The Department of Health and Human Services (HHS) is seeking comments on a proposed rule that would revise its regulations on research involving humans. On 22 July 2011, HHS announced the changes it is considering to the 20-year old rule. The Department argues that the revisions would strengthen protections for people who participate in research studies.

Among the changes being considered are:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.

Comments on the proposed rule are being accepted until 26 September 2011. For more information, visit


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