The DAIDS Protection of Participants, Evaluation, and Policy Branch (ProPEP) and the DAIDS RSC Human Subjects Protection Team
DAIDS ProPEP is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). DAIDS ProPEP provides subject matter expertise on human subjects protections matters (i.e., 45 CFR 46, 21 CFR 50, and 21 CFR 56), IRB/EC requirements, and HSP/GCP compliance issues. ProPEP also develops and maintains DAIDS policy documents to promote harmonization and to ensure compliance with applicable laws, regulations, guidelines, and policies, and serves as the DAIDS liaison to Office for Human Research Protections (OHRP).
The DAIDS RSC Human Subjects Protection (HSP) Team works closely with DAIDS ProPEP and provides support by reviewing all Informed Consents (ICs) during review at the P/CSRC and Regulatory Review stages. These include ICs for DAIDS-sponsored network and investigator-initiated protocols supported through DAIDS' grants. The DAIDS RSC HSP Team is also responsible for the translation of Sample ICs to Spanish.