Conducting Ethical Research. The Institutional Review Board at Eastern University

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1 Conducting Ethical Research The Institutional Review Board at Eastern University

2 History and Definitions Historical Precedents Legal Acts

3 History 1: Nazi Experiments WWII medical experiments conducted by doctors in concentration camps EX: "Cold and hot water immersion experiment claimed to be at Dachau concentration camp The subject (a prisoner who was forced to participate) is wearing a Luftwaffe garment. Note the floating blocks of ice. [from Wikipedia]

4 Result: Nuremberg Code 1947 War crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects. Among other requirements, this document enunciates: The requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body. Risk must be weighed against the expected benefit Unnecessary pain and suffering must be avoided. Doctors should avoid actions that injure human patients.

5 History 2: Tuskegee Syphilis Study The Public Health Service and Tuskegee Institute Nearly 400 poor black men with syphilis from Macon County, Ala. Never told they had syphilis, nor were they ever treated for it. The men were told they were being treated for "bad blood NAACP files a class action suit 1997 President Bill Clinton apologizes for the US government

6 Results: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHS) was established on July 12, 1974, under Title II of Public Law , the National Research Act, Developed guidelines which should be followed in biomedical and behavioral research involving human subjects.

7 Belmont Report (BR) 1976 Principles The principles of the Belmont Report govern all research supported by the U.S. Government. The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research.

8 Belmont Report Boundaries of Research distinguish between biomedical and behavioral research and the practice of accepted therapy in order to know what activities ought to undergo review for the protection of human subjects of research. research designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). practice refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.

9 Belmont Report Ethical Principle 1: Respect for Persons The principle of respect for persons divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. [NOTE: autonomy is a person's capacity for self-determination] Application: Informed consent

10 Belmont Report Ethical Principle 2: Beneficence Persons are treated in an ethical by making efforts to secure their well-being. Two general rules : (1) do not harm and (2) maximize possible benefits and minimize possible harms. Application: Assessment of Risks and Benefits.

11 Belmont Report Ethical Principle 3: Justice People should be treated equally (and fairly). Widely accepted formulations of just ways to distribute burdens and benefits. To each person (1) an equal share, (2) according to individual need, (3) according to individual effort, (4) according to societal contribution, and (5) according to merit. Application: fair procedures and outcomes in the selection of research subjects.

12 Common Rule 1991 Regulations The Common Rule is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services. These regulations regulate human research and the work of the IRB.

13 Eastern University Institutional Review Board

14 Eastern IRB Online

15 Institutional Review Board The Eastern University Institutional Review Board (IRB) is a committee: comprised of four faculty and one community member reviews all proposed research involving human subjects that is conducted at Eastern University ensures the safety and welfare of research subjects. reviews research proposals and Approves or requires modifications (in order to secure IRB approval), or disapproves of the study.

16 IRB Purpose The primary purpose of the IRB is to: promote ethical research and to ensure that research participants are treated justly. IRB asssesses research projects to ensure they are: operating for the common good minimizing harm and maximizing benefits being respectful of individuals rights, and fairly distributing benefits and costs to stakeholders.

17 Do You Need IRB Approval? Yes, if you are engaging in: Observational Studies Interventions with specific groups Surveys or Interviews Educational Tests Analyzing Human Subjects Data

18 The Rules All research on human subjects must be reviewed and approved by the IRB (Institutional Review Board) before participants can be recruited and data collection started. Under no circumstances may you begin your research until you have been notified of IRB approval.

19 Who should care and why? Primary reason: Concern for the ethical and moral treatment of people Important to the University in establishing a culture of research The IRB is important in obtaining federal grants Anyone conducting research involving people (human subjects). This includes both faculty and student research. Currently HS research is conducted by faculty and students in the areas of Psychology, Communications, Sociology, Science, Urban Studies, and Education

20 Institutional Responsibilities The responsibility for the protection of human subjects does not rest solely with the IRB. It is a shared responsibility between the Institutional Official (Provost), the IRB, and the investigator. Each has a crucial, yet distinct, role to play.

21 Eastern University IRB Dr. Walter Chung Dr. J. Nathan Corbitt Dr. Kathy-Ann C. Hernandez Dr. Jeffrey A Lawton, Chair

22 Who are human subjects? A human subject is a living individual about whom an investigator conducting research obtains: data through intervention or interaction with the individual, or identifiable private information. includes both children and adults, but precludes data collected about non-living persons, such as historical records or artifacts.

23 What is research? Research means a systematic investigation, (including research development), testing and evaluation, designed to develop or contribute to generalizable knowledge. Examples: projects where the researcher(s) seek out subjects to included in their investigation; the findings will be analyzed, interpreted, and/or disseminated to a wider audience; or investigations where there is a likelihood that knowledge gained can lead to a new procedure or process.

24 What types of data gathering do not require IRB approval? Data gathered: in conjunction with classroom activities where the sole purpose of the assignment is to train students or acquaint them with a research process. for classroom training in research methods for which the only foreseeable purpose is to facilitate the student s learning of research methodologies. Neither the instructor nor the student intends to disseminate the data gathered. administrative purposes only such as that gathered in order to improve internal services or operations

25 What statement should appear in a syllabus? Any study originating at Eastern University involving the observation of or interaction with human subjects, and which results in data or generalizable knowledge that will or potentially might in the future be disseminated for public use, must be reviewed and approved by the Institutional Review Board (IRB) for the protection of human subjects. Consult with your course instructor early in the course to ascertain if your project needs to be reviewed by the IRB and/or to secure the appropriate forms and procedures for the IRB review.

