Friday, September 18, 2015

NPRM. Statute? What Statute?

The NPRM cites 42 U.S.C. 289 as its statutory authority, but it does not seem to care much about following the language of the statute.

The statute applies to “biomedical or behavioral research involving human subjects,” and does not mention social science. The NPRM acknowledges that “some of the commenters [on the ANPRM] recommended that the definition of research be focused more explicitly by being limited to ‘biomedical and behavioral research,’ in accordance with the statutory provision underlying the Common Rule.” But it makes no effort to focus the definition or to explain why the drafters felt comfortable ignoring this part of the statute.

Similarly, the statute requires IRB review of research supported by a “grant, contract, or cooperative agreement under this chapter.” When the 1981 version of 45 CFR 46 was promulgated, the Federal Register notice explained,

HHS has carefully considered its proposed policy regarding the regulation of non HHS-funded research in light of the comments received and the statutory basis for the more expansive interpretation. The public comment, including that of the President’s Commission, revealed a broad based and significant amount of objection to the extension. Further, the HHS General Counsel has advised that there is no clear statutory mandate in the National Research Act to support a requirement for IRB review of other than Public Health Service-funded research. Therefore, the Secretary of HHS, after considering a number of possible options, has decided not to extend the requirements for prior IRB review and approval to non HHS-funded research. (8369)

Now, the 2015 reverses that interpretation and “proposes an extension that would ensure that clinical trials are covered by the Common Rule if conducted at an institution in the United States that receives federal support for non-exempt and non-excluded human subjects research, regardless of the funding source of the specific clinical trial.” (53989)

The 2015 NPRM acknowledges that ANPRM comments “argued that such a change was an overreach of federal oversight and constituted an unfunded mandate.” But it offers no legal analysis of why regulators feel comfortable overriding public concern and the legal reasoning of previous HHS counsel.

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