Proposed Changes to Human Subjects Regulations Are Open for Comment

As many researchers know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research.

In September 2015, the Department of Health and Human Services (HHS) published proposed changes to the Common Rule through a Notice of Proposed Rulemaking (NPRM), which is now open for public comment through December 7, 2015.

The NPRM contains many wide-ranging changes to the Common Rule, with the aim of modernizing the current regulations to reflect how research is done today.

Some of the proposed changes include:

  • A requirement that in most cases research being conducted at more than one institution (multisite research) must rely on a single Institutional Review Board (IRB).
  • Applying the Common Rule regulations to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency.
  • Implementing new data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.

The research community is encouraged to submit comments as described on the NPRM website at The HHS Office of Human Research Protections has also published a number of resources on its website to help you review the proposed changes and submit comments.

Excerpted from Open Mike posted on October 23, 2015 by Mike Lauer