htm#usgovprinciles) Public Health Service. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Washington, DC: GPO, (available at: htt:// htm) United States. Congress. Animal Welfare Act, PL , (available at: htt:// United States Deartment of Agriculture. USDA Animal and Plant Health Insection Animal Care Policy Manual, Washington, DC: GPO, nd. (available at: htt:// html) General Information Web Sites Association for the Assessment and Accreditation of Laboratory Animal Care. Home Page. htt:// National Institutes of Health. Office of Laboratory Animals Welfare. Home Page. htt:// United States Deartment of Agriculture. Animal Care Program. Home Page. htt:// 64

81 Chater 4: The Welfare of Laboratory Animals Additional Reading Baird, RM, Rosenbaum, SE. Animal Exerimentation: The Moral Issues, Buffalo, NY: Prometheus Books, Gluck, JP, DiPasquale, T, Orlans, FB. Alied Ethics in Animal Research: Philosohy, Regulation, and Laboratory Alications, West Lafayette, IN: Purdue University Press, Hart, LA. Resonsible Conduct with Animals in Research, New York: Oxford University Press, Monamy, V. Animal Exerimentation: A Guide to the Issues, Cambridge, United Kingdom; New York: Cambridge University Press, Paul, EF, Paul, J. Why Animal Exerimentation Matters: The Use of Animals in Medical Research, New Studies in Social Policy, New Brunswick, NJ: Social Philosohy and Policy Foundation: Transaction, Rudacille, D. The Scalel and the Butterfly: The War Between Animal Research and Animal Protection, New York: Farrar, Straus and Giroux, Russell, WMS, Burch, RL. The Princiles of Humane Animal Exerimental Technique, London: Methuen, Smith, CP, Animal Welfare Information Center (U.S.). Animal Welfare and Ethics: Resources for Youth and College Agricultural Educators, Revised and enlarged ed. AWIC resource series; no. 6, Beltsville, MD: U.S. Deartment of Agriculture Agricultural Research Service National Agricultural Library Animal Welfare Information Center,

82 Whose interest comes first?

83 Chater 5: Conflicts of Interest 5. Conflicts of Interest Researchers work hard, often sending long hours and sometimes weekends in the laboratory, library, or at rofessional meetings. Their motivation for working hard stems from many sources. Research: advances knowledge, leads to discoveries that will benefit individuals and society, furthers rofessional advancement, and/or results in ersonal gain and satisfaction. Each of these incentives or interests is commonly recognized as resonsible and justifiable. Researchers are allowed to and even encouraged to rofit from their work (see the discussion of the Bayh-Dole Act, below). Professional advancement as a researcher deends on roductivity. Society exects researchers to use the Case Study Early in his undergraduate education, Dr. Sam M. decided to dedicate his studies to finding a cure for a sychological disorder that seemed to run in his family. As a biology major, he ursued indeendent research rojects and worked long hours as a lab assistant. He then enrolled in a PhD rogram in sychoharmacology and is now comleting a 3-year ostdoc in the neurosciences. During his ostdoc he worked on a romising comound he first discovered during his graduate years. His work has gone well and he feels the time is right to exlore clinical alications. After more than a decade of living on student and ostdoc wages, he is also ready for a better aying job. As Sam weighs the otions of an academic versus an industry job, he begins to wonder about who owns or will own the useful alications of his work, if and when there are any. Will it be owned by: his graduate institution, where he first worked on the romising comound? his ostdoc institution, where he refined his ideas? his future academic or industry emloyer? himself, based on his hard work and innovative ideas? society, which funded arts of his education and most of his research? Who has a legitimate interest in Sam s work and when do his own ersonal financial interests create a conflict of interest? 67

84 ORI Introduction to the Resonsible Conduct of Research i funds it sulies to advance knowledge and to make useful discoveries. Personal gain and satisfaction rovide strong incentives for doing a good job and acting resonsibly. Researchers interests can and often do conflict with one another. The advancement of knowledge is usually best served by sharing ideas with colleagues, utting many minds to work on the same roblem. But ersonal gain is sometimes best served by keeing ideas to oneself until they are fully develoed and then rotected through atents, coyrights, or ublications. Legitimate research interests can create cometing resonsibilities and lead to what is commonly called conflicts of interest. It is imortant to understand that conflicts of interest are not inherently wrong. The comlex and demanding nature of research today inevitably gives rise to cometing obligations and interests. Researchers are exected to serve on committees, to train young researchers, to teach, and to review grants and manuscrits at the same time they ursue their own research. Conflicts of interest cannot and need not be avoided. However, in three crucial areas: financial gain, work commitments, and intellectual and ersonal matters, secial stes are needed to assure that conflicts do not interfere with the resonsible ractice of research. 5a. Financial conflicts Personal interests and the rosect of financial gain should not, but unfortunately can, imroerly influence a researcher s fundamental obligation to truth and honesty. Although researchers should not, they can find ways to delay unfairly a cometitor s work in order to secure a atent or some other financial advantage for themselves. Financial interests can rovide a strong incentive to overemhasize 68

85 Chater 5: Conflicts of Interest or underemhasize research findings or even to engage in research misconduct (Chater 2). Financial conflicts of interest are situations that create erceived or actual tensions between ersonal financial gain and adherence to the fundamental values of honesty, accuracy, efficiency, and objectivity (Section I). Financial interests are not inherently wrong. Researchers are ermitted to benefit financially from their work. A 1980 Congressional law known as the Bayh-Dole Act encourages researchers and research institutions to use coyrights, atents, and licenses to ut research ideas to use for the good of the ublic. Prior to this time, there were no uniform olicies regulating the ownershi of ideas develoed with ublic funding. Bayh-Dole essentially gives that ownershi to research institutions as an incentive to ut ideas to work for the overall good of society. It not only aroves of but, in fact, strongly encourages researchers and research institutions to have financial interests as a way of ensuring that the ublic s investment in research is used to stimulate economic growth. While financial interests should not and in most instances do not comromise intellectual honesty, they certainly can, esecially if the financial interests are significant. Bayh-Dole Act (Public Law: ) Policy and Objective 35 USC Part II, Chater 18, Section 200 It is the olicy and objective of the Congress to use the atent system to romote the utilization of inventions arising from federally suorted research and develoment efforts; to romote collaboration between commercial concerns and nonrofit organizations, including universities; to ensure that inventions made by nonrofit organizations and small business firms are used in a manner to romote free cometition and enterrise without unduly encumbering future research and discovery; to romote the commercialization and ublic availability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally suorted inventions to meet the needs of the Government and rotect the ublic against nonuse or unreasonable use of inventions; and to minimize the costs of administering olicies in this area. htt:// 69

86 ORI Introduction to the Resonsible Conduct of Research Universities are currently starting hundreds of new businesses based on researchers ideas. Some of these businesses will generate significant rofits (hundreds of thousands to millions of dollars each year). If the difference between commercial success and failure rests on one key ublication, the ressure to ut the best face on that ublication can be considerable. Financial conflicts also arise from the ever-resent ressure researchers have to secure funds to suort their research. A rivate sonsor might withdraw suort from a roject if it does not roduce the right results. Success in the stiff cometition for research grants can rest on having the right reliminary results. Research is exensive, funding often in short suly. The ressure simly to survive, much less rofit ersonally, can and does create financial conflicts of interest. Federal olicies. Concerns about the actual or otential adverse effect of financial interests on research romted the Public Health Service (PHS) and the National Science Foundation (NSF) to adot conflict of interest olicies in the mid-1990 s. These olicies require research institutions to establish administrative rocedures for: reorting significant conflicts before any research is undertaken; managing, reducing, or eliminating significant financial conflicts of interest; and roviding subsequent information on how the conflicts were handled. Significant financial conflict is defined as: additional earnings in excess of $10,000 a year, or equity interests in excess of 5 ercent in an entity that stands to benefit from the research. The financial interests of all immediate family members are included in these figures. 70

87 Chater 5: Conflicts of Interest Deartment of Health and Human Services Conflict of Interest Definitions 45 CFR 94.3 Significant Financial Interest means anything of monetary value, including but not limited to, salary or other ayments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock otions or other ownershi interests); and intellectual roerty rights (e.g., atents, coyrights and royalties from such rights). The term does not include: (1) Salary, royalties, or other remuneration from the alicant institution; (2) Any ownershi interests in the institution, if the institution is an alicant under the SBIR rogram; (3) Income from seminars, lectures, or teaching engagements sonsored by ublic or nonrofit entities; (4) Income from service on advisory committees or review anels for ublic or nonrofit entities; (5) An equity interest that when aggregated for the Investigator and the Investigator s souse and deendent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to ublic rices or other reasonable measures of fair market value, and does not reresent more than a five ercent ownershi interest in any single entity; or (6) Salary, royalties or other ayments that when aggregated for the investigator and the investigator s souse and deendent children over the next twelve months, are not reasonably exected to exceed $10,000. htt:// / State and local olicies. Although the Federal requirements aly only to PHS- and NSF-funded research, many research institutions have adoted global olicies that aly to all researchers. Many also use different values for defining significant, to as low as any financial interest. Researchers therefore should check their local conflict-ofinterest olicy to find out when and what they are required to reort. They also need to kee in mind that many states have their own conflict-of-interest olicies, which aly to all state-aid emloyees. i 71

88 ORI Introduction to the Resonsible Conduct of Research AAMC Task Force Recommendations Financial Conflicts of Interest in Clinical Research (December 2001) B. In the event of comelling circumstances, an individual holding significant financial interests in human subjects research may be ermitted to conduct the research. Whether the circumstances are deemed comelling will deend in each case uon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. C. Institutional olicies should require full rior reorting of each covered individual s significant financial interests that would reasonably aear to be affected by the individual s research, udated reorting of any relevant change in financial circumstances, and review of any significant financial interests in a research roject by the institution s COI committee rior to final IRB aroval of the research. COI committee findings and determinations should inform the IRB s review of any research rotocol or roosal, although the IRB may require additional safeguards or demand reduction or elimination of the financial interest. htt:// New England Journal of Medicine Conflict of Interest Policy June 13, 2002 [B]eginning with this issue of the Journal, we have modified the statement in Information for Authors to read as follows: Because the essence of reviews and editorials is selection and interretation of the literature, the Journal exects that authors of such articles will not have any significant financial interest in a comany (or its cometitor) that makes a roduct discussed in the article. The addition of the word significant acknowledges that not all financial associations are the same. Some, such as the receit of honorariums for occasional educational lectures sonsored by biomedical comanies, may be aroriately viewed as minor and unlikely to influence an author s judgment. Others, such as ownershi of substantial equity in a comany, are of greater concern. It is our intent to focus on the financial relationshis that, in our judgment, could roduce bias, or the ercetion of bias, in an article. htt://

89 Chater 5: Conflicts of Interest Professional societies and journal olicies. A number of rofessional societies have issued reorts or made recommendations on aroriate ways to handle conflicts of interest. Similarly, more and more journals now require researchers to disclose real or otential financial conflicts. Sometimes disclosure must be made to the journal editor, who decides what, if any, action is needed. Sometimes disclosures must be included in the ublication itself. Before submitting an article to a journal for ublication, researchers should carefully check and make sure they have followed that ublication s conflict of interest olicies. i 5b. Conflicts of commitment Conflicts of commitment arise from situations that lace cometing demands on researchers time and loyalties. At any time, a researcher might be: working on one or more funded rojects; rearing to submit a request for a new roject; teaching and advising students; attending rofessional meetings and giving lectures; serving as a eer reviewer; sitting on advisory boards; or working as a aid consultant, officer, or emloyee in a rivate comany. Each of these activities requires time and makes demands on a researcher s institutional commitments. Care needs to be taken to assure that these commitments do not inaroriately interfere with one another. Allocation of time. Researchers must be careful to follow rules for the allocation of time. Federally funded researchers must follow the rules for cost accounting ublished by the Office of Management and Budget in a document known as Circular A-21. Most research 73

90 ORI Introduction to the Resonsible Conduct of Research i institutions also have rules for how researchers send their time, articularly time serving as aid consultants, giving aid lectures, or working as an emloyee in a rivate comany. At a minimum, these rules require that researchers: honor time commitments they have made, such as devoting a secified ercentage of time to a grant or contract; refrain from charging two sources of funding for the same time; and seek advice if they are unsure whether a articular commitment of time is allowed under an institution s or the Federal Government s olicies. Although researchers will frequently work on several rojects at the same time, in the final analysis rimary work obligations must be met. In addition, the time devoted to one roject ordinarily cannot be billed to another. Relationshis with students. Academic researchers involved in start-u ventures often have oortunities to hire students. This uts them in a situation where they can hire their own students. As mentors, they have a rimary obligation to hel students develo into indeendent researchers. As heads of start-u comanies, their rimary obligation is to see romising ideas commercialized. While the two resonsibilities can comlement one another, they can also be in conflict. Should an individual who is both the researcher s student and emloyee be advised to develo a romising idea that could lead to an indeendent career or to work on a more routine roblem that will benefit the start-u comany? Situations such as these create conflicts and should be avoided or aroriately managed. Use of resources. Equiment and sulies urchased with ublic funds can easily be used to advance rivate research interests. While this might seem like a harmless ractice, articularly if the equiment is not in constant use, unless a researcher has ermission to use the equiment to suort rivate research, this ractice is not 74

91 Chater 5: Conflicts of Interest Stanford University Conflict of Commitment Policy 1. Outside consulting rivileges are not normally available to Academic Staff. They may consult only with ermission, as noted below. Under no circumstances may any Academic Staff member s outside consulting work exceed the limits imosed by the faculty consulting olicy, i.e., 13 days er calendar quarter (that is, one day in seven) on a full-time equivalent basis. Academic Staff may not use University resources, including facilities, ersonnel, equiment, or confidential information, excet in a urely incidental way, as art of any outside consulting activities nor for any other uroses that are unrelated to the mission of the University. 2. Academic Staff must maintain a significant resence on camus (main or overseas) throughout each quarter in which they are emloyed by Stanford, consistent with the scoe of their aointment. 3. Academic Staff must not allow other rofessional activities to detract from their rimary allegiance to Stanford. For examle, Academic Staff emloyed on a full-time basis must not have significant outside managerial resonsibilities nor act as a rincial investigator on sonsored rojects that could be conducted at Stanford University but instead are submitted and managed through another institution. htt:// aroriate. The equiment can be used for other university work since this is allowed by the government. But it cannot be used for a ersonal roject without ermission. It also cannot be used for research that is exlicitly rohibited by the Federal government, such as stem cell research using lines not authorized by the President s olicy. Disclosure of affiliations. It is widely agreed that outside affiliations that create conflicts of interest should be listed on academic ublications, but should researchers list their academic affiliations on other ublications? As resident or CEO of a new comany, is it aroriate for a researcher to also note in the end-of-the-year financial reort that she or he is also a full rofessor at a restigious university? Should researchers who serve on rivate boards list their academic affiliation? Researchers must be careful to searate their academic or institutional work from their i 75

