Visit the VCU Controller website for current rate information.

Pre-award

Proposal forms

• F&A exemption request form [Word]
• F&A exemption request form [PDF]
• Generic proposal face page
• Grant transfer to VCU
• Grant transfer from VCU
• NIH eRA commons account request
• Principal investigator (PI) eligibility exception
• VCUHS employee participation approval (Required for engagement in sponsored project activities)

Budget development

• Cost sharing authorization form
• Detailed budget worksheet, 1-5 year project
• Loaded budget worksheet, 1-5 year project
• Modular budget worksheet, 1-5 year project
• Percent of time and effort to person months conversion table 
• RAMS-SPOT SF424 detailed subaward RR budget
• VCUHS ancillary services request

Subrecipient(s)

• Subrecipient commitment form
• VCU IDC Uniform Guidance letter to subrecipient

Resources and references

• All occasion letter to PTE when VCU is subrecipient
• Intellectual property definitions
• VCU IDC uniform guidance letter to sponsor

Award set-up

• Administrator new award set-up checklist

Post-award

Award acceptance, establishment and management

• Grant transfer to VCU
• Grant transfer from VCU
• Principal investigator change certification form
• Grants and Contracts Accounting and Effort Reporting forms

Industry and clinical trials

• Accelerated CDA template
• Accelerated Clinical Trial Agreement (ACTA) template
• ClinicalTrials.gov account create form
• Industry clinical trial budget template

• Disposition of research data form
• VCU international employee/visitor pre-screening form
• Sponsored project/research volunteer documentation form
• Visiting nonemployee scholar agreement
• TMP exception form
• Subrecipient interest disclosure form
• VCU employee and facility use guidelines for clinical research
• VCU request for OVPRI matching funds - equipment

• Checklist – Applying for Virginia Board of Pharmacy and DEA registrations
• Personnel screening form - authorized user
• VCU controlled substances inspection information form for DEA
• Authorized users signature log – Schedule I controlled substances
• Authorized users signature log – Schedule II-V controlled substances
• Controlled substance inventory record
• Controlled substance dispensing record
• Controlled substance usage log and wastage record
• Controlled substance disposal log

To request a copy of a sample completed application or form, or a Word version of the form, please email controlsub@vcu.edu.

• Invention disclosure form
• Copyright disclosure form

VCU HRPP/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.

Protocol templates

These protocol templates are able to be used for the submission of new research studies immediately. Required for use effective June 1, 2023.

• HRP-503 - TEMPLATE PROTOCOL (rev. 10/23/24) - submission of biomedical studies and clinical trials
• HRP-503a - TEMPLATE SBS PROTOCOL (rev. 2/1/24) - submissions not involving an investigational agent
• HRP-503b - TEMPLATE NHSR (v. 11/26/24) - submissions for 'not human subjects research' determinations (new toolkit document)
• HRP-508 - TEMPLATE Site supplement to sponsor protocol (rev. 10/23/24) - provides VCU-specific information about research procedures and participant enrollment where there is an accompanying sponsor protocol

For additional updates about the HRPP toolkit and HRPP transformation project, visit the HRPP blog.

IRB reliance forms

• HRP-811 - FORM - Basic site information (rev. 2/1/24)
• HRP-812 - FORM - Site continuing review (rev. 3/1/24)
• HRP-813 - FORM - Site modification (rev. 3/1/24)
• HRP-814 - FORM - Site reportable new information (rev. 2/1/24)
• HRP-815 - FORM - Institutional profile (rev. 2/1/24)
• HRP-816 - FORM - External IRB study update (rev. 11/21/24)

HIPAA forms

Refer to the VCU Informatics webpage for all guidance related to use of protected health information (PHI) from databases housed under the VCU Health System. To receive the template for requests of HIPAA Limited Data Sets (LDS), reach out to hrpp@vcu.edu. The template for internal limited data sets only applies to protected health information housed under VCUHS and VCUHS covered entities.

