Proposed changes to “Common Rule” now open for comment

In September of this year, the Department of Health and Human Services published proposed changes to the Federal Policy for the Protection of Human Subjects, most often referred to as the Common Rule. The Notice of Proposed Rulemaking (NPRM) is now open for public comment and includes a wide range of changes to the Common Rule with the goal of modernizing regulations to reflect current research conduct.

Some of the proposed changes include:

  • Requiring 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.
  • Defining secondary use of non-identified biospecimens as “human subjects” for research purposes.
  • Expanding consent requirements, including written consent for use of an individual’s biological samples (blood or urine, for example) for research with the option to consent to their future use for unspecified studies.

These changes may have a significant impact on your research so make your voices heard! Comments must be submitted by December 7, 2015 via the NPRM website. For additional commentary on these proposed changes, check out this Open Mike blog entry from Deputy Director for Extramural Research, Michael Lauer.