CITI Program has created the resources below to help the research community understand the revisions to the Common Rule issued on 19 January 2017 and set to take effect in July 2018. They were developed with the assistance of expert authors and peer reviewers. We will be updating these resources and CITI Program courses to reflect the revisions and any regulatory changes accordingly.
Handout 2 – Institutional Implementation of Final Rule
Note: These resources are based on the Final Rule and Interim Final Rule issued by the U.S. Department of Health and Human Services (HHS) at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (the Common Rule) on 19 January 2017 and 22 January 2018, respectively. The effective and compliance dates of the revised Common Rule were delayed for six months by the Interim Final Rule as published on 22 January 2018 (“Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”), which are now 19 July 2018. A Notice of Proposed Rulemaking (NPRM) was published 20 April 2018 that proposes to delay the effective compliance date an additional six months until 21 January 2019. This NPRM would allow regulated parties to implement three specific provisions from the revised Common Rule during the delay period.