On October 20, the US Department of Health and Human Services (HHS) and Office for Human Research Protections (OHRP) held a Town Hall Meeting to further solicit comments and questions concerning proposed changes to the Common Rule, which addresses the ethical treatment of human subjects in research. As we previously noted, the proposed rule was published in the Federal Register on September 8.

The discussion involved robust questioning surrounding the proposed rule’s strengthened informed consent provisions and the treatment of de-identified biological specimens in human subject research. Highlights from the Town Hall Meeting include the following:

  • Many commenters requested further clarification on the proposed rule’s strengthened informed consent provisions, and in particular, how OHRP intends to revise the essential elements of informed consent documents. OHRP clarified that informed consent documents should specifically, and in a summary fashion, outline the real benefits and risks of participating in human subject research and avoid generalizable, boilerplate language. OHRP envisions a core consent document with a summary of real benefits and risks, with more detailed information included in an appendix. OHRP requested comment from the public on what should be included in a template informed consent document to share with the community.
  • Many commenters questioned the proposed rule’s expansion of the definition of “human subject” to include de-identified biological specimens. Currently, research involving de-identified biological specimens is not subject to the Common Rule, and thus does not require informed consent, because the definition of “human subject” does not encompass de-identified biological specimens. De-identified data is also excluded from this definition. In justifying expanding the definition of “human subject” to include de-identified biological specimens (and keeping de-identified data excluded), OHRP stressed that a basic premise underlying the proposed rule is that individuals have greater interest in secondary research involving their biological specimens than in secondary research involving their data. Many commenters disagreed with this position. OHRP encouraged commenters to provide insight on whether de-identified biological specimens and de-identified data should be similarly treated under the Common Rule.
  • Many commenters requested further clarification on one particular exclusion from the required informed consent—i.e. the exclusion for research involving de-identified biological specimens designed to generate information already known about an individual. OHRP clarified that, where the design or purpose of the research is to generate new information about an individual and/or biological specimen donor, this type of research would require informed consent. Commenters offered numerous examples to help clarify the distinction between excluded and non-excluded research, but the distinction remains unclear. OHRP solicited comment on whether the proposed rule draws the line appropriately and whether further description is needed.

OHRP also remains open to public comment concerning changes in procedure, including whether the comment period should be extended. OHRP urged the public to continue to submit detailed comments prior to the end of the public comment period on December 7, 2015. Comments may be submitted electronically through www.regulations.gov, by mail, or by hand courier. Detailed instructions on how to submit comments are provided on the HHS website.

.*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.