92 ORI Introduction to the Resonsible Conduct of Research rivate work. In articular, they should not inaroriately use their institutional research affiliation to advance their rivate interests by imlying, for examle, that rivate work has the suort of their research institution if it does not. Reresenting outside entities. The results researchers commercialize in rivate ventures, such as drugs used in a university hosital, a software rogram used in an accounting office, or a consultation service for emloyees, might be used by their rimary emloyer. In these cases, the researcher could be the resident exert on the goods and services in question. Each emloyer in this case resumably wants the best deal on the goods and services, whereas the researcher is also interested in ersonal rofits, creating a conflict of commitment. i Since the situations described above are often not subject to secific olicies or guidance, judgments about resonsible conduct often rest with the researcher. In making judgments about the best way to deal with institutional conflicts, it is helful to take into consideration: how others will view your commitments and the judgment of someone who has no stake in the outcome. In addition, it is always a good idea, even if it is not required, to seek advice from an institutional official. 5c. Personal and intellectual conflicts Researchers are also exected to avoid bias in roosing, conducting, reorting, and reviewing research. They therefore should be careful to avoid making judgments or resenting conclusions based solely on ersonal oinion or affiliations rather than on scientific evidence. Personal conflicts are usually the easiest to identify and resolve. Researchers generally should not serve as reviewers for grants and ublications submitted by close colleagues and students. Their resumed interest in seeing 76

93 Chater 5: Conflicts of Interest their colleagues and students succeed could conflict with their obligation to makes judgments based solely on the evidence at hand. Most granting agencies require reviewers to disclose conflicts of interest, including ersonal conflicts, as a condition of service. Intellectual conflicts are more difficult to identify, but are nonetheless imortant. If a researcher holds strong ersonal views on the imortance of a articular area of research or set of research findings, those views should be disclosed so that others can take them into consideration when judging the researcher s statements. The same is true of strong moral convictions that could influence a researcher s scientific oinions. This is articularly true when researchers serve as exert witnesses or advisors. It is for recisely this reason that the National Academy of Sciences, which has rovided essential science advice to the Federal Government since the Civil War, carefully considers all conflicts of interest when it sets u advisory anels (see box, below). Federal Advisory Committee Act Public Disclosure Requirements Alicable to the National Academy of Sciences January 5, 1997 The Academy shall determine and rovide ublic notice of the names and brief biograhies of individuals that the Academy aoints or intends to aoint to serve on the committee. The Academy shall determine and rovide a reasonable oortunity for the ublic to comment on such aointments before they are made or, if the Academy determines such rior comment is not racticable, in the eriod immediately following the aointments. The Academy shall make its best efforts to ensure that (A) no individual aointed to serve on the committee has a conflict of interest that is relevant to the functions to be erformed, unless such conflict is romtly and ublicly disclosed and the Academy determines that the conflict is unavoidable, (B) the committee membershi is fairly balanced as determined by the Academy to be aroriate for the functions to be erformed, and (C) the final reort of the Academy will be the result of the Academy s indeendent judgment. The Academy shall require that individuals that the Academy aoints or intends to aoint to serve on the committee inform the Academy of the individual s conflicts of interest that are relevant to the functions to be erformed. htt:// 77

94 ORI Introduction to the Resonsible Conduct of Research 5d. Reorting and managing significant conflicts If a researcher has a significant conflict of interest, as defined by Federal, state, institutional, journal, or other olicies, it must be reorted and managed or eliminated. Managing a conflict means finding a way to assure that the interests do not adversely influence the research. Some otions for managing conflicts of interest include: requiring full disclosure of all interests so that others are aware of otential conflicts and can act accordingly; monitoring the research or checking research results for accuracy and objectivity; or removing the erson with the conflict from crucial stes in the research rocess, such as the interretation of data or articiating in a articular review decision. i These and other otions are either worked out by a conflict of interest review committee or an administrator charged with overseeing conflicts of interest. If the conflicts cannot be managed and could have an adverse imact on the research, then they must be eliminated, by divesting equity, reducing the income received from the research, assigning suervisory resonsibilities to someone else, steing out of the room when a articular roosal is discussed, or some other action. Finally, it is imortant to note that research administrators, funding agencies, journal editors, and conflict of interest committees, not the researcher, should make final decisions about the management of conflicts of interest. This rotects the researcher from charges of acting in her or his own interest and hels assure that the most resonsible decisions are made. 78

95 Chater 5: Conflicts of Interest Questions for discussion 1 Is $10,000 or a 5 ercent equity stake an aroriate level for raising concerns about ossible conflicts of interest or should other values be used? 2 Should researchers be allowed/encouraged to rofit ersonally from their research aart from their normal comensation? 3 What are aroriate mechanisms for managing financial conflicts of interest? 4 What are aroriate mechanisms for rotecting students from a mentor s conflict of commitment? 5 What are aroriate mechanisms for managing intellectual and ersonal conflicts of interest? 79

96 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Association of American Medical Colleges. Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research, Washington, DC: AAMC, (available at: htt:// colleges.guidelines.html). Protecting Subjects, Preserving Trust, Promoting Progress II: Princiles and Recommendations for Oversight of an Institution s Financial Interests in Human Subjects Research, Washington, DC: AAMC, (available at: htt:// start.htm) Association of American Medical Colleges, Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress Policy and Guidelines for Oversight of Individual Financial Interests in Human Subjects Research, Washington, DC: AAMC, (available at: htt:// Association of American Universities. Reort on Individual and Institutional Financial Conflict of Interest, Washington, DC: AAU, (available at: htt:// Council on Government Relations. Recognizing and Managing Personal Conflicts of Interest, Washington, DC: COGR, (available at: htt:// Deartment of Health and Human Services. Final Guidance Document: Financial Relationshis and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, Washington, DC: HHS, (available at: htt://www. Drazen, JM, Curfman, GD. Financial Associations of Authors, The New England Journal of Medicine 346, 24 (2002): (available at: htt:// Food and Drug Administration. Guidance: Financial Disclosure by Clinical Investigators, Washington, DC: FDA, (available at: htt:// Institute of Medicine. National Academies of Science. Study Conduct: Bias and Conflict of Interest, Washington, DC: IOM, nd. (available at: htt:// National Institutes of Health. Objectivity in Research, Federal Register 60, 132 (1995): (available at: htt:// html) National Science Foundation. Investigator Financial Disclosure Policy, Federal Register 60, 132 (1995): (available at: htt:// Office of Management and Budget. Circular A-21, Washington, DC: OMB, (available at: htt:// circulars/a021/a021.html) 80

97 Chater 5: Conflicts of Interest United States, Congress. 105th Congress. First Session. Federal Advisory Committee Act Amendments of 1997, PL (1997). (available at: htt:// e=about_faca) General Information Web Sites Association of American Universities. Conflict of Interest and Misconduct. htt:// Association of University Technology Managers. Home Page. htt:// National Institutes of Health. Office of Extramural Research. Conflict of Interest. htt:// Additional Reading Boyd, EA, Bero, LA. Assessing Faculty Financial Relationshis With Industry: A Case Study, Journal of the American Medical Association 284 (2000): Cambell, TID. Understanding the Potential for Misconduct in University-industry Relationshis: An Emirical Study. In Persectives on Scholarly Misconduct in the Sciences, edited by John M. Braxton, Columbus, OH: Ohio State University Press, Cho, MK, Shohara, R, Schissel, A, Rennie, D. Policies on Faculty Conflicts of Interest at US Universities, Journal of the American Medical Association 284 (2000): Jefferson, T, Smith, R, Yee, Y, Drummond, M, Pratt, M, Gale, R. Evaluating the BMJ Guidelines for Economic Submissions: Prosective Audit of Economic Submissions to BMJ and The Lancet, Journal of the American Medical Association 280, 3 (1998): National Institutes of Health. Financial Conflict of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards, Washington, DC: NIH, (available at: htt:// html) Shamoo, AE. Role of Conflict of Interest in Scientific Objectivity: A Case of a Nobel Prize Work, Accountability in Research 2, 1 (1992): United States. Congress. House. Committee on Government Oerations. Human Resources and Intergovernmental Relations Subcommittee. Federal Resonse to Misconduct in Science, Are Conflicts of Interest Hazardous to our Health?: Hearing before a Subcommittee of the Committee on Government Oerations, House of Reresentatives, One Hundredth Congress, second session, Setember 29, 1988, Washington: U.S. G.P.O.,

98 Part III.

99 Conducting Research

100 ORI Introduction to the Resonsible Conduct of Research Part III: Conducting Research Once lanning is comlete, researchers can finally get on with the work they resumably enjoy most conducting research. This is when hyotheses and new techniques are finally tested, when efforts get underway to solve roblems and ut new information to use. At this stage in any research roject, three additional areas of resonsibility become imortant: 84

101 Part III: Conducting Research Chater 6, Data Management Practices, discusses how researchers should collect, store, rotect, and share data, mindful of the need to maintain its integrity, validity, and accuracy. Ownershi issues must be considered. Some data must be shared with colleagues; other data must be rotected from unaroved use. Some data must be reserved for secified eriods of time; some destroyed to rotect confidentiality. Chater 7, Mentor and Trainee Resonsibilities, covers the role of the researcher as teacher. The continued growth of research in all fields is vitally deendent uon a constant suly of well-trained researchers. New researchers learn many of the techniques of their rofession as they work side by side with established researchers. Established researchers therefore should take their resonsibilities as mentors seriously. Chater 8, Collaborative Research, exlores secial resonsibilities that arise when researchers work with colleagues, whether in their own disciline or in other discilines, at other institutions, and in other countries. When collaborating with colleagues, how should intellectual roerty agreements be worked out? Which country or institution s research olicies should be followed? How should roject funds and roject resonsibilities be managed? 85

102 Who owns research data?

103 Chater 6: Data Management Practices 6. Data Management Practices Researchers send much of their time collecting data. Data are used to confirm or reject hyotheses, to identify new areas of investigation, to guide the develoment of new investigative techniques, and more. We launch sace robes to collect data that hel us understand the origins of the universe and use gene databases as tools for understanding and curing disease. Science as we know and ractice it today cannot exist without data. Data management ractices are becoming increasingly comlex and should be addressed before any data are collected by taking into consideration four imortant issues: ownershi, collection, storage, and sharing. The integrity of data and, by imlication, the usefulness of the research it suorts, deends on careful attention to detail, from initial lanning through final ublication. Case Study Dr. Marion W. long ago learned that good data management ractices are essential to resonsible research. She therefore carefully suervises the work of her assistants and students, checking notebooks, backing u comuter files, and from time to time verifing results for herself. As she is wraing u work on one roject before starting another, the technology transfer officer at her university calls. A graduate student who reviously worked in her laboratory has moved to another university and filed a atent for work that may have been done in Dr. W. s laboratory on her research funds? If this is the case, the graduate student may not be able to lay claim to the atent. What records will Dr. W. need to rove that the work was done in her laboratory? Who owns and controls the data collected in her laboratory? Do comuter records ose any unique roblems in this case? 87

104 ORI Introduction to the Resonsible Conduct of Research 6a. Data ownershi i i Research roduces data. As a roduct, common sense might suggest that the erson who conducts the research should own the roduct the data. In fact, conditions imosed by funders, research institutions, and data sources may dictate otherwise. Funders. Funders rovide suort for research for different reasons. Government is interested in imroving the general health and welfare of society. Private comanies are interested in rofits, along with benefits to society. Philanthroic organizations are interested in advancing articular causes. These different interests translate into different ownershi claims. Tyically: Government gives research institutions the right to use data collected with ublic funds as an incentive to ut research to use for the ublic good (see the discussion of the Bayh-Dole Act, Chater 5). Private comanies seek to retain the right to the commercial use of data. Philanthroic organizations retain or give away ownershi rights deending on their interests. Since the claims of funders can and do vary considerably, researchers must be aware of their obligations to them before they begin collecting data. With government funding, it is imortant to distinguish between grants and contracts. Under grants, researchers must carry out the research as lanned and submit reorts, but control of the data remains with the institution that received the funds (see below). Contracts require the researcher to deliver a roduct or service, which is then usually owned and controlled by the government. If your research is suorted with government funds, make sure you know whether you are working under a grant or a contract. The difference is significant and could determine who has the right to ublish and use your results. 88

105 Chater 6: Data Management Practices University of Pittsburgh Guidelines on Data Retention and Access Data Ownershi and Access to Data Both the rincial investigator and the University have resonsibilities, and hence, rights concerning access to, use of, and maintenance of original research data. Research data belongs to the University of Pittsburgh, which can be held accountable for the integrity of the data even after the researchers have left the University. Although the rimary data should remain in the laboratory where it originated (and hence at the University), consistent with the recets of academic freedom and intellectual integrity, the investigator may be allowed to retain the research records and materials created by him/her. In the event that the investigator leaves the University, an Agreement on Disosition of Research Data may be negotiated by the investigator and the Deartment Chair or Dean to allow transfer of research records. However, consistent with the same recets, it should be secified in the agreement that the University has the right of access to all research records and materials for a reasonable cause after reasonable rior notice regardless of the location of the resonsible investigator... Some circumstances may warrant an excetion, requiring that the rimary data be retained by the University... Slit of collaborative team: When a collaborative team is dissolved, University of Pittsburgh olicy states that each member of the team should have continuing access to the data and materials with which he/she had been working, unless some other agreement was established at the outset. The unique materials reared in the course of the research should be available/accessible under negotiated terms of a transfer agreement. htt:// Research institutions. Suort for research is tyically awarded to research institutions, not to individual researchers. As the reciients of research funds, research institutions have resonsibilities for budgets, regulatory comliance, contractual obligations, and data management. To assure that they are able to meet these resonsibilities, research institutions claim ownershi rights over data collected with funds given to the institution. This means that researchers cannot automatically assume that they can take their data with them if they move to another institution. The research institution that received the funds may have rights and obligations to retain control over the data. 89

