The U.S. Department of Health and Human Services has revised the Common Rule governing the protection of patients who donate biospecimens for research. The final rule eliminates a controversial proposal that would have required researchers to obtain renewed consent for use of donated samples beyond their original purpose.

The U.S. Department of Health and Human Services (DHHS) has issued a final rule updating the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule. Published in the Federal Register, the rule is intended to provide stronger protections for research participants while reducing administrative burdens on investigators (see

The revisions, slated to take effect next January, represent the first major update of the Common Rule since 1991 and reflect the significant technological advances that have changed the nature of biomedical research. The DHHS collaborated with 15 other federal departments and agencies to clarify requirements surrounding patient consent for ongoing use of biospecimens and to streamline the regulatory review process for large studies spanning multiple institutions.

“The final Common Rule significantly reduces the regulatory burden on researchers and patients, while effectively protecting patient privacy,” says Gilbert Omenn, MD, PhD, director of the Center for Computational Medicine and Bioinformatics at the University of Michigan in Ann Arbor and chair of the American Association for Cancer Research's (AACR) Health Policy Subcommittee.

The AACR and other major cancer groups objected to a provision in the proposed rule that would have required researchers to obtain new consent forms for any additional use of deidentified samples. Even though all direct personal identifiers are permanently removed from deidentified biospecimens, recent technology has made it possible to break through those protections, says Omenn. Nonetheless, the system works very well overall and is accepted by most institutional review boards (IRB).

Requiring investigators to reidentify those samples and track down affected individuals long after the initial research has taken place would have represented a significant administrative and financial burden, he says. Alternatively, the final rule allows research participants to grant broad consent for use of identifiable biospecimens—those where personal identifiers have been removed and replaced with codes that can be unlocked and traced back to the source when appropriate.

Under the final rule, investigators have the option of using deidentified samples without obtaining new consent for additional research or requesting broad consent to use identifiable biospecimens for unspecified future research. The latter has the advantage of making it easier for participants to be notified about actionable findings resulting from future research, notes Omenn.

The final rule also encourages creation of a single IRB for federally funded multisite studies, beginning in 2020.

“We're pleased that the final rule allows for the use of a broad but simple consent from a research participant regarding the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens,” says Omenn. “With a single multisite IRB review it's estimated that investigators will spend half as much time engaging with the review process as they would have if separate reviews were required at each site.” –Janet Colwell

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