OHRP Announces the Availability of A Draft Guidance Document Related to the Revised Common Rule

The Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance document that relates to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July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  The draft guidance document is titled, “Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements.”  The Notice of Availability (NOA) of this draft guidance document is available today for public inspection in the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/11/19/2018-25202/activities-deemed-not-to-be-research-public-health-surveillance-2018-requirements. The draft guidance document can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-activities-deemed-not-be-research-public-health-surveillance/index.html.

The NOA will be published in the Federal Register on November 19, 2018 and will include a docket in which the public can submit comments on the draft document during a 30-day period (starting from the day the NOA publishes).

Note: this listserv announcement will be updated and sent out to subscribers when the NOA is published in the Federal Register.

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.