The Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule has been released! The proposed changes to the regulations will have significant impact on the conduct and oversight of human subjects research, if passed. For example, completely deidentified biospecimens may become covered by the Common Rule, and their use in research will require informed consent in almost all cases (even if the specimens were originally collected solely for clinical purposes).
Also, new data security measures will become required for research that does not already fall under HIPAA (e.g. research on deidentified specimens or data); those measures have not yet been described however. The idea is for many non-interventional studies to become exempt from IRB review, or even excluded entirely from coverage by the Common Rule, with the more robust data security balancing out the removal of oversight. In another revision, single IRB review would be required for all cooperative research studies, with some exceptions. A good-news highlight is the removal of the continuing review requirement for many minimal risk studies.
Comments on the NPRM may be made on Regulations.Gov until Dec. 8, 2015.
The Office for Human Research Protections has a series of webinars on the topic. The NPRM contains 88 specific requests for feedback, which you can find by searching for “question for public comment” within the PDF of the revised rule. But we encourage you to comment on any part of the revisions. Emory’s VP for Research, David Wynes, has been responding to requests for his input from national organizations, and will be organizing Emory Research Administration’s official comments.
From the Institutional Review Board
irb@emory.edu