Four broad discussion areas emerged during the CAB meetings. These included 1) informed
consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma
experiences and 4) specific ethical concerns relating to the project.
Informed consent procedures
One of the key challenges in genomics research in Africa is obtaining valid informed
consent from research participants 18]. Research participants should be adequately informed about the study, have an appropriate
level of understanding about the science and research methods of the study, and give
voluntary consent to participate 18]–20]. However, low literacy and education levels, combined with language and cultural
differences make this a challenging process and community engagement has been suggested
as a helpful mechanism in achieving this instrumental goal 18], 21]. In our project, these challenges were further compounded in that the written Xhosa
language is not standardized, making conceptually and linguistically equivalent language
translations from English to Xhosa difficult 21].
In reviewing the information sheets and informed consent documents that had been prepared
for the study, the CAB made three suggestions. Firstly, CAB members acknowledged the
complexity of the scientific and medical terminology used in genomics research, and
emphasized the need for fieldworkers involved in the recruitment process to use simple,
accessible language and visual aides in explaining the project. Secondly, CAB members
noted the difficulty in finding appropriate terminology to refer to schizophrenia
in the Xhosa language. Initially one of the project managers had suggested “iingxaki
ezenziwa lufuthe lwemeko kunye neengxaki zeengcinga†(emotional or thought problems).
However some CAB members considered this too broad a description. Additional suggestions
included “ukuphazamiseka kwengqondo†(general disturbances of the mind) or “ukushiywa
zingqondo†(losing your mind). These three examples illustrate to some extent the
difficulty in finding agreement about this term in the Xhosa language. It was decided
to use the word “schizophrenia†as this was the most clear and least offensive, and
rely on fieldworkers to explain the term to the participants. Thirdly, CAB members
suggested pragmatic changes to the informed consent material that included a separate
document for consenting to HIV testing, and the correction of spelling and grammar
mistakes in the Xhosa translations of the informed consent materials.
In these discussions the CAB recognized the challenges relating to the complexity
of genomics terminology. While these have been documented in the literature 19], 20], 22] highlighting these challenges reiterated the need for intensive training of fieldworkers
about the science behind the project, in order to adequately equip them with the skills
necessary to explain the project in language understandable to potential participants.
Feedback from the CAB also allowed the research team to gauge the accessibility and
appropriateness of their informed consent material before introducing it to potential
research participants. Through these interactions with the CAB the research team was
able to gain feedback that reiterated their own understandings about challenges that
could arise in the community during recruitment, and to develop and discuss possible
ways of managing these challenges. However few solutions were found to these challenges.
Recruitment strategies
An additional instrumental goal of community engagement within genomics research in
African settings is improved recruitment strategies, particularly in contexts where
permission is required by community gatekeepers like chiefs and elders 22], 23]. Such engagement establishes trust and rapport between the research team and the
community. Our study recruited patients in urban areas and we had not initially identified
who the community gatekeepers in our setting would be. However, during discussions
about recruitment, the CAB suggested that the research team co-ordinate their recruitment
through community hospital nurses who were familiar with the communities in the catchment
areas targeted for research. This strategy was suggested as a way of utilizing the
trust and rapport already established by these nurses with the community, in order
to assist in recruitment. CAB members also noted that some research participants may
move to different residential addresses or new communities and geographical areas.
They therefore encouraged research assistants to obtain multiple contacts for research
participants. These were helpful, practical suggestions that assisted the research
team in planning their recruitment strategies. These CAB contributions highlighted
how individuals less familiar with biomedical research processes were able to make
valuable contributions to recruitment procedures.
Patient illness beliefs and stigma experiences
Biomedical research takes place within a wider social, economic, political and cultural
context that frames research participants’ understandings of medicine, medication,
their illness experiences and the research process 12], 21], 23]–25]. Community engagement aims at building awareness and sensitivity to these unique
contextual factors at play within the research process, promoting respect for and
understanding of the community, and in this way promoting a respectful relationship
between the research team and the participants 12]. The CAB highlighted that schizophrenia could be perceived within Xhosa communities
as a bewitchment that requires traditional healing. Therefore some Xhosa patients
may be unfamiliar with seeking help for their symptoms from a hospital or clinic where
they are presented with illness explanations that challenge their currently held traditional
beliefs about their illness. In other words, potential research participants could
struggle with a biomedical explanation of schizophrenia. CAB members voiced concerns
regarding poor mental health literacy about schizophrenia within Xhosa communities
that included 1) unfamiliarity with the term schizophrenia and biomedical explanations
of the illness, and 2) feelings of shame experienced amongst family members for being
related to a patient diagnosed with schizophrenia. CAB members commented that poor
formal education, low socio-economic status, and rural living conditions restricting
access to psycho-educational material about severe mental illness all contributed
to the stigma experienced by patients with schizophrenia.
In response to these concerns the CAB recommended that a local community newsletter,
produced and distributed by a mental health advocacy group promoting community mental
healthcare issues, be used as a forum for updating the community about the project.
