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Academic groups worried by human subject proposals

Two university groups are expressing concern over a rule that the Department of Health and Human Services (HHS) proposed in July to enhance protections for human subjects enrolled in federal research and reduce burden, delay, and ambiguity for the investigators involved.

The deadline to submit comments on the proposal to HHS was 26 October. In a 25 October letter to Jerry Menikoff, head of HHS’ Office of Human Research Protection, the presidents of the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU) warned about HHS’ plan to extend federal human subjects protection regulations to all research regardless of funding source.

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