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U.S. to finalize new human subject protections

After 4 years of mulling, the U.S. Department of Health and Human Services (HHS) is preparing to tighten rules designed to protect people who participate in research funded by the federal government and many private entities. HHS, along with 15 other agencies, released a Federal Register notice today describing the intended changes, which include tighter consent requirements for the reuse of stored blood or tissue in new research.

The requirements, collectively known as the Common Rule, have been in place since 1991. But the expanding scale of research involving human subjects—enabled in part by more sophisticated ways to analyze biospecimens and by the large-scale collection of digital health records—has inspired an overhaul. In 2011, HHS announced plans to tighten the rules, and began collecting public feedback.

The notice released today follows through on several ideas floated in that announcement. One major change would require researchers to get a participant’s consent to analyze donated biospecimens in future studies that are unrelated to the original research. For now, researchers can make use of stored samples leftover from previous studies or clinical tests without explicit consent by stripping them of any personal identifying information. That sidesteps the typical consent by “taking the human out of human subjects research,” says Kathy Hudson, deputy director for science, outreach, and policy at the National Institutes of Health (NIH) in Bethesda, Maryland. But “that is not really consistent with the views we have about the partnership we have with research participants,” she adds. The new rule would “show respect” for these subjects, she says, by asking them to give broad consent to any unspecified future research use of their blood or tissue.

Another section aims to simplify the informed consent forms given to potential subjects in a study. The notice calls for making these long and complicated forms clearer by requiring a few essential components in the body of the form, and by relegating other details to an appendix.

Not all of the revisions raise the ethical bar. Another set of changes would exempt eight categories of study from Common Rule requirements. The exempted research includes studies conducted as part of a public health surveillance effort and social science studies that involve collecting oral histories and biographies. Another simplifying measure would require that a research project spanning multiple institutions be consolidated under a single institutional review board.

The move comes as NIH itself is gearing up for an ambitious bit of human subjects research—a longitudinal study of at least 1 million volunteers as part of the White House’s precision medicine initiative. Hudson says she expects the new rules will make it easier to make use of samples and data from that broad cohort as the study evolves.

After the notice is officially published in the Federal Register next week, there will be a 90-day comment period before the release of a final rule.