Office of Responsible Research Practices
The Ohio State University

Reciprocity with Nationwide Children’s Hospital

The Ohio State University has an IRB Authorization Agreement with Nationwide Children’s Hospital (NCH) that 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
  • An Ohio State or NCH investigator performs a study involving both locations.

For most studies, IRB review will be provided by only one organization.  The organization responsible for review is determined by the location of the research (Ohio State or NCH) and the primary population involved.  Efforts will be made to avoid duplicative review; off-site research may have additional requirements.

IRB Review

Under this agreement, IRB review will generally be provided as described below:

  • Ohio State will provide IRB review for studies involving adults
  • NCH will provide IRB review for studies involving children
  • Studies involving both children and adults will be evaluated by the institutions to determine appropriate review arrangements.

Exempt Determinations

Under this agreement, exempt determinations will be made as follows:

  • Ohio State will provide exempt determinations for studies performed at Ohio State
  • NCH will provide exempt determinations for studies performed at NCH
  • Studies involving both locations will be reviewed by both organizations.

Exceptions

The following research is excluded from the IRB Authorization Agreement:

  • Industry-sponsored and industry-initiated clinical trials (reviewed for Ohio State by Western IRB)
  • Planned emergency research
  • Gene transfer
  • Xenotransplantation
  • Embryonic stem cell research

Submission Instructions

For Ohio State review (PI must be from Ohio State):

  • Submit the study for IRB review or exemption using the Buck-IRB online system.
  • For NCH personnel, verify that human subjects educational requirements are met (e.g., via CITI completion report) and NCH Conflict of Interest (COI) disclosures have been submitted.

For NCH review:

  • Studies submitted for NCH review must first be screened by Office of Responsible Research Practices (ORRP) staff to determine that the research is appropriate for submission to NCH and to confirm that the necessary institutional requirements (e.g., CITI training, COI disclosure) for Ohio State personnel have been completed.
  • Use the Buck-IRB online system to request NCH review of Ohio State research.  Selecting the NCH IRB in the Buck-IRB system will direct the user to questions and requests for document uploads (e.g., protocol, consent form) that will provide the information necessary to determine that the research meets the requirements for ceding review.
  • Following screening, Ohio State authorization to submit to NCH will be sent to investigators by ORRP staff. Submissions will not be accepted by NCH without Ohio State authorization. Submission questions and/or approval will be communicated directly to the PI/research staff by NCH.
  • Submit the study to NCH via the NCH electronic eTRAC system.
  • Register all research personnel listed on the protocol in the eTRAC.
  • Enter study information in the online application and attach PI’s current curriculum vitae.

Note: 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 the Buck-IRB system and receive Ohio State authorization before submitting the change to NCH.

Questions or Assistance

Sandra Meadows, MPH, CIP
Quality Improvement Specialist
The Ohio State University
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-688-8641 | Fax: 614-688-0366 | Email: meadows.8@osu.edu

Debbie Fine
Director, Research Services
The Research Institute at Nationwide Children’s Hospital
700 Children’s Drive
Columbus, OH 43205
Phone: 614-722-2708 | Fax: 614-722-2716 | Email: Debbie.Fine@nationwidechildrens.org