A revised version of the Common Rule will remove the need for additional informed consent when studying biospecimen data of clinical trial participants.
Clinical investigators, in most cases, will not have to obtain new consent from clinical trial participants to study their stored identifiable data or biospecimens, an important change from an earlier proposal for updating the federal government’s Common Rule governing biomedical research. Instead, researchers will be able to rely on an initial broad consent for future research involving a subject’s blood or tissue, according to the final update to the Common Rule affecting the Department of Health and Human Services (HHS) and 15 other federal agencies [see https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects].
The revised final Rule drops a number of controversial policies included in a rulemaking proposal issued in September 2015. Researchers and patient advocates filed more than 2000 comments on the plan, with scientists and investigators raising strong objections that certain new requirements would impose added regulatory burdens on research institutions and study sponsors.
Patient privacy advocates had championed a requirement that researchers obtain written patient consent before using any biospecimens obtained during earlier medical procedures to protect individual privacy. The aim was to prevent situations where an individual learns later that a specimen was used in research without their knowledge, as in the infamous Henrietta Lacks case involving unauthorized use of cancer cell tissue in the 1950s without permission or patient knowledge.
To avoid excessive roadblocks to future research, however, the updated Common Rule drops the need for added informed consent for research involving non-identified biospecimens. And it continues to permit investigators to obtain waivers to consent requirements.
The revised Rule further clarifies that informed consent must include a clear description of a study, its risks and benefits, and appropriate alternative treatments. And it requires researchers to inform patients if a study might include whole-genome sequencing, which could be used to identify donated specimens. But a clear aim is to reduce the length and complexity of consent documents to help research subjects make informed choices about participation in a study. The government “is very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants,” commented Jerry Menikoff, director of the HHS Office for Human Research Protections.
In addition, the final Rule supports the use of a single institutional review board (IRB) for multi-institutional research studies and reduces the need for additional IRB approval on future research where consent had been obtained earlier. These provisions further seek to allow IRBs to focus more attention on higher risk studies, as opposed to more routine use of biospecimens covered by earlier broad consent.
Important for sponsors of commercial clinical trials, the revised policy drops an earlier proposal to extend Common Rule requirements to research that does not receive federal funding, as is the case for most studies funded by pharmaceutical and medical products makers. However, academic research institutions and medical centers, which routinely receive government grants and participate in public health programs, are affected and thus must adhere to the federal standards.
The revised Rule goes into effect in 2018, unless Congress puts it on hold. Broad access to biospecimens for subsequent research is considered critical for carrying out the Cancer Moonshot and the Precision Medicine Initiative, which rely on access to huge numbers of samples for investigating cancer, neuroscience, genetics and other fields.