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Ethical Challenges

8. Current Issues Concerning Ethics Committees

Conflict of Interest

Some claim that institutional committees have an inherent conflict of interest because external research funds that benefit the institution are contingent on IRB approval of the research.  Review by free-standing committees to avoid this conflict is an alternative but is much less commonly used in the US, especially if the free-standing committee is a for-profit organization.  Aside from institutional conflicts of interest, investigators may have individual financial conflicts of interest, personal conflicts of interest, and professional conflicts of interest that may affect their behavior as reviewers of manuscripts and funding applications.  IRBs may be assigned the task of identifying and managing conflicts, especially financial conflicts of interest, in addition to their other responsibilities.

Cost and Burden

There is general agreement that the US ethics review system is expensive, weighed down by procedural requirements, and time-consuming for all involved.  Yet, we do not know how well human participants are protected or how consistent that protection is across institutions and research projects.  Some good research on this issue would be a major contribution.
The proposed changes to the Common Rule address many of these issues.  A table summarizing the proposed changes and the rationale underlying them has been prepared by OHRP (US Department of Health & Human Services, 2011).

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