106 ORI Introduction to the Resonsible Conduct of Research i Data sources. Increasingly research subjects and other entities that are the source of data are seeking some control over data derived from them. Countries with unique resources, such as troical rain forests, individuals with rare medical conditions, and entities with unique databases, have at one time or another claimed ownershi of research results based on their data. Research subjects and entities that have or can be the source of imortant data may no longer be willing to rovide or be the source of data without some ownershi stake in the end results. Well before any data are collected, ownershi issues and the resonsibilities that come with them need to be carefully worked out. Before undertaking any work, make sure you can answer the following questions: Who owns the data I am collecting? What rights do I have to ublish the data? Does collecting these data imose any obligations on me? If you do not have firm answers for each of these questions, referably in writing when financial interests are involved, you are not ready to begin your research. It is also imortant to note that in most cases ownershi rovisions must be aroved by the institution that receives and is resonsible for the administration of research funds. Researchers therefore should not enter into agreements that affect the control and use of data without getting institutional aroval. The results could be disastrous and exensive if ownershi is disuted later. 6b. Data collection There is no one best way to collect data. Different tyes of research call for different collection techniques. There are, however, four imortant considerations that aly to all data collection and that will hel ensure the overall integrity of both the rocess and the information collected. 90

107 Chater 6: Data Management Practices Aroriate methods. Reliable data are vitally deendent on reliable methods. If you use a test that can detect an effect in one of every 100 samles to find an effect that may not occur more frequently than 1 in every 1,000 cases, your results will not be reliable. Failure to find the effect could be due to either your exerimental design or the lack of an effect, but you will not know which is true. The common saying, garbage in, garbage out, alies to research methods. Although the need for aroriate methods might seem obvious, studies have suggested that researchers sometimes use inaroriate statistical tests to evaluate their results (see articles by DeMets and Gardner, Additional Reading). Methods can also be comromised by bias choosing one method or set of exerimental conditions so that a articular conclusion can be drawn or sloy technique. Whatever the origin, the use of inaroriate methods in research comromises the integrity of research data and should be avoided. Resonsible research is research conducted using aroriate, reliable methods. Attention to detail. Quality research requires attention to detail. Exeriments must be set u roerly and the results accurately recorded, interreted, and ublished. A failure to ay attention to detail can result in mistakes that will later have to be corrected and reorted. Correcting the record takes time and resources that are better sent on the research itself. Obviously, it is not ossible to avoid all mistakes in research. However, take a look at the errata section of any scientific journal and ask yourself how the mistakes reorted could have been avoided. Did the authors check to make sure that each figure was correctly labeled? Were the calculations double checked? Did someone check to make sure the authors were roerly listed? Since others rely on their work, researchers have a resonsibility to make sure their work is carefully undertaken and reorted. Sloy research wastes funds and should be avoided. i i 91

108 ORI Introduction to the Resonsible Conduct of Research i Authorized. Many tyes of data collection need to be authorized before they can roceed. Tyically ermission is needed to use: human and animal subjects in research; hazardous materials and biological agents; information contained in some libraries, databases, and archives; information osted on some Web sites; ublished hotograhs and other ublished information; and other coyrighted or atented rocesses or materials. Researchers have a resonsibility to know when ermission is needed to collect or use secific data in their research. If you are not sure whether ermission is needed, check before roceeding with data collection. Recording. The final ste in data collection is the hysical rocess of recording the data in some tye of notebook (hard coy), comuter file (electronic coy), or other ermanent record of the work done. The hysical formats for recording data vary considerably, from measurements or observations to hotograhs or interview taes. However data are recorded, it is imortant to kee in mind that the urose of any record is to document what was actually done and the results that were achieved. In recording data, kee two simle rules in mind to avoid roblems later, should someone ask about or question your work: Hard-coy evidence should be entered into a numbered, bound notebook so that there is no question later about the date the exeriment was run, the order in which the data were collected, or the results achieved. Do not use loose-leaf notebooks or simly collect ages of evidence in a file. Do not change records in a bound notebook without noting the date and reasons for the change. 92

109 Chater 6: Data Management Practices Electronic evidence should be validated in some way to assure that it was actually recorded on a articular date and not changed at some later date. It is easy to change dates on comuters and thereby alter the date a articular file seems to have been created. If you collect your data electronically, you must be able to demonstrate that they are valid and have not been changed. As you record your data, it may be helful to think about them as the legal tender of research the currency researchers cash in when they aly for grants, ublish, are considered for romotion, and enter into business ventures. To have and hold their value, research data must be roerly recorded. i 6c. Data rotection Once collected, data must be roerly rotected. They may be needed later: to confirm research findings, to establish riority, or to be reanalyzed by other researchers. Over time, data, as the currency of research, become an investment in research. If the data are not roerly rotected, the investment, whether ublic or rivate, could become worthless. Data storage. The resonsible handling of data begins with roer storage and rotection from accidental damage, loss, or theft: Lab notebooks should be stored in a safe lace. Comuter files should be backed u and the backu data saved in a secure lace that is hysically removed from the original data. Samles should be aroriately saved so that they will not degrade over time. Care should be taken to reduce the risk of fire, flood, and other catastrohic events. Proerly store and rotect your data. They are valuable. 93

110 ORI Introduction to the Resonsible Conduct of Research Confidentiality. Some data are collected with the understanding that only authorized individuals will use them for secific uroses. In such cases, care needs to be taken to assure that rivacy agreements are honored. This is articularly true of data that contain ersonal information that can be linked to secific individuals. It is also true of confidential information about rotected rocesses and materials. If a comany shares confidential data about a rocess with a researcher rior to seeking a atent on that rocess, the researcher must take care to make sure the data are ket confidential. Data that are subject to rivacy restrictions must be stored in a safe lace that is accessible only to authorized ersonnel. Using random codes to identify individual subjects, rather than names or social security numbers, can also further rotect rivate information. Access to these codes can then be restricted to rovide a double layer of rotection. Whatever the method used to rotect rivate or confidential information, the researcher who collects or uses the information has the rimary resonsibility for its rotection. Period of retention. Data should be retained for a reasonable eriod of time to allow other researchers to check results or to use the data for other uroses. There is, however, no common definition of a reasonable eriod of time. NIH generally requires that data be retained for 3 years following the submission of the final financial reort. Some government rograms require retention for u to 7 years. A few universities have adoted data-retention olicies that set secific time eriods in the same range, that is, between 3 and 7 years. Aside from these secific guidelines, however, there is no comrehensive rule for data retention or, when called for, data destruction. It is difficult to redict when data collected sometime in the ast could be useful. When a new disease emerges, such 94

111 Chater 6: Data Management Practices as AIDS, researchers use stored samles/data to inoint first occurrences and the likely course of develoment of the disease. Although the original data were not stored for this urose, they nonetheless can be useful for tracking diseases years later. Stored data are also useful for understanding social questions. The Deartment of Energy committee that made recommendations on aroriate comensation for imroer human radiation exeriments conducted during the Cold War ulled together data collected as far back as the 1950 s. Researchers also cannot redict when someone will challenge their work and ask to see the original data. Given the different reasons data could be useful over long eriods of time, researchers should give some thought to retaining data longer than some minimum eriod required by secific regulations. How long is reasonable will vary from field to field and institution to institution. Nevertheless, it is imortant to have a clear retention olicy that balances the best interests of society with those of the research institution and the individual researcher. Before throwing out notebooks, cleaning out files, or erasing your comuter memory, give careful consideration to who might benefit from or ask to see your data in the future. i 6d. Data Sharing It is widely agreed that research data should be shared, but deciding when and with whom raises questions that are sometimes difficult to answer. Researchers are not exected to and in most instances should not release reliminary data, that is, data that have not been carefully checked and validated. The one excetion to this rule would be reliminary data that could otentially benefit the ublic. A researcher who has strong reliminary indications of a major threat to ublic health, such as unexected side effects from a drug or an unrecognized environmental health roblem, may have good reason to 95

112 ORI Introduction to the Resonsible Conduct of Research NIH Data Sharing Policy and Imlementation Guidance (Udated: March 5, 2003) Goals of Sharing Data Data sharing romotes many goals of the NIH research endeavor. It is articularly imortant for unique data that cannot be readily relicated. Data sharing allows scientists to exedite the translation of research results into knowledge, roducts, and rocedures to imrove human health. There are many reasons to share data from NIH-suorted studies. Sharing data reinforces oen scientific inquiry, encourages diversity of analysis and oinion, romotes new research, makes ossible the testing of new or alternative hyotheses and methods of analysis, suorts studies on data collection methods and measurement, facilitates the education of new researchers, enables the exloration of toics not envisioned by the initial investigators, and ermits the creation of new datasets when data from multile sources are combined. In NIH s view, all data should be considered for data sharing. Data should be made as widely and freely available as ossible while safeguarding the rivacy of articiants, and rotecting confidential and rorietary data. To facilitate data sharing, investigators submitting a research alication requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003, are exected to include a lan for sharing final research data for research uroses, or state why data sharing is not ossible. htt:// share this information with the ublic and other researchers before it is fully validated. Data that have no immediate ublic benefit, such as the discovery of a basic scientific rocess that could eventually lead to ublic benefits, in most instances is best held until the researcher is confident that the results will stand. Researchers can withhold confirmed or validated data until they have had time to establish their riority for their work through ublication or, in rare cases, a ublic announcement. They do not have to release data on a day-to-day or exeriment-to-exeriment basis for other researchers to use, even though this might seed the advance of knowledge. Provided no agreements have been made to the contrary, keeing data confidential rior to 96

113 Chater 6: Data Management Practices ublication is a commonly acceted ractice that most researchers and funding agencies accet. Once a researcher has ublished the results of an exeriment, it is generally exected that all the information about that exeriment, including the final data, should be freely available for other researchers to check and use. Some journals formally require that the data ublished in articles be available to other researchers uon request or stored in ublic databases. In the secific case of federally funded research that is used in setting olicies that have the effect of law, research data must be made available in resonse to Freedom of Information Act (FOIA) requests (OMB, Circular A-110). There is, in other words, considerable suort for sharing data with other researchers and the ublic unless there are comelling reasons for confidentiality. 6e. Future considerations The continued evolution of data olicies will likely be driven by a number of different issues, including the growing comlexity of data and debates about roer control. Comlexity. Our caacity to generate data sometimes outstris our caacity to store and share it. Data storage and sharing were major roblems during the early years of the Human Genome roject. They continue to ose roblems for any research area that is able to generate massive amounts of information efficiently and inexensively. DNA microarray chis can generate 10,000 bits of information with a single, easily conducted test. The logistics of storing and sharing this information resents a monumental challenge for everyone engaged in research. Even when researchers want to, it is not always clear how they should go about collecting, storing, and sharing data resonsibly. Control. In large rojects, questions frequently arise about the control of data, articularly when financial interests are at stake. Should researchers articiating in large, 97

114 ORI Introduction to the Resonsible Conduct of Research Research Committee, Society for Academic Emergency Medicine Guidelines for Clinical Investigator Involvement in Industry-sonsored Clinical Trials IV. Trial Data Management 1. The industry sonsor and the investigators should have a firm commitment to thorough monitoring of the trial at every ste. 2. All data collected in the trial should be oen to scrutiny by both the investigators and the industry sonsor. 3. Clinical investigators should have substantial inut into the initial analytic lan and also any subsequent amendments that occur during the trial eriod. 4. When ossible, statistical analysis of the data should be conducted by an entity indeendent of the researchers and the sonsor. For trials using interim analysis, use of an indeendent entity is articularly imortant. Decisions to rematurely sto a trial should be based uon redetermined criteria. 5. Consideration should be given to the use of an unbiased, blinded clinical evaluation committee for trials that involve assessment of otentially subjective endoints. 6. The industry sonsors must share the results of all data analyses with the rincial investigators. Selective withholding or incomlete reorting of data analyses to the rincial investigators is unaccetable. 7. Trial results and data analysis should be shared with the rincial investigators as soon as they become available. Delays by the industry sonsors for marketing or related uroses are unaccetable. htt:// multi-site clinical trials have the right to ublish their own findings, that is, retain some control over their own data, or should the collection, storage, and interretation be centralized? This issue is currently unresolved and the subject of intense ublic debate. National security. Recent events have heightened concerns about the ossible use of data from ublicly suorted research by terrorists and nations that could ose a threat to national security. Efforts are underway to address these concerns through voluntary olicies and new 98

115 Chater 6: Data Management Practices Federal regulations (e.g., USA Patriot Act of 2001) that will assure reasonable control without unduly restricting the ability of researchers to share their work and ideas freely with one another (see the recent reort, Biological Threats and Terrorism, Additional Reading). Researchers whose work could be affected by these concerns should kee abreast of ongoing olicy develoment and regulation. However these issues are resolved, researchers have been the most imortant comonent of resonsible data management ractices in the ast and will likely remain so as long as the ublic feels the majority of researchers can be trusted. With this in mind, ask yourself how someone funding your research would feel if he or she had a chance to take a close look at your data management ractices. Questions for discussion 1 Should research data belong to researchers rather than to research institutions? 2 Should data recording ractices be standardized to facilitate sharing and monitoring? What recording ractices could be standardized? 3 What interretation ractices could be standardized? How does your laboratory verify the accuracy and validity of data before its disclosure or use in grant roosals and ublications? 4 Who should ay the cost of sharing data? Who should have access to the data? 5 How long should researchers be able to withhold data to allow time to rotect ownershi claims? How long should research data be stored? 99

116 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements American Statistical Association. Ethical Guidelines for Statistical Practice, Alexandria, VA: American Statistical Association, (available at: htt:// on=ethicalstatistics/) Council on Government Relations. Policy Considerations: Access to and Retention of Research Data, Washington, D.C.: (available at: htt:// /docs/ DataRetentionIntroduction.htm) Food and Drug Administration. Good Laboratory Practices for Designing Toxicology Studies for Petition Submissions and Notifications, 21 CFR Part 58 (2002). (available at: htt://www. Harvard University, Office of Technology Licensing. Record-Keeing Procedures, (available at: htt:// National Institutes of Health. NIH Data Sharing Policy and Imlementation Guidance, (available at: htt://grants1.nih. gov/grants/olicy/data_sharing/data_sharing_guidance.htm) Society for Clinical Data Management. Good Clinical Data Management Practices, Version 2, Hillsborough, NJ: Society for Clinical Data Management, (available at: htts:// org/gcdmp/ United States. Congress. USA Patriot Act of 2001, PL , (available at: htt:// cgi?dbname=107_cong_ublic_laws&docid=f:ubl df) University of Pittsburgh. Guidelines on Data Retention and Access, Pittsburgh, PA: University of Pittsburgh, (available at: htt:// General Information Web Sites National Institutes of Health. Office of Extramural Research. NIH Data Sharing Policy, Washington, DC: National Institutes of Health. htt:// Society for Clinical Data Management. Home Page. htt:// org/ 100

