The proposed revisions to the Common Rule (known as the Notice of Proposed Rulemaking, or NPRM) is still working its way through the public comment process. You may recall that it took about 4 years for the NPRM to be released after the Office for Human Research Protections (OHRP) announced its intent to revise it by releasing an Advanced NPRM. While predicting the future, especially when that future involves federal regulations, is always dicey, the consensus is that it won’t take another 4 years to come up with a final rule.
Click on the image above to reach OHRP’s webpage about the NPRM. The page includes links to several OHRP webinars about the NPRM, and also shows you how to access the comments that have been submitted about it so far. (A trend — there is much wailing and gnashing of teeth about the proposal to require informed consent for the future use of biospecimens.)
While it’s unclear what form the final rule will take, or when, exactly, it will be implemented, we are pretty confident that once it does take effect, there will be some significant changes in the oversight of human subject research.