The Volokh Conspiracy - Reforming Institutional Review Boards:

Institutional Review Boards (IRBs) are boards comprised mostly of faculty at an educational institution that review and approve/disapprove research involving human subjects to ensure that the research meets minimum ethical guidelines demanded by the institution and/or by federal regulations when the research is federally funded. While the most obvious concerns involve medical experimentation, the jurisdiction of IRBs extends to social science research as well, including not just behavioral studies but also journalism and historical research. I have written a new paper that can be downloaded here arguing that IRBs have gone too far in the regulation of social science research, limiting and chilling potentially important research for dubious gains in human protection. From the abstract:

It is time to rethink the role of Institutional Review Boards (IRBs) in approving social science research. While most law professors conduct their research in an almost unregulated environment -- poring through cases, statutes, and each other's articles, all without the kind of human interaction subject to IRB regulation -- their colleagues elsewhere in the university have been coping for decades with an increasingly intrusive bureaucracy that sometimes undermines basic academic values.

Three things seem very clear. First, there are a lot of IRBs -- at least 4,000 -- and their numbers are growing. Second, they have recently increased their scrutiny of social science protocals and all indications suggest even more scrutiny is imminent. Third, social scientists are increasingly frustrated, annoyed, and upset by IRB decisions, inconsistencies, delays, and misunderstandings.

There is much less consensus on what, if anything, should be done about these developments. Some experts favor even more IRB oversight, expanded IRB jurisdiction, and larger budgets and staffs for IRBs. The cure for the ills of IRBs, on this view, is more IRBs.

In this article, I suggest a different and more liberalized path. In Part I, I describe the regulatory metastasis of IRBs and some problems it is causing for social science research. In Part II, I offer some thoughts on the ways in which these problems might arise from the pro-regulatory incentives to which IRBs are exposed.

Finally, in Part III, I outline some modest liberalizing reforms to counter the effects of these pro-regulatory incentives. The reforms I propose broadly fall into three categories: IRB membership and structure, substantive IRB jurisdiction, and institutional liability. In the first category, IRB membership and structure, I propose that we should require basic First Amendment training for IRB members and include a First Amendment expert as a member of the IRB; that we should require that more than one, perhaps even a majority, of the members of the IRB have the expertise and competence to evaluate the risks and benefits of the particular research being reviewed; and that every research institution using IRBs should establish separate boards for biomedical and social science research.

In the second category, substantive IRB jurisdiction, I propose that oral history and other interview-based research should be exempt from IRB approval; that IRBs should be permitted to prohibit or alter research in the social sciences only where the risks of the research substantially outweigh the anticipated benefits; that rather than have IRBs screen social science research before it is performed, they should review it (and enforce internal discipline on researchers, if necessary) only after ethical breaches cause some harm; and that social science researchers themselves, rather than IRBs, should determine at the threshold whether their research is exempt from prior IRB approval.

In the third category, institutional liability, I propose that evidentiary rules in civil trials should exclude evidence of a university's failure to adopt the [federal guidelines] for non-federally-funded research.

Many details of these proposals will need to be worked out, but I offer them in this Article as a starting point for reform efforts.

The paper will be published in an upcoming IRB symposium issue of the Northwestern Law Review, to which co-Conspirators Jim Lindgren and Todd Zywicki have also contributed. Please take the time to download and read the paper before commenting. I especially welcome comments and suggestions sent to my email address, dalecarp@umn.edu.

	[Dale Carpenter, December 4, 2006 at 12:13pm] Trackbacks Reforming Institutional Review Boards: Institutional Review Boards (IRBs) are boards comprised mostly of faculty at an educational institution that review and approve/disapprove research involving human subjects to ensure that the research meets minimum ethical guidelines demanded by the institution and/or by federal regulations when the research is federally funded. While the most obvious concerns involve medical experimentation, the jurisdiction of IRBs extends to social science research as well, including not just behavioral studies but also journalism and historical research. I have written a new paper that can be downloaded here arguing that IRBs have gone too far in the regulation of social science research, limiting and chilling potentially important research for dubious gains in human protection. From the abstract: It is time to rethink the role of Institutional Review Boards (IRBs) in approving social science research. While most law professors conduct their research in an almost unregulated environment -- poring through cases, statutes, and each other's articles, all without the kind of human interaction subject to IRB regulation -- their colleagues elsewhere in the university have been coping for decades with an increasingly intrusive bureaucracy that sometimes undermines basic academic values. Three things seem very clear. First, there are a lot of IRBs -- at least 4,000 -- and their numbers are growing. Second, they have recently increased their scrutiny of social science protocals and all indications suggest even more scrutiny is imminent. Third, social scientists are increasingly frustrated, annoyed, and upset by IRB decisions, inconsistencies, delays, and misunderstandings. There is much less consensus on what, if anything, should be done about these developments. Some experts favor even more IRB oversight, expanded IRB jurisdiction, and larger budgets and staffs for IRBs. The cure for the ills of IRBs, on this view, is more IRBs. In this article, I suggest a different and more liberalized path. In Part I, I describe the regulatory metastasis of IRBs and some problems it is causing for social science research. In Part II, I offer some thoughts on the ways in which these problems might arise from the pro-regulatory incentives to which IRBs are exposed. Finally, in Part III, I outline some modest liberalizing reforms to counter the effects of these pro-regulatory incentives. The reforms I propose broadly fall into three categories: IRB membership and structure, substantive IRB jurisdiction, and institutional liability. In the first category, IRB membership and structure, I propose that we should require basic First Amendment training for IRB members and include a First Amendment expert as a member of the IRB; that we should require that more than one, perhaps even a majority, of the members of the IRB have the expertise and competence to evaluate the risks and benefits of the particular research being reviewed; and that every research institution using IRBs should establish separate boards for biomedical and social science research. In the second category, substantive IRB jurisdiction, I propose that oral history and other interview-based research should be exempt from IRB approval; that IRBs should be permitted to prohibit or alter research in the social sciences only where the risks of the research substantially outweigh the anticipated benefits; that rather than have IRBs screen social science research before it is performed, they should review it (and enforce internal discipline on researchers, if necessary) only after ethical breaches cause some harm; and that social science researchers themselves, rather than IRBs, should determine at the threshold whether their research is exempt from prior IRB approval. In the third category, institutional liability, I propose that evidentiary rules in civil trials should exclude evidence of a university's failure to adopt the [federal guidelines] for non-federally-funded research. Many details of these proposals will need to be worked out, but I offer them in this Article as a starting point for reform efforts. The paper will be published in an upcoming IRB symposium issue of the Northwestern Law Review, to which co-Conspirators Jim Lindgren and Todd Zywicki have also contributed. Please take the time to download and read the paper before commenting. I especially welcome comments and suggestions sent to my email address, dalecarp@umn.edu.