Office of the Vice President forResearch and Innovation

• HRP-100 - HRPP Toolkit table of contents (rev. 8/7/25)
• HRP-101 - Human Research Protection Program plan (rev. 8/7/25)
• HRP-103 - Investigator manual (rev. 8/7/25)
• HRP-103p - Investigator manual - Single IRB review of multi-site research (pSite) (rev. 8/7/25)
• HRP-104 - Brochure - Should I take part in research? (rev. 8/7/25)
• HRP-105 - Office for Human Research Protections (OHRP) Food and Drug Administration (rev. 8/7/25)
• HRP-109 - IRB member manual (rev. 8/7/25)
• HRP-214 - FORM - Reportable new information (rev. 8/7/25)

• HRP-501 - TEMPLATE MINUTES (rev. 8/7/25)
• HRP-502 - TEMPLATE CONSENT DOCUMENT (rev. 8/7/25)
• HRP-503 - TEMPLATE PROTOCOL (rev. 8/12/25)
• HRP-503a - TEMPLATE SBS PROTOCOL (rev. 8/12/25)
• HRP-503b - TEMPLATE NHSR (rev. 8/7/25)
• HRP-504 - TEMPLATE LETTER - School permission to conduct research (rev. 8/7/25)
• HRP-506 - TEMPLATE CONSENT DOCUMENT - Emergency use or compassionate device use (rev. 8/7/25)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (rev.  8/7/25)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Spanish) (rev. 8/7/25)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Chinese) (rev. 8/7/25)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Arabic) (rev. 8/7/25)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Vietnamese) (rev. 8/7/25)
• HRP-508 - TEMPLATE Site supplement to sponsor protocol (rev. 8/7/25)

If a sponsor's/multisite protocol is in place that describes all information captured in the HRP-503 protocol, the HRP-503 protocol is not required in addition to the sponsor's/multisite protocol. Upload the HRP-508 Site supplement to the sponsor protocol with the sponsor's/multisite protocol. (updated 5/14/25)

• HRP-801 - SOP - Establishing authorization agreements (rev. 8/7/25)
• HRP-802 - SOP - Institutional profile management (rev. 8/7/25)
• HRP-805 - SOP - External IRB updates (rev. 8/7/25)
• HRP-806 - SOP - Review request to rely on external IRB (rev. 8/7/25)
• HRP-811 - FORM - Basic site information (rev. 8/7/25)
• HRP-812 - FORM - Site continuing review (rev. 8/7/25)
• HRP-813 - FORM - Site modification (rev. 8/7/25)
• HRP-814 - FORM - Site reportable new information (rev. 8/7/25)
• HRP-815 - FORM - Institutional profile (rev. 8/7/25)
• HRP-830 - WORKSHEET - Communication and responsibilities (rev. 8/7/25)
• HRP-832 - WORKSHEET - Relying on external IRB (rev. 8/7/25)
• HRP-833 - WORKSHEET - Considerations for serving as the sIRB (rev. 8/7/25)
• HRP-834 - WORKSHEET - Institutional requirements for rely (rev. 8/13/25)

• HRP-301 - WORKSHEET - Review materials (rev. 8/7/25)
• HRP-302 - WORKSHEET - Approval intervals (rev. 8/7/25)
• HRP-303 - WORKSHEET - Communication of review results (rev. 8/7/25)
• HRP-304 - WORKSHEET - IRB composition (rev. 8/7/25)
• HRP-305 - WORKSHEET - Quorum and expertise (rev. 8/7/25)
• HRP-306 - WORKSHEET - Drugs and biologics (rev. 8/7/25)
• HRP-307 - WORKSHEET - Devices (rev. 8/7/25)
• HRP-308 - WORKSHEET - Pre-review (rev. 8/7/25)
• HRP-309 - WORKSHEET - Ancillary review matrix (rev. 3/27/24)
• HRP-310 - WORKSHEET - Human research determination (rev. 8/7/25)
• HRP-311 - WORKSHEET - Engagement determination (rev. 8/7/25)
• HRP-312 - WORKSHEET - Exemption determination (rev. 8/7/25)
• HRP-313 - WORKSHEET - Expedited review (rev. 8/7/25)
• HRP-314 - WORKSHEET - Criteria for approval (rev. 8/7/25)
• HRP-314a - WORKSHEET - Criteria for consent (rev. 8/7/25)
• HRP-315 - WORKSHEET - Advertisements (rev. 8/7/25)
• HRP-316 - WORKSHEET - Payments (rev. 8/7/25)
• HRP-317 - WORKSHEET - Short form of consent documentation (rev. 8/7/25)
• HRP-318 - WORKSHEET - Additional federal agency criteria (rev. 8/7/25)
• HRP-320 - WORKSHEET - Scientific or scholarly review (rev. 8/7/25)
• HRP-321 - WORKSHEET - Review of information items (rev. 8/7/25)
• HRP-322 - WORKSHEET - Emergency use (rev. 8/7/25)
• HRP-323 - WORKSHEET - Criteria for approval humanitarian use device (HUD) (rev. 8/7/25)
• HRP-325 - WORKSHEET - Device compassionate use (rev. 8/7/25)
• HRP-326 - WORKSHEET - Performance evaluation for IRB chairs (rev. 8/7/25)
• HRP-327 - WORKSHEET - Performance evaluation for IRB members (rev. 8/7/25)
• HRP-328 - WORKSHEET - Performance evaluation for IRB staff (rev. 8/7/25)
• HRP-330 - WORKSHEET - HIPAA authorization (rev. 8/7/25)
• HRP-331 - WORKSHEET - FERPA compliance (rev. 8/7/25)
• HRP-332 - WORKSHEET - NIH genomic data institutional certification (rev. 8/7/25)
• HRP-333 - WORKSHEET - Certificate of confidentiality (rev. 8/7/25)
• HRP-351 - WORKSHEET - Protocol-specific emergency-disaster risk mitigation plan (rev. 8/7/25)
• HRP-352 - WORKSHEET - Additional emergency-disaster review considerations (rev. 8/7/25)