117 Chater 6: Data Management Practices Additional Reading Cambell, EG, Clarridge, BR, Gokhale, M, Birenbaum, L, Hilgartner, S, Holtzman, NA, Blumenthal, D. Data Withholding in Academic Genetics: Evidence from a National Survey, Journal of the American Medical Association 287, 4 (2002): Council on Government Relations. Materials Transfer in Academia, Washington, DC: Council on Government Relations, DeMets, DL. Statistics and Ethics in Medical Research, Science and Engineering Ethics 5, 1 (1999): Gardner, MJ. An Exloratory Study of Statistical Assessment of Paers Published in the British Medical Journal, Journal of the American Medical Association 263, March 10 (1990): Kanare, HM. Writing the Laboratory Notebook, Washington, DC: American Chemical Society, Knobler, SL, Mahmoud, AAF, Pray, LA, eds. Biological Threats and Terrorism: Assessing the Science and Resonse Caabilities: Worksho Summary. Washington, DC: National Academy Press, Stevens, AR. Ownershi and Retention of Data, Washington, DC: National Association of College and University Attorneys,

118 Mentor-trainee working relationshis?

119 Chater 7: Mentor and Trainee Resonsibilities 7. Mentor and Trainee Resonsibilities While conducting investigations, researchers often assume the added role of mentors to trainees.* The mentor-trainee relationshi is comlex and brings into lay otential conflicts. How much time training time for the mentor, research time for the trainee should each devote to the other? Who gets credit for ideas that take shae during the course of a shared exeriment? Who owns the results? When does a trainee become an indeendent researcher? The essential elements of a roductive mentor-trainee relationshi are difficult to codify into rules or guidelines, Case Study At a recent meeting, several faculty in a large, research-oriented science deartment raised concerns about their mentoring rogram. While mindful of the many demands they all faced, they wondered whether changes were needed in the way the deartment assigned, trained, and oversaw mentors. The ensuing discussion raised some otentially good suggestions, which most agreed were best referred to a secial committee for further discussion and recommendations. With a little arm twisting, Susan D., an advanced graduate student; Dr. Linda L., a ostdoc; and Dr. Bill K., an established researcher, were recruited to serve. At their first meeting, the three colleagues quickly agreed to tackle first the question of goals. If they knew what mentoring was exected to achieve, they could then assess the strengths and weaknesses of their current rogram and make suggestions for change. With this settled, they decided to send some time talking with their eers and then get back together to comare notes. When they met the next time: What goals would you exect each member of the committee to recommend? Why might different members of the committee recommend different goals? Assuming they came to the conclusion that some imrovements were needed, what avenues are oen to change the way mentors and trainees interact? * The term trainee is used in this chater to refer to anyone learning to be a researcher under an established researcher s suervision. This includes rincially graduate students and ostdoctoral fellows (ostdocs), but may also include undergraduate and high school students working on research rojects or junior research faculty, research scientists, and research staff. 103

120 ORI Introduction to the Resonsible Conduct of Research leaving most of the decisions about resonsible mentoring to the individuals involved. Common sense suggests that good mentoring should begin with: a clear understanding of mutual resonsibilities, a commitment to maintain a roductive and suortive research environment, roer suervision and review, and an understanding that the main urose of the relationshi is to reare trainees to become successful researchers. i Understandings and agreements, however, will count for little if they are not backed u by firm commitments to make a relationshi work. Knowing the imortance of ersonal commitments, researchers should carefully consider what resonsibilities they have to trainees before they take on the essential task of training new researchers. Trainees, in turn, should be we aware of their resonsibilities to mentors before acceting a osition in a laboratory or rogram. 7a. Basic resonsibilities Mentor-trainee relationshis begin when an exerienced and an inexerienced researcher agree to work together. Each brings something to the table under such an arrangement. The exerienced researcher has knowledge and skills that the inexerienced researcher needs to learn. She or he may also rovide suort for the trainee s research and education. Inexerienced researchers, whether graduate student, ostdoctoral student (ostdoc), research staff, or junior researcher, rovide labor and fresh ideas. Under a roductive relationshi, the two work together to advance knowledge and ut ideas to work. When the relationshi breaks down, it is often because one of the arties is not getting from the relationshi what she or he exected. 104

121 Chater 7: Mentor and Trainee Resonsibilities National Academy of Sciences On Being a Mentor to Students in Science and Engineering What is a Mentor? In the broad sense intended here, a mentor is someone who takes a secial interest in heling another erson develo into a successful rofessional. Some students, articularly those working in large laboratories and institutions, find it difficult to develo a close relationshi with their faculty adviser or laboratory director. They might have to find their mentor elsewhere erhas a fellow student, another faculty member, a wise friend, or another erson with exerience who offers continuing guidance and suort. In the realm of science and engineering, we might say that a good mentor seeks to hel a student otimize an educational exerience, to assist the student s socialization into a discilinary culture, and to hel the student find suitable emloyment. These obligations can extend well beyond formal schooling and continue into or through the student s career. htt:// One way to avoid roblems is to establish basic understandings about imortant issues early in the relationshi. Trainees need to know: how much time they will be exected to send on their mentor s research; the criteria that will be used for judging erformance and form the basis of letters of recommendation; how resonsibilities are shared or divided in the research setting; standard oerating rocedures, such as the way data are recorded and interreted; and, most imortantly, how credit is assigned, that is, how authorshi and ownershi are established. Clarifying these issues early in a mentor-trainee relationshi can revent roblems from arising later. The need for early understanding is not one sided. Mentors need to know that a trainee will: 105

122 ORI Introduction to the Resonsible Conduct of Research do assigned work in a conscientious way, resect the authority of others working in the research setting, follow research regulations and research rotocols, and live by agreements established for authorshi and ownershi. Mentors invest time and resources in trainees. Trainees should resect this time and use resources resonsibly, keeing their mentors informed about changing research interests or other circumstances that could affect their work. A Guide to Training and Mentoring in the Intramural Research Program at NIH A mentor is a erson who has achieved career success and counsels and guides another for the urose of heling him or her achieve like success. Research suervisors should always be mentors; they have the resonsibility to discuss with and advise a trainee on asects of his or her work and rofessional develoment. The trainee may find additional mentors informally or the training institution may designate them. They are very imortant in the overall exerience of the trainee and may contribute to research roductivity as well... Training in the skills of mentorshi itself is imortant, esecially for those who lan careers in research or teaching. Postdoctoral trainees should learn to train and guide others, for examle, by working with more junior individuals, suervising technical staff, or training students. The characteristics considered imortant by a fellow in selecting a suervisor and other mentors interest in contributing to the career develoment of another scientist, research accomlishments, rofessional networking, accessibility, and ast success cultivating the rofessional develoment of fellows are characteristics that trainees may eventually strive to emulate in their own careers. Although this Section has emhasized the resonsibilities of suervisors and others in research institutions to rovide mentoring to trainees to facilitate their rofessional develoment, trainees also have resonsibilities. Collaborative research frequently requires roductive interactions among fellows themselves as well as recognition of their roles as art of a team effort. In addition, fellows must have a commitment to the work of the laboratory and Institute and to the achievement of their goals. They cannot be assive articiants in their training; they should aroriately make known their satisfactions, dissatisfactions, and needs clearly and often. htt:// 106

123 Chater 7: Mentor and Trainee Resonsibilities Arriving at basic understandings early in a mentortrainee relationshi is not easy, given the unequal ower relationshi between them. Mentors are in a osition to lay out exectations, but it can be difficult for a trainee to raise questions early in a relationshi about credit and authorshi ractices. To avoid utting trainees in the awkward osition of having to raise these issues, mentors should be reared to take the lead in raising issues that are of concern to the trainee as well as those that are of interest to the mentor. Develoing written guidance on a laboratory s authorshi and ublication ractices should also be considered. i 7b. Research environment Different mentors establish different research environments. Some laboratories are highly cometitive; others emhasize cooeration. Some mentors are intimately involved in all asects of the rojects they suervise; others delegate authority. Similarly, different researchers like to work in different environments. Some enjoy indeendence; others like to have close working relationshis with colleagues. Some thrive in cometitive environments; others refer cooerative working relationshis. Although there is no single formula for a good research environment, there are some fundamentals that mentors and trainees should kee in mind. Equal treatment. Research ability is not tied to race, gender, ethnicity, or sexual orientation. These factors have no bearing on one s success as a researcher. Therefore, research environments should not ut someone at a disadvantage based on who they are. If cometition is encouraged in a way that uts any distinguishable grou at a significant disadvantage, it is not accetable. All students should be subject to the same level of suervision and scrutiny. Aside from legal obligations to avoid discrimination in the worklace, researchers have a i 107

124 ORI Introduction to the Resonsible Conduct of Research University of Michigan Mentoring within a Diverse Community Need for Role Models Students from historically underreresented or marginalized grous have a harder time finding faculty role models who might have had exeriences similar to their own. As some students say, they want to find someone who looks like me; someone who immediately understands my exeriences and ersectives; someone whose very resence lets me know I, too, can make it in the academy. Feelings of Isolation Students from historically underreresented grous can feel articularly isolated or alienated from other students in their deartments, esecially if the comosition of a rogram is highly homogenous. Burden of Being a Sokeserson Students from underreresented grous often exend a lot of time and energy seaking u when issues such as race, class, gender, or sexual orientation arise or are being ignored. These students oint out how most of their eers have an advantage in not carrying such a burden. Seeking Balance Students observe that rofessors need to devote large arts of their lives to their work in order to be successful in the academy. Students from all discilines tell us that they feel faculty exect them to send every waking minute on their work. This ercetion of faculty exectations, accurate or not, is of grave concern to students who have children or wish to, as well as for those who want to balance their lives with their other interests. htt:// rofessional obligation to work to assure equal access to their rofession, articularly if their work is ublicly suorted. Professional ractice. Researchers should maintain research environments that resect acceted ractices for the resonsible conduct of research. Trainees learn by examle as well as formal training. They assume, not unreasonably, that the ractices they observe are aroriate ractices. Mentors therefore have an obligation to maintain research environments that set aroriate examles. They should not themselves make unreasonable authorshi demands, fail to honor agreements made with 108

125 Chater 7: Mentor and Trainee Resonsibilities trainees, inaroriately cut corners in research, or engage in other ractices that run counter to acceted ractices for the resonsible conduct of research. Training in the resonsible conduct of research. Beginning in 1989 and in line with recommendations made by the Institute of Medicine (IOM, 1989), the National Institutes of Health (NIH) required reciients of National Research Service Institutional Training Program awards (training grants) to offer instruction in the resonsible conduct of research (RCR). The National Science Foundation (NSF) has a similar requirement for reciients of its Integrative Graduate Education and Research Traineeshi (IGERT) Program awards. Later reorts, notably by the 1995 Commission on Research Integrity, called for broadening this requirement to all PHS-funded research, but such a requirement has not been imlemented. Nonetheless, there is widesread agreement that RCR training should be integral to the research environment, with heavy emhasis given to the role the mentor lays in roviding this training. 7c. Suervision and review When mentors accet trainees, they assume resonsibility for assuring that the ersons under their suervision are aroriately and roerly trained. This resonsibility is articularly imortant in research since for the most art there are no other checks on the qualifications of new researchers. Researchers do not take licensing exams. They are judged rimarily by the quality of their research, which should be best known to the erson directly suervising their work, that is, to their mentor. Proer suervision of a trainee takes time. In one way or another a mentor needs to: assure roer instruction in research methods, foster the intellectual develoment of the trainee, 109

126 ORI Introduction to the Resonsible Conduct of Research imart an understanding of resonsible research ractices, and routinely check to make sure the trainee develos into a resonsible researcher. i Mentors do not need to check all asects of a trainee s work directly. In large laboratories, ostdocs often suervise graduate students and laboratory technicians might teach secific laboratory skills. Training in the resonsible use of animals is often done through an animal care rogram. However, the ultimate resonsibility for training rests with the mentor. Proer suervision and review lay an imortant role in quality control. Trainees can make mistakes. Some have deliberately falsified or fabricated data. Mentors should review work done under their suervision carefully enough to assure that it is well done and accurate. This can be accomlished by: Emory University School of Medicine Policy for Postdoctoral Fellows Mentor Obligations Postdoctoral research oortunities at Emory University School of Medicine are intended to foster the training of basic and clinical research scientists. Included within this goal is the concet that ostdoctoral fellows, with the guidance of their mentors, will develo a scientific roject that utilizes the creativity and indeendence of the fellow. In this sirit, the mentor will rovide adequate facilities, funds, and the aroriate guidance to achieve the agreed-uon goals of the roject. In addition, mentors should rovide guidance in critical review of scientific information, grant writing, manuscrit writing and rearation, resentation of scientific information, and in the art of erforming research. Mentors should also advise and as ossible, aid fellows in decisions regarding future emloyment otential and career aths. Mentor review of fellow erformance and career develoment should be conducted at least once er year. A member(s) of the deartmental senior faculty should be designated to serve as liaison with deartmental ostdoctoral fellows, faculty, and the Office of Postdoctoral Education and its advisory committees. htt:// doctoral%20fellows% df 110

127 Chater 7: Mentor and Trainee Resonsibilities reviewing laboratory notebooks and other comilations of data; reading manuscrits reared by trainees carefully to assure that they are accurate, well-reasoned, and give roer credit to others; meeting with trainees on a regular basis to kee in touch with the work they are doing; and encouraging trainees to resent and discuss data at laboratory meetings. Some of this resonsibility can be delegated to others, but as with all other matters regarding training, the mentor should assume ultimate resonsibility. i 7d. Transition to indeendent researcher The ultimate goal of research training is to roduce indeendent researchers who can establish their own research rograms, take on trainees, and hel researchdeendent discilines grow. This means that the mentor s final resonsibility to trainees is to hel them get established as indeendent researchers. History has reeatedly shown that exerienced researchers often do not give over control to the next generation easily. They have a difficult time seeing ideas they lanted grow in another erson or having someone they trained head out in new directions. And yet in many fields, it is well documented that researchers are most roductive early in their careers, when they are first making their way as indeendent researchers. The roblem of trainee versus indeendent researcher is most aarent in ostdoctoral training. Postdocs, as they are commonly known, are usually well reared to undertake indeendent work, and yet they are still working under someone else s suervision. The fact that they are neither official students nor official faculty gives them few rights and rotections. The fact that they are usually suorted by 111

