Office of Research Compliance

Overview of the Final Rule Revisions 

 

Changes to the federal regulations at 45 CFR 46, Subpart A, "Federal Policy for the Protection of Human Subjects" scheduled to go into effect on January 19, 2018 have been delayed by six months following the announcement of an Interim Final Rule.  The Interim Final Rule requires that revised provisions that conflict with the pre-2018 rule not be implemented until July 19, 2018.  The conflicting revised provisions include the new exempt categories 3 and 4.  If you plan to submit a new proposal using either exempt category 3 or 4, we recommend that you contact the Office of Research Compliance before creating the new protocol.

In preparation, the Ohio University Office of Research Compliance (ORC) has prepared a presentation with an overview of the changes and how they will be implemented at Ohio University.

 

ORC Overview of Important Changes to the Final Rule and Implementation at Ohio University

 

The following documents from the Collaborative Institutional Training Initiative (CITI) also provide details about the changes. 

 

CITI Overview of Important changes to the Final Rule

CITI Comprehensive Overview of the Final Rule Revisions