The document is a joint comment letter from major academic and research associations—including the Association of American Medical Colleges (AAMC), the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), and the Council on Governmental Relations (COGR)—addressed to the Department of Health and Human Services (HHS) in response to a Notice of Proposed Rulemaking regarding the revised Federal Policy for the Protection of Human Subjects, known as the "revised Common Rule." The associations express support for the proposal to maintain the existing effective date while delaying the general compliance date by six months, to January 21, 2019, thereby granting institutions additional time to prepare for implementation. They also endorse the option for voluntary early adoption of three "burden-reducing" provisions during the delay period.
The letter underscores the urgent need for the swift conclusion of the rulemaking process to provide institutions with certainty regarding compliance timelines and stresses the importance of timely issuance of agency guidance to ensure correct and consistent application of the revised regulations. The associations highlight that ambiguities in the revised Common Rule and the lack of critical guidance documents have hindered institutional readiness, particularly concerning issues such as informed consent requirements and exemption categories. Furthermore, they stress the necessity of clear communication from the Office of Human Research Protections (OHRP) regarding the practical implications of implementing burden-reducing provisions during the delay, to avoid confusion and unintended consequences. The associations offer their assistance in developing effective guidance and communication tools and reaffirm their commitment to supporting both regulatory compliance and the ethical conduct of human subjects research.
