Skip to main content
Premium Trial:

Request an Annual Quote

Start From Scratch

The National Academies of Sciences, Engineering, and Medicine has advised the White House to abandon its effort to revise the Common Rule that protects people who participate in medical research and start again, NPR reports.

The regulations haven't been updated in some 25 years, NPR notes, and the Department of Health and Human Services has recently put together a proposal of changes it would like to make. For instance, one proposed change would require secondary consent for any research on leftover biospecimens like blood samples. Critics of this proposed change say that it may make anonymous samples that have been stripped of identifying information unusable.

Further, in its report, the National Academies says the proposal from HHS is "marred by omissions, the absence of essential elements, and a lack of clarity." It further says that HHS should withdraw its proposal and the White House and Congress should instead set up an independent commission to revise the regulations.

In particular, it notes that as much research "does not involve physical risk to participants" but instead "possibility of informational harm resulting from the inadvertent release of confidential information," it further recommends that agencies following the Common Rule implement risk-stratified system to protect research participants. In that way, minimal-risk research isn't subject to as high a regulatory burden, while riskier research has more intense oversight.

According to NPR, HHS is reviewing the report along with other comments it has received regarding its proposal.