Hostname: page-component-84b7d79bbc-tsvsl Total loading time: 0 Render date: 2024-07-30T03:16:20.271Z Has data issue: false hasContentIssue false

Views and Experiences of IRBs concerning Research Integrity

Published online by Cambridge University Press:  01 January 2021

Extract

Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to best oversee research to protect these participants from harm.

For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest (COI), and may interact with IRBs. In 2002, the Institute of Medicine (IOM) report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research.

Type
Independent
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Kennedy, D., “Responding to Fraud,” Science 314, no. 5804 (2006): 1353.CrossRefGoogle Scholar
Institute of Medicine, Committee on Assessing the System for Protecting Human Research Participants; Federman, D. D. Hanna, K. E. Rodriguez, L. L., eds., Responsible Research: A Systems Approach to Protecting Research Participants (Washington, D.C.: National Academies Press, 2002).Google Scholar
NBAC, the DHHS Office of Inspector General, the General Accounting Office, the Advisory Committee on Human Radiation Experiments, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, as cited in Responsible Research: A Systems Approach to Protecting Research Participants, 2003.Google Scholar
Department of Health & Human Services, Office of Inspector General, “Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards,” U.S. Government Printing Office, Washington, D.C., 2005, available at <http://oig.hhs.gov/fraud/docs/complianceguidance/PHSResearchAwardsDraftCPG.pdf> (last visited May 12, 2011).+(last+visited+May+12,+2011).>Google Scholar
Grant, G. Guyton, O. Forrester, R., “Creating Effective Research Compliance Programs in Academic Institutions,” Academic Medicine 74, no. 9 (1999): 951971.CrossRefGoogle Scholar
Heath, E., “The IRB's Monitoring Function: Four Concepts of Monitoring,” IRB: Ethics and Human Research 1, no. 5 (1979): 13 and 12.CrossRefGoogle Scholar
Weijer, C. Shapiro, S. Fuks, A. Glass, K. C. Skrutkowska, M., “Monitoring Clinical Research: An Obligation Unfulfilled,” Canadian Medical Association Journal 152, no. 12 (1995): 19731980.Google Scholar
Greene, S. M. Geiger, A. M., “A Review Finds that Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board Approval,” Journal of Clinical Epidemiology 59, no. 8 (2006): 784790.CrossRefGoogle Scholar
Jones, J. White, L. Pool, L. Dougherty, J., “Structure and Practice of Institutional Review Boards in the United States,” Academic Emergency Medicine 3, no. 8 (1996): 804809.CrossRefGoogle Scholar
Parsons, T., The Social System (Glencoe, Ill.: Free Press, 1951).Google Scholar
Stevenson, A. Siefring, J. Brown, L. Trumble, W. R., eds., Oxford English Dictionary (Oxford: Oxford University Press, 2002).Google Scholar
U.S. Department of Health and Human Services, Office of Research Integrity, “Research – Extramural,” retrieved September 8, 2005, available at <http://ori.hhs.gov/research/extra/index.shtml> (last visited May 12, 2011).+(last+visited+May+12,+2011).>Google Scholar
Martinson, B. Anderson, M. de Vries, R., “Scientists Behaving Badly,” Nature, 435, no. 9 (2005): 737738.CrossRefGoogle Scholar
Korenman, S. G. Berk, R. Wenger, N. S. Lew, V., “Evaluation of the Research Norms of Scientists and Administrators Responsible for Academic Research Integrity,” JAMA 279, no. 1 (1998): 4147.CrossRefGoogle Scholar
Mello, M. Clarridge, B. Studdert, D., “Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry,” New England Journal of Medicine 352, no. 21 (2005): 2202–210; Koocher, G. Keith-Speigel, P., IRB Researcher Assessment Tool (IRB-RAT): A User's Guide (Boston: Harvard Medical School, 2005).CrossRefGoogle Scholar
