EGRP News Flash - August 10, 2011

Request for Comment on Proposed Rule to Improve Protections for Human Research Subjects

The U.S. Department of Health and Human Services (HHS) announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations - which have been in place since 1991and are often referred to as the Common Rule - the government is seeking the public's input on an array of issues related to the ethics, safety, and oversight of human research in order to modernize and revise the protections to be more effective. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 26 Federal Register. The proposed changes are to better protect human subjects who are involved in research, while facilitating valuable research and reducing the burden, delay, and ambiguity for investigators.

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

Comment is sought on the following:

  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 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.

The public's input on these matters will be critically important to the government's efforts to ensure that regulations keep up with today's changing research environment, and will be considered by HHS as it develops new proposed rules, which will also be made public for comment. The ANPRM comment period closes 5:00 p.m. Monday, September 26, 2011. Submit comments identified by docket ID number HHS-OPHS-2011-0005.

Get additional information about the changes under consideration and read the proposed rule onlineExternal Web Site Policy.

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