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 that went into effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.

What the Final Rule Changes Mean for Your Research
Overview Definitions
Continuing Review Exempt Research
Informed Consent Cooperative Research

Continuing Review Revisions

The Final Rule eliminates continuing review (CR) for many minimal risk studies.  At Ohio State, these studies will require an annual check-in through submission of an annual status report (ASR) application.  Unless an IRB determines otherwise, a CR application submission is not required if:

  • The research was initially approved under 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 and 3 at Ohio State); or
  • The research was initially approved by a convened IRB and has progressed to the point that it involves only one or both of the following activities:
    • 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.

An overview of how submission are routed for annual review is available here.