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Business and Policy Areas
Business and Policy Areas

Changes Proposed to Rules Protecting Human Subjects

September 18, 2015

For the first time in more than two decades, the federal government has proposed a major revision to its rules protecting human subjects of research.

Known as the Common Rule, the Federal Policy for the Protection of Human Subjects was jointly promulgated by 15 agencies in 1991 to foster uniformity and ease of compliance. Given significant changes in the research environment over the years, the group of agencies (which has now expanded)  began an effort to rewrite the rules in 2011. The Department of Health and Human Services has led the effort.

Published in a notice of proposed rulemaking (NPRM) on September 8, the language would tighten some requirements, while loosening others. The comment period ends December 7.

According to the NPRM, its goals are "to increase human subjects' ability and opportunity to make informed decisions; reduce potential for harm and increase justice by increasing the uniformity of human subject protections in areas such as information disclosure risk, coverage of clinical trials, and coverage of IRBs [institutional review boards]; and facilitate current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems through reduced ambiguity in interpretation of the regulations, increased efficiencies in the performance of the review system, and reduced burdens on researchers that do not appear to provide commensurate protections to human subjects."

The proposed changes include:

  •  Expanding coverage of the rules to include clinical trials that do not receive federal funding in some circumstances.
  • Tightening requirements around informed consent, and what and how information must be provided to prospective subjects.
  • Providing specific rules concerning secondary use of stored biospecimens.
  • Adding new categories of exempt and excluded activities to better match protections to risk.
  • Mandating use of a single IRB for cooperative research, and encouraging use of unaffiliated IRBs.


Office of Human Research Protection, HHS

McDermott, Will & Emery, HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections (September 8, 2015)


Anne Gross
Vice President, Regulatory Affairs