The US Department of Health and Human Services along with 15 other agencies published an Interim Final Rule (IFR) in the Federal Register on January 22, 2017. The Interim Final Rule was made available for the public to view on January 17, 2018, and can be found here.
The IFR was written to delay the effective date and compliance date of the revisions to “Federal Policy for the Protection of Human Subjects,” also known as the Common Rule which was to have its revisions published in the Federal Register on January 19, 2017. The delay in implementation of the revised provisions allows additional time for regulated entities to comply with the new requirements.
The new effective date and compliance date of the revised Common Rule per the IFR is July 19, 2018, with ongoing talks to determine if further delay is needed. During the delay, regulated entities must follow the pre-2018 requirements if they are stricter, and may opt to follow any 2018 requirements that are stricter.
A public comment period about the IFR is open through the end of March 19, 2018 and can be accessed here to post or search comments.
-The Clinical Pathways Team
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