Advarra IRB is a commercial IRB under contract with The Ohio State University to primarily review and monitor research projects that are industry-sponsored and industry initiated. Ohio State will also cede non-industry-initiated multi-site research to Advarra IRB when the lead site has elected to use Advarra IRB as the single IRB of record and may cede Ohio State investigator-initiated studies on a case-by-case basis.
For proposed industry-sponsored and industry-initiated research to be considered for submission to Advarra IRB, it must meet all the following criteria:
- It must be written and designed by the sponsor or lead site (without any scientific contribution by Ohio State faculty). Note: If the study is federally supported and subject to single IRB requirements, exceptions are granted on a case-by-case basis.
- It must not involve xenotransplantation or embryonic stem cells.
- The principal investigator (PI) must meet Ohio State requirements to serve as PI on a research project.
Submission Instructions
Initial Review Submissions
Studies submitted for Advarra IRB review will be screened by Office of Responsible Research Practices (ORRP) staff to determine that the research is appropriate for submission to Advarra IRB and to confirm that the necessary institutional requirements (e.g., CITI training and COI disclosures) have been completed. Ohio State investigators and/or their designees must submit the following materials for initial review using the Huron IRB system:
- Research protocol and External IRB Site Supplement
- Proposed consent form (Advarra IRB-approved consent form or sponsor template)
- Advarra will insert Ohio State template language (e.g., compensation for injury, HIPAA authorization language, and costs) into consent documents at the time of IRB review. Contact Advarra to see if an Advarra -approved template is on file or contact the sponsor to obtain the sponsor’s template prior to submitting materials to ORRP for review.
- Sponsor requests for revisions to the Ohio State institutional language are negotiated during the Advarra IRB pre-review process; these requests must be accompanied by a rationale for all proposed changes and submitted to ORRP for institutional sign-off using the Huron IRB system. ORRP will not negotiate changes to the Ohio State boilerplate language prior to receiving the sign-off request in the Huron IRB system.
- Clinical Scientific Review Committee (CSRC) approval (for cancer-related research)
- Institutional Biosafety Committee (IBC) approval letter, if applicable
- Human Subject Radiation Committee (HSRC) approval (research radiation exposure studies), HRP-510 Appendix O – Radiation, radiation dose calculations, and risk language for consent form
Notes
- Following screening, Ohio State authorization to submit to Advarra IRB will be sent to investigators by ORRP staff. The investigator can then proceed with submission of materials directly to Advarra IRB. Submissions will not be accepted by Advarra IRB without Ohio State authorization. Submission questions and/or approval will be communicated directly to the PI/research staff by Advarra IRB.
- For more information about Advarra operations and submission procedures visit Advarra IRB Services.
Submissions after Initial Approval
After initial approval, investigators should submit all subsequent study requests and documents directly to Advarra IRB, following Advarra guidelines (see exceptions noted below). These may include the following:
- Amendments (excluding personnel changes and some consent form changes – see below)
- Adverse event reports, protocol violations, and/or unanticipated problems involving risks to subjects or others that occur in Ohio State research
- IND safety reports or other event reports from sponsors that are not submitted directly to Advarra IRB by the sponsor
- Continuing reviews
- Closure notifications
Exceptions
Changes to the following items must be submitted in the Huron IRB system prior to submission to Advarra for ongoing research:
- Changes in PI, co-investigators, or key personnel
- Addition or removal of Ohio State research locations
- Addition of new funding source
- Adding or revising radiation procedures
- Revisions to the Ohio State institutional language
Advarra IRB will contact the investigator/staff directly with questions about the submission after receipt and all approval documents will be sent directly to the investigator. A copy is concurrently sent by Advarra to ORRP.
Additional Information
Contact irbagreements@osu.edu with any questions.