HRPP Toolkit Update
Effective September 25, 2026, the HRPP is updating the suite of Toolkit documents.
Going forward, it is anticipated that these documents will be updated on a quarterly basis.
This update includes two NEW Standard Operating Procedures (SOPs) (HRP-028, HRP-067), one new form (HRP-817), and both major and minor changes to the current documents. A summary of the relevant changes can be found in the table below.
Please begin utilizing the updated templates when developing materials for your study application, and review the new/updated SOPs and other Toolkit documents, as applicable.
In addition, these documents have been added to the VIRBs Library and will be posted on our website in the coming days. Reminder: always source the current Toolkit documents from the VIRBs Library or HRPP website! These are living documents and that is the best way to ensure you are using the most recent version.
Thank you all for your commitment to the protection of human participants in research. For any questions, please reach out to us at [email protected].
| Toolkit Document | Version Date | Summary of Changes |
| NEW – SOPs and Worksheets | ||
| HRP-028 – SOP – Administrative Withdrawals and Discards | 9/25/2026 | Establishes a transparent and consistent process for administratively withdrawing or discarding human research submissions in VIRBs. |
| HRP-067 – SOP – Advisory Council | 9/25/2026 | Establishes a process for a Human Research Protection Program Advisory Council (HRPP AC). |
| HRP-817 – FORM – Site Closure | 9/25/2026 | Use this form to close out a study at an external study site (p-Site). |
| Revised Templates | ||
| HRP-502 – TEMPLATE CONSENT DOCUMENT | 9/25/2026 | – Added section for VIRBs Protocol # (HM) – Added section and template language when contributing to NIH genomic database |
| HRP-502a – TEMPLATE CONSENT DOCUMENT with combined HIPAA | 9/25/2026 | – Added section for VIRBs Protocol # (HM) – Added section for language when contributing to NIH genomic database |
| HRP-503b-TEMPLATE NHSR | 9/25/2026 | – Clarified that when two separate VCU data/sample sources are linked, the study cannot be NHSR – Clarified HIPAA Waiver is required for case reports using VCU datasets – Expanded project type options – Added HIPAA Waiver section (for Case Reports) – Clarified a case series is three cases or fewer – Other editorial changes were made |
| HRP-506-TEMPLATE CONSENT DOCUMENT-Expanded Access | 9/25/2026 | – Revisions as provided by VCU’s Clinical Research Regulatory Affairs office, and inclusion of HIPAA Authorization – Other editorial changes were made. |
| Revised SOPs | ||
| HRP-001-SOP-Definitions | 9/25/2026 | – Clarified UPIRTSO criteria #2 to include “possibly related” to the research |
| HRP-013 – SOP – LARs, Children and Guardians | 9/25/2026 | – Updated section 3.1.2.2 to mirror language from Virginia Code 32.1-162.18 regarding consent |
| HRP-020-SOP-Incoming Items | 9/25/2026 | – Updated to reflect exempt studies now require departmental approval – Revised triage process in alignment with new SOP, HRP-028 – Added HRPP Director “designee” for emergency use notification by HRPP staff – Other editorial changes were made |
| HRP-021-SOP-Pre-Review | 9/25/2026 | – Clarified process for confirming CV, CITI training, and COI review – Removed requirement for HRPP to confirm VCUHS medical privileges – Clarified process for exceptions to HRP-309 requirements – Other editorial changes were made |
| HRP-023 – SOP – Emergency Use, Expanded Access | 9/25/2026 | – Editorial changes were made |
| HRP-040-SOP-IRB Meeting Preparation | 9/25/2026 | – Updated timelines for closure of agenda, providing agenda to IRB members, and receipt of completed reviews for convened meetings |
| HRP-052-SOP-Post-Review | 9/25/2026 | – Clarified Director will be notified of committee reportable determinations |
