The Ohio State University

Office of Responsible Research Practices
The Ohio State University
Home > Human Subjects > Policies, Procedures, Regulations and Guidance > WCG IRB | ORRP

WCG IRB

WCG IRB (formerly the Western Institutional Review Board (WIRB) 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 subject to the single IRB mandate to WCG IRB when the lead site has elected to use WCG IRB as the single IRB of record.

For proposed industry-sponsored and industry-initiated research to be considered for submission to WCG IRB, it must meet all of 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, gene transfer, or embryonic stem cells.
  • The principal investigator (PI) must meet Ohio State requirements to serve as PI on a research project. See Becoming a Principal Investigator.

Submission Instructions

Initial Review

Studies submitted for WCG IRB review will be screened by Office of Responsible Research Practices (ORRP) staff to determine that the research is appropriate for submission to WCG IRB 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 (WCG IRB-approved consent form or sponsor template). Note: WCG will insert Ohio State template language (e.g., compensation for injury, HIPAA authorization language, costs) into consent documents at the time of IRB review. Contact WCG at clientservices@wcgirb.com to see if a WCG-approved template is on file or contact the sponsor to obtain the sponsor’s template prior to submitting materials to ORRP for review.
    • Note: Sponsor requests for revisions to the Ohio State institutional language are negotiated during the WCG IRB pre-review process; these requests must be accompanied by a rationale for all proposed changes. WCG will contact ORRP directly for institutional sign-off on any changes to boilerplate language. ORRP will not negotiate changes to the Ohio State boilerplate language prior to receiving the sign-off request fromWCG’s staff.
  • Please note: The Ohio State University WIRB Institution Number, requested on the WIRB submission form, is 3654.
  • Clinical Scientific Review Committee approval (for cancer-related research)

Note: Following screening, Ohio State authorization to submit to WCG IRB will be sent to investigators by ORRP staff. The investigator can then proceed with submission of materials directly to WCG IRB. Submissions will not be accepted by WCG IRB without Ohio State authorization. Submission questions and/or approval will be communicated directly to the PI/research staff by WCG IRB.

For more information about WCG operations and submission procedures see, WCG IRB or contact WCG Client Services at 1-800-562-4789.

Submissions after Initial Approval

After initial approval, investigators should submit all subsequent study requests and documents directly to WCG IRB, following WCG 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 WCG IRB by the sponsor
  • Continuing reviews
  • Closure notifications

Exceptions: Changes to the following items must be submitted in Buck-IRB prior to submission to WIRB 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

WCG 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 WCG to ORRP.

Questions or Assistance