HRPP Toolkit Update
The HRPP has updated the following toolkit documents. Please start using these updated templates.
- HRP-100 -HRPP Toolkit Table of Contents
- HRP-103 and HRP-103p Investigator Manual/P-Site
- HRP-316 – WORKSHEET – Payments
- HRP-502 – Template Consent Document
- HRP-502a – Template Consent with combined HIPAA language
- HRP-502b – Template Consent Addendum Document (Participant Payments)
- HRP-503/503a and HRP-503/503a (fillable versions) – Template Protocol
A summary of these changes can be found below.
In addition, the following existing documents have now been added to the VIRBs Library:
- HRP-214 – FORM – Reportable New Information
- HRP-309 – WORKSHEET – Ancillary Review Matrix
- HRP-811-FORM-BasicSiteInformation
- HRP-812 – FORM-Site Continuing Review
All the above documents have been posted to the VIRBs Library, and will be posted on our website in the coming days.
Please use these updated documents when developing materials for your study application.
The best practice to ensure use of current versions is to always go directly to the VIRBs Library and download the applicable document(s).
To ensure the highest quality of our HRPP Toolkit, we continuously evaluate document content and anticipate additional updates. As they are issued, we will keep the research community informed through these communications.
Thank you all for your commitment to the protection of human participants in research.
| Toolkit Document | Version Date | Summary of Changes |
| HRP-100 – HRPP Toolkit Table of Contents | 2/20/26 | The Table of Contents was updated to include the addition of HRP-502a and HRP-502b. |
| HRP-103 – Investigator Manual And HRP-103p – Investigator Manual-pSite | 2/20/26 | Clarified who can serve as a PI at VCU.Updated CITI requirements to include GCP for clinical trial studies. Added the requirement to include HRP-503 for Humanitarian Use Device requests. Updated references to ICF template to include HRP-502a in addition to the current HRP-502. Updated formatting to include section numbers to improve document use. |
| HRP-316 – WORKSHEET – Payments | 2/20/26 | Addressed VCU’s procurement changes regarding IRS threshold for payments ($250 from $50). |
| HRP-502 – Template Consent Document | 2/20/26 | This basic consent template has been updated as follows: Removed appended HIPAA Authorization Form. This consent template is for use when HIPAA does not apply or when using a separate HIPAA Authorization Form. Revised instructions and text regarding participant payment to reflect the change in reporting threshold (now $250 in a calendar year). Updated selection instructions pertaining to future use of data/samples. Note: Existing studies with an IRB-approved consent document are not required to convert to this version. |
| HRP-502a – Template Consent Document with combined HIPAA | 2/20/26 | This is a NEW consent template created to embed HIPAA authorization language prior to the consent signature block sections. This now allows for single signature for Informed Consent and HIPAA when HIPAA language is included in main part of ICF prior to the consent signature blocks. Notes: For a consent template without HIPAA authorization, see HRP-502. Existing studies with an IRB-approved consent document are not required to convert to this version. Previous HRP-502a (Template Consent Addendum Document – Participant Payment) has been reassigned to a new HRP number (HRP-502b), to allow for the use of HRP-502a for this new consent template. |
| HRP-502b – Template Consent Addendum Document-Participant Payments | 1/1/26 | Changed the Toolkit Number for this addendum. This document was initially posted in January 2026 as HRP-502a; but has been relabeled as HRP-502b See 1/15/26 HRPP Update blog – https://blogs.vcu.edu/humanresearch/2026/01/15/hrpp-update-research-participant-payments-and-tax-reporting-requirement/ for further details. |
| HRP-503/503a and HRP-503/503a (fillable versions) – Template Protocol | 2/20/26 | Instructions updated to note that italicized instructions are to be RETAINED within the document. Ancillary review content expanded to include additional committees or departments. Language added regarding measures taken to prevent fraudulent responses for compensated online surveys. Expanded to request additional data security information. Updated references to ICF templates. Corrected formatting issues. |
| HRP-214 – FORM – Reportable New Information | 8/7/25 | This existing toolkit Form has been added to the VIRBs Library. |
| HRP-309 – WORKSHEET – Ancillary Review Matrix | 3/27/24 | This existing toolkit Worksheet has been added to the VIRBs Library. |
| HRP-811-FORM-BasicSiteInformation | 8/7/25 | This existing toolkit Form has been added to the VIRBs Library. |
| HRP-812 – FORM-Site Continuing Review | 8/7/25 | This existing toolkit Form has been added to the VIRBs Library. |