Public Comment Sought on Proposed Changes to Research Regulations

The U.S. Department of Health and Human Subjects (HHS) recently issued a press release outlining proposed changes to the “Common Rule”, which has gone essentially unrevised since its adoption in 1991. The revisions now being considered by HHS are significant and have the potential to affect many areas of the research enterprise.

The full notice published in the Federal Register on July 26, 2011 raises numerous questions for discussion. Areas of focus include:

  • Matching the review process more closely to the level of risk, particularly with regard to social and behavioral research
    • Eliminating annual continuing review of research that meets criteria for expedited review
    • Streamlining the review process for minimal risk research, to include updating the list of activities that are considered minimal risk
    • Moving from “exempt” to a broader concept of research that is “excused” from IRB review, with greater regulatory flexibility and less IRB involvement
  • Reducing duplicative IRB oversight of multicenter trials
  • Informed consent
    • Defining appropriate content, format and length
    • Refocusing the consent process on protection of participants vs. legal protection of institutions
    • Clarifying requirements for waivers of consent
    • Requiring consent for research use of biospecimens and data, and for certain types of “excused” research
  • Informational risk
    • Clarifying what constitutes individually identifiable data
    • Defining mandatory data security standards for all research
  • Evaluating the effectiveness of research oversight
  • Extending protections to research that currently falls outside of Common Rule regulation

It is important to note that HHS is not proposing changes to the review process for research that poses greater than minimal risk, except in the sense that future multicenter trials might be able to undergo fewer convened IRB reviews. Investigators will still be required to seek IRB approval for modifications to ongoing research projects, and to report unanticipated problems as well as any instances of noncompliance with an approved protocol or research plan.

HHS’ stated goal in reviewing the existing regulations is to strengthen human research protections while reducing administrative burden. It is unclear whether the latter aim will be met in practice. The response by institutions and IRBs to the proposed revisions will vary widely, and it will be more important than ever for investigators to maintain accurate and complete records to document compliance. Administrative burden will almost certainly increase in the short term as institutions and especially IRBs work to update their internal policies and procedures. Other bodies that have come to rely on IRB approval as part of their own review process may also have to make adjustments.

HHS will accept public comments through 5:00 PM on Monday, September 26, 2011. More information is available at their website.

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