• HRP-001 - SOP - Definitions (rev. 7/23)
• HRP-012 - SOP - Observation of consent process (rev. 7/23)
• HRP-013 - SOP - Legally authorized representative (LAR), children, and guardians (rev. 7/23)
• HRP-020 - SOP - Incoming items (rev. 7/23)
• HRP-021 - SOP - Pre-review (rev. 10/23)
• HRP-023 - SOP - All emergency use, compassionate use (device only) and individual patient expanded access (drug only) review (rev. 7/23)
• HRP-024 - SOP - New Information (rev. 10/23)
• HRP-025 - SOP - Investigations (rev. 7/23)
• HRP-026 - SOP - Suspension or termination issued outside of convened IRB (rev. 10/23)
• HRP-027 - SOP - All emergency use, compassionate use (device only) and individual patient expanded access (drug only) post-review (rev. 7/23)
• HRP-030 - SOP - Designated reviewers (rev. 7/23)
• HRP-031 - SOP - Non-committee review preparation (rev. 7/23)
• HRP-032 - SOP - Non-committee review conduct (rev. 7/23)
• HRP-040 - SOP - IRB meeting preparation (rev. 10/23)
• HRP-041 - SOP - IRB meeting conduct (rev. 10/23)
• HRP-042 - SOP - IRB meeting attendance monitoring (rev. 7/23)
• HRP-043 - SOP - IRB meeting minutes (rev. 10/23)
• HRP-044 - SOP - Not otherwise approvable research (rev. 7/23)
• HRP-050 - SOP - Conflicting interests of IRB members (rev. 7/23)
• HRP-051 - SOP - Consultation (rev. 7/23)
• HRP-052 - SOP - Post-review (rev. 10/23)
• HRP-060 - SOP - Annual evaluations of the HRPP (rev. 7/23)
• HRP-061 - SOP - Quarterly evaluations of the HRPP (rev. 7/23)
• HRP-062 - SOP - Daily tasks (rev. 7/23)
• HRP-063 - SOP - Expiration of IRB approval (rev. 7/23)
• HRP-064 - SOP - NIH genomic data sharing (GDS) institutional certification (rev. 7/23)
• HRP-065 - SOP - Response plan for emergencies-disasters impacting the HRPP (rev. 7/23)
• HRP-070 - SOP - IRB records (rev. 7/23)
• HRP-071 - SOP - Standard operating procedures (rev. 7/23)
• HRP-072 - SOP - IRB records retention (rev. 7/23)
• HRP-080 - SOP - IRB formation and registration (rev. 7/23)
• HRP-081 - SOP - IRB removal (rev. 7/23)
• HRP-082 - SOP - IRB membership addition (rev. 7/23)
• HRP-083 - SOP - IRB membership removal (rev. 7/23)
• HRP-084 - SOP - IRB meeting scheduling and notification (rev. 7/23)
• HRP-090 - SOP - Informed consent process for research (rev. 7/23)
• HRP-091 - SOP - Written documentation of consent (rev. 7/23)
• HRP-801 - SOP - Establishing authorization agreements (rev. 7/23)
• HRP-803 - SOP - Reliance pre-review (rev. 7/23)
• HRP-804 - SOP - External IRB post-review (rev. 10/23)
• HRP-805 - SOP - External IRB updates (rev. 10/23)

• HRP-100 - HRPP Toolkit table of contents (rev. 10/23)
• HRP-101 - HUMAN RESEARCH PROTECTION PROGRAM PLAN (rev. 10/23)
• HRP-103 - Investigator manual (rev. 10/26/23)
• HRP-103p - Investigator manual - Single IRB review of multi-site research (pSite) (rev. 10/26/23)
• HRP-104 - Brochure - Should I take part in research? (rev. 7/23)
• HRP-105 - Office for Human Research Protections (OHRP) Food and Drug Administrat (rev. 7/23)

• HRP-501 - TEMPLATE MINUTES (rev. 7/23)
• HRP-502 - TEMPLATE CONSENT DOCUMENT (rev. 8/23)
• HRP-503 - TEMPLATE PROTOCOL (rev. 7/23)
• HRP-503a - TEMPLATE SBS PROTOCOL (rev. 7/23)
• HRP-504 - TEMPLATE LETTER - School permission to conduct research (rev. 7/23)
• HRP-506 - TEMPLATE CONSENT DOCUMENT - Emergency use or compassionate device use (rev. 8/23)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (rev.  8/23)
• HRP-507 - TEMPLATE CONSENT DOCUMENT - Short form (Spanish) (rev. 8/23)
• 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. 8/23)
• HRP-508 - TEMPLATE Site supplement to sponsor protocol (rev. 10/23)
• HRP-509 - TEMPLATE - Veteran Administration (VA) minutes supplement (rev. 7/23)