| HRP-063 – SOP – Expiration of IRB Approval | 9/25/2026 | – Clarified that researchers have 30 days to respond to “clarifications requested” – Other editorial changes were made. |
| HRP-064 – SOP – NIHGDS Institutional Certification | 9/25/2026 | – Updated NIH website links – Other editorial changes were made |
| HRP-065-SOP-Response Plan | 9/25/2026 | – Editorial changes were made |
| HRP-071-SOP-Toolkit Management | 9/25/2026 | – Added procedure for adding Toolkit updates to VIRBs Library |
| HRP-080-SOP-IRB Formation | 9/25/2026 | – Aligned with OHRP requirements for roster updates |
| HRP-083-SOP-IRB Membership Removal | 9/25/2026 | – Aligned with OHRP requirements for roster updates |
| Revised General Documents | ||
| HRP-100 – HRPP Toolkit Table of Contents | 9/25/2026 | – Addition of 3 new toolkit documents (HRP-028, HRP-067, and HRP-817) |
| HRP-101-HUMAN RESEARCH PROTECTION PROGRAM PLAN | 9/25/2026 | – Corrected web link for HRPP website – Added reference to policies/procedures access via VIRBs Library tab |
| HRP-103 – INVESTIGATOR MANUAL | 9/25/2026 | – Updated: – Q. 4 to clarify that CITI training verification can be included in the VIRBs training tab and also that CITI certification documentation must be included for co-investigators in addition to PI etc. – Q. 5 to defined the roles for which a COI review will be conducted, including co-investigators – Q. 6 to reflect that exempt studies require department review/approval – Q. 17 to add 45 CFR 46.118 Determination (HSR not currently defined) – Q. 22 to add reference to new HRP-817 – Site Closure form – Q. 23.16 to clarify what needs to be submitted in VIRBs after approval by an external IRB – Q. 28 to reference OVPRI record retention policy, and revise minimal record retention period to no less than five years – Other editorial changes were made |
| HRP-103p – INVESTIGATOR MANUAL – pSite | 9/25/2026 | – Q. 2 aligned with HRP-103 to reflect CITI requirements, including that certifications must be provided for Co-Investigators – Q. 4 updated to include reference to new HRP-817 – FORM – Site Closure |
| Revised Worksheets, Checklists, Forms | ||
| HRP-308-WORKSHEET – Pre-Review | 9/25/2026 | – Removed checkbox lines regarding: (1) VCUHS privileges, and (2) Signed PI Eligibility Request form, as non-employees can no longer serve as PI |
| HRP-309-WORKSHEET-Ancillary Review Matrix | 9/25/2026 | – Ancillary review matrix updated throughout. HRPP reached out to each listed group to request input. The revised version incorporates the content provided by each group. |
| HRP-314a – WORKSHEET – Criteria for Consent | 9/25/2026 | – Q. 3 – For NIH genomic data sharing, added checkbox to confirm disclosure of data sharing is included per HRP-332 – Other editorial changes were made |
| HRP-315-WORKSHEET – Advertisements | 9/25/2026 | – Clarified criteria to note the advertisement does not “overly” emphasize payment. – Other editorial changes were made |
| HRP-323-WORKSHEET-Criteria for Approval HUD | 9/25/2026 | – Added reference to HRP-307 if HUD used for research purposes |
| HRP-330 – WORKSHEET – HIPAA Authorization | 9/25/2026 | – Clarified that HIPAA forms must have an expiration date or event; “none” is no longer an option |
| HRP-416 – CHECKLIST – Children | 9/25/2026 | – Clarified Docusign cannot be used for e-assent from minors, and REDCap cannot be used for e-assent from minors under 14 years of age |
| HRP-430-CHECKLIST – Investigator Quality Improvement Assessment | 9/25/2026 | – Revised document retention requirement to 5 or 6 years, to align with VCU record retention policy |
| HRP-431-CHECKLIST – Minutes Quality Improvement Assessment | 9/25/2026 | – Clarified requirements in IRB minutes |
| HRP-834 – WORKSHEET – Institutional Requirements for Rely | 9/25/2026 | – Updated to add “non-significant risk device” option under Special Determinations section – Other editorial changes were made. |