The Bay Area Reporter - October 13, 1998
Bill Snow, ACT UP/Golden Gate Writers Pool

A few farsighted government officials in NIAID, the National Institute of Allergy and Infectious Diseases, either realized that there might be some value in getting patient input and support, or saw a losing battle. They worked with the activists to establish a formal means to include them, and in fact it was the government that forced this marriage on some very reluctant scientists.

The first group created was the AIDS Clinical Trials Group (ACTG) Community Constituency Group (CCG). As its name implies, this national group has continued to be a group that represents a variety of constituents for AIDS drug trials. As such, it has open national applications periodically and tries to maintain a mix of geographic and interest groups.

Somewhat separate from this national group are community advisory boards (CAB) required for each ACTG site. Later groups have tended to be organized from the bottom up, with local CABs electing representatives to a national CAB.

Now the Division of AIDS (DAIDS) alone has CABs for seven AIDS networks of treatment and vaccine clinical trials and natural history studies. This effort led to the normalization of CABs, which have been a vanguard for other healthcare institutions and activities. Many private clinical trials, academic institutions, and pharmaceutical companies also have adopted some variation of the CAB concept. But unlike institutional review boards, CABs are not required unless as part of the requirements of a specific NIH grant or contract.

Hop in

In theory, and often in practice, CABs can play an essential role in the conduct of research. Hundreds of times CABs have identified potential problems for investigators or helped make trials more ethical, attractive, and feasible. In addition to their advisory and watchdog function, CABs have also helped their communities by disseminating information and arguing the case for participants, people with AIDS and the stigmatized communities that bear the brunt of the epidemic.

The best investigators have learned to respect and work with their CABs and the best CABs have earned their investigators' respect and work well with them. This constructive engagement between investigators and communities requires understanding each other's points of views and interests, sharing information openly, and often negotiating solutions that work for scientific inquiry and individual rights and needs, which must never be compromised if the research enterprise is to work at all.

In addition to goodwill, CABs, which are voluntary in nature, require organizational support. This may include staff to support administrative needs, a budget to cover costs, facilitated access to technical support such as phones, messaging, computers, copies. CABs must have regular written and verbal updates in a timely manner by staff in general and investigators in particular, who need to be available at times convenient for CAB members. CABs also require time and assistance to develop and maintain their own mechanisms and procedures for functioning well, including orientation and training for new members.

Often this process works very well indeed. NIAID Division of AIDS conducted a review of its CABs in 1996 and is in the process of trying to respond to participants concerns and provide better communications, training, logistics, funding, and interchange. The independent review by investigators and CAB members ends with the following summary statement, "The panel agreed that although a vague unease still exists regarding the institute's commitment to involving the community constituencies, the overall trust between the national groups and DAIDS has improved considerably."

Taking a ride

Joining and participating in a CAB can be an act of charity or enlightened self-interest. It also can turn out to be a punishing experience. In the beginning, God made CAB members who were perfect in every way: motivated AIDS activists who had the needs of people with AIDS as a fire in their guts. They fought and learned, wheedled and screamed, and seldom gave up. Many gave freely with a seemingly endless amount of time, energy, and enthusiasm. No pay, no gratitude, no authority, all in the face of a lot of bad studies, wasted money, and useless or disappointing results. Too many have literally died in the process.

CABs today are often very different. Some cities have enough CABs to keep an activist out of the bars every weeknight. A great deal of the business of CABs is bureaucratic, dreary, and difficult to understand. One may need to sit on seemingly endless conference calls and put up with the incredibly inefficient way scientists run their business. Often we find out about important decisions or trials after they've gone down the wrong path, or individual investigators have little to say about what happens in the national networks, or they patronize us in any one of a hundred ways.

The role of CABs is still unclear, and we cannot rely on staff or government to define it or initiate participants. Word of mouth among CAB members, mentoring, and a tradition of dissent has to be instilled by other activists and CAB members.

