Thursday, May 12, 2016

NPRM Comments Focus on Biospecimens

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), has reviewed and analyzed (they don’t say “read”) all 2,186 public comments submitted in response to the 2015 NPRM. The analysis suggests that the debate over biospecimens is crowding out discussion of other proposed reforms.

[Council on Governmental Relations, “Analysis of Public Comments on the Common Rule NPRM,” May 2016. h/t Michelle Meyer.]

Nearly 70 percent (1520 of 2186) of the comments “addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes” on the grounds that “the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health.”

By contrast, only 15 percent of responses commented on the proposed mandate for single IRB review for multisite studies, and less than 10 percent commented on imposing the Common Rule regardless of funding source, security safeguards, and posting consent forms to a public website.

We don’t know what percentage commented on the stuff I care about, like interviews and ethnography. The COGR analysts did not code for that.

Once again, concerns about biomedical research dominate both the regulatory process and the public response to it. We’ve been on that path for over 50 years; why stop now?

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