April 9, 2015
Amidst the 80-plus participants at AVAC’s African Partners’ Forum, one face may have stood out more than any other. The one participant from Thailand, an AVAC partner of almost eight years, brought into the room a global perspective and a wealth of research advocacy expertise— that, despite his solitary role and his sometimes quiet demeanor, was palpable throughout the three days.
Udom is a consultant for AVAC working on community engagement in HIV research, and a consultant for the Retrovirology Department of Armed Forces Research Institute of Medical Sciences (AFRIMS) on CAB constitution since 2010. His work at AVAC is to promote community participation in HIV research and Good Participatory Practice (GPP) implementation in the country. Udom is also a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai civil society involving in HIV/AIDS. One of the founders of Thailand National Community Advisory Boards (NCAB) on HIV research.
Through the Thai NGO Coalition on AIDS, he has championed the AVAC/UNAIDS Good Participatory Practices—both with research entities and national bodies—and has helped move the dial on stakeholders’ roles in the research process in Thailand. We asked him to share his experiences with the group, in particular development of a National Community Advisory Board. Here are some of his words:
Community participation in HIV research in Thailand can be divided roughly into two stages – before RV144 stage, and RV144 (and beyond) stage. RV144 was the world’s largest HIV vaccine efficacy trial and conducted in Thailand. In Thailand, the concept of community participation in HIV research was rarely mentioned before the RV144 vaccine trial. In the pre-RV144 era, almost all HIV studies in Thailand were treatment, and participants were AIDS patients of the hospitals that also contain research centers. Hence there was no need to engage others besides the patients and their families. Recruitment strategies of that time were word of mouth, banners posted around the hospitals, and pamphlets. For HIV prevention trials such as HIV vaccine, recruitment might involve one or two meetings with villagers of the target area and the local health officers.
Due to its sheer size and the resources that came with it, RV144 inadvertently changed all of these. A few Thai AIDS activists heard about the trial for the first time at an international AIDS conference and were upset for being left out. They thus demanded that the researchers discuss the plan of the trial with the communities living in the target area to prepare them. Attempting to pacify the NGOs, the researchers held several meetings to discuss the ways to move forward with them. Even though both sides agreed that community participation was necessary, they couldn’t agree on the approach or the definition of community. At the same time, the model of the community advisory board (CAB) had been used in the USA for quite some time. The Thai NGOs involved in the meetings seized on the idea of CAB because it allows laypersons to become involved in HIV research, and it was romantically linked to AIDS activism. From then on, CAB became popular among Thai NGOs. Later on, some institutes conducting HIV research in the country also adopted the CAB model to appease Thai AIDS activists (or agitators depending on viewpoint) and to fulfill requirement of the trials’ sponsors. As a result, several CABs were desultorily formed; a couple of CABs were formed even before the responsible research institutes had a study to consult them with.
Unfortunately only the name (of CAB) is adopted. Most CABs in Thailand are not clear about their roles and responsibilities. In the beginning, a couple of CABs existed in name only. There was no meeting, no activity. The selection (of CAB members) process was, and still is, not clearly defined. Criterion for CAB members is ambiguous; some CABs include researchers and members of research teams as bona fide members. In many cases, CAB members were selected based on their deferential attitude toward researchers and staff rather than their qualifications, experiences, or representativeness. The only CAB activity is bimonthly meetings that dedicated mainly to routine update of the trials with very little (or no time) for other discussion. CAB members are not consulted about the meeting agenda ahead of the meeting. The consultations sought from CAB members in the meeting are limited to informed consent forms and, occasionally, educational/communication materials. Most CABs, except one, have never seen protocols of the studies about which they are to give advice. A few CAB members think that the purpose of informed consent is to absolve the researchers from legal responsibility. Many CAB members think that CAB is an additional arm of the research team to recruit people for the trials.
In general CAB members receive no formal or structured training on relevant topics including clinical research and research ethics. Other activities that could improve CAB capability are also lacking such as orientation for new members, mentoring and coaching for new and old members who may benefit from such activities, or reading materials to improve their research knowledge. Regarding capacity building for CAB, the only exception is the youngest CAB formed about 3 years ago by a bio-ethicist working with a few AIDS activists who have CAB experience. This particular CAB has regular CAB training sessions built into their bimonthly CAB meetings as well as annual training workshop and orientation for new members.
The idea of the national CAB was born during the implementation of RV144. A few AIDS activists involved in community engagement of the trial wanted to create an autonomous coordinating CAB to promote cross-learning between existing CABs. After informal discussions with other NGO workers who were CAB members of various research institutes and a meeting to discuss the idea, the national CAB was formed in May 2014. The goal of the National CAB is to promote ethical HIV clinical research through meaningful community participation. The national CAB wants to focus on capacity building in HIV research and research ethics for existing CABs and relevant community members. Members of the national CAB are selected from six HIV CABs in the country. Notwithstanding the name, the national CAB receives no funding from government agency or research institutes.
Almost from the beginning all associated research institutes, except one, are supportive of the national CAB. Only one research institute reckons that the national CAB has to be linked to specific institute/s and formalized by a government body.The national CAB meets every 2 months to discuss various topics that are not specific to trials or institutes but related to wider issues such as the national guidelines on HIV prevention and treatment, ethics of HIV research on vulnerable populations, and the drafts of the national law on human subjects research. The national CAB also conducts activities including GPP training for CABs and community groups, annual NCAB workshop, and training on research ethics for CABs and community groups.
It is too early to gauge the impact of the national CAB. For Thailand, this kind of CAB, an independent and NGO-initiated CAB, is unprecedented. Presently key HIV research institutes and a few HIV-related national bodies are aware of the national CAB and have no object regarding its existence or function. A chairperson of a national sub-committee related to HIV wants the national CAB to serve as additional IRB in parallel with other IRBs in reviewing biomedical HIV prevention trials conducted in Thailand. This is an important challenge for the national CAB considering its tender age and the members’ combined experience. To fulfill the expectation, members of the national CAB have to significantly improve their knowledge on HIV science and research ethics. They also have to expand their involvement horizontally and vertically. It is naïve to expect that this will be easy or encounter no opposition or resistance from other stakeholders. In the end it is left to members of the national CAB to prove that they are relevant and capable of the responsibility.