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July/August 2011
Policy and Advocacy
HHS Seeks Input on Major Changes to Rules Protecting Human Research Subjects

The Department of Health and Human Services (HHS) proposed sweeping changes (PDF) in late July to regulations that govern research on human subjects, and federal officials are seeking input on several issues. Often referred to as the Common Rule, the regulations have not been substantially revised since they were established in 1991 to guide federally funded research involving human subjects.

HHS’ goal is to strengthen protections for subjects while also modernizing and simplifying the current system. The research landscape has changed dramatically in the past 20 years, and the proposed changes are an attempt to keep pace and improve gaps and inconsistencies in federal regulations, HHS says. A government FAQ document explains the proposal, and a related table compares existing regulations with the changes, many of which address issues IDSA has raised about the increasing regulatory burden on research (see IDSA’s related policy statement). The government’s proposal is the first step in a months-long process during which HHS plans to gather input widely.

The proposed changes include:

  • revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk

  • using a single Institutional Review Board review for all domestic sites of multi-site studies

  • extending federal regulatory protections to all research conducted at U.S. institutions receiving funding from the 15 Common Rule federal agencies

  • implementing a systematic approach to collecting and analyzing adverse events data across all trials to harmonize the complicated array of definitions and reporting requirements

IDSA plans to submit comments on the proposed changes and encourages IDSA members to do so as well. Comments are due Sept. 26. Visit the HHS website for instructions. For more information, or to share comments with IDSA, contact Audrey Jackson, PhD, at IDSA.

In related news, IDSA urged federal officials to exempt research from the Health Insurance Portability and Accountability Act (HIPAA) and create a new privacy protection framework for research, in response to a separate HHS proposal to exempt research from one requirement of HIPAA (see related article).

Additional Resources:

Advance Notice of Proposed Rulemaking: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (PDF)

HHS website (links to proposal, FAQ, press release, and comment submission instructions)

IDSA policy statement:  Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts

Commentary by Ezekiel J. Emanuel, MD, and Jerry Menikoff, MD: Reforming the Regulations Governing Research with Human Subjects, New England Journal of Medicine 
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