• Standalone HIPAA authorization template (rev. 1/11/24)
• Verbal HIPAA authorization script template (rev. 11/21)

Visit HRPP Special Guidance - HIPAA in Research for additional guidance.

General consent and assent templates

These templates comply with the 2018 Final Rule Requirements for informed consent documents.

• HRP-502 - TEMPLATE CONSENT DOCUMENT (rev. 10/23/24)
• Child assent template (rev. 10/18)
• Exempt study information sheet template (rev. 11/21)

Consent templates for specific types of studies

• Research repository consent template (rev. 11/21)
• Expedited or full board online survey consent template (rev. 11/21)
• Expedited or full board telephone interview consent template (rev. 11/21)
• HRP-506 - TEMPLATE CONSENT DOCUMENT - Emergency use or compassionate device use (rev. 2/1/24) - to be used in conjunction with HUD patient labeling
• REDCap eConsent settings worksheet
  This worksheet is to be completed and included in an IRB submission proposing to use REDCap's eConsent templates. Guidance on REDCap's eConsent templates can be found under the "informed consent" accordion on the HRPP's Policies and Guidance page. For assistance setting up REDCap's eConsent templates, contact the Wright Center's Bioinformatics Core using their BIC request form.

Consent short forms for non-English speaking subjects

Translated versions will be posted as they become available. Please reach out to hrpp@vcu.edu if you have an immediate need for a language.

• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (rev. 3/1/24)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Spanish) (rev. 3/1/24)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Chinese) (rev. 8/23)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Arabic) (rev. 8/23)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Vietnamese) (rev. 3/1/24)

Supplemental submission forms

• Contingency protocol form for non-COVID situations (rev. 6/22)
  This form is only for temporary changes to an approved study’s protocol/smartform during the exceptional or emergency circumstances that will be defined in this document (i.e. an adaptive protocol plan for crises, emergencies, and major disruptions to normal study conduct). Instructions for use are contained within the document.
• COVID-19 contingency protocol form (rev. 3/20)
  If amending a study in response to COVID-19, please utilize this form. Instructions for use are contained within the document.
• Principal investigator eligibility form (rev. 10/6/23)
  For non-employees of VCU/VCUHS who have a VCU faculty status.
• Certificates of Confidentiality:
  • CoCs for NIH-funded research: Since 2017, NIH-funded research meeting specific criteria are automatically deemed to have a Certificate of Confidentiality.
  • CoCs for research not funded by NIH: The NIH continues to consider requests for Certificates of Confidentiality for specific projects that are not funded by NIH but are considered to be within the NIH mission. Reference: FDA CoC guidance (v. September 2020)
  1. 1. Log in to eRA Commons

     2. Carefully complete questions about the project and project CoC eligibility. Use the following information for questions 11-15:

        Virginia Commonwealth University
        800 East Leigh Street; Suite 3000
        Box 980568
        Richmond, Virginia 23298-0568
        United States of America
        
        Name of Institutional Official*: Lisa R. Ballance
        Email of Institutional Official*: lballanc@vcu.edu 
        Phone of Institutional Official*: (804) 827-2267

What may be reviewed by WCG IRB?

All industry sponsored research involving human participants should be submitted in RAMS-IRB requesting review by WCG IRB, 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 U.S. Navy and Marine Corps personnel
• Involve naval military personnel and U.S. 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
• Are using DoN property, facilities or assets

How do I submit to WCG IRB?

