U.S. aims to overhaul ethics rules for research with people

Signing up for a research study may feel like a short-term commitment. A blood draw or a cheek swab and it’s done. But those specimens and the data they yield last much longer, and might end up in studies that did not even exist when the participants first gave their consent.

“Maybe I consented to the study that I initially participated in, but you’re now using my sample for a study I don’t believe in — one I never would have consented to,” says Karen Rommelfanger, director of neuroethics at Emory University in Atlanta, Georgia. “There wasn’t an opportunity for me to say, ‘Hey, I don’t want my blood used for this research.’” Dr. Rommelfanger is a faculty member in the NS program.

New rules proposed by the U.S. Department of Health and Human Services (HHS) address this potential ethical lapse. The rules add privacy protections for participants, streamline the ethical review process for clinical research and redefine ‘human subjects’ to include genetic data and tissue specimens.

The revisions would require scientists to destroy biological specimens if they don’t have the explicit consent of the participant for further use.

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