ProPEP has a two-part mandate. ProPEP staff (i) serve as the Division’s Human Subjects Protection experts, and (ii) oversee the development and maintenance of DAIDS’ Clinical Research Policies by:
- Serving as the DAIDS’ Human Subject Protections (HSP) subject matter experts (SMEs) by participating in protocol development (contributing to Scientific Review Committee reviews and full regulatory reviews) and protocol implementation, by providing recommendations in accordance with all applicable HSP laws, regulations, guidelines, policies, and procedures.
- Providing consultation and expertise on complex HSP regulatory issues, as well as clinical research policies and the informed consent process.
- Serving as the primary DAIDS liaison to the Office for Human Research Protections (OHRP).
- Collaborating with appropriate subject matter experts (SMEs) to facilitate the development of a coordinated set of clinical research oversight policies consistent with applicable regulations, and guidelines, as well as NIAID and NIH policies.
- Providing direction, oversight and evaluation of the DAIDS RSC (Regulatory Support Center) contract regarding HSP, and DAIDS’ clinical research policies.
Related Training Courses on the DLP
Note: All staff members working with study participants or participant data must be certified in HSP and GCP. Sites can choose to use a combination of the options listed below or take comparable training from their institution to meet the DAIDS requirements.
|Name||Description and Audience|
|GCP/HSP Training Option: DAIDS eLearning||Duration of 4 hours, this course fulfills both the GCP and HSP requirement.|
|HSP Training Option: ACRP eLearning||Duration of 2.25 hours, this course ONLY fulfills the HSP requirement, NOT the GCP requirement.|