• HRP-401 - CHECKLIST - Pre-review (rev. 8/7/25)
• HRP-402 - CHECKLIST - Non-committee review (rev. 8/7/25)
• HRP-403 - CHECKLIST - Limited IRB review (rev. 8/7/25)
• HRP-410 - CHECKLIST - Waiver or alteration of consent process (rev. 8/7/25)
• HRP-411 - CHECKLIST - Waiver of written documentation of consent (rev. 8/7/25)
• HRP-412 - CHECKLIST - Pregnant women (rev. 8/7/25)
• HRP-413 - CHECKLIST - Non-viable neonates (rev. 8/7/25)
• HRP-414 - CHECKLIST - Neonates of uncertain viability (rev. 8/7/25)
• HRP-415 - CHECKLIST - Prisoners (rev. 8/7/25)
• HRP-416 - CHECKLIST - Children (rev. 8/7/25)
• HRP-417 - CHECKLIST - Cognitively impaired adults (rev. 8/7/25)
• HRP-418 - CHECKLIST - Non-significant risk device (rev. 8/7/25)
• HRP-419 - CHECKLIST - Waiver of consent process for emergency research (rev. 8/7/25)
• HRP-430 - CHECKLIST - Investigator quality improvement (rev. 8/7/25)
• HRP-431 - CHECKLIST - Minutes quality improvement (rev. 8/7/25)
• HRP-441 - CHECKLIST - HIPAA waiver of authorization (rev. 8/7/25)

• HRP-001 - SOP - Definitions (rev. 8/7/25)
• HRP-012 - SOP - Observation of consent process (rev. 8/7/25)
• HRP-013 - SOP - Legally authorized representative (LAR), children, and guardians (rev. 8/7/25)
• HRP-020 - SOP - Incoming items (rev. 8/7/25)
• HRP-021 - SOP - Pre-review (rev. 8/7/25)
• HRP-023 - SOP - All emergency use, compassionate use (device only) and individual patient expanded access (drug only) review (rev. 8/7/25)
• HRP-024 - SOP - New Information (rev. 8/7/25)
• HRP-025 - SOP - Investigations (rev. 8/7/25)
• HRP-026 - SOP - Suspension or termination issued outside of convened IRB (rev. 8/7/25)
• HRP-027 - SOP - All emergency use, compassionate use (device only) and individual patient expanded access (drug only) post-review (rev. 8/7/25)
• HRP-030 - SOP - Designated reviewers (rev. 8/7/25)
• HRP-031 - SOP - Non-committee review preparation (rev. 8/7/25)
• HRP-032 - SOP - Non-committee review conduct (rev. 8/7/25)
• HRP-040 - SOP - IRB meeting preparation (rev. 8/7/25)
• HRP-041 - SOP - IRB meeting conduct (rev. 8/7/25)
• HRP-042 - SOP - IRB meeting attendance monitoring (rev. 8/7/25)
• HRP-043 - SOP - IRB meeting minutes (rev. 8/7/25)
• HRP-044 - SOP - Not otherwise approvable research (rev. 8/7/25)
• HRP-050 - SOP - Conflicting interests of IRB members (rev. 8/7/25)
• HRP-051 - SOP - Consultation (rev. 8/7/25)
• HRP-052 - SOP - Post-review (rev. 8/7/25)
• HRP-060 - SOP - Annual evaluations of the HRPP (rev. 8/7/25)
• HRP-061 - SOP - Quarterly evaluations of the HRPP (rev. 8/7/25)
• HRP-062 - SOP - Periodic tasks (rev. 8/7/25)
• HRP-063 - SOP - Expiration of IRB approval (rev. 8/7/25)
• HRP-064 - SOP - NIH genomic data sharing (GDS) institutional certification (rev. 8/7/25)
• HRP-065 - SOP - Response plan for emergencies-disasters impacting the HRPP (rev. 8/7/25)
• HRP-070 - SOP - IRB records (rev. 8/7/25)
• HRP-071 - SOP - Toolkit management (rev. 8/7/25)
• HRP-072 - SOP - IRB records retention (rev. 8/7/25)
• HRP-080 - SOP - IRB formation and registration (rev. 8/7/25)
• HRP-081 - SOP - IRB removal (rev. 8/7/25)
• HRP-082 - SOP - IRB membership addition (rev. 8/7/25)
• HRP-083 - SOP - IRB membership removal (rev. 8/7/25)
• HRP-084 - SOP - IRB meeting scheduling and notification (rev. 8/7/25)
• HRP-090 - SOP - Informed consent process for research (rev. 8/7/25)
• HRP-091 - SOP - Written documentation of consent (rev. 8/7/25)

