Guidelines

The following is a joint recommendation of the ACTG Executive Committee, the ACTG Network Community Advisory Board (NCAB), and ACTG Community Advisory Board (CAB) members for the effective operation of Community Advisory Boards.

  1. Each ACTG Clinical Trials Unit (CTU) shall maintain a Community Advisory Board (CAB). Geographically distant Clinical Research Sites (CRS) within the same CTU shall maintain a local CAB. CTU's with multiple CRS's within the same geographic area should strive to have a CAB which reflects the demographic diversity of the catchment area. In general, CABs, Principal Investigators (PIs), and other ACTU staff shall:

    Encourage active discussion and participation of the CAB in all phases of protocol development, implementation, accrual and outcomes; and

    Maintain periodic reports at each site on the progress of trials, and work toward solving any problems of accrual and retention in those trials.

  2. Each CAB shall be organized jointly by community representatives and Principal Investigators. Community representatives on the CABs shall include people infected with HIV and trial participants; others may include, patient advocates, parents, community based health care providers, religious leaders, and representatives of underserved communities.

    The membership of the CAB shall strive to accurately reflect the demographics of HIV infection in the area. PI, staff, and other CAB members shall work together to educate and inform new CAB members of all issues pertinent to the local CAB.

  3. The organizational structure of the CAB shall be determined by its community members, and as such, it is assumed that the structure of each Board will vary. The following issues should, however, be consistent

    Monthly meetings are strongly recommended; a CAB shall strive to meet at least six times a year.

    Principal Investigator and ACTG staff may not be voting members of the CAB.

    Some sessions shall be educational in nature to develop an educated constituency. This process shall address basic science, protocol development and evaluation, the ACTG structure, the Adult CCG, and local Institutional Review Board (IRB) process.

    ACTG CRS's shall provide administrative support, including but not limited to: reasonable costs for meetings, computer/internet access, advertising/promotion, telephone, photocopying, fax usage, postage, trials listings, translation of materials, interpretation during meetings, transportation, child care and costs for travel to the national ACTG meetings.

    The Principal Investigator shall be supportive of participation of local CAB members in national ACTG activities, and should provide expense reimbursement to send at least one CAB member to each ACTG meeting. Participation with the NCAB should be encouraged and supported.

    Each ACTU CTU shall designate two individuals to receive Adult CAB communications. One should be an ACTU staff person and the other should be a non-staff CAB member. These individuals should assure that all other CAB members receive these communications in a timely manner.

  4. The CAB and local ACTU staff shall design and efficiently implement outreach programs to bring persons of all socioeconomic statuses into trials and to increase the participation and retention of women, intravenous drug users, adolescents, people of color, and underserved populations.
  5. The PI or his/her delegate(s) shall consult with the CAB on all matters effecting the conduct of clinical trials in each community, including but not limited to:
    1. the preparation of recompetition applications, budgets and budget revisions;
    2. choosing which ACTG protocols to participate in; and
    3. the submission of ACTG concept sheets by local investigators.