Institutional Review Boards: Is This the Least Worst We Can Do?

By Hyman, David A. | Northwestern University Law Review, January 1, 2007 | Go to article overview

Institutional Review Boards: Is This the Least Worst We Can Do?


Hyman, David A., Northwestern University Law Review


INTRODUCTION

Institutional Review Boards ("IRBs") are polarizing institutions. IRB supporters view them as the best thing since sliced bread. Detractors believe IRBs impose costs and have no benefits. Supporters point to the good faith and hard work of those who volunteer to serve on an IRB. Detractors suggest that IRBs emphasize bureaucratic busy-work. Supporters ask for more money and more staff so they can do an even more thorough job reviewing research protocols. Detractors point out that the IRB framework of research oversight would never be approved by an IRB. Supporters counter that notorious examples of abuse show that IRBs are necessary. Detractors respond with anecdotes of IRB stupidity and incompetence. Supporters argue that conducting research is a privilege, not a right. Detractors complain about censorship, restrictions on academic freedom, and the chilling of constitutionally protected free speech. Both sides then return to their respective camps, secure in the knowledge that they are right and those on the other side are self-righteous zealots.

The controversy over IRBs arises from differing preferences, methodological commitments, and risk tolerances. Both sides believe fundamental principles (academic freedom-censorship versus the protection of vulnerable human subjects) are at stake, so the dispute is not readily subject to compromise.1 Even King Solomon would find it difficult to solve the controversy in a way that makes everyone happy-and the original Solomonic strategy (cutting the director of each IRB in half) seems unlikely to do the job. This article offers some perspective on the dispute, and some modest strategies for improving on the status quo.

Part I provides an abbreviated background on the regulatory backdrop. Part II offers a simple theoretical framework for analyzing the issues raised by research oversight. Part III reviews what we know about IRB performance. Part IV assesses how we ended up in this situation. Part V considers whether judicial oversight of IRBs can improve matters. Part VI provides a comparative institutional perspective on the problem and suggests some modest reforms.

I. IRB OVERVIEW

Federal regulations require all research funded by the federal government and involving human subjects to be overseen by an IRB.2 These regulations are rooted in the work of the National Commission for the Protection of Human Subjects of Biomédical and Behavioral Research, which was created in response to several well-publicized biomédical research scandals.3

"Research" is defined by the regulations as "a systematic investigation . . . designed to develop or contribute to generalizable knowledge."4 A human subject in turn is "a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information."5

Each IRB must be composed of at least five members, including men and women, who should have diverse cultural and racial backgrounds.6 At least one member of the IRB should have scientific expertise, while at least one individual must be a nonscientist.7 Each IRB must have at least one member who is not otherwise affiliated with the research facility and has no immediate family members who are so affiliated.8

IRBs have the authority to approve, require modification of, or disapprove research, both in its initial determination and as part of mandatory continuing (at least yearly) review.9 In determining whether to approve a study, an IRB is required to evaluate whether the risks to subjects are minimized; whether those risks are reasonable in light of expected benefits; and whether subjects are selected in an equitable manner, with due concern for the particularized risks of conducting research in vulnerable populations.10 For research that involves multiple institutions, an institution that obtains the appropriate approvals can "enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. …

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