Community Members Clinical Trial
Official title:
Evaluation of the Tak Province Community Ethics Community Advisory Board: Interviews and Focus Group Discussions
A popular form of community engagement is for the researchers to interact with a Community
Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border
for many years and has been informally engaging with the community for its healthcare and
research initiatives, especially in the area of ethics and consent. In January 2009,
community engagement was formalised with the establishment of the Tak Province Border
Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the
investigators have not come across any set up of similar nature involving mobile and unstable
populations residing along a porous border.
Three years on, SMRU questions if the T-CAB has been "successful" and if the current T-CAB
model is the best model for this community. In order to evaluate the T-CAB, first an
evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,
then the evaluation will be carried out.
1. Background
Research on the Thai-Myanmar border
Since 1986, the Shoklo Malaria Research Unit (SMRU) has provided basic healthcare and carried
out research aimed at reducing the impact of multi-drug resistant malaria and other
infectious diseases in the area on the border between Thailand and Myanmar. SMRU's main area
of interest is in malaria, with special interest in children and pregnant women - the groups
most at risk from malaria - and it has combined this research with the operation of antenatal
clinics along the border. SMRU currently runs multiple free clinics for the Karen and Burman
border population that would otherwise lack access to health care. The most distant clinic is
about 120 km from the SMRU office in Mae Sot. Carrying out research and providing care along
the border presents a range of unique practical and ethical challenges. This in part because
the people who live near the border are mostly migrants or refugees from elsewhere in Myanmar
who have, since the 1980s, moved to the border area to escape economic hardship and sometimes
conflict and persecution. There are currently thought to be two million migrants from Myanmar
living in Thailand (about 150 000 in refugee camps) and a further million 'internally
displaced' people living near the border inside Myanmar, although numbers are difficult to
verify. The vast majority of these people, who come from a very diverse range of different
ethnic, religious, political and language groups, live in insecure, unsafe conditions and
face a number of serious health difficulties.
Until 1995, SMRU focused its activities primarily in the refugee camps in the border area and
a strong collaboration was established with non-govermental organisations (NGOs) to control
malaria in the refugee population through the operation of "the Malaria Task Force" (MTF).
This was largely successful and malaria is now a minor problem within the camps. As a
consequence, whilst SMRU remains responsible for antenatal and obstetric care and the
treatment of malaria patients in refugee camps such as Mae La, since 1995 it has increasingly
extended its activities to reach out to the wider displaced populations who have little
alternative access to malaria diagnosis and treatment or antenatal care. This is done in
collaboration with the Thai Ministry of Public Health (MOPH) and in close collaboration with
the district hospitals and the Tak provincial health authorities. In 2001-2003 the Tak
Malaria Initiative, supported by the Bill & Melinda Gates Foundation deployed the malaria
control strategy developed by SMRU in the refugee camps to all 200 affected villages in the
province's border districts with substantial success. When the funding from the Gates
Foundation came to an end, the MOPH took over the program.
The border between Thailand and Myanmar is at the forefront of the global fight against
malaria because it is on the frontline in the battle against the development and spread of
resistance to anti-malarial drugs. Malaria parasites found here are some of the most
drug-resistant on earth and their expansion and spread is a very real global threat (research
has already demonstrated that the most drug-resistant malaria parasites found in Africa
originated in South East Asia) . This is particularly urgent and important in the populations
living along the border because there is published evidence that the malaria parasites may
become tolerant even to the most advanced artemisinin combination therapies (ACTs) now at the
forefront of global malaria treatment.
Rationale for the establishment of the community advisory board
There is widespread agreement on the need for community engagement in clinical research,
particularly where the research involves minority groups and other vulnerable populations.
However there has been little research on the effectiveness and challenges associated with
different forms of engagement, and little or no evidence base on which to base engagement
strategies.
A popular form of community engagement is for the researchers to interact with a Community
Advisory Board. The Shoklo Malaria Research Unit has been working on the Thai-Burmese border
for many years and has been informally engaging with the community for its healthcare and
research initiatives, especially in the area of ethics and consent. In January 2009,
community engagement was formalised with the establishment of the Tak Province Border
Community Ethics Advisory Board (T-CAB). The T-CAB is the first of its kind as the
investigators have not come across any set up of similar nature involving mobile and unstable
populations residing along a porous border.
At the time of its establishment, the T-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 - it's 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 T-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 T-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.
Three years on, SMRU questions if the T-CAB has been "successful" and if the current T-CAB
model is the best model for this community. In order to evaluate the T-CAB, first an
evaluation tool has to be developed as there are no off-the-shelf evaluation tools for CABs,
then the evaluation will be carried out.
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