Executive Committee (PEC)

The PEC is responsible and accountable for the proper design and conduct of PACTG studies, for the ethical and professional standards of the PACTG, and for ensuring that the results of clinical trials and scientific endeavors are arrived at in the most cost-effective manner possible. The PEC is ultimately responsible for selecting the group chair and the PACTG leadership. The PEC sets and approves budgets; allocates resources; sets bylaws and policies to be implemented; receives reports from the RACs, Scientific Committees, and Resource Committees; assesses institutional performance; approves and integrates the scientific agendas; reviews and validates research decisions; and provides general direction to the group leader for the allocation of resources by the Operations Center.

The PEC has the ultimate responsibility for the approval and oversight of clinical trials and for the analysis and dissemination of study results. Target resource allocations will be made by the PEC to each of the four RACs for protocol development. These allocations will be made based upon the scientific priority of the proposed studies and resources required to accomplish these studies. The PEC will oversee the allocation of resources for the support of the CORC, including distributions for the core laboratories, the Operations Center, the SDMC, the RACs, the Scientific Committees, the Resource Committees, the CCG, overhead accounts (telephone, mailings, electronic network, etc.), and discretionary funds.

The Steering Committee of the PEC will assist the group leader in carrying out the general administration and day-to-day management of the project. The Steering Committee will be comprised of the chair and vice chair of the PEC, a DAIDS representative, the Operations Center director, and the director of the SDMC. The existence of the Steering Committee will allow for quick-turnaround decisions and planning, but the committee will have limited decision-making authority.

The PEC is responsible for the overall conduct of the PACTG, including the following:

• Approval of the scientific agenda of the PACTG.
• Final approval or disapproval of concept sheets, protocols, and other scientific activities of the group.
• Election of chairs and vice chairs of the Scientific, Research Agenda, and Resource Committees.
• Fiscal management of the NIAID, PACTG, including, but not limited to, establishment of the schedule for the Group Chairs fiscal reports to the PEC.
• Allocation of resources of the central PACTG core award, including, but not limited to, establishment of the level at which approval by the PEC is required for expenditure of funds.
• Establishment of policies and procedures of the PACTG.
• Establishment of performance standards for all participating sites and members, including SDMC and the Operations Center.
• Determination of disciplinary action for participating sites and members, including recommendations to NIAID and NICHD regarding site funding.
• Development of a problem-resolution policy and process.

The voting members of the Pediatric Executive Committee are: a Group Chair; a Group Vice Chair; a Group Ex-Chair; a total of 13 NIAID and NICHD Investigators, with no more than 6 of the total 13 being NICHD Investigators, selected by a majority of the NIAID and NICHD Principal Investigators; two (2) obstetrical members chosen by a majority of the Obstetrical Subcommittee of the Perinatal Transmission RAC; two (2) members of the Pediatric CCG; one (1) representative from each of the Pediatric SDAC, the Operations Center, the Pediatric Site Resource Committee, the Adolescent Trials Network (ATN) and DAIDS.

Non-voting members of the Pediatric Executive Committee are: two (2) representatives from DAIDS/PMB; two (2) representatives from NICHD/PAMA; one additional non-voting member of SDAC and the Pediatric CCG; and one member from each of the following groups: Data Management Center, National Cancer Institute, FDA, and Pharmaceutical Industry Advisory Panel. The Pediatric Site Resource Committee Ex-Chair will serve one year as a non-voting member.

Members of DAIDS and the FDA will serve as nonvoting members of the PEC. The PEC will meet twice monthly by conference call. Summaries of the PEC meetings and conference calls will be distributed to principal investigators. At each PACTG meeting, the PEC will meet with the chairs of the RACs, the Scientific Committees, the Resource Committees, and the principal investigators to facilitate communications within the PACTG.