The practicality and sustainability of a community advisory board at a large medical research unit on the Thai-Myanmar border

Abstract

Community engagement is increasingly promoted to strengthen the ethics of medical research in low-income countries. One strategy is to use community advisory boards (CABs): semi-independent groups that can potentially safeguard the rights of study participants and help improve research. However, there is little published on the experience of operating and sustaining CABs. The Shoklo Malaria Research Unit (SMRU) has been conducting research and providing healthcare in a population of refugees, migrant workers, and displaced people on the Thai-Myanmar border for over 25 years. In 2009 SMRU facilitated the establishment of the Tak Province Community Ethics Advisory Board (T-CAB) in an effort to formally engage with the local communities to both to obtain advice and to establish a participatory framework within which studies and the provision of health care take place. In this paper, we draw on our experience of community engagement in this unique setting, and our interactions with the past and present CAB members to critically reflect upon the CAB’s goals, structure and operations with a focus on the practicalities, what worked, what did not, and its future directions.

Introduction

There is now a widespread recognition of the importance of community engagement, for example through community advisory boards, in guiding the conduct of clinical research [1]. This is particularly so for research conducted in developing countries, away from major hospitals, and for studies that will recruit vulnerable groups of people [2, 3]. Potentially, CABs can play an number of important roles. These include ensuring that: the information given to study participants is understandable; that the study is culturally acceptable; that issues of consent, confidentiality, and compensation (where appropriate) have been addressed according to locally acceptable standards; and, more broadly, that the rights of participants are safeguarded [4-6]. These considerations are particularly important in communities where norms, standards and expectations are likely to be different from those of the ethical and scientific review committees that govern clinical research. Most CABs are ad hoc, short term and are established to inform particular studies. There is little published experience of ‘general purpose’ CABs, which have existed for several years and have reviewed many different studies [7].

The Tak Province Community Ethics Advisory Board (T-CAB) was set up in January 2009 as an effort initiated by the Shoklo Malaria Research Unit (SMRU) and the Mahidol Oxford Tropical Research Unit to formally engage with the communities it serves [8]. The aim was both to obtain advice and also to establish a participatory framework within which studies and the provision of health care take place. The hope was that, what is in reality, a range of vulnerable and complex communities could eventually be not just passive recipients of services, but could identify their own problems and organise solutions. It was hoped that in a small way, this process may be supported through the participation of individuals from the communities in understanding and planning local services, including medical services and research.

The Thai-Myanmar border community and the rationale and structure of the T-CAB have been described in detail previously and a brief summary with some additional background is provided below (Cheah et al., 2010). In this paper we describe the evolving experience of the advisory board as it has matured over several years and discuss possible future directions. We draw on our experience in this unique setting, and our interactions with the past and present CAB members to critically reflect upon the CAB’s goals, structure and operations with a focus on the practicalities, what worked, and what did not.

The Thai-Burmese borderline population in the Tak Province: demographics & history

The Thai-Burmese border region has been unstable for decades. Political conflicts within Myanmar have forced hundreds of thousands of refugees to take shelter in Thailand since the 1980s. In addition the economic stagnation in Myanmar has driven millions of migrant workers to the border region and into Thailand in search of work and healthcare. As a consequence of these two sets of factors, the political situation in Myanmar has shaped the population of the border region, and recent changes in Myanmar continue to affect it. An estimated 2-3 million Myanmar and Karen migrants and refugees now live in Thailand, and a large proportion have no legal status. The border population is highly mobile, moving between the two countries and in some cases involving resettlement to third countries. Major political changes inside Myanmar have occurred since the establishment of the T-CAB and the effects of these on the population in this area over the coming years are uncertain. Health care is very limited in the border areas such as Kayin state (directly across the border from Tak province). Often people will travel for long distances to access health care on the Thai side of the border, including at clinics run by SMRU.

