Interim Final Rule – Notice of Delay of the Common Rule
Over the past year, the Office for the Protection of Research Subjects (OPRS), has been revising Institutional policies and procedures and preparing to implement those revisions in order to comply with the new Federal Policy for the Protection of Human Subjects (Revised Common Rule).
Yesterday, we learned that both the implementation and effective date of the Revised Common Rule that was to become effective today (January 19, 2018) has been delayed for a period of 6 months. At the present time, the new effective date is July 19, 2018. However, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies are in the process of developing a proposed rule to further delay implementation of the 2018 common rule.
The rationale for the delay, according to HHS and other regulatory agencies, include the final rule’s complexity, the absence of needed guidance, and the need to revamp institutional procedures and electronic systems in order to come into compliance with the requirements of the rule.
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.” Unfortunately, this means that, at this time, OPRS will not be able to implement certain burden reducing provisions of the revised rule, including: new categories of exemptions, elimination of the continuing review requirement for certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications.
I want to assure you that OPRS remains committed to identifying strategies to improve processes and reduce administrative burdens for researchers while meeting our ethical and regulatory obligations to research subjects.
We will keep you informed as new information about the proposed new rule becomes available.
Best Wishes for your continued success in your research endeavors.
Elaine Fluder, MSN
Office for the Protection of Research Subjects
Office of the Vice Chancellor for Research
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