The intention would be to use the newsletter to disseminate information about a biomedical
explanation of schizophrenia to the community. The newsletter was also suggested as
a platform to disseminate findings from the project as they became available. In addition,
CAB members questioned how the mental health needs of the control group were being
managed within the study and recommended referral channels and services that would
assist these individuals in managing both emotional and social problems.
The insights and suggestions shared by the CAB relating to explanatory models of mental
illness and schizophrenia within Xhosa communities, as well as patient stigma experiences
have been documented in South African mental health literature 26]–30]. However recognition of these explanatory models and stigma experiences by the CAB
emphasized the need for culture-sensitive training of research assistants involved
in recruitment within the target communities. This training required a focus on understanding
and being sensitive to the beliefs held by the Xhosa community about severe mental
illness and schizophrenia, as well as the stigma experiences of patients with schizophrenia.
This understanding would assist the fieldworkers in establishing a working rapport
with potential research participants, and contribute towards upholding the respect
and dignity of the Xhosa community and their traditional beliefs.
The CAB’s knowledge contributions regarding indigenous Xhosa explanatory illness models
and patient stigma experiences are well established in the South African mental health
literature. However CAB opinions and suggestions about how to manage this knowledge
strengthened the research team’s understandings of these challenges. In this way the
CAB promoted the respect and dignity of the community’s cultural and traditional beliefs
and in so doing promoted a respectful relationship between the research team and the
participants.
Specific concerns relating to the research project
In accordance with the literature, while the use of a CAB is a popular mechanism of
community engagement, the employment of community members as fieldworkers is an additional
way of taking the contextual factors and social relationships at play within a community
into account during research 31]. These community members have cultural insights into traditional community beliefs
and cultural norms, speak the language and are considered insiders and as such can
assist with trust and rapport building 17]. The CAB included Xhosa psychiatric nurses employed as fieldworkers. These nurses
played a dual role as research team members as well as Xhosa people, representative
of the community from which Xhosa patients with schizophrenia were being recruited.
Having these nurses actively participate in the CAB allowed for a unique exchange
of opinions and suggestions.
The research team brought two specific ethical concerns to the CAB for comment. The
first involved the sharing and secondary analysis of genomic material and related
data. This complex issue had been raised as an ethical concern by the Research Ethics
Committee (REC) at our institution. Specific challenges that were identified related
to difficulties in translating these concepts and understandings into Xhosa, challenges
in ensuring that participants understood their right to choose whether to allow the
sharing of their genomic material and data, and understanding of the implications
of choosing to donate their samples for future research. Presentation of these issues
to the CAB resulted in interesting discussion and debate. CAB members felt that people
with schizophrenia, despite low health literacy and particular explanatory models,
were able to give valid informed consent to issues relating to data sharing and secondary
analysis. The CAB was supportive of the view that collaborative science between developed
and developing countries was needed, and similarly that international genomics research
should also involve people of Xhosa ancestry. In addition CAB members felt that if
other, non-schizophrenia patients could give consent for sample sharing for unspecified
future research, there was no reason to restrict psychiatry patients in their choices.
Some members felt that restricting this choice could be experienced as stigmatizing
to patients with schizophrenia, whilst others suggested it could cause individuals
unnecessary distress in not knowing how their genomic material and data was going
to be used. The CAB consensus was that individual research participants should be
given the choice to decide whether or not to consent to secondary sample and data
sharing.
The research team also asked the CAB to comment on a challenge arising in the recruitment
of control participants. In accordance with REC recommendations each individual who
participated in the project received R150 for their time and effort. However, considering
the tremendous socio-economic inequalities that currently exist in South Africa, with
the average annual income for a black South African estimated at R21 075 in 2010 (approximately
R1760/month) 16], compensation of R150 for one day of participation in a research study is a substantial
incentive. As a result word quickly spread about the Genomics of Schizophrenia recruitment
process, and in the first few weeks of the study fieldworkers were overwhelmed by
willing control participants who had been encouraged by friends and family to enroll
in the study in order to receive financial compensation for their blood samples. The
research team was uncertain as to how to manage this and sought advice from the CAB.
One suggestion made by the CAB was to change the sites where the controls were being
recruited to community centres and churches. However other CAB members noted that
these settings may be more difficult to contain. An additional suggestion was to request
that the community hospital-based nurses at each site be the primary channel of referral.
These nurses would be familiar with the patients and able to guide the referral of
these patients to the research assistants.
In these examples the CAB provided a platform for the research team to bring ethical
concerns emerging in the field to the CAB for comment and debate. The CAB in turn
provided suggestions about how these challenges could be managed. Some of these suggestions
were helpful and informative, while others presented their own ethical challenges.
For example the CAB’s suggestion of addressing the high rate of control volunteers
by screening through local community nurses may result in favoritism and selection
bias. While CAB members did not provide resolution to these ethical concerns, they
provided a space where the research team could bring these particular ethical concerns
for discussion. They also provided insights into different opinions that may surface
within the community relating to these issues, equipping the research team with additional
community understandings that could assist in managing these potential ethical concerns.