OHRP Announced the Availability of Three Draft Guidance Documents Related to the Revised Common Rule

The Office for Human Research Protections (OHRP) announced in the July 25, 2018 issue of the Federal Register the availability of three draft guidance documents that relate to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July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  The three draft guidance documents are titled: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 explains how certain scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected are deemed not to be research under the 2018 Requirements of the regulations for the protection of human subjects (45 CFR Part 46, subpart A), and consequently do not have to satisfy the requirements of those regulations.

1. “When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements.”  It provides information on the HHS regulations for the protection of human research subjects at 45 CFR part 46 related to the circumstances in which continuing review of research is not required. In particular, this guidance applies to research that transitions to comply with the 2018 Requirements during the 6-month delay period from July 19, 2018 through January 20, 2019. This guidance only applies during the 6-month delay period.

1. “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements.”  It provides guidance on the elimination of the requirement in the pre-2018 Requirements (45 CFR 46.103(f)) that each application or proposal for research undergo IRB review and approval as part of the certification process.

Note: the example in the “When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements” draft document, in section 2. “Nonexempt Research that Has Progressed to a Certain Point,” that was included in the July 20, 2018 listserv announcement was deleted to prevent potential confusion with research that is regulated by FDA.  For FDA-regulated research, including research that is subject to both FDA’s regulations and 45 CFR 46, subpart A, IRBs must comply with FDA’s continuing review regulations at 21 CFR 56.109(f). 

The Federal Register notice of availability can be accessed at https://www.gpo.gov/fdsys/pkg/FR-2018-07-25/pdf/2018-15908.pdf.  The draft guidance documents and instructions for how to submit comments can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html. There is a different docket for each draft guidance document in which the public can submit comments during the comment period of 7/25/2018 to 8/24/2018.

To access both the draft guidance documents and the dockets directly from this announcement, do the following:

• For the draft guidance “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,” go here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html, and https://www.regulations.gov/searchResults?rpp=25&po=0&s=HHS-OPHS-2018-0012&fp=true&ns=true, respectively.
• For the draft guidance, “When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,” go here: 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,  and https://www.regulations.gov/searchResults?rpp=25&po=0&s=HHS-OPHS-2018-0013&fp=true&ns=true, respectively.
• For the draft guidance, “ Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,” go here: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-elimination-of-irb-review-of-research-applications-and-proposals/index.html, and https://www.regulations.gov/searchResults?rpp=25&po=0&s=HHS-OPHS-2018-0014&fp=true&ns=true, respectively.

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.