Office of Inspector General, “Institutional Review Boards: Their Role in Reviewing Approved Research,” DHHS Publication No. OEI-01-97-00190, Washington, D.C., U.S. Government Printing Office (1998a); Office of Inspector General, “Institutional Review Boards: Promising Approaches,” DHHS Publication No. OEI-01-91-00191, Washington, D.C., U.S. Government Printing Office (1998b); Office of Inspector General, “Institutional Review Boards: The Emergence of Independent Boards,” DHHS Publication No. OEI-01-97-00192, Washington, D.C., U.S. Government Printing Office (1998c); Office of Inspector General, Department of Health and Human Services, “Institutional Review Boards: A Time for Reform,” DHHS Publication No. OEI-01-97-00193, Washington, D.C., U.S. Government Printing Office (1998d); Office of Inspector General, “Protecting Human Research Subjects: Status of Recommendations,” DHHS Publication No. OEI-01-97-00197, Washington, D.C., U.S. Government Printing Office (2000a); Office of Inspector General, “Recruiting Human Subjects: Pressure in Industry-Sponsored Clinical Research,” DHHS Publication No. OEI-01-97-00195, Washington, D.C., U.S. Government Printing Office (2000b); Office of Inspector General, “Recruiting Human Subject: Sample Guidelines for Practice,” DHHS Publication No. OEI-01-97-00196, Washington, D.C., U.S. Government Printing Office (2000c); Office of Inspector General, “Clinical Trial Web Sites: A Promising Tool to Foster Informed Consent,” DHHS Publication No. OEI-01-97-00198, Washington, D.C., U.S. Government Printing Office (2002); Moreno, J. Caplan, A. Wolpe, P., and the Members of the Project on Informed Consent, Human Research Ethics Group, “Updating Protections for Human Subjects Involved in Research,” Journal of the American Medical Association 280, no. 22 (1998): 1951–1958; Burman, W. Reves, R. Cohn, D. Schooley, R., “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,” Annals of Internal Medicine 134, no. 2 (2001): 152–157.Google Scholar
Campbell, E. G. Weissman, J. S. Clarridge, B. Yucel, R. Causino, N. Blumenthal, D., “Characteristics of Medical School Faculty Members Serving on Institutional Review Boards: Results of a National Survey,” Academic Medicine 78, no. 8 (2003): 831836.CrossRefGoogle Scholar
Greene, S. M. Geiger, A. M., “A Review Finds That Multicenter Studies Face Substantial Challenges but Strategies Exist to Achieve Institutional Review Board Approval,” Journal of Clinical Epidemiology 59, no. 8 (2006): 784790.CrossRefGoogle Scholar
Klitzman, R., “How Local IRBs View Central IRBs in the US,” BMC Medical Ethics 12, no. 13 (2011).CrossRefGoogle Scholar
Klitzman, R., “‘Members of the Same Club’: Challenges and Decisions Faced by US IRBs in Identifying and Managing Conflicts of Interest,” PLoS ONE in press).Google Scholar
Klitzman, R., “The Myth of Community Diferences as the Cause of Variations among IRBs,” AJOB Primary Research (in press).Google Scholar
Klitzman, R., “US IRBs Confronting Research in the Developing World,” Developing World Bioethics (in press).Google Scholar
See Klitzman, , supra note 19; Klitzman, , supra note 21.Google Scholar
Geertz, C., Interpretation of Cultures: Selected Essays (New York: Basic Books, 1973).Google Scholar
Strauss, A. Corbin, J., Basics of Qualitative Research – Techniques and Procedures for Developing Grounded Theory (Newbury Park: Sage Publications, 1990).Google Scholar
See Jones, et al., supra note 9.Google Scholar
Leonard, N. H. Beauvais, L. L. Scholl, R. W., “Work Motivation: The Incorporation of Self-Concept-Based Processes,” Human Relations 52, no. 8 (1999): 969998.CrossRefGoogle Scholar
See Jones, et al., supra note 9; Koocher, G. P., “The IRB Paradox: Could the Protectors Also Encourage Deceit?” Ethics & Behavior 15, no. 4 (2005): 339349.Google Scholar
Merton, R. K., “Social Structure and Anomie,” American Sociological Review 3, no. 5 (1938): 672682.CrossRefGoogle Scholar
See Kennedy, , supra note 1.Google Scholar
Tyler, T. Kramer, R., “Whither Trust?” in Kramer, R. Tyler, T., eds., Trust in Organizations (Thousand Oaks, Calif.: Sage, 1996); Hardin, R., Trust and Trustworthiness (New York: Russell Sage Foundation, 2002); Nagel, T., “Concealment and Exposure,” Philosophy and Public Affairs 27, no. 1 (1998): 3–30.Google Scholar
Callahan, E. S. Dworkin, T. M., “The State of State Whistleblower Protection,” American Business Law Journal 38, no. 1 (2000): 99175.CrossRefGoogle Scholar
Katz, D. Kahn, R. L., The Social Psychology of Organizations (New York: Wiley, 1996).Google Scholar