An emerging priority in international health research is increasing the role of the community in all aspects of research activities [34
]; however, models for community engagement in research in sub-Saharan Africa remain undefined. Examining community members’ understanding of research and informed consent within a multinational research collaboration in Kenya provides insight into how community engagement might be strengthened in similar settings. While community members generally understood the concepts of research and informed consent, their emphasis on the benefits reaped from research participation and their equating of research with HIV testing or care could inform education around topics such as research risks. Community-level consent was widely accepted as either a prerequisite to, a supplement to, or a substitute for individual informed consent in this setting.
Employing the baraza
-- a culturally accepted public assembly for the purpose of community dialogue [42
] -- we gathered novel data on community members’ understanding of research, informed consent, and community consent. We built on previous qualitative work in Kenya that used focus group discussions with community leaders and members to better understand their perceptions of research and informed consent [17
], and we tried to fill the continued gaps in understanding how a community’s perspective on informed consent relates to participation in the research [11
]. While the community’s understanding of research generally encompassed the principles of inquiry and investigation, the strong expectation to receive direct benefits for research participation was an important belief to consider and understand. The community members often focused on the goods, services, capacity building or development that might be offered as part of the research activities. This is consistent with other findings from poor communities, where research activities were equated with development projects whose aim is to improve conditions in the community, rather than to collect information or test interventions [25
]. While some research studies offer access to health care or other resources of value to the participants, others might not benefit one’s health, education, or finances. In our work, the participants expressed that the potential benefits of the research would be scrutinized – rather than the protocol. These expectations for direct benefits should inform how researchers present research proposals to the community and how they protect vulnerable individuals within that community. This community view could shift the risk-benefit ratio such that research benefiting the community would be endorsed at the community-level despite individual risks to the participants. These findings also point to the need to be explicit about possible risks. In this context, studies with few direct benefits may be unlikely to recruit participants from similarly underserved or impoverished settings, while studies with obvious benefits might draw in participants despite having significant risks. Considering this interpretation of the risk/benefit ratio for this particular setting and striving to make clear the risks that the participants might not otherwise consider would be important targets for researchers within this cultural context. A multinational research team might be seen as even more likely to offer direct benefits for research participants, reinforcing the need for researchers to understand the unique community perspectives in order to adequately address community concerns and provide protections for vulnerable populations. Understanding how the history, poverty, and unique resources of a given community shape the community’s attitude towards research is vital for researchers entering that community.
Another important cultural perception revealed in the mabaraza was the conflation of HIV and research. Given that the most sophisticated healthcare system in this community in western Kenya was designed for HIV care and that much of the research which has taken place has been related to HIV, it is conceivable why participants would assume biomedical research involved HIV testing or HIV-related outcomes. AMPATH has conducted research in this setting since its inception in 2001, and AMPATH’s services within this county have included home-based HIV counseling and testing, and multiple locations provide voluntary counseling and testing for HIV. Conflating HIV and research may thus be a unique finding to a setting with significant HIV services. However, since HIV infection continues to be significantly stigmatized in this society, the equation of research with HIV means that HIV-related concerns for privacy and confidentiality are prominent in the minds of community members. In fact, “risks” associated with research were largely interpreted to mean risks related to diagnosis and disclosure of HIV status, rather than any other harm. Studies with no HIV-related components might want to take particular care to make this clear to potential participants. Issues of confidentiality, stigma, and HIV disclosure need to be addressed carefully within any research project in this setting.
