FDAnews Drug Daily Bulletin

HHS Relaxes Proposed Common Rule Restrictions on Biospecimen Research

Jan. 25, 2017

HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information.

HHS decided not to pursue that course after receiving more than 2,100 comments in the 90 days following the rule’s initial proposal in September 2015.

Instead, HHS is allowing researchers to proceed based on broad consent that informs the subject that de-identified samples may be used in the future for separate research projects, such as genome sequencing studies. That would act as an alternative to seeking a consent waiver from an institutional review board.

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