May 22, 2018
On January 17, 2018 (just two days before the previously revised rule was scheduled to go into effect), an interim rule to delay the implementation and effective dates of the revisions to the Federal Policy for the Protection of Human Subjects (the revised Common Rule) was posted in the Federal Register. This interim rule delayed both the effective and general compliance dates of the requirements of the revised Common Rule until July 19, 2018. In addition to allowing institutions that conduct human research regulated entities) additional time to prepare for the requirements of the revised Common Rule, the interim rule is intended to provide “additional time for the departments and agencies to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.” The interim rule was published in response to requests from key stakeholders, including the Association of American Medical Colleges, the Association of American Universities, the Council on Governmental Relations, and the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which all cited the revised Common Rule’s complexity, the lack of guidance from the Office for Human Research Protections (OHRP), and the requirement to revise and update institutional-based electronic systems as the key drivers for the requested delay.
The gift of an additional six months presents a golden opportunity to re-evaluate institutional preparedness to comply with the requirements of the revised Common Rule.
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