Community consultation commonly refers to engaging communities and eliciting feedback from community members that researchers can incorporate into the design of their research work to enhance protection and benefits for the community, increase legitimacy and share responsibility of activities and outcomes [48
]. Community advisory boards have been utilized for community consultation in HIV research [49
], but there is little empirical data on the effectiveness of these boards in the consultation process [51
]. Communities in western Kenya have worldviews that emphasize communitarian rather than individualistic living, a philosophy that may render community consultation all the more necessary [52
]. The use of a traditional community assembly such as the baraza
offers a potential venue for community consultation, and for additional research activities such as community consent. Involving the community in review of research proposals in assemblies such as mabaraza
was widely perceived as culturally acceptable and an important protective measure. Community consent is a process of seeking permission from the community to solicit individuals to participate in research [48
]. Our findings from Kenya suggest that this is a setting in which community consent may be appropriate and necessary, even before individual consent, in order to extend protections from the individual to the community-level [41
]. Using community consent as a supplement to individual consent would be in accordance with the 2002 Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects, which endorses “obtaining permission from a community leader, a council of elders or another designated authority.” [35
] Our findings begin to answer key questions needed to implement this guideline: 1) defining the community, 2) describing the content and purpose of community consent, and 3) identifying the legitimately empowered local leaders who could make decisions about research on the community’s behalf [54
]. As there have been very few studies investigating community consent processes in sub-Saharan Africa [18
] and no guidelines as to its implementation, these formative data offer an important description of how one community would answer these questions. The limited body of research investigating effective strategies for community engagement in consultation and consent processes warrants further investigation [36
Community consent might offer a particular benefit to especially vulnerable populations, such as orphaned children, where the community’s consideration of the research could offer an additional level of protection against potential harms or the opportunity to advocate for including these children when benefits might be present. The potential advantages of community consent need to be examined carefully against potential harms that could result if the community were to value community benefits over the protection of an individual; however, the usual measures for protecting against abuse, from emphasizing researcher integrity to requiring local IRB review, could help minimize those risks. Not only must researchers ensure that the procedures, risks, and benefits to their proposed work are well understood, but they must take precautions to minimize risks for vulnerable individuals.
Dissenting views also merit further consideration when considering community consultation or consent. Balancing individual autonomy and the choices of the broader social context must be carefully weighed in implementing ethical research [31
]. Child dissent was not discussed, nor was the possibility that the voices of some members of the community might not be heard in the context of community deliberations or assemblies. Within this setting in Kenya, women, younger community members, and families of lower socio-economic status in the village may not feel able to speak freely in group deliberations, and thus their opinions may go unheard in community discussions. To try to counter this tendency in our assemblies, the facilitator of the mabaraza
specifically asked for responses from women within the groups and periodically asked participants who had been quiet to offer their opinions. This increased participation among groups that might face gender or social inequalities, and did result in hearing some diverse opinions. However, their concerns may not have been fully expressed, and addressing these inequalities within the context of a community assembly requires direct attention or may require complementing the community mabaraza
with smaller, more homogeneous group discussions (men only, women only, youth only, etc.). A family or individual’s decision to withdraw from a study for which community consent has been given is another important form of dissent to address from the beginning. The participants in these discussions did not talk about that issue. The weight given to community consent compared to individual consent or dissent may also be altered by the design of the study, taking into account factors such as cluster or individual randomization and whether individual consent is possible. Additional investigation of how to address, protect, and respond to minority views within this cultural context would be helpful.
This study does have limitations that merit consideration. The model relies on the contextual data and lived experiences of subjects in a very particular part of the world – two locations in western Kenya. Thus, the results may not generalize to other geographic locations. The mabaraza took place in peri-urban areas that would be classified as slums, which may make the findings less generalizable to more rural or urban settings. Nonetheless, this is a population often under-represented in research, and the population caring for many of the orphans and vulnerable children we sought to evaluate. Furthermore, the methodology has the inherent limitations of using relatively small, convenience samples which can limit generalizability. However, the lived experiences of subjects in this particular resource-limited setting may have more generalizability for subjects in other resource-limited settings than do similar studies conducted in resource-rich settings. Despite these limits to the sample, validity was supported by thematic saturation. In addition, there have been no published studies specifically using mabaraza, or similar traditional assemblies, to gain community perspectives on informed consent processes in biomedical research settings, and so the data from this population offer an important window into ethical cross-cultural research practice. A baraza gathering might not lend itself to hearing from every participant or to collecting in-depth responses from any one participant in the manner of an individual interview or a smaller focus group. Nonetheless, it does provide a community overview and broader perspective on the community’s beliefs. Moreover, in this context, it made use of a structure being proposed to serve a similar purpose in future research endeavors and thus testing its own possibilities.
Our study suggests that any attempt to conduct ethical multinational health research must take into account the community’s understanding of research and informed consent, particularly when involving vulnerable populations. The informed consent process and the individual weighing of risks and benefits may not be well understood by a given community, and so these procedures need to be addressed in a manner that is accessible to all community members, regardless of their socioeconomic background. Researchers should also recognize that there may be strong expectations of direct benefits for research participation, as well as expectation that HIV testing or care are part of the activities, and researchers should incorporate education on these issues relevant to the particular project. The community’s beliefs about community consent can be examined, and in settings where consent given by a community leader is considered appropriate, these procedures may be incorporated into research development and implementation. Moreover, traditional assemblies within these cultures, such as a baraza in Kenya, can be used effectively to gather these critical cultural data and act as a forum to obtain community consultation or consent.