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HHS Proposes Making Changes to the Common Rule

by Joshua A. Green, JD, MPH on July 31st, 2011

For the first time in more than two decades, the U.S. Department of Health and Human Services announced on July 22  it is contemplating making significant changes to regulations governing research involving human subjects frequently referred to as the Common Rule. In recognition that the human research landscape has changed dramatically since the Common Rule was first created, the government has promulgated a number of changes with two overarching goals in mind:  (1) to enhance the protection of research subjects and (2) to improve the efficiency of the review process.

The proposed changes were published last Monday in the Federal Register in an Advance Notice of Proposed Rulemaking (ANPRM) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.

HHS has roughly categorized the concerns being addressed by the promulgated rule changes into seven areas:

  1. Addressing concerns that the current regulations do not adequately calibrate the review process to the risk of research, the ANPRM contains amendments that would ensure protections are commensurate with the level of risk of the research study.
  2. At the time the Common Rule was established most research occurred in single site studies. HHS acknowledges a substantial amount of research is now conducted by means of multi-site studies. In light of complications that have arisen with multi-site studies, the ANPRM proposes using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. In an attempt to update the forms and processes used for informed consent, HHS is considering a number of modifications to the regulations concerning consent.
  4. Addressing data security and privacy concerns inherent in an increased  use of genetic information, biospecimens, medical records, and administrative claims data, HHS proposes establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. In order to facilitate the evaluation of the effectiveness of the research oversight system in protecting human subjects, to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient, the ANPRM proposes implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials.
  6. Although many institutions receiving federal funding have voluntarily adopted the Common Rule to all research conducted at their institutions including research that is not federally funded, it is not required. The proposed rules would extend federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. HHS acknowledges there is a substantial amount of conflicting guidance concerning the Common Rule from the various Common Rule agencies that have been criticized as complex, inconsistent and lacking in clarity. In response to this criticism HHS would like to improve the harmonization of regulations and related agency guidance.

HHS is requesting public comment on these proposed changes for 60 days. For information on submitting a comment or reviewing submitted comments you can go here.

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From → Health Law