Is a protocol required for HIV recent infection surveillance?
Yes. Because of the “research use” label of the RTRI, any CDC-funded activities that include the RTRI must be implemented under a research protocol and will require local IRB approval. Protocol templates for HIV recent infection surveillance are available for countries to adapt and reference for their local institutional review board (IRB) protocol submissions. Country teams are encouraged to submit their protocols to the local IRB at least 6 months prior to planned implementation to ensure there is sufficient time to obtain IRB approval (or Ministry of Health approval, if local IRB review is not indicated) and CDC research approval before the activity begins. Note that Ministries of Health may include recency testing as part of routine program activities per national HIV guidelines and policy, and therefore not require local IRB approval for the activity. In this case, if any portion of the activity is funded by CDC, a CDC research protocol is still required, along with documentation of MOH approval of the activity. Under a research designation, all or part of the consent process may be waived with opt-out options, if the activity meets criteria for being minimal risk to participants as per 45 CRF 45.116(f)(3).