On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The original Common Rule had been in place for almost 30 years, with little change despite significant research and technology advances during that time. Further change is on the horizon for the Common Rule, as the 21st Century Cures Act (Cures) includes a mandate for HHS and the Food and Drug Administration (FDA) to harmonize long-standing differences between the Common Rule and FDA Human Subject Protection regulations.
The Cures requirement to harmonize the Common Rule and FDA Human Subject Protection regulations could have been a much bigger challenge had HHS not made significant changes from its original proposal for updating the Common Rule, published in a September, 2015 Notice of Proposed Rulemaking (NPRM). The NPRM prompted more than 2100 public comments, many of them critical, and it appears that HHS has attempted to address public concerns in the final revised Common Rule. One welcome change from the NPRM is the removal of a provision that would have required researchers to obtain consent before using a study participant’s de-identified blood and tissue samples for secondary research. Had it been included in the final rule, this provision would have been contrary to FDA’s policy of facilitating the use of leftover blood and tissue for secondary research and would also have been inconsistent with HIPAA, which does not apply to de-identified samples. Removal of the proposed consent requirement makes the path to harmonization a little bit smoother for researchers. Other highlights of the revised Common Rule include:
- A requirement for simplifying research consent forms which have grown to significant length and complexity over the years. The rule requires study consent forms to concisely state a study’s scope, risks and benefits so that individuals can make informed decisions regarding participation.
- Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies, but with substantial flexibility in allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
- For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement.
- As under the current rule, researchers will still not have to obtain consent for studies on de-identified, stored data or biospecimens.
- The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under HIPAA.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
While these revisions are generally positive for those involved in clinical research, it’s not clear how attached we should get to the new Common Rule. Cures requires HHS and FDA to harmonize FDA human subject protection regulations with the Common Rule, and to harmonize associated guidance within three years of the enactment of Cures (by January 2020). Cures’ goal is to reduce regulatory duplication and unnecessary delay, but the immediate result will likely be a period of uncertainty.
Be sure to join Mintz Levin for further discussion of clinical research post-Cures, including Common Rule updates, in Part II of our Cure Act Webinar Series. Additional information and registration is available here.