128 ORI Introduction to the Resonsible Conduct of Research i someone else s funding leaves them oen to exloitation. To rotect against such exloitation, a new organization, the National Postdoctoral Association, has recently been established to address national issues relevant to ostdocs and focus ublic debate on how to imrove the lives of ostdocs at all levels. Researchers who suervise ostdocs should carefully work out their relationshi with this unique and imortant grou of researchers in training. Some suervision is still necessary, but not as much as for graduate students. Postdocs may have their own funding and assume all the duties of a rincial investigator, even if for administrative uroses their funding comes through their mentor. They may deserve first authorshi on all of their aers, even though the mentor was involved in the research. Most imortantly, they should be encouraged to develo the indeendence and record needed to get a regular research aointment, thereby aying back society s investment in years of research training and the student s investment in her or his own career. 112

129 Chater 7: Mentor and Trainee Resonsibilities Questions for discussion 1 Can elements of the mentor-trainee relationshi be reduced to a written agreement that both arties would sign at the beginning of the relationshi? 2 What are the qualities of a good mentor? A good trainee? 3 What are the qualities of a good research environment and how can they be fostered? 4 What is the urose of ostdoctoral training and how long should it last? 5 Can good mentoring be taught, monitored, and evaluated? 113

130 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Commission on Research Integrity. Integrity and Misconduct in Research: Reort of the Commission on Research Integrity, Washington, DC: Health and Human Services, (available at: htt:// Gottesman, MM. A Guide to Training and Mentoring in the Intramural Research Program at NIH, Bethesda, MD: National Institutes of Health, (available at: htt://www1.od.nih. gov/oir/sourcebook/ethic-conduct/mentor-guide.htm) Institute of Medicine. The Resonsible Conduct of Research in the Health Sciences, Washington, DC: National Academies of Science, (available at: htt:// books/ /html/) National Institutes of Health. Alcohol, Drug, and Mental Health Administration. Requirement for Programs on the Resonsible Conduct of Research in National Research Service Award Institutional Training Programs, NIH Guide for Grants and Contracts 18 (1989): 1. (available at: htt:// guide/historical/1989_12_22_vol_18_no_45.df) National Science Foundation. Integrative Graduate Education and Research Traineeshi (IGERT) Program, Washington, DC: NSF, (available at: htt:// nsf02145.df) General Information Web Sites Association for Women in Science. Home Page. htt:// MentorNet. The E-Mentoring Network for Women in Engineering and Science. htt:// National Postdoctoral Association. Home Page. (available at: htt:// DBBE/NPA_Home.htm ) 114

131 Chater 7: Mentor and Trainee Resonsibilities Additional Reading Association for Women in Science. Mentoring Means Future Scientists, Washington, DC: Association for Women in Science, Gadlin, H, Jessar, K. Preemting Discord: Prenutial Agreements for Scientists, The NIH Catalyst, May-June (2002). (available at: htt:// National Academy of Sciences, National Academy of Engineering, Institute of Medicine. Adviser, Teacher, Role Model, Friend: On Being a Mentor to Students in Science and Engineering, Washington, DC: National Academy Press, (available at: htt:// University of Michigan. Horace H. Rackham School of Graduate Studies. How to Mentor Graduate Students: A Guide for Faculty in a Diverse University, Ann Arbor, MI: University of Michigan, (available at: htt:// Publications/FacultyMentoring/contents.html) 115

132 Collaboration or cometition?

133 Chater 8: Collaborative Research 8. Collaborative Research Researchers increasingly collaborate with colleagues who have the exertise and/or resources needed to carry out a articular roject. Collaborations can be as simle as one researcher sharing reagents or techniques with another researcher. They can be as comlex as multicentered clinical trials that involve academic research centers, rivate hositals, and for-rofit comanies studying thousands of atients in different states or even countries. Any roject that has more than one erson working on it requires some collaboration, i.e., working together. In most rojects, however, one erson, commonly called the rincial investigator or PI, is in charge. Others work under the PI s direction. In this chater, the focus will be on grous of researchers who are all more or less equal artners working on a common, collaborative roject. In collaborative rojects, researchers continue to have the resonsibilities discussed in other chaters in the ORI Case Study Sharon, Ben, and Terra met during a late-night discussion at a rofessional meeting. They share a common interest in learning disorders but come from different scientific backgrounds. Sharon works at the cutting edge of brain imaging technology. Ben is an educational sychologist interested in re-school children in inner cities. Terra has been utting her knowledge as a hysiologist to work exloring the effects of alternative medicines. As late night turns to early morning, the newly met trio begins to see benefits from working together and starts sketching out a grant roosal. The scientific ideas quickly fall into lace, but some of the logistics raise questions that need answers. Who should submit the roosal, through which university? Do all three need to get IRB aroval to work on the roject? What will haen if their work has ractical alications? How should they go about answering these questions? Are there other imortant questions that should be asked as well? 117

134 ORI Introduction to the Resonsible Conduct of Research i Introduction to RCR, but they assume some additional resonsibilities stemming from collaborative relationshis. These additional resonsibilities arise from the added burdens of: the increasingly comlex roles and relationshis; common, but not necessarily identical, interests; management requirements; and cultural differences inherent in any large roject but esecially in collaborative rojects. Secial attention to these added burdens can hel kee collaborative rojects running smoothly. 8a. Roles and relationshis Effective collaboration begins with a clear understanding of roles and relationshis, which should begin the day the collaboration is established by discussing and reaching agreement on the details of the collaborative relations. Before any work is undertaken, there should be some common understanding of: the goals of the roject and anticiated outcomes; the role each artner in the collaboration will lay; how data will be collected, stored, and shared; how changes in the research design will be made; who will be resonsible for drafting ublications; the criteria that will be used to identify and rank contributing authors; who will be resonsible for submitting reorts and meeting other requirements; who will be resonsible for or have the authority to seak ublicly for the collaboration; how intellectual roerty rights and ownershi issues will be resolved; and 118

135 Chater 8: Collaborative Research how the collaboration can be changed and when it will come to an end. Clear understandings in advance are the best way to avoid comlications and disagreements later in a collaboration. Obviously, situations can arise during a collaboration that could not have been anticiated in advance. For this reason, it is imortant for effective communication to continue throughout any collaborative roject. Collaborators should: share findings with colleagues in the collaboration and ay attention to what others are doing; reort and discuss roblems as well as findings; make other collaborators aware of any imortant changes, such as changes in key ersonnel; and share related news and develoments so that everyone in the collaboration is equally knowledgeable about imortant information. i All of these oints may seem obvious, but they can easily get lost in the day-to-day details of doing research. However, if you are working with collaborators, kee in touch. Without effective communication, collaborations can easily run into roblems and dissolve. 8b. Management In addition to effective communication, collaborative rojects should have effective management lans that cover: financial issues, training and suervision, formal agreements, and comliance. When a PI is in charge of all of the work done on a roject, the lines of resonsibility are clear. The PI is ultimately resonsible for all asects of the roject, from financial 119

136 ORI Introduction to the Resonsible Conduct of Research exenditures to staff training, data collection, reorting, and wraing u the roject. In collaborative research, the artners in the collaboration share resonsibilities. Under these circumstances, an effective management lan is essential. Financial management. The exenditure of Federal research funds is subject to financial management rules issued by the Office of Management and Budget in Circulars A-21 and A-110 (see boxes, below and next age). A-21 covers all asects of financial management, from accounting rocedures to reorting requirements. For examle, one section carefully describes, in fairly technical terms, allowable and unallowable exenses. Some travel costs are allowed; others are not. A-110 sets out rules for issuing government grants and contracts. It exlains how equiment should be urchased and used, even after the roject has come to an end. Office of Management and Budget Circular A Travel costs. a. General. Travel costs are the exenses for transortation, lodging, subsistence, and related items incurred by emloyees who are in travel status on official business of the institution. Such costs may be charged on an actual basis, on a er diem or mileage basis in lieu of actual costs incurred, or on a combination of the two, rovided the method used is alied to an entire tri and not to selected days of the tri, results in reasonable charges, and is in accordance with the institution s travel olicy and ractices consistently alied to all institutional travel activities. b. Lodging and subsistence. Costs incurred by emloyees and officers for travel, including costs of lodging, other subsistence, and incidental exenses, shall be considered reasonable and allowable only to the extent such costs do not exceed charges normally allowed by the institution in its regular oerations as a result of an institutional olicy and the amounts claimed under sonsored agreements reresent reasonable and allocable costs. c. Commercial air travel. Airfare costs in excess of the lowest available commercial discount airfare. htt:// 120

137 Chater 8: Collaborative Research Office of Management and Budget Circular A Equiment. (c) The reciient shall use the equiment in the roject or rogram for which it was acquired as long as needed, whether or not the roject or rogram continues to be suorted by Federal funds and shall not encumber the roerty without aroval of the Federal awarding agency. When no longer needed for the original roject or rogram, the reciient shall use the equiment in connection with its other federally-sonsored activities, in the following order of riority: (i) Activities sonsored by the Federal awarding agency which funded the original roject, then (ii) activities sonsored by other Federal awarding agencies. htt:// Every federally funded research roject must adhere to the rules set out in A-21 and A-110. Therefore, collaborative rojects must be managed in ways that assure that all exenditures are in comliance, from those incurred by the rimary investigators working at major research institutions to survey workers or clinicians working in the field. Training and suervision. Wherever they work, research staff should be roerly trained and suervised. In some instances the training is mandatory. Anyone who works with research animals or human subjects must have formal training. The same is true of staff who work with hazardous substances or biohazards. These requirements extend to everyone working on a collaborative roject, whether they are at a different institution, in another state, or even another country. Management lans for collaborative rojects therefore should include the training and suervision of all researchers and staff working on the roject. i Formal agreements. Some asects of collaborative rojects must be worked out in advance in formal agreements. For examle, when research is carried out in more than one lace, it is sometimes necessary to transfer 121

138 ORI Introduction to the Resonsible Conduct of Research materials from one institution to another. Since many materials are carefully controlled, to rotect either safety or ownershi, the terms of transfer should be carefully selled out, including (see NIH-recommended rovisions below): who owns the materials, the use to which they can be ut, and roer acknowledgment of the source. These agreements hel rotect the interests of the collaborators by assuring that ownershi will be resected and that the materials will be roerly used. Comliance. Increasingly, research institutions must in one way or another certify that they are in comliance with secific research regulations. When research institutions are involved in collaborative rojects, an institution s resonsibility for comliance can extend to other institutions. If the other institution is a U.S. university with a large National Institutes of Health Recommended Provisions for a Materials Transfer Letter 1. The [sulied] MATERIAL is the roerty of the PROVIDER and is made available as a service to the research community. 2. THIS MATERIAL IS NOT FOR USE IN HUMAN SUBJECTS. 3. The MATERIAL will be used for teaching or not-for-rofit research uroses only. 4. The MATERIAL will not be further distributed to others without the PROVIDER s written consent. 6. Any MATERIAL delivered ursuant to this Agreement is understood to be exerimental in nature and may have hazardous roerties. 7. The RECIPIENT agrees to use the MATERIAL in comliance with all alicable statutes and regulations. 8. The MATERIAL is rovided at no cost, or with an otional transmittal fee solely to reimburse the PROVIDER for its rearation and distribution costs. If a fee is requested, the amount will be indicated here: [insert fee] htt:// 122

139 Chater 8: Collaborative Research research ortfolio, that institution most likely already has a comliance lan in lace. However, if the other institution does not do a great deal of research or is located in another country, it may not have thought about its comliance resonsibilities. Management lans for collaborative rojects must take into account the need for meeting comliance resonsibilities throughout the roject sites and not just at one institution. i 8c. Different research settings Most researchers devote their careers to one field of research and send their time talking with colleagues with similar interests. However, science is increasingly best served when researchers work with colleagues in other fields. Physicians and engineers have teamed together to develo miniature wireless devices that can gather information while assing normally through the body. Comuter scientists are working with organic chemists and biologists to develo faster comuters and more flexible dislay devices. Collaborative rojects encourage researchers to ursue interdiscilinary research. For the most art, interdiscilinary research follows the same rules and ractices as discilinary research. There are times, however, when researchers in different fields bring different ractices or exectations to a roject. When this haens, researchers might think of adoting two commonsense rules: do not ignore any resonsibilities, and when there are choices about aroriate action, select the most demanding otion. When in doubt, it makes sense to seek the highest rather than the lowest denominator. Different exectations can enter a roject in a number of ways, esecially when judgments about resonsible ractice are involved. The government and some research i 123

140 ORI Introduction to the Resonsible Conduct of Research i institutions allow researchers to earn u to $10,000 through consulting or other outside emloyment before they have to declare a otential conflict of interest (discussed in Chater 5). Others institutions use lower thresholds, in some cases requiring researchers to reort conflicts of interest if they have any outside financial interests. Different institutions also manage conflicts of interest in different ways, from suervision or reorting to outright rohibition. When there are differences in reorting olicy, the rudent course of action is to go with the lowest financial threshold and accet the most stringent management lan, even though some researchers working on the collaborative roject may not be required to do so. Ownershi issues also raise questions about which rules to follow. One arty to a collaboration may have no interest in reorting a romising idea for develoment; another may feel under an obligation to do so, following either a university s or Federal olicy. There may also be different understandings among the different institutions that are art of a collaboration about what constitutes disclosable information and who owns the information once it is disclosed. Given the consequences of disutes that can erut in these situations, it is essential that every collaborative roject settle disclosure and ownershi issues early in the roject before disutes arise. Waiting longer oens the door for misunderstandings and disuted claims when one of the arties in the collaboration makes a valuable discovery. Finally, there are significant differences in the way researchers in different fields and even different laboratories carry out the routine business of collecting data and ublishing results. Some still collect data in bound laboratory notebooks; others use comuters. In some fields, it is common ractice to circulate early results in newsletters and/or abstracts; in other fields, journal ublications are the referred mode of communication. Different fields have 124