• HRP-811 - FORM - Basic study information (rev. 7/23)
• HRP-812 - FORM - Site continuing review (rev. 7/23)
• HRP-813 - FORM - Site modification (rev. 7/23)
• HRP-814 - FORM - Site reportable new information (rev. 7/23)

• HRP-301 - WORKSHEET - Review materials (rev. 7/23)
• HRP-302 - WORKSHEET - Approval intervals (rev. 10/23)
• HRP-303 - WORKSHEET - Communication of review results (rev. 10/23)
• HRP-304 - WORKSHEET - IRB composition (rev. 7/23)
• HRP-305 - WORKSHEET - Quorum and expertise (rev. 7/23)
• HRP-306 - WORKSHEET - Drugs and biologics (rev. 7/23)
• HRP-307 - WORKSHEET - Devices (rev. 7/23)
• HRP-308 - WORKSHEET - Pre-review (rev. 10/23)
• HRP-309 - WORKSHEET - Ancillary review matrix (rev. 10/23)
• HRP-310 - WORKSHEET - Human research determination (rev. 7/23)
• HRP-311 - WORKSHEET - Engagement determination (rev. 7/23)
• HRP-312 - WORKSHEET - Exemption determination (rev. 10/23)
• HRP-313 - WORKSHEET - Expedited review (rev. 7/23)
• HRP-314 - WORKSHEET - Criteria for approval (rev. 10/23)
• HRP-315 - WORKSHEET - Advertisements (rev. 7/23)
• HRP-316 - WORKSHEET - Payments (rev. 10/23)
• HRP-317 - WORKSHEET - Short form of consent documentation (rev. 7/23)
• HRP-318 - WORKSHEET - Additional federal agency criteria (rev. 7/23)
• HRP-319 - WORKSHEET - Limited IRB review (rev. 7/23)
• HRP-320 - WORKSHEET - Scientific or scholarly review (rev. 7/23)
• HRP-321 - WORKSHEET - Review of information items (rev. 7/23)
• HRP-322 - WORKSHEET - Emergency use (rev. 7/23)
• HRP-323 - WORKSHEET - Criteria for approval humanitarian use device (HUD) (rev. 7/23)
• HRP-325 - WORKSHEET - Device compassionate use (rev. 7/23)
• HRP-326 - WORKSHEET - Performance evaluation for IRB chairs (rev. 7/23)
• HRP-327 - WORKSHEET - Performance evaluation for IRB members (rev. 7/23)
• HRP-328 - WORKSHEET - Performance evaluation for IRB staff (rev. 7/23)
• HRP-330 - WORKSHEET - HIPAA authorization (rev. 7/23)
• HRP-331 - WORKSHEET - FERPA compliance (rev. 7/23)
• HRP-332 - WORKSHEET - NIH genomic data institutional certification (rev. 7/23)
• HRP-333 - WORKSHEET - Certificate of confidentiality (rev. 7/23)
• HRP-351 - WORKSHEET - Protocol-specific emergency-disaster risk mitigation plann (rev. 7/23)
• HRP-352 - WORKSHEET - Additional emergency-disaster review considerations (rev. 7/23)

• HRP-401 - CHECKLIST - Pre-review (rev. 7/23)
• HRP-402 - CHECKLIST - Non-committee review (rev. 7/23)
• HRP-410 - CHECKLIST - Waiver or alteration of consent process (rev. 7/23)
• HRP-411 - CHECKLIST - Waiver of written documentation of consent (rev. 7/23)
• HRP-412 - CHECKLIST - Pregnant women (rev. 7/23)
• HRP-413 - CHECKLIST - Non-viable neonates (rev. 7/23)
• HRP-414 - CHECKLIST - Neonates of uncertain viability (rev. 7/23)
• HRP-415 - CHECKLIST - Prisoners (rev. 7/23)
• HRP-416 - CHECKLIST - Children (rev. 7/23)
• HRP-417 - CHECKLIST - Cognitively impaired adults (rev. 7/23)
• HRP-418 - CHECKLIST - Non-significant risk device (rev. 7/23)
• HRP-419 - CHECKLIST - Waiver of consent process for emergency research (rev. 7/23)
• HRP-430 - CHECKLIST - Investigator quality improvement (rev. 7/23)
• HRP-431 - CHECKLIST - Minutes quality improvement (rev. 7/23)
• HRP-441 - CHECKLIST - HIPAA waiver of authorization (rev. 7/23)

