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For organizations choosing to implement the three burden-reducing provisions in the revised Common Rule during the delay period (19 July 2018 – 20 January 2019), the Office for Human Protection (OHRP) released draft guidance documents to help with general compliance.
- Scholarly and Journalistic Activities Deemed Not to be Research
- When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019
- Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals
The comment period for these draft guidance documents is open until 24 August 2018.
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