The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

Abstract

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.

Keywords:

• human subjects research
• informed consent
• IRB
• research ethics
• self-censorship

Notes

¹For the purposes of this article, the issue of whether IRBs should review non-federally funded research will not be explored.

²A pejorative term often used to refer to the IRB system's growing purview; for example, see the Center for Advanced Study's White Paper on the IRB system (Gunsalus et al., 2006).

³Another key factor is whether the form of research is specifically delineated as qualifying for expedited review under federal guidelines (HHS, 1998).

⁴According to a survey by De Vries, DeBruin, and Goodgame, “[…] nearly 70% of boards have 30% or more of their members drawn from biology and medicine” (De Vries et al., 2004, p. 355). The survey had a sample size of 87 IRBs.

⁵Of course, the analogy between peer review and IRB review is not exact since each respective process focuses on different dimensions of research. The procedure for selecting peer reviewers and IRB members is also not equivalent. Yet the point should not be lost that in order for both types of review to function well, expertise with regard to the type of research being scrutinized is a vital element.

⁶But this is not necessarily a bad thing if human subjects are protected from harm.

⁷One thing that may distinguish the different projects is the source of funding, but many IRBs already review research that is not supported by federal funds.

⁸A likely reason why consent forms have become overly technical and complicated is due to concerns about legal liability. As a by-product, many of the consent forms that result are fairly opaque and cumbersome.

⁹According to one report, “most oral history interviewing projects” are exempt from IRB review but not all (Oral History, 2004). This leads to confusion regarding which ones still need to be examined by an IRB.

¹⁰One place where this type of approach has been articulated is within the Illinois White Paper (Gunsalus et al., 2006, pp. 21–22).