HPTN Oversight and Operations Committees
The EC Chair recommends, and the full EC approves, chair(s) and membership of the HPTN committees. Committee members serve for the duration of the cooperative agreement, and chairs serve three-year terms unless otherwise specified. Terms of committee chairs may be extended with the approval of the EC Chair. In addition to the SCs, and WGs, six key standing Network oversight and operations committees include:
The SRC is responsible for providing the HPTN leadership (EC and PMG) with a thorough scientific, ethical, and operational assessment of study concept plans and protocols. The SRC ensures that study protocols are statistically, operationally, and ethically sound as well as accurate, consistent, complete and, to the extent possible, standardized relative to other HPTN protocols.
The SMC functions as an arm of the EC to provide a peer review of the conduct of all HPTN studies. Active HPTN studies are typically reviewed by the SMC within the first four to six months of study implementation and thereafter, approximately every six months including prior to Data and Safety Monitoring Board (DSMB) reviews (see Section 15.4). The SDMC PI in collaboration with HPTN leadership will determine the need for and frequency of SMC reviews for each study. Observational and Feasibility studies that are not being reviewed by the DSMB and others that may be determined by HPTN leadership to not require this frequency of review will have a modified review frequency and process. In addition, studies that may take less than a year to complete may not be reviewed by the SMC.
The primary responsibility of the MRC is to ensure that
manuscripts that contain data or statistically related content from HPTN
studies are developed, reviewed and endorsed, according to HPTN Operating
Policy 011: HPTN Publication Policy, prior to submission for publication.
The MRC is responsible for ensuring the timely development of manuscripts by
the protocol team. It is responsible for the review (within 10 days of
submission to the MRC) that provides written comments on the manuscript and
specific rationale for any revisions requested. Reviews are conducted via
conference calls on an as-needed basis upon manuscript submission.
Conference calls are organized by the MRC Chair.
The MRC Chair and SDMC statistician also review, and/or delegate for review, abstracts prior to submission for presentation at conferences.
The PEC is responsible for overseeing a continuous, comprehensive evaluation of the HPTN (see Section 19 for more information about the Network evaluation). The PEC designs and directs implementation and reporting of the internal evaluation of the HPTN. This includes assessing performance of the CTUs as well as key organizations and entities that are also part of the HPTN (e.g., CORE, SDMC, NL and protocol teams).
The goal of the evaluation is to provide data to assist in leadership decisions about changes necessary to improve HPTN functioning. In regard to the CTUs, the primary purpose of the evaluation is to provide data to determine if the sites are contributing effectively to the protocols that they have undertaken and to elicit corrective action, if necessary, so that all sites are functioning at peak performance level.
The PPG, with membership from the CORE, SDMC, and the NL, is a working group tasked with developing and maintaining the HPTN Manual of Operations (MOP) and HPTN Operating Policies.
The EAC is responsible for providing guidance to HPTN protocol teams with regard to determination of HIV endpoints. Decisions of the EAC are considered final for purposes of primary analyses of HIV endpoints. The NL will work with the SDMC to establish an HIV EAC. The EAC will prepare a document to define how various data will be evaluated when determining HIV status for the protocol participants. Each site may be asked to identify one site clinician to serve as an ad hoc member of the EAC. This person will be contacted to help resolve any discrepancies between clinical records, participant self-reported HIV status, prior testing and testing in the protocol. The site clinician must be able to confidentially access the participant's site records, including any data obtained from external sources (obtained with permission of the study subject), to assist with investigations.