External IRB Submissions

What Needs to be Submitted to WIRB?

All industry sponsored research involving human subjects should be submitted to WIRB for review, except projects that meet one or more of the following criteria:

  • Funding provided by the Department of Defense as a direct award or subaward;
  • involve human subject activities conducted by Navy and Marine Corps personnel;
  • involve naval military personnel and Department of Navy (DoN) employees as research subjects;
  • are supported by naval activities through any agreement (e.g., contract, grant cooperative agreement, development agreement [CRADSs], or other arrangement), regardless of the source of funding, funding appropriation, nature of support, performance site, or security classification; or
  • are using DoN property, facilities or assets.

How do I Submit a New Study to WIRB?

All new WIRB Submissions from VCU must first be submitted to the VCU IRB for institutional review and not directly to WIRB. All new WIRB protocols should be submitted through RAMS-IRB. Please review the following submission steps carefully:

  1. CRS Injury Language Review: The CRS reviews consent forms for industry funded clinical trials to ensure compliance with subject injury language in contracts.
    1. The PI/Study team emails the informed consent documents to CRSAdmin@vcu.edu before submitting a WIRB study in RAMS-IRB.
      1. Email subject line should include PI name, sponsor name, and study number or title.
      2. Email should include:
        1. Informed consent document(s), attached
        2. Clinical trial agreement (CTA), as appropriate, attached
        3. Sponsor contact information for negotiation purposes
        4. PT number associated with the study
    2. The CRS will review and negotiate the appropriate revisions to the subject injury language directly with the sponsor or contract research organization (CRO), as appropriate.
    3. Once CRS has completed negotiation of the language, they will send an approval memo with the VCU/Sponsor approved ICF template via email to the department for inclusion in the WIRB submission packet.
  2. Submit WIRB Submission through RAMS-IRB: Unless the CRS is contracted to perform the regulatory and IRB submissions, study teams should initiate a submission in RAMS-IRB and complete the smart form. When requested, select External IRB (WIRB) as the reviewing IRB. When the smart form is complete, submit the study. This replaces the prior method where WIRB documents were being sent via email or VCU filedrop to CRS for verification and submission.
    1. Documents that should be uploaded into the RAMS-IRB study workspace include:
      1. Study protocol
      2. Informed consent form(s)
      3. Memo from CRS indicating injury clause language in consent has been approved
      4. Cost Coverage Analysis Packet
    2. The CRS will prepare the RAMS-IRB submission and the WIRB submission when a study team contracts with the CRS to perform these services.
  3. The submission will be routed to the CRS.
    1. The CRS review will:
      1. Verify documentation of how payment will be made for WIRB review
      2. Ensure that the documentation of Injury Clause review and approval has been done
      3. Ensure a Cost Coverage Analysis has been completed
    2. The CRS will no longer be verifying that current forms are being utilized, that addresses match across documents, or that the correct number of items (e.g., investigator CV’s) are included. This will be the responsibility of the individual preparing the WIRB submission packet.
    3. When the CRS review is complete, the RAMS-IRB submission will be forwarded to the Office of Research Subjects Protection (ORSP) for further institutional review.
  4. The ORSP conducts an institutional review
    1. The review will:
      1. Request that a COI review be conducted and ensure final COI review disposition
      2. Verify mandatory training completion
      3. Confirm appropriate HIPAA PHI pathway
    2. Upon completion of the ORSP review, the PI will receive an email memo indicating the review is complete and the study may be submitted to WIRB.
  5. The Study Team submits the study to WIRB
    1. ORSP will no longer submit study/review documents to WIRB.
    2. The PI/Study Team is responsible for submitting all required documents to WIRB. (OR CRS on behalf of the Study team if using this CRS resource.) In addition to all study related documents, the following documents must be included with the WIRB submission in order for a review to occur:
      1. ORSP memo indicating institutional review is complete
      2. Verification that injury clause language has been reviewed
    3. The study team may decide to submit to WIRB via document upload or smart form completion, depending on investigator preference or instructions from WIRB.

Please contact CRSAdmin@vcu.edu if you have questions about ICF injury clause review. Please contact ORSP@vcu.edu for questions about WIRB submissions in RAMS-IRB.