The AAMC June 21 joined the Association of American Universities (AAU), the Association of Public and Land Grant Universities (APLU), and the Council on Government Relations (COGR) in a letter to the Department of Health and Human Services (HHS) Director of the Office for Human Research Protections (OHRP) Jerry Menikoff, MD, JD.
The letter requests a delay in the compliance date of the Federal Policy for the Protection of Human Subjects (“the Common Rule”) to January 19, 2019, one year from the January 18, 2018 effective date, which would allow institutions to implement the changes to the regulation throughout that one year period instead of having to be compliant with the regulations on the effective date.
On January 19, 2017, HHS and 15 other federal departments and agencies released the final revisions to the Common Rule which governs federal supported research involving human subjects. These revisions represent the first changes to the regulations since it was issued in 1991. The AAMC submitted a letter to HHS in response to the agency’s request for comments on the Notice of Proposed Rulemaking and the Advanced Notice of Proposed Rulemaking.
Signatories to the letter express significant concerns about the process for implementing these changes, which include educational efforts, drafting policies, and establishing new processes and information technology systems. The letter adds, “[a]s a result of the uncertainty surrounding the status of the revised Common Rule over the course of the last five months, and the significant costs involved, universities, medical schools, and other entities have been hesitant to fully move forward in implementing the rule.”
Further, since there are several guidance documents and templates that have not been issued and for which institutions will rely to draft their policies, the letter notes that “[…] such a delay in the compliance date of the Common Rule will be beneficial for all affected institutions and relevant agencies. Importantly, this time could be used to advance harmonization efforts to align the FDA’s human subject protection regulations with the Common Rule as required by the 21st Century Cures Act.”