26 Who should apply for IRB approval? Undergraduate students, Graduate students, and Faculty members doing research with real and living people, with plans of disseminating the findings outside of the Eastern University community needs to apply for IRB approval.

27 What is the process of applying for IRB approval? Determine that your project qualifies as research and that you are using human subjects Determine what type of review is necessary. Researcher can apply for exempt review status, expedited review, or full board review. Obtain the forms for the IRB website. Submit to the advisor of your research who approves and sends to the IRB Chair. Once submitted, the chairperson will notify you regarding your approval status. The timeline varies depending on what type of review is required. Do not start your project without IRB approval.

28 IRB Process Researcher downloads forms, completes and forwards to advisor for approval. Included are application, research questions, and informed consent statements Step 1 Application is reviewed for accuracy and returned for revision or forwarded to IRB Step 3 Step 2 (3) IRB designates status, approves/denies, may return for corrections, and then approves

29 What is exempt research? Exempt from partial board or full board review and may be evaluated. You are still required to submit an application for approval. Educational Research. Surveys, Questionnaires, Interviews, or Observation of Public Behavior. Archival Research. Research Examining Public Benefit or Public Service Programs. Taste Evaluation Research

30 What is expedited research? Expedited research is research that does not qualify for Exempt Review status, but is noninvasive and possesses minimal risk to the subjects. The IRB chairperson and at least one other member of the IRB examine projects that qualify for expedited review.

31 What is full board review? Examined by the full membership of the IRB. Projects do not meet the criteria for exempt or expedited review or, May have initially been submitted as exempt or expedited, but the chairperson or a board member requested it receive full board review. The final decision as to the classification of the research rests with the IRB.

32 Who are protected populations? Vulnerable populations children (those under the age of 18), prisoners, pregnant women and fetuses, Mentally impaired persons, and economically or educationally disadvantaged persons. Review the IRB policy manual and the guidelines for this type of research.

33 Where can I obtain IRB forms?

34 Where do I send the completed forms? Send your completed forms by to your research advisor, or department or program coordinator for their review and approval. They will then send by (through an eastern.edu account) to the Chair of the IRB. DO NOT SEND YOUR APPLICATION DIRECTLY TO THE IRB.

35 What are the deadlines? The deadline depends upon your research. Generally, you should submit your IRB application one month prior to beginning your work with human subjects. The IRB reviews the applications as they are received. DO NOT BEGIN YOUR RESEARCH WITH HUMAN SUBJUCTS BEFORE IRB APPROVAL.

36 How long does the process take? A complete application requesting exempt status or expedited review will typically be reviewed and approved within 10 days of receipt. A study requiring full board review MAY require that you be present at a next regularly scheduled IRB meeting, and therefore may take 3 to 6 weeks, depending on the date of the meeting, and factors such as the risks of the study, the age of the subjects, and the research procedures.

37 What about re-applying for IRB approval? IRB approval is valid for a maximum of one year. If your study continues beyond one year, you need to seek a continuing review (if your study is ongoing, but unchanged), and seek re-approval (if your study has been modified or altered).

38 More Definitions From: University of Wisconsin-Eau Claire Office of Research and Sponsored Programs

39 Anonymity The investigator(s) cannot associate the identity of a particular subject with her/his responses.

40 Confidentiality The investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a respondent.

41 Data collection Any research procedure, instrument, or device that is intended to elicit from or record the actions, reactions, attitudes, and/or other behavioral manifestations of subjects in conjunction with a research project.

42 Deception In research, means that the subject/respondent, at the time of the data collection, is not fully informed of the nature and purpose of the research in which she/he is involved so as to prevent potentially biased reporting of data/information.

43 Human subject A living individual about whom an investigator (whether professional or student) conducting research obtains: 1. Data through intervention or interaction with the individual, or 2. Identifiable private information.

44 Human subject at risk Any individual who may be exposed to the possibility of injury (including economic, legal, physical, psychological, or social injury) as a consequence of participation as a subject in any research project or related activity that departs from the application of those established and accepted methods necessary to meet the person s needs or that increase the ordinary risks of daily life, (including the recognized risks inherent in a chosen occupation or field of service). Individuals who have received routine acceptable educational, medical, nursing, psychological, or social services that were in effect prior to the initiation of the research project in question are not considered human subjects at risk.

45 Informed consent The voluntary, knowing consent of an individual or her/his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

46 Interaction Communication or interpersonal contact between investigator and subject.

47 Intervention Both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject s environment that are performed for research purposes.

48 Minimal risk The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

49 Private information Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is stated or may readily be ascertained by the investigator or is associated with the information) in order to obtain the information to constitute research involving human subjects.

50 Research Any activity generally associated with the acquisition and/or development of knowledge. It is assumed that any research data collected through scholarly research efforts is intended for presentation at professional meetings and/or possible publication. All master s theses are considered to fall into the category of scholarly research.

51 Survey methodology Includes, but is not limited to, mail and web-based questionnaires, telephone interviews, personal interviews, and group questionnaires that seek to collect data from any population or sample of individuals.

52 Treatment/stimulus Any agent or technique that directly influences the attitudes, behavior, or body organism of the human subject.

53 END

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