• NIH decision chart – Determining when research involving private information or biological specimens is human subjects research
• OHRP guidance on research involving coded private information or biological specimens

• 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. 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

• VCU CEnR and IRB FAQs: Community Engaged Research and the IRB
• Looking at Community-Based Participatory Research (CBPR) Through the Lens of the IRB (v. 10-30-08)
• VCU Division of Community Engagement: Community Engaged Research

• VCU policy: Research data ownership, retention, access and security
• VCU Technology Services askIT website, including information about the following resources:
  • University resources such as survey tools and FileLocker
  • Software Center for data analysis programs
  • RedCap survey and database tool, a free web-based tool for VCU researchers to securely conduct internet surveys and store research data
• VCU Technology Services Data Management System website
• VCU Technology Services Records Management website
• OHRP guidance on withdrawal of subjects from research: Data retention and other related issues
• FDA guidance on data retention when subjects withdraw from FDA-regulated clinical trials
• IT policies, standards, baselines and guidelines

VCU IRB’s Guidance on Enrolling Limited English Proficiency (LEP) Subjects in Research

• The Belmont Report
• Declaration of Helsinki
• Nuremberg Code

• FDA guidance on exception from informed consent requirements for emergency research
• VCU IRB’s EFIC Guidance

• NIH Genomic Data Sharing website
• NIH points to consider for IRBs and institutions
• NIH policy for sharing of data obtained in NIH-supported or conducted genome-wide association studies 

• FDA’s ICH guidance documents
• FDA's clinical trials and human subjects protection
• FDA's clinical trial guidance documents

The HIPAA Privacy Rule establishes conditions under which covered entities, including the VCU affiliated covered entity can provide researchers access to and use of Protected Health Information (PHI). The rule is not intended to impede research. However, it does provide for specific ways that PHI can be accessed and used by researchers as well as defines how individuals have control over their health information when they are research participants.

HIPAA forms and templates

See the IRB forms page.

VCU IRB’s guidance for researchers

• VCUHS privacy board
• Tips for a successful VCUHS privacy board application
• The VCU IRB refers to the HRP-309 - WORKSHEET - Ancillary review matrix for all ancillary review processes, including the VCU HS Privacy Board and VCU Dental Privacy office.

Additional guidance for researchers

• NIH Researcher Booklet – Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
• Office of Civil Rights: Health Information Privacy Information and Resources for Individuals and for Professionals
• VCUHS Policies about Information Security and Medical Records

• Informed consent tips (OHRP website)
• Informed consent checklist (OHRP website)
• Informed consent evaluation instrument for assessing whether an individual is able to provide consent for their own participation in research
• VCU’s informed consent templates
• E-Consent comparison: REDCap vs. DocuSign
  Infographic comparing two methods of obtaining e-consent — REDCap and DocuSign
  
  • Guidance on using REDCap for exempt information sheets
  • REDCap template - layout for an exempt study information sheet
  • Guidance on using REDCap for eConsent
  • REDCap E-Consent instructional setup guide
• Comparison of different methods of obtaining consent signatures remotely
  Compares different methods of obtaining and documenting consent remotely and provides examples of options for common scenarios
• Video: Re-consenting in research involving children
  15-minute video covers the topic of obtaining re-consent from children who reach the age of majority while participating in a research study
• OHRP decision chart 13: When can informed consent be waived/altered?
• OHRP decision chart 14: Can documentation of consent be waived?