Initial submissions

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

1. OSP Red (Contracts) Injury Language Review: OSP reviews informed consent forms (ICF’s) for industry funded clinical trials to ensure compliance with subject injury language in contracts. An OSP Subject Injury Language Review Task List has been created in OnCore to track OSP subject injury language review and approval for submission to WCG IRB. 
   1. Prior to submitting a WCG IRB study in RAMS-IRB, the PI/study staff reviews consent form for revisions to non-injury language and coordinates with their school/department for the creation of a funding proposal in RAMS-SPOT for subsequent notification to OSP.
      1. School/department reviews ICF, makes any changes related to costs, uploads latest ICF redline (as appropriate) to OnCore under Task Number 1 of the OSP Subject Injury Language Review Task List and records the date under “Completed Date”.
      2. School/department creates a review record in RAMS-SPOT via the Submit Document for Review section, uploads the contract, links the funding proposal and logs a comment in the Funding Proposal stating that the consent form is available through OnCore for review.
      3. The Document Review should include sponsor/CRO contact information for both the consent form and the contract for negotiation purposes.
      4. School/department will access OnCore and record the “Completed Date” that contract was uploaded to SPOT under Task Number 2 of the OSP Subject Injury Language ReviewTask List.
   2. OnCore will generate a report to OSP Red indicating an ICF Subject Injury Language review is needed. OSP will access OnCore and record the “Completed Date” under Task Number 3 when the reviewer begins ICF review and 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 OSP has completed negotiation of the language, it will upload an approval memo with the VCU/Sponsor approved ICF template to OnCore under Task Number 4 of the OSP Subject Injury Language Review Task List and record the “Completed Date.” OnCore will generate a report and send it to the school indicating: OSP Approval and Upload of Approved Injury Language ICF and Memo.
   4. Study team/school (as appropriate) will access approval documents in OnCore under the OSP Subject Injury Language Review Task List and will mark the “Completed Date” under Task Number 5 of the task list.
   Please contact ospred@vcu.edu with any questions.
2. Submit WCG IRB submission through RAMS-IRB: Study teams should initiate a submission in RAMS-IRB and complete the smart form. When requested, select External IRB (WCG IRB) as the reviewing IRB. When the smart form is complete, submit the study.
   1. Documents that should be uploaded into the RAMS-IRB study workspace include:
      1. Study protocol
      2. Informed consent form(s)
      3. HIPAA Authorization(s) if separate from informed consent(s)
      4. Investigator brochure
      5. PI curriculum vitae
      6. Memo from OSP indicating injury clause language in consent has been approved
3. The submission will be routed to the ORSP for a compliance review.
   1. The ORSP will:
      1. Request that a COI review be conducted
      2. Verify mandatory training completion (human subjects and GCP)
      3. Ensure the PI is appropriately credentialed and privileged to perform clinical work
      4. Confirm appropriate HIPAA PHI pathway
      5. Verify documentation of how payment will be made for WCG IRB review
      6. Ensure that the documentation of injury clause review and approval has been done
      7. Ensure compliance with VCU policy, "Reporting Sponsor-Investigator INDs or IDEs"
   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 WCG IRB.
4. The study team submits the study to WCG IRB
   1. The PI/study team is responsible for submitting all required documents to WCG IRB via the WCG IRB electronic submission system. In addition to all study related documents, the following documents must be included with the WCG IRB submission for a review to occur:
      1. ORSP memo indicating institutional review is complete
      2. Verification that injury clause language has been reviewed

Please contact OSPRed@vcu.edu if you have questions about ICF injury clause review. Please contact HRPP@vcu.edu for questions about WCG IRB submissions in RAMS-IRB.

Maintaining approval and ongoing submissions

1. Once the initial submission is approved, the PI is responsible for directly submitting all future submissions to WCG IRB 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 WCG IRB.

2. RAMS-IRB will send a reminder to the PI/study team around the expiration date of the study. The PI/study team is responsible for updating the expiration date based on the most recent continuing review completed by WCG IRB and providing a summary of progress. WCG IRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WCG IRB strictly enforces deadlines.

WCG IRB submission forms

The most efficient way to submit to WCG IRB is directly through the WCG IRB electronic system called Connexus. If choosing to submit application documents via document upload, be sure to use the most recent forms obtained directly from the WCG IRB website.

VCU requires that specific informed consent template language be used. Be sure to use the template below when creating a consent form.

• External IRB clinical trial - VCU consent template (rev. 3/17/16)
• VCU-DNA consent addendum