141 Chater 8: Collaborative Research different ways and standards for listing authors. These and other differences should be addressed oenly and early in any collaboration to assure that misunderstandings do not arise later over data collection and ublication. i Questions for discussion 1 Why should collaborative research be encouraged? 2 When should research collaborations be formalized? 3 Are there any drawbacks to collaborative research? What roblems can they raise? 4 Which country s rules should be used in collaborative rojects that are carried out in different countries? 5 What stes should be taken when a collaborative roject comes to an end or a collaboration is dissolved? 125

142 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements National Institutes of Health. Princiles And Guidelines for Reciients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 FR (1999). (available at: htt:// dfs/64fr72090.df) Office of Management and Budget. OMB Circular A-110, Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hositals and Other Non-Profit Organizations, Washington, DC: OMB, (available at: htt:// html). Circular A-21: Cost Princiles for Educational Institutions, Washington, DC: OMB, (available at htt://www. Additional Reading Davis, TP, ed. Management of Biomedical Research Laboratories: Proceedings of a National Conference, Tucson, AZ: University of Arizona, (available at: htt:// ast_conf.shtml) Gadlin, H, Jessar, K. Preemting Discord: Prenutial Agreements for Scientists, The NIH Catalyst, May-June (2002). (available at: htt:// 126

143 Chater 8: Collaborative Research Gottesman, MM. Funding of Intramural Research Program/ Extramural Research Program Collaborations, (available at: htt:// htm) Government-University-Industry Research Roundtable, NetLibrary Inc. Overcoming Barriers to Collaborative Research: Reort of a Worksho, Washington, DC: National Academy Press, Macrina, FL. Dynamic Issues in Scientific Integrity: Collaborative Research, Washington, DC: American Society for Microbiology, (available at: htt:// CCLIBRARYFILES/FILENAME/ /research.df) Schwartz, J. Silence is not Golden: Making Collaborations Work, Bethesda, MD: National Institutes of Health, nd. (available at: htt:// Vonortas, NS, Hamdi, M. United Nations Conference on Trade and Develoment. Partnershis and Networking in Science and Technology for Develoment, New York: United Nations, Wagner, CS, United States. Office of Science and Technology Policy, Science and Technology Policy Institute (Rand Cororation). Linking Effectively: Learning Lessons from Successful Collaboration in Science and Technology, Santa Monica, CA: Rand,

144 Part IV.

145 Reorting and Reviewing Research

146 ORI Introduction to the Resonsible Conduct of Research Part IV: Reorting and Reviewing Research Research has no value if it is not made ublic. Results are shared with colleagues so they can be tested, used to advance knowledge, and ut to work. They are shared with the ublic and olicymakers so that they can be used to make decisions about funding and ractical alication. 130

147 Part IV: Reorting and Reviewing Research While researchers might engage in research simly for their own satisfaction, if their work receives ublic suort, they have a resonsibility to share that work with others. Chater 9, Authorshi and Publication, covers the resonsibilities researchers have when they share results with others through informal communications, oral resentations, scholarly ublications, and ublic statements. Whatever mechanism is used, research results should be shared honestly, efficiently, and without bias. Dishonesty and bias undermine the usefulness of research ublications; inefficiency (ublishing the same research several times) wastes ublic funds and the valuable time of reviewers and journal editors. Chater 10, Peer Review, describes the resonsibilities researchers have when they review the work of other researchers. Non-eers individuals who do not have equal training and knowledge cannot evaluate the quality and imortance of research. Peers can and therefore lay a crucial role in many imortant decisions about the funding, ublication, and use of research. 131

148 Resonsible authorshi?

149 Chater 9: Authorshi and Publication 9. Authorshi and Publication Researchers share the results of their works with colleagues and the ublic in a variety of ways. Early results are usually shared during laboratory meetings, in seminars, and at rofessional meetings. Final results are usually communicated to others through scholarly articles and books. Public communication takes lace through ress releases, ublic announcements, newsaer articles, and ublic testimony. Some of these ways of communicating research results (i.e., of ublication) are well structured and controlled; others are informal and have few controls. Whether structured or informal, controlled or free ranging, resonsible ublication in research should ideally meet some minimum standards. All forms of ublication should resent: Case Study As his first major grant is coming to an end, several imortant elements of Dr. Sanjay K. s research suddenly fall into lace. The last series of exeriments his graduate student ran clearly link the gene they are studying to a articular tye of cancer. His ostdoc s work on the roteins associated with this gene could ave the way for ossible cures. With these results in hand, he is finally ready to make a strong case for continued suort and, haily, his ending romotion. All he has to do now is ublish the results. A week later, Sanjay s otimism starts to fade. As might have been exected, his deartment chair was delighted with his rogress, but then suggested that the first aer announcing the results come out under her name to give it broader circulation. Meanwhile, his ostdoc and graduate student have gotten into a heated debate about the order their names should aear on the aer; the university s ublic affairs office has asked for a summary of the results for a ress release; and the technology transfer office has called telling him to hold all ublications until they can evaluate the commercial otential of his work. What should Sanjay do? Which of these roblems should Sanjay tackle first? Is there anything he could have done to assure that things went more smoothly when he was ready to ublish his results? 133

150 ORI Introduction to the Resonsible Conduct of Research a full and fair descrition of the work undertaken, an accurate reort of the results, and an honest and oen assessment of the findings. In assessing the comleteness of any ublications, researchers should ask whether they have described: what they did (methods), what they discovered (results), and what they make of their discovery (discussion). It is, however, not as easy as one might anticiate to meet these exectations. 9a. Authorshi The names that aear at the beginning of a aer serve one imortant urose. They let others know who conducted the research and should get credit for it. It is imortant to know who conducted the research in case there are questions about methods, data, and the interretation of results. Likewise, the credit derived from ublications is used to determine a researcher s worth. Researchers are valued and romoted in accordance with the quality and quantity of their research ublications. Consequently, the authors listed on aers should fairly and accurately reresent the erson or ersons resonsible for the work in question. Contribution. Authorshi is generally limited to individuals who make significant contributions to the work that is reorted. This includes anyone who: was intimately involved in the concetion and design of the research, assumed resonsibility for data collection and interretation, articiated in drafting the ublication, and aroved the final version of the ublication. There is disagreement, however, over whether authorshi should be limited to individuals who contribute to all hases 134

151 Chater 9: Authorshi and Publication ICJME Statement on Authorshi An author is generally considered to be someone who has made substantive intellectual contributions to a ublished study.... Authorshi credit should be based on 1) substantial contributions to concetion and design, or acquisition of data, or analysis and interretation of data; 2) drafting the article or revising it critically for imortant intellectual content; and 3) final aroval of the version to be ublished. Authors should meet conditions 1, 2, and 3. All ersons designated as authors should qualify for authorshi, and all those who qualify should be listed. Each author should have articiated sufficiently in the work to take ublic resonsibility for aroriate ortions of the content. htt:// of a ublication or whether individuals who made more limited contributions deserve authorshi credit. The widely acceted Uniform Requirements for Manuscrits Submitted to Biomedical Journals, authored by the International Committee of Medical Journal Editors (ICMJE), sets a high standard for authorshi. It recommends limiting authorshi to ersons who contribute to the concetion and design of the work or to data collection and interretation and, in addition, lay an imortant role in drafting and aroving the final ublication. Anyone who lays a lesser role can be listed under acknowledgments but not at the beginning of the aer as an author. As influential as they are, the ICMJE recommendations on authorshi are not uniformly followed, even in journals that subscribe to the ICMJE Requirements. Practices for determining authors vary considerably by disciline and even from laboratory to laboratory. This laces most of the resonsibility for decisions about authorshi on the researchers who articiated in the work reorted in each i 135

152 ORI Introduction to the Resonsible Conduct of Research ublication. These decisions are best made early in any roject, to avoid misunderstandings and later disutes about authorshi. Imortance. Authors are usually listed in their order of imortance, with the designation first or last author carrying secial weight, although ractices again vary by disciline. Academic institutions usually will not romote researchers to the rank of tenured faculty until they have been listed as first or last author on one or more aers. As with the rincile of contribution, however, there are no clear rules for determining who should be listed as first author or the order in which other authors should be listed. The ICMJE Requirements simly note that: The order of authorshi on the byline should be a joint decision of the coauthors. Authors should be reared to exlain the order in which authors are listed. i Some journals have secific rules for listing authors; others do not, again lacing most of the resonsibility for this decision on the authors themselves. Corresonding or rimary author. Many journals now require one author, called the corresonding or rimary author, to assume resonsibility for all asects of a ublication, including: the accuracy of the data, the names listed as authors (all deserve authorshi and no one has been neglected), aroval of the final draft by all authors, and handling all corresondence and resonding to inquiries. In acceting this resonsibility, corresonding authors should take secial note of the fact that they are acting on behalf of their colleagues. Any mistakes they make or fail to catch will affect their colleagues as well as their own careers. 136

153 Chater 9: Authorshi and Publication 9b. Elements of a resonsible ublication Each element of a ublication serves an imortant urose and must be carefully reared to make sure it serves that urose. Abstracts. Abstracts summarize the content of ublications in sufficient detail to allow other researchers to assess relevance to their own work. Abstracts, therefore, should neither understate nor overstate the imortance of findings. Negative results that might be imortant to other researchers or the ublic should be mentioned. The data resented in the abstract should be the same as the data resented in the body of the ublication an obvious requirement, but one that studies of ublication ractices show some authors do not follow (see Pitkin, Additional Reading). Standards for Reorting Research Results The CONSORT Statement Abstract To comrehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interretation. That goal can be achieved only through comlete transarency from authors. Desite several decades of educational efforts, the reorting of RCTs needs imrovement. Investigators and editors develoed the original CONSORT (Consolidated Standards of Reorting Trials) statement to hel authors imrove reorting by using a checklist and flow diagram. The revised CONSORT statement resented here incororates new evidence and addresses some criticisms of the original statement. The checklist items ertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because emirical evidence indicates that not reorting the information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to deict the assage of articiants through an RCT. The revised flow diagram deicts information from four stages of a trial (enrollment, intervention allocation, follow-u, and analysis). The diagram exlicitly shows the number of articiants, for each intervention grou, included in the rimary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-totreat analysis. htt:// 137

154 ORI Introduction to the Resonsible Conduct of Research i i To ensure comleteness and accuracy, many journals now use structured abstracts. This assures that all of the key elements of the ublication are mentioned and easily identified. With scientific ublications now running in the millions er year in well over 100,000 journals, researchers cannot read all seemingly relevant ublications in detail. They must rely on abstracts to oint them to imortant develoments and findings. Methods. Researchers cannot check and build on the work of others without knowing how it was conducted. Methods therefore should be described in sufficient detail to allow other researchers to relicate them. When researchers use well-established methods, this section of a ublication can be shortened, rovided aroriate references are given to a full descrition of the methods along with any changes that have been made. New or unique methods should be described in more detail to allow other researchers to relicate the work. Results. Research results should be reorted in sufficient detail to allow other researchers to draw their own conclusions about the work. This does not mean that every iece of recorded data should be reorted. Researchers can and must rocess their raw data before ublication (to kee ublications to a reasonable size if for no other reason). However, results should not be left out just because they do not agree with the conclusions the authors would like to reach. The results section should reresent a comlete summary of what was discovered, leaving interretations for the closing discussion. Discussion. Researchers can and should evaluate the significance of their findings under discussion also called conclusion or summary. This ortion of a ublication hels those who are less familiar with the field understand the imortance of the findings. It also rovides a venue for identifying unresolved roblems and future research needs. 138

155 Chater 9: Authorshi and Publication Since the discussion is read by individuals who may not be able to evaluate its validity, it is articularly imortant that authors avoid bias and one-sided reorting in this section. Cautions and other interretations should be mentioned along with the limitations of the study to rovide a balanced view of the reorted results. Review articles (articles that survey research findings in articular areas) should make an honest effort to cover all relevant work. It is not always easy to recognize one s own biases, which is a good reason to ask colleagues to read and comment on manuscrits before they are submitted for ublication. i Notes, bibliograhy, and acknowledgments. Notes, bibliograhy, and acknowledgments should be used to lace ublications in context and to give credit to others for their ideas, suort, and work. They serve to: rovide suort for imortant statements of fact or assumtions, document the work of others used in the ublication, oint to additional reading and resources, and recognize the suort of funding agencies or colleagues and staff who do not qualify as authors. Since others rely on and trust this information, it, along with every other element of a resonsible ublication, should be fair and accurate. 9c. Practices that should be avoided Cometition in research for funding and recognition laces considerable ressure on researchers to ublish. Ideally, quality should matter more than quantity, but in reality quantity the number of articles ublished is often used as a measure of roductivity and ability. However, no matter how imortant it may be to ublish, some ublication ractices should be avoided. 139

156 ORI Introduction to the Resonsible Conduct of Research The Council of Science Editors A New Standard for Authorshi (1998 roosal) Paul J. Friedman, MD Publication has become the essential achievement for academic advancement for both clinical and basic scientists, although the tye and number of ublications demanded may vary widely. Desite a recent increased emhasis on teaching as a meritorious activity, faculty and trainees realistically feel intense ressure to ublish. One unfortunate result has been a roliferation of aers and journals and a variety of abuses of trainees, junior colleagues, and atients, and of integrity. To hel restore a sense of roortion and confidence in the validity of biomedical ublication, this conference rooses a new ste in the evolution of the concet of authorshi. We roose to ublish the contributions of the individuals associated with a manuscrit. The information will be solicited on a modified coyright form, which will be filled out and signed by all the authors. We roose a check-off list, such as the following: Concet Data collection and/or rocessing Design Analysis and/or interretation Suervision Literature search Writing Critical review Resources Material htt:// Honorary authorshi. The ractice of listing undeserving authors on ublications, called honorary authorshi, is widely condemned and in the extreme considered by some to constitute a form of research misconduct. However, common agreement notwithstanding, honorary authorshi is a significant roblem in research ublication today (see articles by Drenth and Flanagin, Additional Reading). Researchers are listed on ublications because they: are the chair of the deartment or rogram in which the research was conducted, rovided funding for the research, are the leading researcher in the area, rovided reagents, or served as a mentor to the rimary author. 140