Shoklo Malaria Research Unit: Its origins and the ethical issues relating to research & the community

Since 1986, the Shoklo Malaria Research Unit (SMRU-MORU) attached to the Faculty of Tropical Medicine, Mahidol University in Bangkok, and the University of Oxford, UK, has worked among the border population to reduce the impact of multi-drug resistant malaria and other infectious diseases. SMRU-MORU’s focus has always been on the groups at most risk from malaria: children and pregnant women. Beyond the serious impact that malaria has in the Myanmar “displaced” population, there is also a global dimension to malaria on the Thai-Myanmar border because the malaria parasites found in this part of Asia are some of the most drug-resistant on earth and their expansion and spread is a very real threat (research has already demonstrated that the most drug-resistant malaria parasites found in Africa originated in South East Asia) and must be stopped. This is particularly urgent and important in the “displaced” population living along the border since there have been worrying signs that the malaria parasites may become tolerant even to the artemisinin combination therapies (ACTs) now at the forefront of global malaria treatment [9-11]. The conducting of research in this setting presents a range of important ethical issues not encountered elsewhere. Some of these issues have been discussed previously in relation to this population [12,13].

The main SMRU offices and laboratories are in Mae Sot. The centre of clinical activities for refugees is a network of a hospital in Mae La refugee camp and clinics along the Thai-Myanmar border. These facilities are run by locally trained qualified Karen and Myanmar staff, many of grew up and live locally. Further information on the structure of SMRU is available at http://www.shoklo-unit.com/.

Tak Province Border Community Ethics Advisory Board (T-CAB): structure & history

Since its creation in the 1980s, SMRU has been informally engaging with village and community leaders, key workers, patients and their relatives, a process which over the years has improved the provision of healthcare and the conduct of research. However, it was recognised that within SMRU that there was a need to establish a more robust and formal participatory framework within which discussion of the implications of studies for communities could take place. Although all research conducted by SMRU is reviewed by at least two ethics committees: the University of Oxford Tropical Medicine Ethics Committee (OXTREC) and the Mahidol University Bangkok Faculty of Tropical Medicine Ethics Committee, it was felt a supplementary formal advisory body would add value.

It was in this context that, in 2009, the T-CAB was established. Its founding document, the T-CAB charter, which is available in English, Thai, Karen and Burmese describes the operational guidelines and constitution of the CAB.

Evolution of the T-CAB

Goals

Although community engagement is promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries, there is no widely agreed definition of community engagement and approaches adopted and the justifications given for its use vary. In addition to its agreed intrinsic value as way of treating communities with appropriate respect, community engagement is also usually taken to be of instrumental value in many different ways. Community engagement is, for example, seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and even in the provision of better health care.

At the time of its establishment, the CAB had three main goals. The first of these was that, after a period of training – about diseases such as malaria and the nature and goals of research – members would be able to advise on whether a study is acceptable to and perceived as beneficial by, the communities in the region. The second was that, the CAB would play a key role in advising researchers on the ethical and operational aspects of proposed studies such as: informed consent procedures, fair compensation, risks and benefits, how to protect the confidentiality of research subjects, and so on. The third, aim was that the CAB would act as a ‘bridge’ between the communities and researchers. It would on the one hand, provide communities with an opportunity to express views on proposed research and to influence and direct research aims, and on the other, provide a means by which the researchers might feedback the results of the research to the community. The T-CAB was not set up to replace existing methods of community engagement but to supplement it in a more formal way.

A series of interviews conducted with the T-CAB members (Lwin et al., 2012 in press) revealed that the goals of the CAB had evolved from what was set out in the beginning. CAB members felt that in addition to the above, they see the CAB as a place to learn and to better themselves. They also feel that they have increased responsibilities towards their communities e.g. they see themselves as health educators and health care workers, and that they are obliged to help out in non health matters including getting travel documents for their fellow villagers. This of course was not a remit of the CAB but it has evolved that way, and has posed new challenges for the CAB. Because the CAB is in theory independent, it can evolve in a way that is responsive to the community needs. Supporting the CAB especially in non health matters is not SMRU’s role.

