1 Comments
As you may recall, NIH issued guidance for implementing the burden-reducing provisions of the 2018 Common Rule (NOT-OD-18-211). Subsequently on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions in the revised Common Rule that institutions may choose to implement during the delay period (July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):
- 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OHRP issued a Federal Register Notice of Availability (NOA) about these draft guidance documents and has posted these guidance documents in draft form because the general compliance delay period began on July 19, 2018.
I’m sure everyone appreciates that these “3” “provisions” are supposed to be “burden-reducing” (since you universally add that reference to the word), but I trust the team at DHHS/OHRP realizes that the repeated (and hard to justify) delays in implementing the 2017 rule are burden-enhancing. We will not be implementing any changes in the piecemeal fashion you recommend and I suspect few other organizations will do so.
Please let us move forward here.