Friday, July 17, 2009

AAHRPP and the Unchecked Box

Regular readers of this blog likely know that most United States universities submit "federalwide assurances" (FWAs) pledging to abide by the Common Rule for research funded directly by federal agencies that have adopted that rule.

Section 4 of the standard assurance includes an optional pledge that "This Institution elects to apply . . . to all of its human subjects research regardless of the source of support, except for research that is covered by a separate assurance" either the Common Rule or the Common Rule and subparts B, C, and D of 45 CFR 46. Institutions that check this box--as seems to have been common in the past--with one stroke of the pen eliminate one of the major concessions made by federal regulators in 1981, when they promised that non-federally-funded research would not be regulated.

Recently, however, at least 164 universities have "unchecked the box," declining to promise to apply the regulations to all research. The American Association of University Professors has strongly recommended that universities uncheck the box as a first step toward devising procedures less burdensome than those specified in the regulations.

Malcolm Feeley has noted that unchecking the box could also yield important empirical data:

If there are few reports of negative consequences . . . they might encourage national officials to rethink the need for such an expansive regulatory system . . . On the other hand, if opt-out results in increased problems, the findings might help convince Katz, Dingwall, me, and still others of the value of IRBs.

Nor are such comments confined to outsiders. At the July 16, 2008, meeting of the Secretary's Advisory Committee on Human Research Protections, committee member Lisa Leiden of the University of Texas system spoke of her own interest in freeing nonfunded research from direct federal regulation:

We have talked about limiting the federal wide assurances, unchecking the box, and I believe the position that we're going to be taking is to advocate in a gentle way thinking about doing that. We have heard both sides of the story or maybe just a few sides, but we think that there are certainly some advantages. And one of the advantages might be . . . what can we do with the expedited review level. It seems that there is a lot of flexibility in that, and we might be able to increase some of that by unchecking the boxes and adding different categories for that.

Unchecking the box is therefore one of the most promising incremental reforms now on the table. This is why I was disappointed to see that the AAHRPP's proposed revised standards, described in my previous post, seem to preclude this option.

A correspondent questioned this assertion, noting that AAHRPP president Majorie Speers had mentioned unchecking the box in her presentation, "Finding Flexibility in the Regulations." But there's nothing in the slides to suggest that AAHRPP or Speers approves of such a practice, and a July 2008 memo from the University of California states that AAHRPP site visitors have told university administrators "that in order for a human research protection program to be accredited, it must apply the Common Rule and its subparts to all human research at the institution, irrespective of funding."

Either AAHRPP forbids accredited organizations from unchecking the box, or its policies are so unclear that its site visitors are giving out bad information. Either way, I suggest that the revised standards permit unchecking the box as a means of reform.

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