CAB Membership

At establishment, potential T-CAB members were approached by SMRU staff through personal contact (October 2008). They were from an existing pool of key community workers residing in SMRU catchment areas. It was felt that approaching the potential members individually was the most respectful and acceptable way in this community. There is no formal community structure for the border population; there is no border “committee” as such that we could have approached, and there was no mechanism for formal elections either. In its first year T-CAB the consisted of 14 volunteer members who were identified by SMRU as being independent (non-employees) “representative” of the community and capable of fulfilling the role required. There were six women and eight men, aged between 21 and 57 years, with various levels of education, most of whom are community leaders and key workers (e.g. village chairman, pastor, teacher, social worker). All T-CAB members were either Burmese, Thai or Karen. Membership was collectively agreed and a secretary was elected to be the rapporteur. All but one member speak Karen; most can also speak Burmese, and a few can speak basic English or Thai. To be a member, they had to be literate in their own language, willing to serve as a volunteer and must not be a political figure. A new T-CAB is established at the beginning of each year; with new members approved by the existing members, according to the representative criteria in the T-CAB charter.

As described in our paper in 2010, there have been many challenges setting up a CAB. Some of these relate to the question of how the relevant ‘community’ is to be identified. Given the wide range and diversity of religious, political, language, and ethnic groups in the region the question of what constitutes the community and who may be a community ‘representative’ is highly likely to be both complex and politically sensitive.

The 2012 CAB has 12 members who live in a range of different settings in the border area, they are seen to be more “representative” than the first committee. Seven of them live in villages opposite the SMRU clinics on the Myanmar side of the border and five on the Thai side. There are nine men and three women on the CAB who are between 26 to 60 years of age, half of them have served since the CAB was established. There are currently three NGO workers, two teachers, two farmers, two village officers, a pastor, a taxi driver, and a housewife. A chair and a co-chair were elected in both the 2011 and the 2012 committees.

When the CAB was established, a decision was made that there whilst there would need to be a CAB secretary no other formal ‘offices’ would be established in order to attempt to create an environment, at least in the meeting room, where – insofar as this was possible - everyone was equal. The concern was that were a ‘chair’ to be created, the most influential members would be elected and other members would be unable to express their own views. The findings from our interviews suggest that whilst the CAB has worked reasonably well without a chair, the members feel more comfortable that a chair and a co-chair were selected, as they are more used to a structured committee.

Organisation of meetings

The CAB has met formally 33 times (up to December 2012) since its establishment. It has considered and commented on 31 studies during this time. The T-CAB has reviewed a range of studies: 12 clinical trials, 7 social science studies, 5 observational studies (with no medical intervention), 5 evaluations of diagnostic tests, and 1 prevalence study of a malaria-related genetic condition, and one malaria prevalence study. Meetings are usually moderated by an SMRU staff who sets the agenda before the meeting and sends out the meeting invitation. The moderator ensures that there is a lively discussion and members get to voice their opinions. Meetings typically involve an update of the important issues that occur in the members’ areas, the presentation of up-coming studies followed by discussion and a review of the information that will be provided to participants. The CAB met formally twice in 2008, four times in 2009 (in 2009, there was fighting and instability along the border), nine times in 2010, ten times in 2011, and eight times in 2012. Within T-CAB meetings the discussion is normally in Burmese and then translated into Karen, with the moderator asking questions of members to check understanding. Thai and English are also used when appropriate.

As described in our paper in 2010, there have been many challenges organising these meetings [8]. Meetings require simultaneous high-quality translation into the main languages spoken in the area: Burmese & Karen. The members are a group, with a wide range of experience, from health professionals to those with little formal education. Ensuring that all participants can follow discussion takes time, and some areas (primarily informed consent, and the methods and rationale for research) have been revisited several times in order to make sure that all members understand. In the first year, minutes were taken in English by an SMRU staff and then translated to Karen and Burmese. This was costly, time consuming and practically challenging, as minutes could not be emailed to members (most of them do not own computers or do emails). Rather, they could only be handed out during the next meeting.

