Building an Institutional Climate and Training Programs for Responsible Conduct of Research

Transcription

1 Building an Institutional Climate and Training Programs for Responsible Conduct of Research Philip J. Langlais, Ph.D. Professor, Dept. of Psychology Former Vice Provost for Graduate Studies & Research Old Dominion University Symposium: Research Integrity & Responsible Conduct of Research-New Challenges in a Turbulent World April 17, 2013 Aarhus University, Aarhus, Denmark

2 Overview THE DEVELOPMENT OF RCR EDUCATION IN U.S. GOALS OF RCR EDUCATION APPROACHES AND BEST PRACTICES BUILDING INSITUTIONAL PROGRAMS AND CLIMATE

3 Impetus for RCR Training* Late 1980s: " biomedical scientists under public scrutiny as a consequence of a decade of reports about misconduct in research, turned to formal education." (Steneck and Bulger, 2007) 1989: "Universities should provide formal instruction in good research practices. incorporated into various places in undergraduate and graduate curricula for all science students." (Committee on the Responsible Conduct of Research, 1989) 1995: " this required educational activity is essential to ensure that all individuals [including senior researchers and technicians] who perform research in institutional settings are sensitized to the ethical issues inherent in research." (Committee on Research Integrity, 1995) *Slide provided by Mike Kalichman

4 Federal Requirements for RCR Training* NIH, 1989 NIH, 1992 NSF IGERT, 1997 PHS, 2000 NIH, 2009 NSF, 2009 *Slide provided by Mike Kalichman

5 NIH Requirements for RCR Instruction* NIH (2009) PHS (2000) NIH (1992) NIH (1989) 1 conflict of interest personal, conflict of interest and conflict of interest conflict of interest professional, and financial commitment 2 data acquisition and laboratory data acquisition, data management data recording and retention tools; management, sharing and management, sharing, ownership and ownership responsible authorship and publication research misconduct and policies for handling misconduct policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices mentor/mentee responsibilities and relationships collaborative research including collaborations with industry publication practices and responsible authorship research misconduct human subjects; research involving animals mentor/trainee responsibilities collaborative science 8 peer review peer review 9 the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research *Slide provided by Mike Kalichman responsible authorship policies for handling misconduct policies regarding the use of human and animal subjects responsible authorship institutional policies and procedures for handling allegations of misconduct policies regarding the use of human and animal subjects professional standards and codes of conduct, bioethics, research conduct, the ideals of science

6 RCR Learning Outcomes Knowledge: Ethical Principles and Application Professional codes and standards Best practices Regulations and policies Where to find help SKILLS: Sensitivity and awareness of issues Ethical decision making Conflict resolution Balancing demands and commitments Effective communication

7 Core Topics Social Responsibility & Accountability Professional Ethics, Codes and Standards Mentoring Research Misconduct Whistleblowing & Responding to Allegations Peer Review Conflicts of Interest and Commitment Collaborations and Intellectual Property Data Management Authorship and Publication

8 Specific Topics Human Subjects Animal Subjects Ethnographic Studies Environmental Protection Dual Use Technology Stem Cells Community-based Participatory Research International Collaborations & Regulations

9 Ways to Engage and Educate Modes of Engaging Discussion groups Laboratory meetings Workshops Courses Guest Lectures Debates Web-based tutorials Research Papers Surveys Materials Textbooks Case Studies Role playing-dramatizations Videos Journal articles and publications Biographies, histories Handbooks

10 Students: Ways to Engage & Educate Integrate RCR topics and discussions into existing graduate courses such as Research methods, Experimental Design and Analyses, Professional Standards Incorporate issues and dilemmas into written and oral predoctoral qualifying exams Post-doc and Faculty: RCR Train-the-Trainer Programs Workshops integrating RCR into laboratory environment Faculty Professional Development Programs Certificates and/or credit towards promotion and tenure decisions

11 Specific Training of Faculty and P.I. s How to lead discussions and modeling of best practices and professional standards. Explaining the how and the why of his/her discipline/professional standards, lab practices, university policies Regular discussions of RCR in routine lab meetings Publish policies and procedures of research group, usually in a handbook or guide Statement of understanding between supervisors and students relative to data collection, ownership, use, publication/authorship Checklists to track topics covered and progress made

12 Educate the Community Graduate and Undergraduate Students Post-doctoral fellows Faculty at all levels Visiting Scholars and Researchers Research and Academic Administrators Institutional Counsel and Auditors Research and Academic Staff IRB, IACUC, Biosafety, Human Resources Research Integrity Officer, Ombudsman

13 Fostering RCR Education: Lessons Learned One size does not fit all disciplinary and organizational differences require flexibility in training content, methods and outcomes. Top Down-Bottom Up commitment & involvement. Training and participation of faculty are critical. Shift emphasis from what is wrong to what is right beyond compliance to conscience, ethics and professional. standards Communication, consistency and transparency are essential.

14 Research Integrity Requires More than RCR Training RCR Training is necessary but not sufficient! Ethical behavior and choices in research activities are nested within multiple levels of organizational context.

