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Institutional Review Board (IRB) Oversight for CDC Tecovirimat (TPOXX) IND Expanded Access Program for Monkeypox: Instructions for CDC IRB Reliance For VA Facilities with Research Programs and Related Support of the CDC Tecovirimat Expanded Access Program

On July 25th, 2022 the VA Research Community was notified that ORD would provide instructions regarding the steps required for VA Facilities with research programs to rely upon the CDC IRB, including the VA Facility concurrence form that the VA Facility Director is required to sign formalizing the CDC IRB reliance agreement.  Both ORD and the VHA Office of Research Oversight (ORO) have finalized the steps regarding the CDC IRB reliance procedures for VA Facilities with research programs.  The document also includes additional information ORD is implementing or in process of implementing to support VA Facilities utilizing this expanded access program.  In addition, ORD has provided a master reliance agreement template as well as a concurrence form for VA facilities to rely up on the CDC’s IRB.

(a) Instructions for CDC IRB Reliance - VA facility participation in the Expanded Access IND Program - Use of Tecovirimat - Revised November 9, 2022

(b) Master National CDC IRB reliance agreement executed between the CDC and ORD

(c) Concurrence Form for VA Facilities to rely upon the CDC IRB (NOTE: The form must be downloaded onto your computer then opened using Adobe Acrobat DC so that the electronic signature box will function.)

Additional Supporting Documents and Tools

Training for VA Personnel Conducting FDA-Regulated Expanded Access Activities for the Treatment of Monkeypox ORD has developed a set of training slides to meet ORD's training requirement in ethical principles for personnel who are conducting any FDA-regulated expanded access program for monkeypox. This abbreviated training serves as an alternative to CITI training. No test is associated with the training slides. The individual can enter his or her name and the date the individual has reviewed the training course on the certificate at the end of the training. This certificate may be sent to your local research office as proof of completion of the training. This training is not required to be completed prior to patient treatment.
ROTC-D Information Security Review (11-9-2022) The information security review covers all VA sites participating in the program and covers the revised protocol version 6.2 (10-24-2022). Please note that ROTC-D will be conducting the central ISSO reviews for any amendments to this program.
Central Privacy Review (11-7-2022) The ORD privacy officer review covers all VA sites participating in the program. This review covers the revised protocol version 6.2 (10-24-2022). Please note that ORD's privacy officer will be conducting the central privacy reviews for any amendments to this program.
Example VA Form 10-5345 HIPAA Template for TPOXX Program Example VA Form 10-5345 HIPAA Template for TPOXX Program - 08-23-2022

ORD Guidance (September 6, 2022): Instructions for Use of VA DocuSign for VA Facilities Conducting the CDC Expanded Access Program: “Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children” (IND 116039/CDC #6402)

ORD in coordination with the IVA DocuSign team within the Office of Information and Technology (OIT), Development, Security, and Operations (DevSecOps) have developed streamlined procedures for using VA DocuSign for this expanded access program with modified submission and review procedures. Please use these specific instructions when using VA DocuSign for this CDC expanded access program.

VA DocuSign Job Aid for the CDC TPOXX Expanded Access Program (November 9, 2022)

The PowerPoint presentation is a tool to assist users with using VA DocuSign for this expanded access program by going thru each step of the process, including how to obtain signatures and retrieve the documents.

Example Table for Submission to IAM to Request Use of the VA Facility’s ORD-Approved DocuSign Envelopes (September 6, 2022)

The documents contains a table in Microsoft Word format that can be used by VA facilities to submit to Identity and Access Management (IAM) as per the ORD guidance document for using VA DocuSign for this expanded access program.

The current version of the CDC-IRB approved protocol, including the CDC-IRB approved informed consent document, CDC IRB approval documents, and required and optional forms are included on the CDC’s dedicated webpage for this program located at Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC.

If you have additional questions regarding the CDC IRB reliance for the expanded access Tecovirimat program, please email VHACOORDRegulatory@va.gov.



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