All the above documents have been posted to the VIRBs Library<\/strong>, and will be posted on our website in the coming days.\u00a0<\/p>\n\n\n\n
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Please use these updated documents when developing materials for your study application. <\/p>\n\n\n\n
The best practice to ensure use of current versions is to always go directly to the VIRBs Library and download the applicable document(s).<\/u><\/strong><\/p>\n\n\n\n
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. <\/p>\n\n\n\n
Thank you all for your commitment to the protection of human participants in research.<\/p>\n\n\n\n
Toolkit Document <\/strong><\/strong><\/td>
Version Date<\/strong><\/strong><\/td>
Summary of Changes<\/em><\/strong><\/em><\/strong><\/td><\/tr>
HRP-100 – HRPP Toolkit Table of Contents<\/td>
2\/20\/26<\/td>
The Table of Contents was updated to include the addition of HRP-502a and HRP-502b.<\/td><\/tr>
HRP-103 – Investigator Manual And HRP-103p – Investigator Manual-pSite<\/td>
2\/20\/26<\/td>
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.<\/td><\/tr>
HRP-316 – WORKSHEET – Payments<\/td>
2\/20\/26<\/td>
Addressed VCU\u2019s procurement changes regarding IRS threshold for payments ($250 from $50).<\/td><\/tr>
HRP-502 – Template Consent Document<\/td>
2\/20\/26<\/td>
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<\/em><\/span><\/strong>: Existing studies with an IRB-approved consent document are not required to convert to this version.<\/span><\/em><\/td><\/tr>
HRP-502a – Template Consent Document with combined HIPAA<\/td>
2\/20\/26<\/td>
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:<\/strong> 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 \u2013 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.<\/td><\/tr>
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