‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more
The HHS Office of Research Integrity (ORI) gets an “A” for effort on its new proposed regulation revising research misconduct rules, but maybe a “D” overall. Most of the nearly 200 comments on the proposed rule posted online...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more
On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.” The...more
On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more