doctor examines a patient

Rules governing research involving human subjects have become a source of controversy.

EdTech/Stanford University (CC BY-NC-ND 2.0)

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

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 some other changes intact.

Biomedical and university research groups that lobbied against the biospecimens provisions are relieved. “We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked,” says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.

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 and exemptions for low-risk studies such as some social science research. 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 study. 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 broad 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 and individual scientists argued in many of the 2100 comments submitted on the proposed rule. Critics also worried that retaining a link between samples and consent forms would create new privacy risks. A committee of the National Academies of Sciences, Engineering, and Medicine urged federal officials to withdraw the entire proposal and form an expert commission to revamp the Common Rule.

Instead, HHS and 15 other agencies have issued the final 543-page rule—but without the new biospecimen provisions.

“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, which begins to take effect next year.

The proposed rules for biospecimens were inspired by the case of Henrietta Lacks, a poor black woman whose cancer cells became widely used in research labs without her or her family’s consent. Kathy Hudson, a former National Institutes of Health (NIH) official who helped shape the revised rule, says she still thinks informed consent “was and is the right and respectful thing to do,” but said that the Common Rule was “a very clunky policy instrument” for achieving that goal, and that the research community’s concerns “had to be considered.” Hudson, who left NIH last month and commented as a private individual, said NIH can now collect evidence to show whether collecting broad consent for samples “is doable.”

Bioethicist Hank Greely of Stanford University in Palo Alto, California, who also supported the biospecimens consent requirement, believes the decision to drop the proposal from the final rule is “a predictable result of the disparity in lobbying power” between research institutions and patients. (Some patient groups had supported the change.)

The final rule also drops a requirement all researchers abide by the Common Rule if their institution receives any federal funds for clinical research. Opponents of the idea argued it would have hindered some social science and student research, and would not have closed what the final rule states is “the real gap” in regulation: institutions that get no federal funding. For universities, which already apply the Common Rule across all research they conduct, the new mandate would have only added “another layer of paperwork,” says Heather Pierce, senior director of science policy at the Association of American Medical Colleges (AAMC) in Washington, D.C.

Another controversial component remains in the final rule, however: that researchers conducting a clinical study across multiple institutions use a single institutional review board (IRB) to streamline oversight. NIH is phasing in a similar requirement. Critics have said it might not make sense for very small studies or some involving local communities. The rule allows some exceptions for such situations. Still, the single IRB review rule “may keep some research from happening,” Pierce says.

*Update, 18 January, 5 p.m.: This story has been updated to include more information on the final rule and comments.