Nationwide Children’s Hospital (NCH) IRB Authorization Agreement permits Ohio State and NCH to collaborate in the review and oversight of human subjects research that would otherwise require review by both organizations. This agreement applies in the following circumstances:
- an Ohio State investigator performs or is engaged in a study at NCH
- an NCH investigator performs or is engaged in a study at Ohio State
For most studies, IRB review or an exempt determination will be provided by only one organization. The overall study principal investigator will submit a request for reliance to their home institution (Ohio State or NCH). A determination will be made (in consultation with the relying institution as needed) as to whether the project is appropriate for reliant review. If so, an IRB of record will be established, or an exempt determination provided. Submission instructions are located below.
Exceptions
The following research is excluded from the reliance agreement:
- research that is designated for reliant review under another reliance agreement or contract (e.g., industry-sponsored and industry-initiated clinical trials that are reviewed for Ohio State by WCG)
- planned emergency research
- gene transfer
- xenotransplantation
- embryonic stem cell research
Submission Instructions
When Ohio State is the IRB of Record
- Submit the study for IRB review or exemption using Buck-IRB.
- List NCH as a study site in the “Domestic Research Sites – Non-Ohio State Locations” section of the application.
- Upload an NCH reliance acceptance notification.
- List all engaged NCH collaborators on the “External Co-Investigators & Key Personnel” page.
When NCH is the IRB of Record
- Submit the study for ceded review using Buck-IRB.
- Select NCH IRB on the “Review Board” page to create an abbreviated “shell” application. Note: Ohio State staff and students working with NCH faculty are able to submit shell applications for ceded review.
- Upload to Buck-IRB copies of the protocol, NCH IRB/exempt application, consent form, and any other relevant study materials necessary to determine that the research meets the requirements for ceding review.
- Following screening, Ohio State’s approval to cede review is issued through Buck-IRB. The approval must be submitted to NCH with the full NCH IRB/exempt application.
Notes
After initial approval, investigators should submit all subsequent study requests and documents (except those involving personnel changes) directly to NCH, following NCH guidelines. Changes in Ohio State PI, co-investigators, or key personnel must be entered into Buck-IRB and receive Ohio State authorization before submitting the change to NCH.
Additional Information
NCH IRB Reliance Contact
Human Research Protection Program
Abigail Wexner Research Institute at Nationwide Children’s Hospital
Phone: 614-722-2708 | Email: IRB.Reliance@nationwidechildrens.org