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University of Wisconsin–Madison

Delay of the Revisions to the Federal Policy for the Protection of Human Subjects

On January 17, 2018, 16 federal departments and agencies filed an Interim Final Rule (IFR) titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects” with the Federal Register for public inspection. The notice indicates a scheduled publication date of January 22, 2018. This IFR delays both the effective and compliance date of the revised rule, published on January 19, 2017, to July 19, 2018.

The notice cites a request from AAMC, AAU, APLU, and COGR, as well as a request from SACHRP a number of months ago to delay the rule. The request from the Council on Governmental Relations and the other higher education associations sent in June 2017 was for a one-year delay in the compliance date, with no delay in the effective date, and is highlighted in a two-page document

A one-year delay of the compliance date alone would have allowed institutions to move forward with implementation of certain provisions of the revised final rule (including those expected to reduce administrative burden) and to delay implementation where additional guidance and education is needed. This would have been particularly helpful as institutions had to be prepared to move forward with the revised rule on January 19, 2018. With a delay in the effective date, as indicated in the notice, “regulated entities are not allowed, prior to July 19, 2018, to comply with the 2018 Requirements in lieu of the pre-2018 Requirements.”

In section III, Good Cause for Interim Final Rule, agencies indicated that “a notice of proposed rulemaking is not required when an agency, for good cause, finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest.” Per the notice, “Without a delay, and without guidance, institutions that have expected a delay who hastily attempt to implement the revised rule without adequate preparation are bound to make mistakes, the consequences of which may jeopardize the proper conduct of research and the safety and wellbeing of human subjects.” The IFR notes categories of activities that have been deemed not research and five new exemption categories as among the areas that will require significant guidance, noting feedback from SACHRP with respect to the latter.

The notice goes on to indicate that “…the federal departments and agencies named in this interim final rule are developing a notice of proposed rulemaking in order to fully engage regulated entities and the public regarding further delay of the 2018 Requirements until January 21, 2019. The additional time provided by the six month delay in this interim final rule will allow sufficient time for the notice and comment rulemaking process to be completed. Issuance of this interim final rule avoids the possible result of having the federal departments and agencies propose an implementation delay but be unable to complete the rulemaking process and publish a final rule that would be effective by January 19, 2018.”

An eleventh hour delay of both the effective and compliance dates, however well-intentioned, presents a challenge to institutions which have strived to comply with the revised final rule on January 19, 2018 as required by regulation prior to yesterday’s notice of a pending IFR. Continued uncertainty about the final effective and compliance date with the proposal of additional rulemaking will add to that challenge. At the time that COGR and others requested a delay in the compliance date they understood the rule to be under administrative review with the fate of the rule, or aspects of the rule, potentially uncertain. At this time, nothing that suggests that the rule itself is likely to change. A proposed rule and request for comments is expected to be specific to an additional 6 month delay, as indicated in the notice, which may be more complex than the across the board delay of the effective and compliance dates implemented with this IFR.

COGR will continue to update members as information becomes available on forthcoming rules and guidance.