Thursday, January 6, 2011

OHRP's New Website

On January 3, the Office for Human Research Protections launched its redesigned website.

Of particular note to those interested in the history of IRBs is the new section on Related Resources, which contains more key documents than the previous website did, including all the reports (with appendices) produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

I am sorry to see that the website features none of the four items I requested when OHRP asked for comments in January 2009.

Moreover, the "Human Subjects Protection Federal Register Notices 1973 - 2007" on the Related Resources page overlooks Department of Health, Education, and Welfare, "Secretary's Interpretation of 'Subject at Risk,'" Federal Register 41 (28 June 1976): 26572, despite my drawing that omission to OHRP's attention in a follow-up e-mail to my comments.

The 1976 notice includes the curious claim that "The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 USC 2891-3 (added by Pub. L. 93-348) . . ."

As I note in my book, neither before or after this notice did federal regulators restrict their rule-making to areas of concern addressed in congressional hearings.

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