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.
For proposed research to be considered for submission to WIRB, it must meet all of the following criteria:
- It must meet the National Institutes of Health (NIH) definition of a clinical trial:
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
- 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.
- The principal investigator (PI) must meet Ohio State requirements to serve as PI on a research project. See Qualifications for Service as a Principal Investigator.
Studies submitted for WIRB review will be screened by Office of Responsible Research Practices (ORRP) staff to determine that the research is appropriate for submission to WIRB and to confirm that the necessary institutional requirements (e.g., CITI training, COI disclosure) have been completed. Ohio State investigators and/or their designees must submit the following materials for initial review using the Buck-IRB online system:
- Research protocol
- Proposed consent form (WIRB-approved consent form, sponsor template, or Ohio State-WIRB consent template. Note: WIRB will insert Ohio State template language (e.g., compensation for injury, HIPAA, costs) into consent documents at the time of IRB review. The Ohio State-WIRB template is only necessary if a WIRB-approved or sponsor template is not already available.
- WIRB Initial Review submission form. (Right-click the link and select ‘Save Target As’ or ‘Save Link As’ to download the file, and open the destination folder to open the form.) This form is a smart PDF and requires Adobe Acrobat version 9.1 or newer. Please see http://wirb.com/Pages/DownloadForms.aspx for further questions regarding the WIRB submission forms.
- Clinical Scientific Review Committee approval, for cancer-related research
Note: Following screening, Ohio State authorization to submit to WIRB will be sent to investigators by ORRP staff. The investigator can then proceed with submission of materials directly to WIRB. The WIRB web site can also be referenced for assistance in submitting materials. Submissions will not be accepted by WIRB without Ohio State authorization. Submission questions and/or approval will be communicated directly to the PI/research staff by WIRB.
See www.wirb.com or contact WIRB Client Services at 800-562-4789 for more information about WIRB operations and submission procedures.
Submissions after Initial Approval
After initial approval, investigators should submit all subsequent study requests and documents directly to WIRB, following WIRB 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 WIRB by the sponsor
- Continuing reviews
- Closure notifications
Note: Changes in PI, co-investigators, or key personnel must be entered into the Buck-IRB system before submitting the change to WIRB. Modifications to the required Ohio State consent template language (e.g., compensation for injury, HIPAA, costs) must also be screened by ORRP staff prior to WIRB submission to ensure that the proposed change(s) meets institutional requirements.
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.
Questions or Assistance
eIRB Program Director
The Ohio State University
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-292-0184 | Email: email@example.com
For general questions, contact WIRB Client Services at 800-562-4789 or firstname.lastname@example.org.