Conflicts of Interest
Recommendation 3.10: Institutional Review Boards should include members who represent
the perspectives of participants, members who are unaffiliated with the institution, and mem-bers whose primary concerns are in nonscientific areas. An individual can fulfill one, two, or all three of these categories. For the purposes of both overall membership and quorum deter-minations 1) these persons should collectively represent at least 25 percent of the Institutional Review Board membership and 2) members from all of these categories should be represented each time an Institutional Review Board meets (see Recommendation 3.9).
Summary
This chapter discussed the important role that education plays in protecting research participants. Individuals should be able to demonstrate that they understand their ethical obligations and how to carry them out. To help investigators and IRBs fulfill their responsibilities, the federal government should promote the development of education and certification programs that apply to all investigators as well as all IRB members and staff.
Institutions and independent IRBs must do a better job of meeting their ethical obligations to research partic-ipants. Accreditation programs are one way in which all organizations involved in conducting or reviewing research can develop highly efficient and effective protec-tion programs.
A key protection is that of ensuring institutional, IRB, and investigator compliance. At all levels in the system, various mechanisms, including assurances of compliance, site inspections, and internal audits, should be used.
Regular periodical monitoring of compliance is the most likely way to detect and remedy problems.
Institutions and IRBs increasingly are confronting conflicts of interest as more investigators and institutions enter into financial arrangements in which they stand to benefit from the results of their research. Conflicts of interest are not new, but they have changed and intensified as the research enterprise has evolved. Disclosure and management of investigator and institution conflicts still seem to be the best strategies. Conflicts affecting the IRB can be handled by increasing the percentage of members who do not have any direct interests in the institution or its research program (unaffiliated members). Increasing the percentage of nonscientists and members who repre-sent the views of participants can also reduce conflicts.
Ultimately, clear policies and guidance will provide the best way for IRBs to fulfill their responsibilities and meet their obligations in educating their members, monitoring for compliance, and avoiding conflicts of interest.
Notes
1 NIH Guide for Grants and Contracts, “Short Term Courses in Research Ethics.” PA-99-051. January 22, 1999; NIH Guide for Grants and Contracts, “Mentored Scientist Development Award in Research Ethics.” PAR-98-006. November 7, 1997. Both available at http://grants.nih.gov/grants/guide. Last accessed December 4, 2000.
2 PRIM&R, “IRB 101 On the Road.” Available at http://www.primr.org/
101road.html. Last accessed December 4, 2000.
3 NIH Guide for Grants and Contracts, “Required Education in the Protection of Human Research Participants.” Notice OD-00-039.
June 5, 2000. Available at http://grants.nih.gov/grants/guide.
Last accessed December 4, 2000.
4 See Peckman, S., “Local Institutional Review Boards.” This back-ground paper was prepared for NBAC and is available in Volume II of this report.
National Bioethics Advisory Commission
5 Association of American Medical Colleges Medical School Graduation (GQ) Questionnaire, 1980–1996.
6 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
7 See http://www.ptcny.com/PDF/ccip2000.pdf. Last accessed May 1, 2001.
8 See http://www.primr.org/aahrpp.html. Last accessed May 1, 2001.
9 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
10 Ibid.
11 See McCarthy, C.R., “Reflections on the Organizational Locus of the Office for Protection from Research Risks.” This background paper was prepared for NBAC and is available in Volume II of this report.
12 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
13 Ibid.
14 OHRP Guidance: “Procedures for Registering Institutional Review Boards and Filing Federal Wide Assurances of Protection for Human Subjects.” December 3, 2000. Available at
http://ohrp.osophs.dhhs.gov/irbasur.htm. Last accessed December 8, 2000.
15 See http://ohrp.osophs.dhhs.gov/humansubjects/assurance/faq.htm.
16 Letter from D.A. Lepay, Food and Drug Administration, to E.M. Meslin, NBAC. February 20, 2001. Providing comments on a draft of this report.
17 Lepay, D., 2000, FDA’s Program for Human Subject Protection.
16 October. Presentation to ORCA Teleconference.
18 NBAC, “Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research.” This staff analysis is available in Volume II of this report.
19 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
20 Ibid.
21 NBAC Town Meeting: April 5, 2000, Pittsburgh, Pennsylvania.
22 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
23 Moorev. The Regents of the University of California et al.
793 P.2d 479. (Cal. 1990).
24 NBAC Town Meetings: February 9, 2000, Houston, Texas;
April 5, 2000, Pittsburgh, Pennsylvania; May 3, 2000, Orlando, Florida; June 7, 2000, Chicago, Illinois; August 14, 2000, Portland, Oregon.
25 39 Fed. Reg.18915.
26 See Holm, S., “The Danish Research Ethics Committee System—Overview and Critical Assessment”; Chalmers, D.,
“Research Ethics in Australia”; and Heath, E., “The History, Function, and Future of Independent Institutional Review Boards.”
These background papers were prepared for NBAC and are available in Volume II of this report.
27 See Heath, E., “The History, Function, and Future of
Independent Institutional Review Boards.” This background paper was prepared for NBAC and is available in Volume II of this report.
28 “Instructions for Registering an IRB or IEC.” Available at http://OHRP.osophs.dhhs.gov. Last accessed March 7, 2001.
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Introduction
T
his chapter addresses two issues central to the ethical analysis conducted by Institutional Review Boards (IRBs)—analysis of risks and potential benefits and the protection of vulnerable individuals—and rec-ommends policy in the form of regulation and guidance to govern the review of research.The current regulatory requirements relating to these ethical issues reflect the principles underlying the recom-mendations of the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report)(National Commission 1979). For exam-ple, the application of the ethical principle of respect for persons gives rise to the concern for vulnerability; the application of the principle of beneficence leads to the necessity of assessing risks and potential benefits;
and the principle of justice requires investigators to attend to the process of recruiting research participants, particularly as it relates to the inclusion of individuals categorized as vulnerable.
In protecting the rights and welfare of participants in research, it is especially important to protect them from avoidable harm. An IRB’s assessment of risks and poten-tial benefits is central to determining that a research study is ethically acceptable and would protect partici-pants, which is not an easy task, because there are no clear criteria for IRBs to use in judging whether the risks of research are reasonable in relation to what might be gained by the research participant or society.
When an IRB determines that risks are reasonable, it must also ensure that all segments of society have the opportunity to participate, as appropriate. But some individuals might be considered vulnerable because of
either intrinsic characteristics (e.g., mentally or terminally ill) or situational factors (e.g., living in poverty, employees of the institution conducting the research) that render their fully informed and voluntary participation more susceptible to coercion or exploitation. Recognizing the various types of vulnerability and providing adequate safeguards can also prove challenging for IRBs.