University of Iowa Assistant Vice President on the NPRM

Badge reads Human Subjects Protections Update

U.S. Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking (NPRM)

On Tuesday, September 8, 2015 the U.S. Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking (NPRM) aimed at updating 45 CFR 46 (the Common Rule for human subjects protections in research). Significant changes have been proposed and HHS is seeking public comment regarding these changes.  Included in the changes are mandated use of a single IRB for collaborative research, use of consent documents for all biospecimens, and the addition of a new review category.  We would like to encourage faculty and staff to provide feedback.  All comments must be received by HHS no later than 5:00 pm on December 7, 2015.  You may provide feedback to the Office for the Vice President of Research & Economic Development for inclusion in our institutional response.  For a detailed summary of the changes or how to submit a response, review:

PDF icon NPRM announcement.pdf