The Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR)—collectively representing the primary recipients of federally funded human subjects research—submitted a letter to Dr. Jerry Menikoff of the Office for Human Research Protections (OHRP) regarding the implementation timeline of the revised Federal Policy for the Protection of Human Subjects, known as the Common Rule. While acknowledging the significant changes and increased compliance demands of the January 2017 final rule, the associations emphasized that institutions require substantial time to adapt internal policies, IT systems, and training efforts. They highlighted both the uncertainty caused by a government freeze on new regulations and the absence of key guidance documents necessary for implementation, which has caused hesitation among universities and research organizations in moving forward with compliance activities.
In response to these challenges, the associations formally requested a one-year delay in the compliance date—to January 19, 2019—while maintaining the original effective date for most provisions. This postponement would provide affected institutions sufficient time to fully implement the revised requirements and ensure compliance. Moreover, the associations advocated for immediate flexibility to adopt provisions aimed at reducing administrative burdens, such as exemptions from certain reviews, in line with the regulation’s intended benefits. They also encouraged OHRP to use the additional time to further coordination with other agencies and harmonize the Common Rule with related FDA regulations. The letter concluded by underscoring the signatories’ willingness to engage in further dialogue and reiterating their commitment to supporting effective, compliant human subjects research.
