WIRB Applications
| WIRB Review |
|---|
The Western Institutional Review Board (WIRB) is a commercial IRB under contract with The Ohio State University to review and monitor research projects that are industry-sponsored and industry-initiated. Ohio State will not permit the use of any other commercial IRB to review research performed by Ohio State 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 Ohio State 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 The Ohio State University requirements to serve as PI on a research project. See Qualifications for Service as a Principal Investigator.
NOTE: The limit for sending and receiving e-mail messages through The Ohio State University e-mail system is limited to 10MB. This is for the entire message (message body plus any attachments). If a message is over these limits, the mail will not be delivered.
Initial Protocol Submission
The Ohio State University 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 Ohio State 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 Ohio State 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 Ohio State performance site; and
- The language presented in the consent document (s) meets institutional requirements.
- All investigators preparing a new submission for WIRB must first contact WIRB (800-562-4789) to determine if the research has already been reviewed and approved by WIRB and if an approved consent document exists.
- If one exists, the WIRB approved consent document should be sent to ORRP for pre-review with the rest of the submission materials.
- If a WIRB-approved consent document does not exist, the sponsor template can be submitted to ORRP for review.
- If a sponsor template does not exist, the OSU/WIRB template available on ORRP’s website can be used.
- Investigators no longer need to insert the Ohio State template language into the consent document. WIRB will insert the language at the time of IRB review.
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.
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.
NOTE: The limit for sending and receiving e-mail messages through The Ohio State University e-mail system is limited to 10MB. This is for the entire message (message body plus any attachments). If a message is over these limits, the mail will not be delivered.
- OSU Instructions and Application for Protocol Review by WIRB
- Updated: 10/31/11 - This form must accompany all submissions to ORRP for initial review. Signatures are required.
- Appendix V - Radiation v3.0 - Updated 7/27/11
- 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: 2/01/12
- This template has been approved by both WIRB and Ohio State and should be used if a sponsor template or WIRB-approved consent form are not available.
- One of the following WIRB Applications must be included:
- WIRB Application for Initial Review of Research - Updated: 1/2012
- WIRB Application for Initial Review of Research
- Updated: 1/2012
- This application should be used if the sponsored research is being performed only at Ohio State or Ohio State is the first to submit to WIRB in a multi-center study.
- WIRB Application for Initial Review of Multi-Center Research - Updated: 1/2012
- WIRB Application for Initial Review of Multi-Center Research - Updated: 1/2012
- 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 authorization 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 Ohio State
- 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 Ohio State 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:
Tish Denlinger
IRB Protocol Analyst
(614) 688-3330 | Fax: (614) 688-0366 | denlinger.33@osu.edu - Submit applications
by campus mail or courier to:
The Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, Ohio 43210-1063 - Submit electronic submissions to denlinger.33@osu.edu
- See www.wirb.com for more information about WIRB operations.
