Common Rule Guidance Available for Institutions Implementing New Revisions on Human Subjects Research
On July 20, 2018, the Office for Human Research Protections at the U.S. Department of Health and Human Services released three guidance documents related to provisions for institutions to implement before the newly revised policy that regulates research using human subjects (known as the Common Rule) goes into effect on January 21, 2019.
The three draft guidance documents are:
- 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
The public has through August 24, 2018, to comment on the draft guidance documents. How to submit and view public comments.
COSSA (the Consortium of Social Science Associations), of which NCFR is a member, has been following this ongoing story closely.
