National Academies’ Report Offers Hope for Scrapping Proposed Changes to Research Regulations

The National Academies of Sciences, Engineering and Medicine released a report last month critical of a controversial proposal to revise regulations that protect people who participate in medical research. The National Academies further recommends that the Obama administration withdraw its proposal and, with Congress, appoint an independent commission to examine and update the ethical, legal, and institutional frameworks governing research involving human subjects.

Known as the Common Rule, these regulations set ethical standards for federally funded researchers who work with human subjects. However, these regulations were put in place in 1981 and have lacked substantial updates over the last several decades, a time in which research technology and sharing of data has changed dramatically. This prompted the U.S. Department of Health and Human Services (HHS) to propose major revisions and “modernizations” to the rules in September 2015. But, the research community largely criticized the revisions as being complex and potentially onerous.

One of the most controversial new requirements would require scientists to obtain explicit consent from patients before using their blood or tissue for research, even when the samples are not linked with any information that could be used to identify the patients. The Common Rule currently allows for research to be conducted using previously collected biospecimens (e.g., blood, urine, or tissue samples) without informed consent as long as the specimens are de-identified. The proposed revisions require “broad,” written consent from specimen donors for future unspecified uses of their de-identified biospecimens—a change in practice that the National Academies calls a “significant departure” from current practice.

“Research on excess or residual biospecimens has contributed enormously to the growth of medical knowledge for nearly a century and a half, improving human health with little evidence of harm to individuals whose biospecimens were used in this way,” the National Academies’ report says. “Moreover, implementation of the proposed rule would necessitate maintaining a link between the consent document and the biospecimens—a proposal that raises substantial risks of re-identification and loss of privacy.”

Experts say with broad consent, patients or research participants give their blanket consent to the use of their biological sample and/or clinical data in research that may not be underway or even specified at the time of consent. By comparison, narrow consent is limited to a specific research endeavor and based on concrete information about planned or currently active research. Given the rise of “big data” and biobanks enabling large-scale genomic research, changes to consent could have enormous implications to the research.

Several recent efforts have tried to illustrate the public’s preferences regarding consent. A systematic review published Nov. 19, 2015 in Genetics in Medicine found that only a minority of respondents favored broad consent when other options, such as tiered or study-by-study consent, were offered. While undeniably some participants objected, broad consent was often preferred over tiered or study-specific consent, when samples were de-identified, logistics of biobanks were communicated, and privacy was addressed, the Vanderbilt University authors found. Interestingly, individuals were generally willing for data or biospecimens to be shared with other academic researchers, but individuals were less willing for their data to be shared in federal databases or with commercial enterprises.

Another study evaluating consent for biobank research was published in BMC Medical Ethics in September 2015. It showed the majority of research participants opted for some version of limited consent, when given the possibility. Consent preferences were influenced by information about pharmaceutical industry sponsorship of biobank research and participants’ perceived trade-off between privacy and perceived utility. This review found, however, participants’ understanding and recall regarding the consent procedure was lacking.

Currently, HHS is reviewing the National Academies’ report as well as more than 2,000 other public comments on the proposed changes to the Common Rule. It remains unclear if the Obama administration or the health agency will scrap its plans. A final decision is expected this fall.

Takeaway: Proposed changes to rules regarding consent for use of biospecimens in medical research continue to draw criticism. While joining those criticizing the regulatory revisions, a new National Academies of Sciences’ report suggests an alternative—an independent commission to review and update research rules.