Wednesday, August 10, 2011

Schrag on updating the IRBs

Zachary Schrag has a PDF up on recent efforts to update IRBs. Count me in as vehemently in favor of two of the proposals that are apparently up for discussion.

First, there is the coverage of fields that simply don't have the human risks that medical research does:
Define some forms of scholarship as non-generalizable and therefore not subject to regulation. As noted above, the current regulations define research as work “designed to develop or contribute to generalizable knowledge.” Since the 1990s, some federal officials and universities have held that journalism, biography, and oral history do not meet this criterion and are therefore not subject to regulation. However, the boundaries of generalizability have proven hard to define, and historians have felt uncomfortable describing their work as something other than research.

I would add computer science to the list. A cleaner solution is as follows:
Accept that the Common Rule covers a broad range of scholarship, but carve exceptions for particular methods. Redefining “research” is not the only path to deregulation contemplated by the ANPRM, so a third possibility would be to accept Common Rule jurisdiction but limit its impact on particular methods.

Schrag's PDF gives limited attention to this option, but it seems the most straightforward to me. If a research project involves interviews, studies, or workplace observations, then it's just shouldn't need ethics review. The potential harms are so minor that it should be fine to follow up on reports rather than to require ahead-of-time review.

Schrag also takes aim at exempt determinations:
Since the mid-1990s, the federal recommendation that investigators not be permitted to make the exemption determination, combined with the threat of federal sanction for incorrect determinations, has led institutions to insist that only IRB members or staff can determine a project to be exempt. Thus, “exempt” no longer means exempt, leaving researchers unhappy and IRBs overwhelmed with work.

Yes! What kind of absurd system declares a project exempt from review but then requires a review anyway?

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