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 July 12, 2023
(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.)
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.