OHRP recently posted new decision charts for the revised Common Rule (2018 Requirements) on their website. These charts are intended to help decision-makers determine if research is considered human subjects research, if exemption categories apply, if continuing review is required, if documentation of consent can be waived, and if informed consent can be waived or altered under the 2018 Revised Common Rule Requirements.
OHRP Human Subject Regulations Decision Charts
CITI Program’s Revised Common Rule Course
Revised Common Rule is intended to help the research community understand the revisions to the Common Rule issued on 19 January 2017 with a general compliance date of 21 January 2019. The course provides a detailed review of the regulatory changes to 45 CFR 46, Subpart A, “Federal Policy for the Protection of Human Subjects” (the Common Rule).
