. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
becomes unethical in human research when it clashes with the protection of research participants. Awareness should be raised at every level within research organizations that conduct human participant research regarding the nature of excessive self-interest and its harmful effects and to promote institutional cultures that do not tolerate runaway ambition (Levinsky, 2002). The evolving accreditation process should incorporate attention to nonfinancial conflicts in its assessments of human research protection programs, and the groups pursuing conflict of interest policies should work to develop guidelines that are as rigorous as those directed at individual financial conflicts.
At the institutional level, structural relationships could threaten the independent activities of individuals or committee operations. For example, junior faculty members serving on Research ERBs may be reluctant to raise concerns about protocols submitted by senior colleagues; this hesitancy may be particularly strong when reviewing a department chair’s project. Similarly, Research ERBs may feel pressure to support institutional perspectives or organizational interests in specific situations (see Chapter 3). Research organizations should take deliberate steps to avoid the potential impact of such scenarios on decisions that affect the protection of research participants.
Disclosure of Conflicts of Interest to Research Participants
Although many private and public organizations agree that information about potential conflicts of interest should be disclosed to participants, agreement on the level of detail and how the conflict should be effectively communicated has not been reached. Concern exists that detailed disclosures in a consent form could be overwhelming and not understandable to most participants. Nevertheless, in order to make informed decisions, participants have a right to know if the investigator, staff, or institution has a potential conflict of interest in the experiment and what that conflict is. Research ERBs should make the final determination about how information about these conflicts is presented to participants.
The consent form might include detailed information about a financial interest and its management (whether it is determined to be a conflict of interest or not). The participant should be advised that more information about the conflict and its management is available upon request. However, simple disclosure is not a substitute for in-depth conflict of interest review and subsequent Research ERB review or for the obligation to adhere to other aspects of ethical research.