• Considerations and recommendations concerning internet research and human subjects research regulations, with revisions (approved by SACHRP, March 2013)
• "Research Ethics in the 2.0 Era: Conceptual Gaps for Ethicists, Researchers, IRBs," a presentation by Michael Zimmer to SACHRP
• "Internet Research Ethics and IRBs," a presentation by Elizabeth Buchanan to SACHRP

• Reliance guidance

The VCU IRB refers to the HRP-315 - WORKSHEET - Advertisements for review of advertisements. All research studies must follow the VCU outgoing sponsorships, advertising and endorsement policy. The most important requirement in this policy is to submit your advertising via a request form to primarily ensure that research recruitment advertisements are brand compliant. Consistency in visual identity and language is critical in building VCU’s brand awareness which in turn, lifts all individual marketing efforts.

Form for submitting ads: Request to advertise
Style guides and assets: Brand identity

Direct any questions about this policy or its requirements to the Division of University Relations: VCU Brand Identity Office at identity@vcu.edu. 

The VCU IRB refers to the HRP-316 - WORKSHEET - Payments for review of advertisements. 

• VCU Office of Procurement Services: Compensate a research or survey participant step by step
• VCU summary of payment methods for non-employees and employees
• VCU procurement payment forms

Determining if an activity is research and/or quality improvement can be challenging. Federal regulations require human subject research to be reviewed and approved by the IRB, while strictly QI activities do not require IRB oversight. However, some QI activities may also be research and, therefore, need IRB approval. Please review the following guidance to determine if your activity likely needs IRB approval PRIOR to beginning the activity.

• OHRP quality improvement FAQ
• NIH/PubMed: How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both (Bass/Maloy)
• Advarra blog: Quality Improvement Activities and Exempt Research

To note, for conduct of QI research activities at VCU, there should always be appropriate departmental/institutional support in place.  The IRB’s approval only covers certain aspects of the research that relate to participant protections and rights that are applied under the federal guidance that governs human subjects research activities. 

Research teams are expected to receive permission and approval through the appropriate ancillary reviews and institutional channels to assure all research activities are conducted in a consistent and ethical manner.  Refer to the HRP-309 - WORKSHEET - Ancillary review matrix for a listing of all applicable ancillary reviews at VCU academic, VCUHS, and VCU dentistry. 

Research teams are encouraged to use the resources available on the HRPP website and reach out to hrpp@vcu.edu for additional guidance when uncertain.

NOTE: If you need documentation from the IRB that your activity is not research or does not involve human subjects, use VIRBs to submit a request for a determination of ‘Not human subjects research’ (NHSR) in the VIRBs new study application.  Complete and upload a HRP-503b - TEMPLATE NHSR to facilitate review of NHSR applications in VIRBs.

Federal and state resources for human research

• Guidance on the use of coded data/specimens
  Use this interactive tool to determine if your use of secondary coded data or specimens requires IRB review. NOTE: Use of this tool does NOT constitute an official IRB determination. It is intended as a resource for investigators to gain the understanding and vocabulary needed to communicate project details effectively to the IRB. If you require an official letter from the IRB with a determination of Not Human Subjects Research, you must submit an NHSR Request in VIRBs.

• Agency for Healthcare Research and Quality, "Registries for evaluating patient outcomes: A user's guides" (4th ed.)
• Registry of patient registries: Project overview
• ORSP webinar slides: "Understanding data registry setup and maintenance policies"
• The Honest Broker at VCU: Provides robust anonymized data for researchers from a broad number of resources. For more information about Honest Broker Services, please contact Cancer Informatics Core or Tamas Gal, Ph.D., director, at (804) 628-2123.
• Registry tracking template
• Registry reg binder tabs for PIs
• SACHRP honest broker
• Registry request process
• PI request flow
• PI data input flow
• Data use agreement for use of limited data set
• Adaptable registry request form
• Adaptable data contribution request form
• Honest broker guidance

The HRPP Toolkit includes SOPs, General Documents and Forms, Templates, Worksheets and Checklists that can be accessed at any time by research teams.  The HRP-430-CHECKLIST – Investigator Quality Improvement was implemented under the HRPP Toolkit to support research teams through the post-approval process.

Self-evaluation tool

• HRP-430 - CHECKLIST - Investigator quality improvement

Contact pame@vcu.edu with any specific requests for resources.