HHS issues Final Rule modifying Common Rule

January 18, 2017

Health Care Alert

Author(s): Gabrielle B. Goldstein, PhD


1. Final Rule issued in last days of Obama Administration

On January 18, 2017, the U.S. Department of Health and Human Services (HHS), along with 15 other federal agencies, issued a final rule (Final Rule) amending the federal regulations pertaining to human subjects research often called the “Common Rule.” The Final Rule will be effective on January 19, 2018, except for certain provisions pertaining to Cooperative Research, which will have a compliance date of January 20, 2020.

The overarching goals of the Final Rule are to strengthen protections for people who participate in biomedical research, and to facilitate research by streamlining administrative requirements. Given its broad reach, the Final Rule will have wide-ranging implications for clinical research sponsors, investigators, research sites, institutional review boards (IRBs) and research participants.

HHS acknowledges in the Final Rule that the research environment has changed dramatically since the Common Rule regulations went into effect in 1991, and that these changes in the institutional landscape necessitate modifications to the regulations. While clinical research once occurred almost entirely at universities and medical institutions, it is now increasingly undertaken in community and other non-academic and non-institutional settings. Further, while research was once generally confined to a single site, studies are now increasingly multi-site. The explosion of medical technology development, the genomics revolution and “big data” have also contributed to the changing dynamics within the research field.

The Final Rule is the culmination of significant agency interest in revisions over the past few years. On July 26, 2011, HHS published an Advance Notice of Proposed Rulemaking (ANPRM) to request comments for how to revise the Common Rule; a Notice of Proposed Rulemaking (NPRM) was then issued on September 8, 2015. HHS states that it has taken public comments on both the ANPRM and the NPRM into account in preparing the Final Rule.

2. Proposals from NPRM not adopted in Final Rule:

The NPRM advanced a number of proposed changes to the Common Rule that were critically received in public comments. As a result of further consultation and consideration, certain proposals have not been finalized in the Final Rule. Among others, these include the following:

  • Non-Federally funded studies. The Final Rule does not adopt the NPRM’s proposal to expand the Common Rule’s reach to include clinical trials that are not federally funded.
  • Biospecimens. The Final Rule does not adopt the NPRM’s proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.

3. Significant changes to the Common Rule:

The Final Rule does include a number of significant changes to the Common Rule. Among others, these include the following:

  • Informed consent. The Final Rule establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process, when appropriate, particularly pertaining to the use of biospecimens, performance of whole genome sequencing and the return of clinically relevant research results.
  • Single IRB for multi-site studies. The Final Rule requires, in many but not all cases, that a single IRB of record be used for multi-institutional research studies.
  • Biospecimens. The Final Rule allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a research participant for storage, maintenance and secondary research use of identifiable private information and identifiable biospecimens. Thus, for studies using 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. Researchers will continue to not have to obtain consent for studies using solely non-identified stored data or biospecimens.
  • Continuing review. The Final Rule eliminates the requirement for certain research studies to undergo continuing review by an IRB, including when remaining research activities only involve data analysis.
  • Public posting of consent forms. The Final Rule requires that the informed consent forms for certain federally funded clinical trials be posted on a publicly accessible website.  

The Final Rule is available here.

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