OHRP Announces the Availability of Three Draft Guidance Documents Related to the Revised Common Rule

The Office for Human Research Protections (OHRP) is announcing the availability of three draft guidance documents that relate to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July 19, 2018 through January 20, 2019) for general compliance with the revised Common Rule.  The three draft guidance documents are titled:

1. Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements; it can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html.

1. When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements; it can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-when-continuing-review-is-not-required-during-the-6-month-delay-period/index.html.

1. Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; it can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-elimination-of-irb-review-of-research-applications-and-proposals/index.html.

OHRP plans to issue a Federal Register Notice of Availability (NOA) about these draft guidance documents soon, but is posting the draft guidance documents here in recognition of the general compliance delay period, which began July 19, 2018. The NOA that will be issued will include a docket for each draft document in which the public can submit comments during a 30-day period (starting from the day the NOA publishes).

Note: this listserv announcement will be updated and sent out to subscribers once the NOA is issued.

Additional information on the revised Common Rule and the three burden-reducing provisions can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.