Draft Guidance Documents Related to Revised Common Rule Released
On July 20, the Office for Human Research Protections (OHRP) the Department of Health and Human Services (HHS) released three draft guidance documents that relate to the three provisions in the revised Common Rule that institutions may choose to implement during the period between July 19, 2018 and January 20, 2019, when the revised Common Rule becomes effective (see COSSA’s coverage of the delay).
The three draft guidance documents are:
- Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
- When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements
- Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements
OHRP will issue a formal Notice of Availability about these guidance documents in the Federal Register but has posted the draft documents on its website in recognition of the beginning of the general compliance delay period, which began July 19, 2018. More of COSSA’s coverage of the Common Rule can be found here.