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 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
Lastest news:  Delay in Common Rule Revisions Announced

What the Final Rule Changes Mean for Your Research

As we approach the end of the year and the upcoming general compliance date of January 21, 2019, we wanted to review our plans with you. Here is what you need to know:

  • There is no phase-in period. Any study approved on or before January 20, 2019, must comply with the current Rule, and any study approved on or after January 21, 2019, must comply with the Final Rule.
  • Buck-IRB will be offline on January 22nd while the system is updated. In addition, there will be a temporary freeze imposed on new study submissions between Thursday, January 17th and Tuesday, January 22nd.
  • Initial IRB submissions submitted on or after January 1, 2019, will likely be approved after January 21, 2019 based on typical review timelines. Further, you may experience a temporary increase in IRB approval timelines during this period while our office implements Common Rule changes.

What you can do:

Currently Approved Studies

  • ANNUAL REVIEW: If your study will expire before February 15, 2019, submit your continuing review/annual status report as soon as possible. As noted above, approval timelines may be slightly longer than normal; allowing ample time for screening and review will decrease the likelihood of study expiration.
  • AMENDMENTS: Please note in Buck IRB once a continuing review is submitted an amendment cannot be submitted until the continuing review has been approved, please prioritize accordingly. If your study expires in the next 60 days, you may wish to submit your continuing review/annual status report prior to submitting new amendments, since approval timelines may be slightly longer than normal.

New Initial Submissions

  • MODIFY QUICKLY: If your initial submission is currently in the review process, respond to modifications as quickly as possible to ensure review and approval will be completed by January 20, 2019, under the current Common Rule regulations. Otherwise, application and consent form revisions may require additional (in some instances significant) modifications to comply with the Final Rule.
  • HOLD or WITHDRAW/RESUBMIT: You may want to wait until after the Final Rule compliance date to submit your initial IRB application.  Under the Final Rule, some types of research will no longer require IRB review and instead will qualify for exemption.  If your initial submission is received after December 31, 2018, it will be screened for possible review options consistent with the Final Rule.
  • PLAN AHEAD: If you are currently in the process of preparing an initial submission, ensure your study documents include the updated consent templates.