The Federal Register recently published an Advanced Notice of Proposed Rulemaking (ANPRM) on Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators.  This represents a unique opportunity for UCI investigators to help shape the future of U.S. regulations regarding human research subject protections.

The ANPRM is a pre-rule and the first step in a formal process for implementing new rules or revising existing rules.  The ANPRM is also the public’s first opportunity to comment on the pre-rule and respond to more than 70 specific questions to assist the federal government with developing a proposed rule (the next step in the rule making process).  The ANPRM seeks comments in the following seven areas:

  • Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.  This revision includes determining whether a subset of studies using common social and behavioral science methodologies exists for which prior review does little to increase protections to subjects
  • Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  • Updating the forms and processes used for informed consent.
  • Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  • 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.
  • Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  • Providing uniform guidance on federal regulations.

Options for the UCI community to respond to the ANPRM include the following:

    • Send comments via e-mail to Comments.DHHS-ANPRM@research.uci.edu — Comments received through this e-mail address will be utilized in several ways, including:  i) developing campus comments for submission to the U.S. Department Health and Human Services (HHS), ii) sharing with the Office of the President as part of a coordinated systemwide effort to submit comments to HHS, and iii) sharing with the University’s advocacy partners (e.g., the Council on Governmental Relations) as part of their efforts to submit comments on behalf of the research universities that they represent.

Please note that comments e-mailed to Comments.DHHS-ANPRM@research.uci.edu should be submitted as soon as possible, but no later than Monday, September 12.  Please see http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html for complete information regarding the pre-rule, including:  access to the ANPRM, FAQs, a table comparing current regulations with the pre-rule changes, the deadline for submitting comments directly to HHS, and much more.

Bruce Morgan
Assistant Vice Chancellor for Research Administration