Office of Research Forms

Sponsored Programs Forms
VCU Innovation Gateway Forms
VCU IRB Forms
Western IRB Forms
ACUP Forms

Click here to view forms in alphabetical order.


Sponsored Programs Forms

For current rate information, please click here.

General

Proposal Development

Proposal Routing and Submission

Pre Award

  • Intellectual Property Assessment (coming soon)
  • Intellectual Property Assignment (coming soon)

Award Set-up

Post Award

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Industry & Clinical Trial

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VCU Innovation Gateway Forms

Invention Disclosure Formword logo

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VCU IRB Forms

Submit all VCU IRB forms to:

  • VCU Office of Research Subjects Protection
  • 800 East Leigh Street, Suite 3000
  • Box 980568
  • Richmond, VA 23298

Most of the following forms are in Microsoft Word format word logo, unless otherwise noted.

NOTE: VCU IRB forms are revised periodically. When preparing a submission, please be sure to use the most current versions of the forms by referring to this website and linking to the forms below. (The IRB will accept the preceding version of the form for 30 days following the posting of a revised form.)

Submission Forms

HIPAA Forms

To learn more about HIPAA guidance, please click here.

VCU IRB Reporting Forms

Consent & Assent Templates

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WIRB Submission Forms

What May be Reviewed by WIRB?

All industry sponsored research involving human participants should be submitted in RAMS-IRB requesting review by WIRB , except projects that meet one or more of the following criteria:

  • Funding provided by the Department of Defense directly to VCU or as a sub-award;
  • 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 to WIRB?

Initial Submissions

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
      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.

Maintaining Approval and Ongoing Submissions
Once the initial submission is approved, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including:

  • Changes in research (amendments)
  • Unanticipated problems
  • Continuing reviews
  • Study closure.

A copy of ALL submissions should be provided to ORSP by performing a “Document Upload” in the study workspace in RAMS-IRB, as well as to WIRB.

WIRB will send continuing review reminder notices to principal investigators.  Please pay close attention to the reminders. WIRB strictly enforces deadlines.

WIRB Submission Forms

Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by obtaining them directly from the WIRB website: http://www.wirb.com/Pages/DownloadForms.aspx or submit via the WIRB Smartform in Connexus. VCU does require that specific informed consent template language be used. Be sure to use the template below when creating a consent form.

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