Since 2011, two sets of meeting minutes are taken; in English by an SMRU staff and either in Karen or Burmese by a T-CAB member identified at the start of the meeting as the minute taker (not necessarily the chair or co-chair). Minutes in Karen/Burmese are handwritten and at the end of the meeting photocopied and circulated to all members. This avoids the requirement for costly translations and also ensures that meeting minutes are available to everyone in a timely fashion.

Review of studies

Ever since the CAB has been in existence all SMRU studies are presented to the CAB for discussion. The members advise us on the ethical and operational aspects of studies: what informed consent procedures are appropriate, how much compensation is deemed fair and not coercive and how to protect confidentiality of research subjects as well as assessing other culturally sensitive issues as they see fit.

Helping use locally appropriate language to communicate to patients and potential study participants is a key function of the T-CAB. Information sheets for study participants are written in Burmese or in Karen. These information sheets were reviewed by the T-CAB as an independent check that the meanings of terms were clear in both languages. Information sheets are typically built around a field-tested template, as for the majority of studies the basic ideas of consent do not vary importantly, and only study specific terms need to be added.

The majority of studies conducted by SMRU recruit participants who attend clinics either with fever, or for antenatal services. Most of the studies discussed by the T-CAB do not represent new demands from participants that cause major ethical concerns, but there are some studies that have justified special attention. The following are three examples of this.

Example 1. Age of Consent

An example of T-CAB deliberations was over the question of the age at which a woman could be considered an adult and capable of deciding her own treatment choices and whether to participate in research. This provoked a lot of debate and differences of opinion within the T-CAB. A common view was that even if a woman is under the age of 18 if she is married and pregnant then she is an adult and should be able to decide for herself whether to join in studies. Other members felt that the Thai legal age of consent, 18, should be respected and binding even if this was not the social norm for the community. Researchers decided that even though local standards may be determined more by status than actual age, that it is necessary to follow national legal guidelines, even if in the context of the Karen border community this means treating someone considered an adult woman as a minor.

Example 2. Compensation

A study was proposed, which would involve the recruitment of people with glucose-6-phosphate dehydrogenase deficiency (G6PD, a common hereditary condition that protects against malaria but also predisposes towards bleeding) of primaquine (a licensed and widely used antimalarial). This required standby blood donors in the unlikely event that a blood transfusion was suddenly required. Primaquine is usually not recommended for people with G6PD, but an effective radical cure of plasmodium vivax malaria (most other drugs cannot prevent relapse) was wanted for this population and so dosages and safety needed to be assessed in a highly controlled environment [it might be good to add a reference to a scientific paper here].

The T-CAB discussed the risks and benefits of the study, and eventually decided that there was a small risk of emergency transfusion among participants to be weighed against a potentially large benefit to local people if treatment guidelines could be revised to allow an effective drug for vivax malaria to be widely used. However, it was the requirement of standby blood donors generated intense debate over what could and could not be expected of community members, and whether this crossed a threshold at which payment should be made to compensate for the time and inconvenience demanded. This was the first time compensation for non study patients had been discussed - in this case these were standby blood donors.

It is hoped that the T-CAB can now be a key part of drawing up a blanket policy on payments to study participants, to achieve consistent standards between studies. There is a real dilemma as there are various international sponsors of SMRU studies and they have differing policies on remuneration. The credibility of a community agreed position would help SMRU insist on consistent guidelines when dealing with sponsors. A real life example is that some studies have offered 3,000bht per week to participants who were asked for a significant time commitment, whereas other studies offered 100bht per day for identical commitment. This is inequitable and potentially divisive. However, it is also clear that any change would need to be made sensitively given the expectations created by previous practice.