15 Research Environment External national, political, regulatory, societal, funding Organization University, Research Center: culture, strategic plan, priorities, performance standards Department/College: norms, rewards, priorities, resources Mentor/Supervisor structure, laboratory climate, modeling, performance standards Individual attitudes, values, beliefs, traits, knowledge

16 Values, Attitudes, Climate and Culture Conscience & Compliance Culture & Training Individual & Organizational

17 Climate and Environmental Factors and Mediators Predictors of research behaviors Competition Normative Social Environment Performance Standards Policies Whistleblowing Emotional comfort and support Exposure to ethical/unethical events Mentoring Leadership Procedural and Distributive Justice Communication Identification

18 Ways to Foster an Ethical Research Climate Build a comprehensive and integrated Top Down-Bottom Up Program addressing: Education Institutional Policies and Procedures Professional Standards and Best Practices

19 Ways to Foster Ethical Research Climate Special Events Presidential Lecture Series College/Dept. Guest Lectures Research Integrity Day Administration sponsored workshops University and College recognition of faculty and students Faculty development awards and small grants Tenure and Promotion criterion

20 Ways to Foster Ethical Research Climate Research Integrity Task Force/Committee responsible for: Assessment of practices, attitudes and perceptions of RCR training and research climate Provide support in developing RCR training programs Provide longitudinal tracking of RCR effectiveness and changes in institutional climate and policies. Administrative support for the RCR Task Force/Committee Periodic review of assessments

21 Summary Training & Climate Assessing & Tracking Outcomes Shared Responsibilities Top to Bottom Enhanced Communication Professional Standards and Compliance

22 Conclusions No Magic Bullets Patience and Persistence Coordinated Goal Directed Program

23 Resources: Texts with Case Studies Korenman, S.G. & Shipp, A.C. (1994). Teaching the Responsible Conduct of Research Through a Case Study Approach: A Handbook for Instructors. Assoc. of American Medical Colleges Macrina, F. (2005). Scientific Integrity: Text and Cases in Responsible Conduct of Research, 3rd edition, ASM Press Steneck, N. H. (2004). ORI-Introduction to the Responsible Conduct of Research, Bebeau., M.J., Pimple, K.D., Muskavitch, K. M., Borden, S.L. & Smith, D.H. (1995). Moral Reasoning in Scientific Research: Cases for Teaching and Assessment. Koocher, G.P. & Keith-Spiegel, P. (1998). Ethics in Psychology: Professional Standards and Cases. 2 nd Ed., Oxford Univ. Press. Nagy, T. F. (2005). Ethics in Plain English: An Illustrative Casebook for Psychologists. 2 nd Ed., American Psychological Association. Penslar, R. L. (1995). Research Ethics: Cases and Materials, Indiana University Press.

24 Resources - General National Academy of Sciences, (2009). On Being a Scientist, 3rd edition, The National Academies Press. Shamoo, A.E. & Resnik, D.B. (2003). Responsible Conduct of Research, Oxford University Press. Grinnell, F. (2009). Everyday Practice of Science, Oxford University Press. 1995: Moral Reasoning in Scientific Research: Cases for Teaching and Assessment (Bebeau et al., 1995). Promoting Research Integrity in a Global Environment, (2012). Mayer, T. & Steneck, N., (Eds.), World Scientific Press. Plante, T. G. (2004). Do the Right Thing: Living Ethically in an Unethical World, New Harbinger Publications, Inc. The Ethical Challenges of Academic Administration, (2010). Englehardt, E.E., Pritchard, M.S., Romesburg, K.D. & Schrag, B.E. (Eds.), Springer Publ. Creating the Ethical Academy (2011). Gallant, T.B. (Ed.), Routledge Publ. Best Practices in Graduate Education for the Responsible Conduct of Research.(2008) Council of Graduate Schools, Washington, D.C. Global Perspectives on Graduate Education: Proceedings of the Strategic Leaders Global Summit on Graduate Education. (2008) Council of Graduate Schools, Washington, D.C.

25 Resources - Videos Integrity in Scientific Research (1996) 5 videos, American Association for the Advancement of Science. The Lab: Avoiding Misconduct. ORI (2011). An interactive movie. Univ. of Nebraska-Lincoln RCR Videos

26 Resources Train-the-Trainer Programs 1993 present: Teaching Research Ethics, Poynter Center, Indiana University : Survival Skills and Ethics, University of Pittsburgh : RCR 101 Workshops, PRIM&R 2005 present: Kalichman, Macrina, and Plemmons UC San Diego and Virginia Commonwealth University

27 Resources OnLine Courses & Centers Collaborative Institutional Training Initiative (CITI): Univ. of Montana, Columbia University: Ethics CORE: Resources for Research Ethics Education: Markkula Center for Applied Ethics: Emory Center for Ethics: National Center for Ethics in Healthcare: The Office of Research Integrity (ORI): Project for Scholarly Integrity, Council of Graduate Schools Online Ethics Center for Engineering and Research, National Academy of Engineering

28 Resources Assessments Anderson, M. S. (1996). Misconduct and departmental context: Evidence from the Acadia Institute's Graduate Education Program. Journal of Information Ethics, 5, Cullen, J. B., Victor, B., & Bronson, J. W. (1993). The ethical climate questionnaire: An assessment of its development and validity. Psychological Reports, 73, Gaddis, B., Helton-Fauth, W., Scott, G., Shaffer, A., Connelly, S., & Mumford, M. (2003). Development of two measures of climate for scientific organizations. Accountability in Research: Policies and Quality Assurance, 10(4), Langlais, P.J. (2006). Ethical and Responsible Conduct of Research: Knowledge and Skills Survey (unpublished). Langlais, P.J. (2003). Professional Development and Responsible Conduct Survey (unpublished). Langlais, P.J. (2002). Responsible Conduct of Research: Survey of Current Practices. Martinson, B. C., Thrush, C. R., & Crain, A. L. (2012). Development and validation of the survey of organizational research climate (SORC). Science and Engineering Ethics, 1-22 Mumford, M. D., Devenport, L. D., Brown, R. P., Connelly, S., Murphy, S. T., Hill, J. H., & Antes, A. L. (2006). Validation of ethical decision making measures: Evidence for a new set of measures. Ethics & Behavior, 16(4), Thumin, F. J., & Thumin, L. J. (2011). The measurement and interpretation of organizational climate. The Journal of Psychology, 145(2),