• 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

• VCU IRB’s Guidance on Certificates of Confidentiality (CoCs)
• NIH Certificates of Confidentiality kiosk

• 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)
• Community-Campus Partnerships for Health, a nonprofit organization that promotes health equity and social justice through partnerships between communities and academic institutions
• CIRTification: Community Involvement in Research Training, a training program in human research protections that is tailored to the unique roles of community research partners
• The power of translating your research, how to write a lay abstract and impact statement
• Lay abstract impact statement presentation
• Writing a lay abstract and impact statement resources

• 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
• Selected FDA GCP/clinical trial guidance documents
• VCU Clinical Research Compliance Program website, which includes links to relevant policies, SOPs, resources and education for clinical research conducted at VCU

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

• Understanding HIPAA and Research at VCU (pathways to access & use PHI)
• Decision Tree 1: Determining When HIPAA Applies to Research
• Decision Tree 2: Determining Pathway to Use PHI for Research
• Decision Tree 3: Review of PHI for Recruitment

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
• 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

• VCU IRB’s guidance on identifying screening activities that involve human subjects
• VCU IRB's guidance to researchers on cold calling recruitment methods
• VCU IRB's guidance to researchers on social media recruitment methods

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. 

• 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 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.

• Quality improvement vs. research
• OHRP quality improvement FAQ

Once you've used these determination tools, if you have questions about whether your project is human subject research that needs IRB approval, please contact the Human Research Protection Program at orsp@vcu.edu.

NOTE: If you need documentation from the IRB that your activity is not research or does not involve human subjects, use RAMS-IRB to submit a request for a determination. Learn how on our blog.

• 45 CFR 46: DHHS Human Subjects Regulations (the Common Rule)
• 21 CFR 50: FDA Protection of Human Subjects Regulations
• 21 CFR 56: Institutional Review Boards
• 21 CFR 312: Investigational New Drug Application
• 21 CFR 812: Investigational Device Exemptions
• Office of Human Research Protections guidance
• FDA clinical trials guidance documents

• 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 RAMS-IRB.

• Agency for Healthcare Research and Quality, "Registries for Evaluating Patient Outcomes: A User's Guides" (3rd 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

Initial reviews

Prior to issuing approval for any initial submission to the IRB, a conflict of interest review must be completed. The COI review may occur concurrently with IRB review, but IRB approval cannot occur until it is determined that no conflicts exist or any conflicts have been acceptably managed.

Investigators should ensure all of the following are completed to help make certain the COI review does not delay IRB approval.

1. Designate in the Personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI investigator.

   *COI investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of COI investigator.

   See the COI page for more information about designating COI investigators.

2. All personnel designated as COI investigators must complete a Financial Interest Report in the Activity and Interest Reporting System. Click here to access AIRS.

Continuing reviews

At the time of continuing review, the IRB will check to ensure that all COI investigators have updated their FIR within the past 12 months. Approval for continuing review will be held until all FIRs are current.

Personnel amendments

When adding personnel who are designated as COI investigators, a COI review will be completed for each prior issuing the IRB approval for the personnel addition. All new COI Investigators should complete a FIR in AIRS prior to submitting the amendment to the IRB.

Initial reviews

Even though an external IRB will review the study, VCU will still conduct a conflict of interest review for each initial submission. The COI review must be complete and a final disposition provided before the Human Research Protection Program will authorize submission of the study to the external IRB. Any conflicts that are found will be managed jointly between VCU and the external IRB.

Investigators should ensure all of the following are completed to make certain the COI review does not delay IRB review.

1. Designate in the personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI investigator.

   *COI investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of COI investigator.

   See the COI page for more information about who is a COI investigator.

2. All personnel designated as COI investigators must complete a Financial Interest Report in the Activity and Interest Reporting System. Click here to access AIRS. The submission will not be forwarded to the external IRB until all FIRs are complete.

Continuing reviews

VCU will not conduct ongoing COI reviews for studies sent to external IRBs. However, investigators are responsible for ensuring all COI investigators update FIRs as required by COI policies.