Example 3. Concerns around Drug Company Led Research vs University Led Research

Rapid diagnostic tests (RDTs) for the detection of malaria can help facilitate rapid, effective treatment, and this is particularly important in resource-limited settings. Many RDTs have been developed, and testing their sensitivity and specificity against microscopy in various epidemiological settings is important. Some RDTs are generic and some proprietary, and this subject was discussed as a study of a new RDT was presented. Some members of the T-CAB were concerned that knowledge to be gained through a collaboration and unpaid volunteers might later be withheld by a company that wished to profit it. Other SMRU studies of RDTs (using similar methods) and initiated by university groups did not provoke any suspicion among T-CAB members and so it is unlikely that there were other unspoken issues. Considerable detail about the company and the use of data from the study was required before the T-CAB felt comfortable that the research was bona fide.

Since 2011 the T-CAB had provided a formal opinion on studies. In order to ensure that they are not biased, a form is completed and put in a sealed envelop to the researchers after the meeting after having adequate time for deliberations. This approval is now documented and made available upon request by the relevant ethics committees. In addition to study specific ethical issues and operational concerns, the authors noted that the content of the topics discussed by the CAB has noticeably shifted to more complicated ethical issues like data sharing and biobanking.

We have also been encouraging researchers to present their results, both at a convenient interim and at the end of the study to the CAB as a means to provide feedback to the community. This is over and above what happens in an ethics committee as they usually get a simple report annually and at study close out.

Capacity building

In addition to reviewing proposals for research, CAB meetings also provide training opportunities for T-CAB members in areas relevant to the discussion. In order to be able to advise the T-CAB members need a minimum level of knowledge of the specific issues relating to studies, and the diseases and drugs that are being studied at SMRU. The Karen, who make up most of the border population are one of the most persecuted minorities in the region, and there is limited access to education apart from NGO run schools. Although the CAB members have a higher than average level of education in the community, most of them have not heard of research and medical research or ethical concepts. In the beginning, we focused on the following themes: types of malaria, its epidemiology, treatment and its knowledge gaps; tuberculosis, HIV/AIDs, informed consent, its challenges and aspects of valid informed consent.

In 2011-2012 topics included more complex subjects like the history of artemisinin combination therapy for malaria, artemisinin resistance, challenges in antimicrobial resistance, concepts in medical research including research methods, randomised controlled trials, and blinding, the role of ethics committees and community engagement. Discussions and activities included topics that are not directly related to specific research projects, but related primarily to developing the T-CAB itself. These workshops allow for an opportunity to look in more general detail at issues surrounding the involvement of the community in medical research, and at more general ethical questions surrounding SMRU and the local population. Classroom teaching and group work forms the backbone of training, but where possible this is supported by other teaching methods. The presentation and handling of the equipment to be used is a useful teaching tool. Visits to study facilities to observe activities, for example, guided tours of our microbiology and malaria laboratories and insectariums help members to understand where blood samples go and what they are needed for.

Discussion

Evaluating the CAB

Given its importance in the context of international research ethics, very little has been published on the evaluation of community engagement. Whilst there have recently been some examples of published attempts to share experiences in and models of good practice in community engagement, there remains a dearth of evidence and advice about the development, introduction and evaluation of sustainable community engagement activities and there have been a number of calls for the evaluation of the many different models of engagement. The T-CAB has functioned long enough to allow some assessment of its performance in relation to research, and how it has met the aspirations of SMRU-MORU when it was established. What have been the strengths and weaknesses of this particular approach? What has been the real function as opposed to what was envisaged? What alternatives might be considered, and where do we go from here? Although the authors are clearly not able to offer an unbiased assessment of the impact of the T-CAB within the wider community several lessons have been learnt.

T-CAB emerged from a particular environment and time. The board has developed from a group of strangers from different sub communities that make up the border community. They are from different ethnic and political backgrounds, locations, religions, legal status; and have been brought to SMRU every four to six weeks into a functioning group. Although the CAB model was chosen as a way of formalising community engagement, it is not the conventional CAB model, where a CAB is established for a particular study or programme e.g. HIV vaccine study, for a fixed length of time in a defined geographical area where the community members are somewhat homogenous, at least for the purpose of the said study or programme, and members are somewhat representative of the community. Instead, the non conventional T-CAB which seemed to have been established against all odds, consist of members who live along the porous Thai-Myanmar border, where the population is fluid and comprised of many overlapping sub-communities and the members review a wide range of projects.

