Report Challenges Proposed Consent Requirements for Research Using Biospecimens

By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies

The National Academies of Sciences, Engineering and Medicine recently released a report critical of a controversial proposal to revise regulations known as the Common Rule, which 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.

The U.S. Department of Health and Human Services (HHS) proposed 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.

The National Academies’ report argues that “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.” 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. A final decision on the proposed changes is expected this fall.