On July 26, the U.S. Department of Health and Human Services (HHS) published an Advance Notice of Proposed Rulemaking to modernize and enhance regulations that govern research on human subjects. 76 Fed. Reg. 44512 (July 26, 2011). The current regulations, often referred to as the Common Rule, 45 CFR Part 46, have been in place since 1991. HHS requests comments by September 26, 2011.  The proposal would substantially change, in several respects, the regulatory framework with which universities and research institutions have had years of experience. For example, if an institution receives federal funding for human subjects research, all human subjects research at that institution would be covered by the regulations; and informed consent, IRB review, and data protection standards would be significantly changed for biospecimen and data research. The proposal aims to reduce IRB workload. It also implicates such questions as how institutions may ensure adequate protection of human subjects and manage liability risk in multi-site studies if such studies are to be reviewed, as the proposal suggests, by a single IRB. We highlight here selected aspects of the ANPRM. Our summary presupposes familiarity with basic Common Rule terms.

HHS offers two broad motivations to update the Common Rule: (1) the research landscape has changed dramatically over the past two decades; and (2) in light of the current research environment, the effectiveness and efficiency of the Common Rule must be improved. HHS will reconsider several elements of the Common Rule, as follows.

A. Extension of the Common Rule to all human subjects research. HHS proposes to extend the Common Rule to research that is not federally funded, but which is conducted at a domestic institution that receives some funding for human subjects research from a Common Rule federal agency. Already, many institutions voluntarily extend the Common Rule to all nonfederal research via election on the OHRP-approved Federal Wide Assurance (FWA), but not all institutions make this election.

B. Level of IRB review required. HHS would refine the regulations to ensure that the level of review is commensurate with the level of risk to human subjects. For example, changes under consideration include these:

  • Elimination of continuing review for all minimal risk studies that undergo expedited IRB review;
  • Regular updates to the categories of research eligible for expedited review, thereby creating a presumption that such studies are indeed minimal risk;
  • Expansion of the categories of research exempt from IRB review, commencement of such studies upon filing a brief form with the IRB, elimination of routine IRB review of such studies, and a requirement for random audits of a sample of exempt studies;
  • Establishment of data security standards for identifiable information and for de-identified information, consistent with the level of risk entailed;
  • Requirement for a brief written consent for research use of any biospecimens collected for clinical purposes.

C. IRB review of multi-site studies. HHS proposes a requirement for all domestic sites in a multi-site study to rely upon a single IRB as the central IRB of record. Changes to the HHS Office for Human Research Protections (OHRP) enforcement procedures would hold an external IRB directly accountable for compliance. Issues under consideration include, among others, how a central IRB would be selected, whether the IRB would have adequate knowledge of each site, and whether a central IRB arrangement could adequately address liability concerns at each institution involved in a study.

D. Informed consent. HHS proposes to enhance the informed consent process in various ways. Modifications under consideration include new consent form requirements that would (1) specify appropriate consent form content; (2) proscribe certain content; (3) limit consent form length; (4) specify how information is presented; (5) reduce institutional "boilerplate" language; and (6) make available standardized consent forms that satisfy applicable regulations. In addition, HHS seeks to clarify criteria for waivers of informed consent and for verbal consent, and HHS would clarify the circumstances under which future research use of data would or would not require informed consent. For example, changes under consideration would require institutions to provide the research subject an opportunity to choose how their biological specimens may be used in the future.

E. Data security and information protections. HHS proposes that the Common Rule incorporate HIPAA standards to define individually identifiable information and de-identified information, but HHS may reevaluate and supplement these definitions. Specific data protection standards, modeled on the HIPAA Security Rule,1 would include administrative, physical, and technical safeguards, as well as data breach notification procedures.

F. Event reporting. HHS proposes to simplify and consolidate reports on unanticipated problems or adverse events, through (1) using standardized but flexible data elements for safety reporting; (2) implementing a web-based, Federal-wide portal for reporting; and (3) harmonizing terminology and reporting timelines across all agencies.

G. Consistency across federal agencies. HHS proposes to examine the extent to which regulatory uniformity across federal agencies and departments is desirable, appropriate, and feasible to address human subjects protections in diverse research populations and contexts, and in view of differing agency mandates and objectives.