The AAMC, along with the Association of American Universities (AAU) and the Association of Public and Land Grant Universities (APLU), submitted a March 19 letter to the Department of Health and Human Services in response to a request for comments on the Interim Final Rule (IFR), which delays implementation of the revised Federal Policy for the Protection of Human Subjects (“Common Rule”) until July 19, 2018, to provide regulated entities additional time to make necessary preparations to implement the regulations [see Washington Highlights, Jan 19]. The association’s letter urges HHS to further delay the compliance date to January 21, 2019, or later. The IFR only delays the effective and general compliance dates for six months.
HHS cites a June 21, 2017, letter from AAMC, AAU, APLU, and the Council on Government Relations (COGR) requesting a one-year delay in the compliance date and notes significant concerns from members of the regulated community about whether they would be able to implement the revised regulations by the initial scheduled compliance date. The March 19 response reiterates the concerns and requests raised in the June 2017 letter.
Signatories to the letter expressed concerns about the state of confusion and uncertainty within the research community in the year following publication of the revised Common Rule in January 2017 until the last-minute delay of the revised regulations, keeping institutions in an “untenable holding pattern” and leaving many “hesitant to move forward with implementing the regulations.” Further, the letter notes the several guidance documents and templates that have not been issued but are critical to the implementation process. Finally, signatories strongly urge HHS to delay the compliance date so the Food and Drug Administration may align its regulations on human subject protections with the revised Common Rule.