The Revised Common Rule is in effect as of January 21, 2019
The revised Federal Policy for the Protection of Human Subjects (45 CFR 46. Subpart A) known as the "Common Rule” went into effect on Jan. 21 of 2019. All studies involving human subjects submitted on or after January 21, 2019 will be reviewed by the IRB in accordance with the requirements of the revised rule.
Review OHRP’s draft guidance on transitioning to the revised Rule to find out how this might affect regulated research with human subjects.
Summary of Major Changes in the Revised Common Rule
Continuing Review - No longer required for most expedited studies. Furthermore, studies approved by the convened IRB, where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data, will no longer require continuing review.
Exemptions - The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (board). The revised Common Rule broadens the types of research that can be reviewed at the exempt level, which is the level requiring the least oversight.
Informed Consent - The revised Common Rule requires a new "Key Elements" section and a rearrangement of the content of consent forms to facilitate a potential subject's decision to participate or not. A "broad consent" option has been added for unspecified future use of identifiable data/biospecimens.
Single IRB-of-Record (sIRB) - Most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB starting Jan. 20, 2020. NIH funded research projects will be required to use a single IRB starting Jan. 25, 2018. See the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research for information about the NIH sIRB policy implementation.
What to Expect
Previously approved studies:
The new regulations will not apply retroactively to existing studies. For approved expedited studies and full review studies, the IRB will evaluate the need for continuing review at the time of the next scheduled continuing review submission.
All studies involving human subjects submitted on or after January 21, 2019 will be reviewed by the IRB in accordance with the requirements of the revised rule.
More information will be forthcoming. Feel free to contact us with any questions you may have at email@example.com or (773) 442-4675.