Office of Responsible Research Practices
The Ohio State University

Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule issued on January 19, 2017 and planned to take effect on July 19, 2018. Please check back often as updates will be made on an ongoing basis.

Overview Definitions
Continuing Review Exempt Research
Informed Consent Cooperative Research
Lastest news: Delay in Common Rule Revisions Announced

Elimination of Continuing Review of Research Under Specific Conditions

The final rule eliminates continuing review for many minimal risk studies.  Unless an IRB determines otherwise, continuing review of research is not required if:

  • The research is eligible for expedited review;
  • The research is reviewed by the IRB in accordance with the limited IRB review procedure described in several of the exemption categories (specifically 2, 3, 7, and 8); or
  • The research has progressed to the point that it only involves data analysis (including analysis of identifiable information or identifiable biospecimens) or access to follow-up clinical data from procedures that subjects would undergo as part of clinical care.

If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented.

Note:  Continuing review is currently required for FDA regulated research studies