U.S. abandons controversial consent proposal on using human research samples

Science Magazine – Federal officials have dropped a controversial plan to impose new rules that researchers say would have made it much harder to use patient blood and tissue samples in research. The final Common Rule released this morning omits these provisions, but leaves other changes intact.

The 26-year-old Common Rule protects people who volunteer for federally funded research studies. The Department of Health and Human Services (HHS) and other agencies began an overhaul in 2011 to incorporate changes in how medical research is done, such as a growing number of clinical trials, the use of electronic medical health records, and privacy concerns raised by advances in genomics.

A proposed rule released in September 2015 contained some uncontroversial revisions, such as requirements for simpler informed consent forms. But the proposal set off alarm bells because it would have imposed new rules for research using blood, urine, tissue, and other specimens leftover from clinical care or a specific research studies. Those samples can currently be used for new research without the donor’s consent if they are stripped of names and other identifying information. But the proposed rule would have required written consent for future use of such deidentified samples. Institutions would have had to set up systems to track the consent data.

This change would have imposed huge costs, and many small hospitals and clinics would likely stop providing samples to researchers, research organizations argued in many of the 2100 comments submitted on the proposed rule. The weightiest criticism came from a committee of the National Academies of Sciences, Engineering and Medicine, which urged federal officials to withdraw the entire proposal and form an expert commission to revamp the Common Rule.

Instead, HHS and other agencies have issued the final rule—but without the new biospecimen provisions. “In general, researchers can continue to use such biospecimens in the way they are currently using them,” HHS stated in a press release.

“Eliminating that proposal is intended to address concerns about the complexity of and lack of justification for the proposed changes in the rule, as well as concerns about embarking on significant changes without evidence that they would improve the system,” the final rule states. Biomedical research groups are welcoming the news but still digesting the 543-page document. 

Image citation: Администрация Волгоградской области, CC BY-SA 3.0

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