157 Chater 9: Authorshi and Publication Persons in these ositions can make significant contributions (see left) to a ublication and may deserve recognition. However, they should not be listed if these are the only contributions they made. Salami ublication. Salami ublication (sometimes called bologna or trivial ublication) is the ractice of dividing one significant iece of research into a number of small exeriments (least ublishable units or LPUs), simly to increase the number of ublications. This ractice may distort the value of the work by increasing the number of studies that aear to suort it. It also wastes valuable time and resources. Before an article is ublished it is reviewed, edited, and in one form or another reared for ublication. After ublication it is entered into indexes and databases, such as the National Library of Medicine s PubMed. Libraries and individuals urchase the journal in which it is ublished. If the same information could be summarized in one article as oosed to two, three, or more, everyone involved, from the ublishers to libraries and the researchers who have to kee u to date on current information, benefits. Researchers therefore should avoid trivial or salami ublication. Dulicate ublication. Dulicate ublication is the ractice of ublishing the same information a second time without acknowledging the first ublication. This ractice not only wastes time and resources but can also distort the research record and endanger ublic health. Researchers rely on meta-analyses (analyses of a grou of similar exeriments or studies of studies) to imrove their understanding of difficult roblems. One clinical trial or eidemiological study may not roduce clear evidence, but the ooled results of many related studies can. However, if some of the studies in the ooled study (meta-analysis) have been ublished two or more times without roer notice, the results of the meta-analysis will be unfairly weighted in the 141

158 ORI Introduction to the Resonsible Conduct of Research direction of the dulicate ublication. Therefore, dulicate ublication is not only decetive but oses real dangers to ublic health and safety (see articles by Jefferson and Tramer, Additional Reading). Premature ublic statements. Academic or scholarly ublication ractices are designed to assure that the information conveyed to broader audiences through these ractices is accurate and fairly resented. While the system is not foolroof and erroneous or biased information is from time to time ublished, standard ublication ractices do serve an imortant quality control role in research. Accordingly, researchers should follow standard ublication ractices when making research results ublic and not issue remature ublic statements about their work before it has been reviewed. From time to time there may be overriding circumstances, such as early indications of a significant threat to ublic health or safety, but for the most art research results should be made ublic only after they have been carefully reviewed and roerly reared for ublication. 142

159 Chater 9: Authorshi and Publication Questions for discussion 1 What are the acceted criteria for authorshi in your field of research? If there are none, what should they be? 2 Should researchers be allowed to omit some details from the methods section of their ublications until they have had time to atent their methods? 3 What should a researcher do if the journal that has acceted a ublication will not let the researcher ublish the method or results in as much detail as the researcher feels is necessary? 4 What should a researcher do if an undeserving author in a osition of some authority demands authorshi status on a aer? 5 What factors should be considered when making a decision to ublish the results of a study in one article versus several articles? 143

160 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements Council of Biology Editors. Scientific Style and Format, CBE, (available at: htt:// style.cfm) International Committee of Medical Journal Editors. Uniform Requirements for Manuscrits Submitted to Biomedical Journals, (available at: htt:// Michigan State University. Michigan State University Guidelines on Authorshi, East Lansing, MI: MSU, (available at: htt:// Society for Neuroscience. Resonsible Conduct Regarding Scientific Communication, SN, (available at: htt:// cfm?agename=resonsibleconduct&section=ublications) Additional Reading Begg, C, Cho, MK, Eastwood, S, Horton, R, Moher, D, Oking, I, Pitkin, RM, Rennie, D, Schulz, KF, Simel, D, Strou, D. Imroving the Quality of Reorting of Randomized Controlled Trials: The CONSORT Statement, Journal of the American Medical Association 276 (1996): Bloemenkam, DGM, Walvoort, HC, Hart, W, Overbeke, AJPM. [Dulicate ublication of articles in the Dutch Journal of Medicine in 1996], Nederlands Tijdschrift voor Geneeskunde 143, 43 (1999): Budd, JM, Sievert, M, Schultz, TR. Phenomena of Retraction: Reasons for Retraction and Citations to the Publications, Journal of the American Medical Association 280, 3 (1998): Budd, JM, Sievert, M, Schultz, TR, Scoville, C. Effects of Article Retraction on Citation and Practice in Medicine, Bulletin of the Medical Libraries Association 87, 4 (1999): Drenth, JP. Multile Authorshi: The Contribution of Senior Authors, Journal of the American Medical Association 280, 3 (1998): Flanagin, A, Carey, LA, Fontanarosa, PB, Phillis, SG, Pace, BP, Lundberg, GD, Rennie, D. Prevalence of Articles with Honorary Authors and Ghost Authors in Peer-reviewed Medical Journals, Journal of the American Medical Association 280, 3 (1998): Hoen, WP, Walvoort, HC, Overbeke, AJ. What are the Factors Determining Authorshi and the Order of the Authors Names? A Study Among Authors of the Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine), Journal of the American Medical Association 280, 3 (1998):

161 Chater 9: Authorshi and Publication Jadad, AR, Cook, DJ, Jones, A, Klassen, TP, Tugwell, P, Moher, M, Moher, D. Methodology and Reorts of Systematic Reviews and Meta-analyses: A Comarison of Cochrane Reviews with Articles Published in Paer-based Journals, Journal of the American Medical Association 280, 3 (1998): Jefferson, T. Redundant Publication in Biomedical Sciences: Scientific Misconduct or Necessity? Science and Engineering Ethics 4, 2 (1998): Jones, AH, McLellan, F. Ethical Issues in Biomedical Publication, Baltimore: Johns Hokins University Press, Pitkin, RM, Branagan, MA. Can the Accuracy of Abstracts be Imroved by Providing Secific Instructions? A Randomized Controlled Trial, Journal of the American Medical Association 280, 3 (1998): Pitkin, RM, Branagan, MA, Burmeister, LF. Accuracy of Data in Abstracts of Published Research Articles, Journal of the American Medical Association 281, 12 (1999): Scherer, RW, Crawley, B. Reorting of Randomized Clinical Trial Descritors and Use of Structured Abstracts, Journal of the American Medical Association 280, 3 (1998): Seck, BW. Publication Peer Review: An Annotated Bibliograhy, Bibliograhies and Indexes in Mass Media and Communications, no. 7, Westort, CT: Greenwood Press, Tarnow, E. The Authorshi List in Science: Junior Physicists Percetions of Who Aears and Why, Science and Engineering Ethics 5, 1 (1999): Tramer, MR, Reynolds, DJ, Moore, RA, McQuay, HJ. Imact of Covert Dulicate Publication on Meta-analysis: A Case Study, British Medical Journal 315, 7109 (1997): Wilcox, LJ. Authorshi: The Coin of the Realm, The Source of Comlaints, Journal of the American Medical Association 280, 3 (1998):

162 One of the benefits of serving as a eer reviewer?

163 Chater 10: Peer Review 10. Peer Review Peer review evaluation by colleagues with similar knowledge and exerience is an essential comonent of research and the self-regulation of rofessions. The average erson does not have the knowledge and exerience needed to assess the quality and imortance of research. Peers do. Therefore many imortant decisions about research deend on advice from eers, including: which rojects to fund (grant reviews), which research findings to ublish (manuscrit reviews), which scholars to hire and romote (ersonnel reviews), and which research is reliable (literature reviews and exert testimony). The quality of the decisions made in each case deends heavily on the quality of eer review. Case Study Dr. Sung L. is struggling with the decision whether to agree to review the work of an advanced graduate student at another university for ublication in the major journal in his field. He is familiar with the student's work and attended a session several months ago at which she resented a brief reort on her work. It clearly overlas with his research in a number of ways, which is one reason he has been asked to serve as a reviewer. Dr. L. knows he is qualified to do the review and is confident he can rovide an objective, constructive judgment of the students's work. However, since his students are working on similar roblems, he is concerned about the aearance of a conflict of interest. In addition, he is not sure he wants to learn more about the work in question until he ublishes his own work, to avoid later charges that he unfairly used some of the student s ideas. Finally, there is the matter of yet another lost weekend doing the review, when his deartment chair has already told him to cut down on unaid rofessional service. Should Dr. L. agree to do the review? If he is uncertain about his resonsibilities, where can he get advice? Would the situation be different if he had been asked to review the student s work for an aointment or romotion decision? 147

164 ORI Introduction to the Resonsible Conduct of Research Peer review can make or break rofessional careers and directly influence ublic olicy. The fate of entire research rograms, health initiatives, or environmental and safety regulations can rest on eer assessment of roosed or comleted research rojects. For eer review to work, it must be: timely, thorough, constructive, free from ersonal bias, and resectful of the need for confidentiality. Researchers who serve as eer reviewers should be mindful of the ublic as well as the rofessional consequences of their evaluations and exercise secial care when making these evaluations. 10a. Meeting deadlines The effort researchers ut into eer review is for the most art not comensated. Researchers may receive reimbursement for travel and er diem when they attend secial grant-review sessions and occasionally are aid a basic daily stiend, but this seldom covers the true cost of reviewing a manuscrit or a stack of grant alications. As uncomensated effort, the time researchers devote to eer review can easily take second lace to other obligations. Running a crucial exeriment or submitting a grant alication on time understandably is more imortant than reviewing someone else s work. However ressed you are for time, if you agree to do a review, you should find the time to meet your obligation in a timely manner. Research is cometitive. Researchers are rewarded for discoveries. They should not lose their riority for a discovery due to the tardiness of a reviewer sending comments on a manuscrit. Research is also useful. The 148

165 Chater 10: Peer Review Editors of the Publications Division American Chemical Society Ethical Obligations of Reviewers of Manuscrits 1. every scientist has an obligation to do a fair share of reviewing. 2. A chosen reviewer who feels inadequately qualified to judge the research reorted in a manuscrit should return it romtly to the editor. 3. A reviewer (or referee) of a manuscrit should judge objectively the quality of the manuscrit, of its exerimental and theoretical work, of its interretations and its exosition, with due regard to the maintenance of high scientific and literary standards. A reviewer should resect the intellectual indeendence of the authors. 4. A reviewer should be sensitive to the aearance of a conflict of interest A reviewer should treat a manuscrit sent for review as a confidential document Reviewers should exlain and suort their judgments adequately. 8. A reviewer should be alert to failure of authors to cite relevant work by other scientists, 9. A reviewer should act romtly, submitting a reort in a timely manner. 10. Reviewers should not use or disclose unublished information, arguments, or interretations contained in a manuscrit under consideration, excet with the consent of the author. htt:// announcement of discoveries that can benefit the ublic should not be delayed because someone who agreed to review a manuscrit does not have the time to do the review. Editors, rogram managers, and others who rely on eer review to make decisions generally rovide a deadline for getting the review done when they first contact reviewers. Anyone who agrees to take on a eer review assignment under these conditions should meet the roosed deadline. If the time frame is not reasonable, either decline to do the review or ask for more time in advance. Do not delay someone else s work just because you are short on time. i 149

166 ORI Introduction to the Resonsible Conduct of Research 10b. Assessing quality i Journal editors, grant administrators, and others rely on eers to assess the quality of roosed and ublished research. Some arts of an alication or manuscrit can be checked fairly easily. Are the calculations correct? Is the method that has been used or roosed aroriate? Do the reorted results suort the conclusions? Other arts are more difficult to confirm. Have the data been accurately recorded and reorted? Were the exeriments run? Did the subjects give consent? Do the articles cited in the references and bibliograhy contain the information they are said to contain? Peers who are asked to make judgments about the quality of a roosed or comleted roject must do their best to determine whether the work they have been asked to review is internally consistent and conforms to the ractices of their field of research. This certainly includes: assessing whether the research methods are aroriate; checking calculations and/or confirming the logic of imortant arguments; making sure the conclusions are suorted by the evidence resented; and confirming that the relevant literature has been consulted and cited. At the very least, eer reviewers should be exected to assess whether the manuscrit or roosal under review makes sense and conforms to acceted ractices, based on the information resented. Research that conforms to acceted ractices can still have roblems. Research quality can be comromised by: careless mistakes made in reorting data and/or listing citations; the deliberate fabrication and falsification of data; imroer use of material by others (lagiarism); 150

167 Chater 10: Peer Review inaccurate reorting of conflicts of interest, contributors/ authors; and the failure to mention imortant rior work, either by others or by the researcher submitting a aer for ublication. However, how much eer reviewers can or should do to detect these and other decetive or sloy ractices remains subject to debate. There are limits to the amount of checking that is both reasonable and ractical. Unless given ermission to do so, reviewers should not discuss the work they are reviewing with the authors. In many cases, reviews are blind (no author identification), so reviewers could not check with Society for Neuroscience Resonsible Conduct Regarding Scientific Communication (1998) 2. Reviewers of Manuscrits 2.1. Thorough scientific review is in the interest of the scientific community A thorough review must include consideration of the ethical dimensions of a manuscrit as well as its scientific merit All scientists are encouraged to articiate if ossible when asked to review a manuscrit Anonymity of reviewers should be reserved unless otherwise stated in the guidelines for authors and for reviewers, or unless a reviewer requests disclosure Reviewers should be chosen for their high qualifications and objectivity regarding a articular manuscrit Reviews should not contain harsh language or ersonal attacks Reviews should be romt as well as thorough Reviewers must not use non-ublic information contained in a manuscrit to advance their own research or financial interests Information contained in a manuscrit under review is confidential and must not be shared with others. htt:// 151

168 ORI Introduction to the Resonsible Conduct of Research i authors even if they wanted to. In addition, it is not reasonable to exect reviewers to check every reference and detail. The fact remains, however, that eer reviewers frequently miss roblems that might have been detected had the reviewer checked a little more carefully. If you agree to serve as a eer reviewer, remember that you have essentially been asked to rovide your stam of aroval for someone else s work. In such circumstances, it is wise to do your homework. Do not give your stam of aroval too easily. 10c. Judging imortance In addition to quality, eer reviewers are also asked to make judgments about the imortance of roosed or ublished research. They are asked to answer questions such as: Assuming a researcher could carry out a roosed research roject, is it imortant to do so? Are these research results imortant enough to ublish? Has a researcher made imortant contributions to a field of study? Is this evidence imortant enough to be used in setting olicy? Along with quality, judgments about imortance essentially determine which research is funded or ublished and which researchers are hired and relied uon for advice. Peer reviewers do not always make judgments about imortance with an oen mind. Studies have shown that they can be swayed by: the stature of the researcher who conducted the research or the institution at which the research was conducted; country of origin; a reference for one research method over another, e.g., a clinical versus a laboratory aroach; and the outcome of the studies under review. 152