The average CAB member is literate, has basic education, has a better than average job, and is not “displaced” whereas the average community member is illiterate, poor, vulnerable and most of them earn daily wages. What is the border community and the sub committees that make up the border community and how representative is the T-CAB of this fluid and hard to define population? What are the unique ethical challenges when researchers engage with host communities for longer periods? What are the key success indicators? How successful has the T-CAB been and how to measure its success, and according to whom?

Future directions

The T-CAB is not intended to replicate an ethics committee or a scientific committee. Its role is complementary to but different from both. The long-established relationship between SMRU and the populations it serves, of which the T-CAB forms an important component, combined with the leadership role in the T-CAB of articulate local Karen staff has meant that many potential problems that an outside research team might face in establishing new clinical studies are identified and addressed at an early stage. The T-CAB is semi-independent, i.e. it is not part of the unit hierarchy and therefore is able to provide a useful and important space for the discussion of ideas and fresh opinions and offers an opportunity for community members to speak to researchers and to SMRU with enhanced authority. The existence of the T-CAB also promotes critical thinking among researchers wishing to introduce new studies, who are aware that that they must consider carefully how best to explain and justify these in ways that will be acceptable to T-CAB members as local representatives charged primarily with safeguarding the most vulnerable, ensuring that research addresses local needs, and respecting the interests and rights of potential research subjects.

Extensive and continuing training was an important factor which made it possible for the T-CAB to engage effectively with SMRU, and the fact that this was possible and is on-going is one important advantage of continuity in a long-term CAB. T-CAB members needed to gain experience and develop the skills required to make judgements about when research was relatively unproblematic and when there were substantive ethical issues calling for in-depth discussion and analysis. It is the opinion of SMRU too, that the T-CAB has been and continues to be valuable, and that the CAB can very usefully complement external scientific or ethical review as a way of ensuring that research is informed by genuine community engagement and is conducted to the highest possible ethical standards.

It is striking that there has been little research on the effectiveness of and challenges associated with different forms of engagement and little or no evidence base on which to base engagement strategies. Against this background, plans are currently underway to systematically evaluate the CAB over the next year using a combination of qualitative and quantitative approaches.

Lessons Learnt

The T-CAB has been in existence for almost four years and valuable lessons have been learnt to maximise the potential for sustainability.

• Flexibility: The structure and operations of a long term CAB must be flexible and could evolve over time in order to be fit for purpose e.g. membership criteria, number of members, meeting frequency may change in response to the needs of the members themselves, the researchers, the host community and other stakeholders.

• Researchers, ethics committees and other stakeholders must be realistic as to what the CAB can do. The CAB is not meant to replace an ethics or a scientific committee, rather it has a complementary role to fill the gaps of the current approval system (SMRU studies are reviewed by two ethics committees, one is Bangkok and one in Oxford)

• Long term CABs have the advantage over study specific ad-hoc CABs as they members have the exposure to a variety of different studies and study design and researchers.

• CABs should be adequately funded and should have a dedicated facilitator(s).

• There should be adequate time in meetings for members to have in-depth discussions and time to deliberate about topics that concern the members (not necessarily the researchers). Meetings duration and frequency should be adequate to build group momentum and group dynamics.

• Ongoing evaluation in one form or another is important to ensure that the CAB is still fit for purpose and members are motivated.

• Repetition is necessary to improve understanding of research concepts, specific research studies and ethical issues.

• Social activities in between meetings or after meetings are necessary to build relationships among members and between members and researchers.

Conclusion

In this paper we describe the background and rationale of the T-CAB and discuss how the goals, membership, and other operational aspects have matured from its beginnings to its current incarnation. The experience of running T-CAB meetings over several years has created a membership that us now exposed to the ethical and practical issues surrounding medical research. The members, the community, and the researchers have all benefited in one way or another and we continue to refine strategies to make it a practical, fit for purpose, effective and sustainable CAB.