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Symposium: Bioethics in Scientific Research: Conflicts between Subject's Equitable Access to Participate in Research and Current Regulations

Looking into the Institutional Review Board: Observations from Both Sides of the Table¹

Department of Research, Connecticut Children’s Medical Center, University of Connecticut, Hartford, CT 06106

²To whom correspondence should be addressed. E-mail: gburke{at}ccmckids.org.

Institutional review board (IRB) reviews offer the benefit of perspective afforded by the board’s distance from the research and the research subjects. At the same time, distance from research subjects that is geographic, socioeconomic, cognitive, linguistic, and cultural can undermine the positive role of perspective. In addition, distance between IRB and investigators, largely a result of attitudes and communication, can prolong the review process and can obscure its message. The tension that often characterizes IRB–investigator relationships is due, in part, to variability in the application of federal regulations by IRBs across institutions and, on the part of investigators, inexperience, communication problems, and difficulties in anticipating the needs of their subjects. Contributing to the variability are the demographics and the culture of the IRB, attitudes that influence IRB–investigator relationships, and the adequacy of support from the institution. The effects of these factors on review decisions and on the performance of the human subjects protection system are largely unstudied. The movement for IRB accreditation is causing institutions to examine their overall research protection system and promises a more collaborative approach, where IRB and investigators accept their common charge to meet the needs of subjects and to improve the quality of research.

KEY WORDS: • IRB • human subjects • research protection

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