169 Chater 10: Peer Review For the most art, these factors should not have a bearing on judgments about imortance and yet they do. Each has been shown to influence the judgments eer reviewers make about the ublication of research results (see articles by Callaham, Cho, Dickersin, Godlee, Jadad, and Link, Additional Reading). There is no simle solution to the roblem of bias in eer review. Peers frequently are not of one mind about what is or is not imortant. One reviewer may feel that a field of research should move in one direction, a second in an entirely different direction. Often, it takes time and more research to find out whether a line of investigation or a articular set of findings is imortant. Nonetheless, researchers can take stes to lessen the imact of bias on their judgments and to hel others judge for themselves whether a researcher has biases. One way to lessen the imact of bias is to write transarent reviews. By transarent is meant laying out clearly for anyone reading the review how it was reared, the literature that was used, and the reviewer s own ossible biases. If reviewers fully and carefully exlain how their judgments about imortance were made, others can assess whether they want to accet those judgments. A second way that has been roosed to lessen the imact of bias is to eliminate anonymous reviews. Some argue that this would lessen the candor and rigor of reviews; others that it would make reviewers more accountable. For the resent, most reviews are anonymous, which laces the burden for fairness on the reviewer. If you have strong feelings about a erson or articular line of investigation, tell the erson who asked you to do the review and consider whether you can, in fact, rovide an imartial assessment. i 153

170 ORI Introduction to the Resonsible Conduct of Research 10d. Preserving confidentiality Some information that is shared during eer review is shared confidentially, that is, with the understanding that it will not be shared with anyone else without ermission. Confidentiality is generally required during: grant reviews, manuscrit reviews, and ersonnel reviews. During grant and manuscrit reviews, confidentiality hels rotect ideas before they are funded or ublished. In ersonnel reviews, confidentiality is imortant to rotect ersonal rivacy. Peer reviewers have an obligation to reserve confidentiality during the review rocess if they have been asked to do so. While this obligation might seem obvious, it can be comromised in some seemingly harmless and other more harmful ways. For examle, although researchers sometimes do, it is not accetable to do any of the following without getting ermission: ask students or anyone else to conduct a review you were asked to do; use an idea or information contained in a grant roosal or unublished manuscrit before it becomes ublicly available; discuss grant roosals or manuscrits you are reviewing with colleagues in your deartment or at a rofessional meeting; retain a coy of the reviewed material (generally manuscrits and grant roosals should be shredded or returned after the review is comlete); and discuss ersonnel and hiring decisions with colleagues who are not art of the review rocess. There may be times when some added advice during a review may be helful, but reviewers should not seek this 154

171 Chater 10: Peer Review advice without getting ermission. It may also be temting to use information in a grant alication or manuscrit to seed u your own research, but until it has been made ublic, confidential information is not available for use, even to reviewers. If you are not comfortable rotecting confidential information, then do not agree to be a eer reviewer. Researchers who are in a osition to ass judgment on the work of colleagues have significant ower. They can hasten or slow that work; credit or discredit it. They have the ower to shae entire fields of research and to influence ublic olicy. If you have that ower, make sure you use it resonsibly and with some comassion, knowing that what you say and do directly affects the careers of other researchers. i Questions for discussion 1 What should researchers or students do if a colleague or mentor asks them to take a look at a manuscrit they have not been authorized to review? 2 What information contained in a manuscrit or roosal should reviewers be exected to check? 3 Should eer review be anonymous? 4 How can researchers who sit on committees that advise on research directions searate their own interests from the best interests of the field they are heling shae? 5 What would haen if the ublic lost confidence in eer review and looked for other mechanisms to judge the quality and imortance of research? 155

172 ORI Introduction to the Resonsible Conduct of Research Resources Policies, Reorts, and Policy Statements International Committee of Medical Journal Editors. Uniform Requirements for Manuscrits Submitted to Biomedical Journals, (available at: htt:// National Institutes of Health. NIH Guide Objectivity in Research, Bethesda, MD: NIH, (available at: htt:// grants/guide/notice-files/not html) University of Michigan Medical School. Guidelines for the Resonsible Conduct of Research: Right and Resonsibilities of Peer Review, Ann Arbor, MI: UM, (available at: htt:// General Information Web Sites International Congress on Peer Review and Biomedical Publication. Home Page, htt:// htm Office of Extramural Research. National Institutes of Health. OER: Peer Review Policy and Issues, htt:// eer/eer.htm Additional Reading Armstrong, JS. Peer Review for Journals: Evidence on Quality Control, Fairness, and Innovation, Science and Engineering Ethics 3, 1 (1997): Black, N, van Rooyen, S, Godlee, F, Smith, R, Evans, S. What Makes a Good Reviewer and a Good Review for a General Medical Journal? Journal of the American Medical Association 280, 3 (1998): Callaham, ML, Baxt, WG, Waeckerle, JF, Wears, RL. Reliability of Editors Subjective Quality Ratings of Peer Reviews of Manuscrits, Journal of the American Medical Association 280, 3 (1998): Callaham, ML, Wears, RL, Weber, EJ, Barton, C, Young, G. Positiveoutcome Bias and Other Limitations in the Outcome of Research Abstracts Submitted to a Scientific Meeting, Journal of the American Medical Association 280, 3 (1998): Cho, MK, Justice, AC, Winker, MA, Berlin, JA, Waeckerle, JF, Callaham, ML, Rennie, D. Masking Author Identity in Peer Review: What Factors Influence Masking Success? Journal of the American Medical Association 280, 3 (1998):

173 Chater 10: Peer Review Dickersin, K. How Imortant is Publication Bias? A Synthesis of Available Data, AIDS Education and Prevention 9, 1 Sul (1997): Dickersin, K, Fredman, L, Flegal, KM, Scott, JD, Crawley, B. Is There a Sex Bias in Choosing Editors? Eidemiology Journals as an Examle, Journal of the American Medical Association 280, 3 (1998): Evans, A, McNutt, R, Fletcher, S, Fletcher, R. The Characteristics of Peer Reviewers Who Produce Good-quality Reviews, Journal of General Internal Medicine 8, August 8 (1993): Fletcher, RH, Fletcher, SW. Evidence for the Effectiveness of Peer Review, Science and Engineering Ethics 3, 1 (1997): Godlee, F, Gale, CR, Martyn, CN. Effect on the Quality of Peer Review of Blinding Reviewers and Asking Them to Sign Their Reorts: A Randomized Controlled Trial, Journal of the American Medical Association 280, 3 (1998): Jadad, AR, Cook, DJ, Jones, A, Klassen, TP, Tugwell, P, Moher, M, and Moher, D. Methodology and Reorts of Systematic Reviews and Meta-Analyses: A Comarison of Cochrane Reviews with Articles Published in Paer-Based Journals. Journal of the American Medical Association 280, 3 (1998): Jefferson, T. Peer Review in the Health Sciences, London: British Medical Journal Books, Justice, AC, Cho, MK, Winker, MA, Berlin, JA, Rennie, D. Does Masking Author Identity Imrove Peer Review Quality? A Randomized Controlled Trial, Journal of the American Medical Association 280, 3 (1998): Link, AM. US and Non-US Submissions: An Analysis of Reviewer Bias, Journal of the American Medical Association 280, 3 (1998): Pitkin, RM, Branagan, MA, Burmeister, LF. Effectiveness of a Journal Intervention to Imrove Abstract Quality, Journal of the American Medical Association 283, 4 (2000): 481. van Rooyen, S, Godlee, F, Evans, S, Black, N, Smith, R. Effect of Oen Peer Review on Quality of Reviews and on Reviewers Recommendations: A Randomised Trial, British Medical Journal 318, 7175 (1999): van Rooyen, S, Godlee, F, Evans, S, Smith, R, Black, N. Effect of Blinding and Unmasking on the Quality of Peer Review: A Randomized Trial, Journal of the American Medical Association 280, 3 (1998): Effect of Blinding and Unmasking on the Quality of Peer Review, Journal of General Internal Medicine 14, 10 (1999):

174 Part V.

175 Safe Driving and Resonsible Research

176 ORI Introduction to the Resonsible Conduct of Research Part V: Safe Driving and Resonsible Research It is not easy to go through life doing everything we must or should do all of the time. It should therefore come as no surrise that in many small and some significant ways, researchers do not always follow the rules of the road for resonsible conduct in research. They roll through sto signs when they clean u their data more than they 160

177 Part V: Safe Driving and Resonsibile Research should, accet honorary authorshi, urchase something with grant funds that is not strictly allowed, or give colleagues more favorable reviews than they deserve. From time to time, they drive faster than the osted seeds to arrive at their destination a grant, a ublication, new knowledge a little more quickly. We ignore musts and shoulds in life for different reasons. For one, society sends mixed messages about obeying rules. Should you turn in someone for cheating or mind your own business? Rules also can conflict with one another. Should you reort misconduct if doing so uts your career at risk? And finally, we are amazingly adet at bending or stretching the rules by thinking u good reasons why a questionable course of action is accetable under a articular set of circumstances, that is, at justifying our actions, whatever they are. The ease with which rules can be bent or ignored is articularly evident early in the career track the majority of researchers traditionally follows. Studies consistently suggest that well over half and robably closer to threequarters of college students cheat during their undergraduate years. In two searate studies, 1 in 10 research trainees reorted a willingness to break the rules to get grants funded or aers ublished. Roughly the same number of students alying for research fellowshis and residencies in medicine significantly misreresents their research ublications on résumés, as confirmed in studies conducted 161

178 ORI Introduction to the Resonsible Conduct of Research in six medical secialties. Presumably most individuals who cheat or inflate résumés know that it is wrong to do so, but they nonetheless find reason for engaging in these ractices. The same atterns of behavior can easily sill over into other asects of research. The ressures that romt students to bend or ignore the rules do not disaear after graduation. Getting into good schools is relaced by getting a good job and romotions. Cometition for grades is relaced by cometition to get funded and ublished. Too little time to study for tests is relaced by too little time to teach, mentor, rovide service, and do research. The stakes may even increase later in careers, as family resonsibilities are added into the mix and ersonal ambitions grow, making it even easier to ut more ressure on the accelerator to get to your destination a little faster. There are many quick-and-easy reasons that can be called u to justify bending or ignoring some of the rules of the road for resonsible research: I already have enough information to know what the results will be, so there is no need to run the controls again, even though they did not give me the exected results the first time. No one funds truly exloratory research, so the only way to test new ideas is to use funds from an existing grant, even though these funds are for other work. If my bosses read my research aers rather than counting them, I wouldn t have to ublish the same research twice or cho it u into small, insignificant ieces. Given the cometition in this field, you cut your own throat if you share your methods and information with colleagues too freely. 162

179 Part V: Safe Driving and Resonsibile Research They will cut off my funds if I reort these results, so for the good of my laboratory and staff I should sit on them for a while longer. I know my research is not going to harm anyone, so why waste my time and the time of the IRB getting ermission. Rules are not always reasonable or rationally alied. Life and colleagues are not always fair. Good guys do sometimes seem to come in last. However, the roblem with quick-and-easy justifications and catchy hrases is they fail to take into consideration the larger consequences of our actions. What would haen if everyone decided, for one good reason or another, to run sto signs, drive on the wrong side of the road, or ignore the seed limit? Obviously, chaos would quickly ensue and driving would no longer be safe (or become even more hazardous than it is already). The same would be true of research if researchers routinely ignored resonsible research ractices and did what they thought was necessary simly to achieve some end, whether the discovery of truth, the develoment of something useful, or ersonal success. As stated at the beginning of the ORI Introduction to RCR, there is no one best way to undertake research, no universal method that alies to all scientific investigations. Acceted ractices for the resonsible conduct of research can and do vary from disciline to disciline and even laboratory to laboratory. There are, however, some imortant shared values for the resonsible conduct of research that bind all researchers together, including honesty, accuracy, efficiency, and objectivity. There are no excuses for comromising these values. Their central role in research is the resonsibility of each and every researcher. Drive safely and be a resonsible researcher. 163

180 ORI Introduction to the Resonsible Conduct of Research Resources Additional Reading Baker, DR, Jackson, VP. Misreresentation of Publications by Radiology Residency Alicants, Academic Radiology 7, 9 (2000): Bilge, A, Shugerman, RP, Robertson, WO. Misreresentation of Authorshi by Alicants to Pediatrics Training Programs, Academic Medicine 73, 5 (1998): Brown, S, Kalichman, MW. Effects of Training in the Resonsible Conduct of Research: A Survey of Graduate Students in Exerimental Sciences, Science and Engineering Ethics 4, 4 (1998): Dale, JA, Schmitt, CM, Crosby, LA. Misreresentation of Research Criteria by Orthoaedic Residency Alicants, Journal of Bone and Joint Surgery 81, 12 (1999): Eastwood, S, Derish, P, Leash, E, Ordway, S. Ethical Issues in Biomedical Research: Percetions and Practices of Postdoctoral Research Fellows Resonding to a Survey, Science and Engineering Ethics 2, 1 (1996): Goe, LC, Herrera, AM, Mower, WR. Misreresentation of Research Citations among Medical School Faculty Alicants, Academic Medicine 73, 11 (1998): Grover, M, Dharamshi, F, Goveia, C. Decetion by Alicants to Family Practice Residencies, Family Medicine 33, 6 (2001): Gurudevan, SV, Mower, WR. Misreresentation of Research Publications among Emergency Medicine Residency Alicants, Annals of Emergency Medicine 27, 3 (1996): Kalichman, MW, Friedman, PJ. A Pilot Study of Biomedical Trainees Percetions Concerning Research Ethics, Academic Medicine 67, 11 (1992): McAlister, WP, Velyvis, JH, Uhl, RL. Misreresentation of Research Criteria by Orthoaedic Residency Alicants, Journal of Bone and Joint Surgery 82-A, 10 (2000): Panicek, DM, Schwartz, LH, Dershaw, DD, Ercolani, MC, Castellino, RA. Misreresentation of Publications by Alicants for Radiology Fellowshis: Is It a Problem? American Journal of Roentgenology 170, 3 (1998): Patel, MV, Pradhan, BB, Meals, RA. Misreresentation of Research Publications among Orthoedic Surgery Fellowshi Alicants: A Comarison with Documented Misreresentations in Other Fields, Sine 28, 7 (2003): ; discussion 31. Sekas, G, Hutson, WR. Misreresentation of Academic Accomlishments by Alicants for Gastroenterology Fellowshis, Annals of Internal Medicine 123, 1 (1995):

181 Notes

182 Notes


184 894626

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