On July 22, 2011, the Department of Health and Human Services (HHS) issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking input on significant changes under consideration to the regulations, known as the Common Rule, governing research on human subjects.   The current version of the Common Rule was “first being formulated” in the early 1980’s and HHS believes that significant changes since that time “have altered the methods and aims of research with human subjects.”  For example, “there have been major increases in the volume of research, in multi-site studies, and in health services and social sciences research” and “new technologies for research” including genomics, imaging, [and] informatics.”

Among the significant changes contemplated by HHS are the following:

  • Requiring specific data security and patient privacy protections, “calibrated to the level of identifiability of the information being collected,” instead of leaving each internal review board (“IRB”) to determine that there are “adequate provisions to protect the privacy of subjects.”
  • Expanding the coverage of the Common Rule to any study conducted by a U.S. institution that receives Common Rule funds, instead of only covering research that is itself funded with Common Rule funds. •Creating a single web-site where all adverse events can be reported instead of having such events “reported to multiple agencies and on multiple time-lines, with no central database as a repository for such data.”
  • Replacing the “relatively vague language about how consent forms should be written” with “greater specificity about . . . what information they should contain, so they can be shorter, more user-friendly, less confusing, [and] contain all of the key information”
  • Requiring written consent from individuals to conduct research on their biospecimens even if the specimens have been stripped of identifiers (the “consent could be obtained using a standard, short form by which a person could provide open-ended consent for most research uses of a variety of biospecimens”). •Encouraging a single IRB to review all of the U.S. sites in a multi-state study.
  • Ensuring consistency in interpretations of the Common Rule across all Common Rule agencies and the FDA unless a difference is “justified by differences [in] the missions of those agencies.” 
  • No longer requiring continuous IRB review “after all subjects in the study have completed any study interventions and the only remaining procedures are standard-of-care procedures.”
  • No longer requiring continuing annual reviews of “studies that are eligible for expedited review unless the reviewer, at the time of initial review, determines that continuing review is required, and documents why.”

HHS has prepared a chart showing a comparison of existing rules with some of the changes being considered that is available at the “read a table” link on HHS’s website, here.  This website also contains links to the news release and actual ANPRM regarding the Common Rule changes.

The ANPRM comment period closes 5:00 p.m. Monday, September 26, 2011.  HHS will use the comments and its deliberations from this Advanced Notice of Proposed Rulemaking to issue specific proposals in a Notice of Proposed Rulemaking.  There will then be another opportunity to comment on HHS’s specific proposals prior to finalization.