WIRB
| WIRB Review |
|---|
The Western Institutional Review Board (WIRB) is a commercial IRB under contract with The Ohio State University (OSU) to review and monitor research projects that are industry-sponsored and industry-initiated. OSU will not permit the use of any other commercial IRB to review research performed by OSU investigators.
In order for the proposed research protocol to be considered for submission to WIRB, it must meet the following criteria:
- It must meet the National Institutes of Health (NIH) definition of a clinical trial [A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)];
- It must be written and designed by the sponsor (without any scientific contribution by OSU faculty);
- The sponsor of the research must be a for-profit entity/company;
- It must not involve planned emergency research, xenotransplantation, gene transfer, or embryonic stem cells;
- It must not receive federal funding or funds from another not-for-profit funding agency; and
- The principal investigator (PI) must meet OSU requirements to serve as PI on a research project. See Qualifications for Service as a Principal Investigator.
Initial Protocol Submission
The OSU investigator and/or their designee must prepare the required materials for initial submission and submit these for review to the WIRB Administrator at ORRP. The required submission materials are listed on the OSU Instructions and Application for Protocol Review by WIRB (link below). The WIRB Administrator will review the materials to ensure the following:
- The research is appropriate for submission to WIRB and the PI meets the OSU requirements to serve as PI on a research project;
- The application is complete and includes all required documents and signatures;
- The PI, co-investigators and key personnel have completed the required CITI human subjects’ training and have current conflict of interest disclosures on file;
- The research is to be performed at an approved OSU performance site; and
- The required OSU template language is present in the consent document (s) (sponsor negotiations are considered).
The WIRB Administrator will respond in a timely fashion to the PI and their staff (if applicable) with an approved authorization form or items requiring resolution.
PLEASE NOTE: Submission to WIRB cannot proceed until the signed authorization form is provided by ORRP. This must be included with the submission materials to WIRB. In addition, if the WIRB Administrator approves modifications to template language of the consent form, the e-mail noting this should be included in submission correspondence to WIRB.
- OSU Instructions and Application for Protocol Review by WIRB
- Updated: 9/25/09 - This form must accompany all submissions to ORRP for initial review. Signatures are required.
- Appendix V - Radiation v.2.2 - Updated 9/25/09
- This form must be submitted if radiologic procedures (e.g., non-clinical care X-rays, DEXA or CT scans, nuclear medicine procedures) are included for research purposes. Approval by the Human Subject Radiation Committee (HSRC) is required prior to authorization for submission to WIRB.
- OSU/WIRB Consent Template - Updated: 10/22/09
- This template has been approved by both WIRB and OSU and should be used to develop the consent form document (s) prior to submission. The required OSU template sections are noted in the document text.
- One of the following WIRB Applications must be included:
- WIRB Application for Initial Review of Research- Updated: 10/01/09
- WIRB Application for Initial Review of Research
- Updated: 10/01/09
- This application should be used if the sponsored research is being performed only at OSU or OSU is the first to submit to WIRB in a multi-center study.
- WIRB Application for Initial Review of Multi-Center Research - Updated: 10/01/09
- WIRB Application for Initial Review of Multi-Center Research - Updated: 10/01/09
- This application should be used if the research is multi-center and has already been reviewed by WIRB. If there is a question as to whether a protocol has been reviewed by WIRB, contact WIRB Client Services at 1-800-562-4789.
Once approval is received from the WIRB Administrator at ORRP, the investigator can proceed with submission of materials directly to WIRB. The WIRB web site can also be referenced for assistance in submitting materials (www.wirb.com).
WIRB 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 also sent to ORRP concurrently by WIRB.
Submissions after Initial Approval
The investigator should submit all subsequent protocol documents directly to WIRB after initial submission following the guidelines provided by WIRB. These may include the following:
- Amendments to protocol documents or personnel (see below)
- Adverse event reports, protocol violations and/or unanticipated problems which occur at OSU
- IND safety reports or other event reports from sponsors which are not submitted to WIRB on the investigator’s behalf
- Continuing review reports
- Closure notification
PLEASE NOTE: If a modification to the research includes changes in PI, co-investigator or key personnel, ORRP must be notified when submitting this change to WIRB. If a modification occurs to the OSU-required consent template language (e.g. compensation for injury, HIPAA, costs), the submission must be sent to ORRP prior to submission to WIRB to ensure that the institution is in agreement with proposed language.
Questions and Contacts
- Need Help?
Direct general questions about submitting to the WIRB to wirbinfo@osu.edu or contact:
Susan Ebert
IRB Administrative Manager
(614) 292-1159 | Fax: (614) 688-0366 | ebert.55@osu.edu - Submit applications to:
The Office of Responsible Research Practices
300 Research Foundation Building
1960 Kenny Road
Columbus, Ohio 43210-1063 - See www.wirb.com for more information about WIRB operations.
