The Role of Community Advisory Boards CABs in

The Role of Community Advisory Boards (CABs) in Resolving Ethical Issues by Michael Marco Clinical Study CAB & Treatment Action Group Solid Organ Transplantation and People with HIV Ethics & Policy Conference Washington, D. C. -- 28 July 2001

Storming the NIH! AIDS Coalition to Unleash Power (ACT UP) May 1990

The Denver Principles (1983) • “We are people LIVING with AIDS. ” • “We are not victims. ” • “We have the right to die – AND TO LIVE – with dignity. ” • “We have the right to participate equally in all organizations dealing with AIDS policy, care, services, research & treatment. ”

NIH/NIAID RFA: AI-98 -013 ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM FOR AIDS The awardees will have the capacity to conduct all phases of clinical trials in patients with early infection to advanced [HIV] disease. $95 million for all Group[s]. • Terms and Conditions of Award: Ø GROUP: 14) Community Representation - The Group will develop and implement a plan for community representation in Group activities. The plan should address how the representatives' inclusion will make a substantive contribution to the overall success of the Group. Ø SITES: 7) Community Advisory Boards (CAB) - All units must establish a CAB representative of the HIV infected community of the catchment area. The unit should have plans that demonstrate how the CAB will be included in the activities to substantively contribute to the success of the unit. Funds requested in the application must be made available to the CAB for reimbursement of reasonable expenses including representation at the annual Group meeting(s).

Adult Clinical Trials Group (ACTG) Group Leader Operations Center Executive Committee Site Evaluation Subcommittee Statistical/Dat a Center ACTUs CABs Scientific Committees Resource Committees Community Constituency Group (CCG) Research Agenda Committees -----------Laboratories

ACTG CAB Mission Statement (Dec. 1997) • The mission of the Community Advisory Boards (CABs) of the AIDS Clinical Trials Group (ACTG) is to integrate community involvement in the AIDS Clinical Trials Units (ACTUs) in order to advance HIV/AIDS research. – CAB’s provide an opportunity for affected communities, especially clinical trials participants to: – understand the clinical research process; – voice concerns regarding specific clinical studies, their development, implementation and outcomes; – give assistance concerning issues related to the accrual and retention of trial participants; – give clinical trial participants necessary advocacy; – forge a viable partnership that will lead to improved knowledge of HIV/AIDS disease; give a means to address grievance issues; and – promote ethical research purposes and practices.

Phase III Data Monitoring Committee in the Eastern Cooperative Oncology Group (ECOG) • Membership Ø At the December 1999 meeting, the spot designated for the ethicist was officially given to a cancer survivor/community representative. Ø The ECOG DMC will consist of nine voting members and seven non-voting members. All voting members are appointed by the ECOG Group Chair. At least 5 of the voting members will be from outside ECOG and will have no other affiliation with the Group. At least one outside member will be a biostatistician, and at least one member will be a cancer survivor. The other voting members will be selected to provide expertise in medical oncology, hematology, cancer therapy modalities, and biostatistics.

HIV Liver Transplant Clinical Study CAB v Mike Donelly, Positive Health Partner/UCSF (SF) v Alan Franciscis, HCV Advocate (SF) v Jeff Getty (SF) v Brian Klein, Hepatitis C Action & Advocacy Coalition (HAAC/SF) v Brenda Lein, Project Inform (SF) v Jules Levin, NATAP (NYC) v Michael Marco, Treatment Action Group (NYC) v Bruce Mirkin (SF) v Mike Shriver, UCSF CAPS (SF)

Ins and Outs of Setting Up a CAB • Should there be one national CAB run out of UCSF, or should we try for independent CABs at each site? What about a national CAB and at least one liaison per site? • Will the surgeon, nurse and study coordinator find the time to attend the CAB meetings? Should they be required? • Will there be funding for CAB member[s] to attend a national CAB meeting[s]? What about funding for outreach & educational projects? • Who is the CAB member accountable to? Should there be minimum standards of conduct?

MAKING USE OF YOUR LOCAL ACTG CAB SITE ACTU? PI CAB CHAIR Cornell YES (Columbia) Roy “Trip” Gulick Tim Horn/Tracy Swan Georgetown YES (Pitt) Mayo NO Sinai Princy Kumar Yvette Delph (TAG) YES (NYU) Jeffrey M. Jacobson Bill Bahlman UCSF YES Mark Jacobson Billy Pick Maryland NO Minnesota YES Henry H. Balfour Lois Crenshaw (WEB) Penn YES Harvey Friedman Bryan C. Cole Smith (WEB) Pitt YES John W. Mellors Barbara Rutecki Virginia NO

Sensitive & Ethical Issues Facing an HIV+ Transplant CAB (1) • Since the beginning of AIDS, the mantra of many AIDS activists was “ACCESS to life-saving medications at any cost!” What do we say to patients in desperate need of a transplant who are ineligible for this study? • It will be our job to explain to patients why certain exclusion criteria exist. • Whom do we advocate for? The patient? The success of the study? • Knowing that CD 4 cells decline in HIV+ patients with progressive liver disease, how will we deal with the patient who becomes ineligible (CD 4 <100) while waiting for a liver? • What about cheating?

Sensitive & Ethical Issues Facing an HIV+ Transplant CAB (2) • Should the CAB advocate for a patient when an HMO has denied to pay for the transplant on grounds that it’s experimental? • What about the protocol’s mandate for patients to have social support? What are there standards? Who sets them? Are CAB members expected to be “buddies? ” • How do we make sure that patients on protocol understands all facets of the study (the risk & other options). Are we to serve as educators? Should we walk a prospective patient through the informed consent? • Is it fair that a patient can be refused entry into the study because he/she is HIV RNA detectable when a site in the next state only has a CD 4 cell requirement?

Future Directions: Education & Communication (1) v CAB members will need to gain a basic knowledge of transplant medicine to be rational and truly effective.

Future Directions: Education & Communication (2) v. Surgeons & others in the transplant community need to know that the natural history of HIV disease has changed dramatically over the past 10 years. The clinical management of HIV disease with the advent of HAART has made HIV/AIDS a “chronic and manageable disease. ”

Mocroft, et al. 1999

CD 4 T Cell Reconstitution on HAART 150 CD 4 100 Memory cell expansion Cells 50 Memory cell recirculation Naïve cell regeneration 0 Autran, el. 1999 3 6 9 12 18 Month

Future Directions: Education & Communication (3) v. Discussion of HIV/HCV coinfection natural history [time to cirrhosis] should be based on large cohort studies which stratify for CD 4 cell count and alcohol use. When done, it appears that only those patients with CD 4 cells counts <200 have an increased rate of fibrosis.

Future Directions: Education & Communication (4) v. At all times, we must remember that we’re in it for the same reasons: the advancement of science and the good of the patients.