CAB gridlock

The government programs have changed, too. A great deal of the most progressive and interesting research is done privately by companies who don't want to be bothered by an open and often inefficient system of government networks (including the CAB process). A new generation of CABbies has arisen: well-meaning people who don't have the fire in their guts and who need to be trained from scratch about the research process and their role in it. Often they are participants who see themselves as primarily there to help the staff, thrilled with their entré into the world of science, or employees of community-based organizations fulfilling a job commitment. They aren't self-taught or as tenacious in their desire to influence change. Some groups and some individuals have a hard time disagreeing with authority, especially doctors.

Membership in any one CAB can be boring, unsatisfying, and frustrating, like any real job. But the demands of many CABs tax the ability of those interested and willing to participate. The job of the CAB is not recruitment or self-improvement, or making trips to Washington. It is advising in an often-thankless effort to improve and speed up research. Many CABs are too small and have too much to cover and do. New members are often left to shift for themselves in a world of acronyms and details. Impacted cities have CAB gridlock, and there are never enough smart, determined activists to man or woman them. Many working members don't have a lot of time to devote to CAB business in the networks, which can occur during business hours or at distant meetings. But imperfect as the system is, it accomplishes great, often unnoticed things.

Often at the national level, there's a conflict between representing a particular constituency and working together with others, in doing the hard work of participating in the scientific enterprise by understanding what the scientific needs are, and seeing what's best for our communities at large. This has in the past erupted into CAB infighting or ineffectual divided CABs. Developing CAB consensus seems to be the only way to offset our lack of actual authority. Not enough people on either side of this tug-of-war understand that good science and good ethics are the same thing.

Certain subjects have traditionally been the areas for CAB input: entry and exclusion criteria, enrollment, compliance and retention, informed consent, after-trial access, communications, and community education. We should have a bigger say in the larger issues of planning, budgeting, and priority setting. We should be part of every concept development and protocol planning team. CAB members do sit on executive and scientific committees, but their effectiveness varies with the individual, who has the difficult job of holding his or her own in a high powered, highly motivated, highly educated, highly-competitive professional group. Communities should be represented as well on institutional review boards that must approve studies and data safety and monitoring boards that must review adverse events and interim data during a blinded trial. t

ACTion UPdate:

Hail a CAB

If we know our destination and watch the meter, CABs can help get us where we want to go, toward the elusive cure and vaccine. Call a research site that interests you and give it a go:

1. HIVNET-San Francisco CAB - Advises the HIV Research Section of the San Francisco Department of Public Health on the local and national conduct of various HIV prevention research projects, including preventive HIV vaccine trials and other studies of prevention technologies. Part of the HIV Network for Prevention Trials (HIVNET), an international research network. Contact Joe Wright, (415) 554-9065

2. HIV Research Section Local Projects CAB - A local CAB that advises two new studies of the HIV Research Section of the San Francisco Department of Public Health. One looks at how gay and bi men are responding to new developments in AIDS technologies which may affect their risk behaviors. The other is a survey of circuit party attendees. Contact Rob Guzman, (415) 554-9342.

3. Post-Exposure Prevention CAB - Advises a "feasibility and consequences" study of post-exposure prevention (PEP) conducted by SFDPH and UCSF; PEP includes administration of antiviral drugs for people with recent exposures to HIV. Contact Jay Eunick, at (415) 597-9266.

4. PCM Standardization and Evaluation Project - CAB will advise a new project evaluating HIV prevention case management services in SF. It will also advise in the development and dissemination of new guidelines for the delivery of prevention case management services. Contact Mike Pendo, at (415) 554-9126.

5. Options Project CAB - CAB advises a study of treatment for people who have very recently been infected with HIV. The Options Project is examining whether early HIV treatment is beneficial for people with primary HIV infection (people who became infected with HIV less than one year previous to entry into the study). Call (415) 502-8100.

6. UCSF AIDS Clinical Trials Group CAB - Follows clinical studies of the federally funded AIDS Clinical Trials Group of which SFGH is one of their sites. Contact Mike Donnelly, at (415) 824-9160.

7. CPCRA/Community Consortium CAB-Follows clinical trials in the community setting at the Community Programs for Clinical Research on AIDS. Contact Greg Szekeres, at (415) 502-8660.

8. Stanford ACTG Community Advisory Board - Follows clinical studies of the federally funded AIDS Clinical Trials Group of which Stanford is one of their sites. Contact Johanna Maquilling, at 415/650-723-8172.

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