On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") and numerous other federal departments and agencies released the long-awaited proposed revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule," now published in the Federal Register and available for public comment.[1]

In an advance notice of proposed rulemaking published in July 2011, HHS commented that the nearly 25-year-old Common Rule has not kept pace with dramatic changes in the research landscape, including new technologies and methods and the proliferation of research settings.[2]

The proposed revisions are intended to promote protections for human subjects while also reducing the administrative burdens and delays for investigators that no longer enhance such protections. A key component of the revised Common Rule is increasing the uniformity of human subject protections and efficacy of research oversight to reduce ambiguity in the interpretation and application of research regulations.

Significant changes to the Common Rule are proposed to accomplish these goals, including several affecting the scope of research to which the Common Rule requirements would apply:  

  • Extending the scope of the Common Rule to cover all clinical trials, regardless of funding source, that are conducted at an institution that receives federal funding for nonexempt human subject research. Notably, however, HHS has not proposed widening the scope to include all human subject research, citing concerns that this would impose unnecessary regulatory burdens on behavioral and social science studies that are inherently low risk.
  • Redefining "human subject" so that most research involving biospecimens, regardless of whether the biospecimens can be associated with identifiable private information, would be subject to the Common Rule.
  • Specifically excluding certain categories of activities from research within the scope of the Common Rule, with "excluded" serving as a new designation developed by HHS to help institutions and investigators determine when an activity would be considered research under the Common Rule. Such excluded activities would include: (i) activities that should not be considered research (e.g., program improvement activities, public health surveillance); (ii) activities that are inherently low risk (e.g., those that present no physical risk and are nonintrusive, such as some surveys and interviews); and (iii) activities subject to protections mandated by another regulatory regime (e.g., activities involving health operations or public health activities that are regulated under the HIPAA Privacy Rule).[3]
  • Adding new categories of research considered exempt from most Common Rule requirements, and development of an "exemption decision tool" that can be used by institutions and investigators in making exemption determinations.

Informed consents would also receive a facelift, with proposed requirements designed to highlight the most important information and make consents shorter, to make it easier for a prospective subject to decide whether or not to participate in research. For research involving biospecimens, while study-specific consent or a waiver of consent would still be required to use specimens collected for a proposed research study, a broad consent would be permitted for the use of stored specimens for secondary research, such as research using a blood sample or tissue extracted during a clinical procedure. According to HHS, this broad consent would help facilitate research involving biospecimens despite the fact that some of this research would be subject to Common Rule requirements for the first time.

The Proposed Rules also include a number of provisions aimed at streamlining Institutional Review Board ("IRB") review of research. For example, when engaged in cooperative research (studies involving more than one institution), institutions would be required to rely on a single IRB. Currently, a local IRB at each participating institution may review the research, which in the opinion of some stakeholders creates unnecessary administrative costs and delays. In addition, the continuing review requirement (ongoing evaluation of research previously approved by the IRB) would be reduced or eliminated for certain studies and stages of research.

To address increasing concerns regarding privacy and data security in the information age, HHS is proposing that institutions and investigators implement reasonable safeguards with respect to all research subject to the Common Rule, giving institutions and investigators the choice of fulfilling this requirement by implementing safeguards that (i) adhere to measures to be published by HHS, or (ii) comply with the mandates of another statute designed to protect identifiable private information. In addition, HHS proposes limitations for the use and disclosure of information and biospecimens, as well as a requirement that IRBs also safeguard records that contain identifiable private information.

While noting a longstanding recognition of the need for greater consistency across federal departments and agencies that oversee the protection of human subjects, HHS stops short of mandating harmonization of requirements, proposing that Common Rule agencies be required to consult each other before issuing guidance on the Common Rule, unless it is not feasible to do so. As such, the Proposed Rules may not satisfy those hoping for a structured plan for increased coordination among agencies. HHS does note, however, the Food and Drug Administration's intent to modify its regulations governing human subject research in light of proposed revisions to the Common Rule.

The notice of proposed rulemaking was published in the Federal Register on September 8, 2015, and comments may be submitted through December 7, 2015.  HHS plans to release several informational webinars and hold a town hall meeting in Washington, D.C. in October.