The process of engaging community members so that there should be a representation from the community is what is called Community Engagement1–4. The validity of any biomedical study hinges not only on the involvement of the participants, but how the participants are involved, how they feel they are part of the process, how they own the whole initiative, and most crucially the feedback they receive in the process of the engagement cycle5. Where human subjects are involved, there is increased need for utmost ethical consideration in biomedical studies.
Thus, Biomedical studies mean research undertakings aimed at understanding health and illness, based on the investigation of biological mechanisms, the use of the randomized clinical trial, and the identification and quantification of disease risks6. In biomedical studies, participants are the representatives of the community in which the study is taking place. The growing discourse on the need to observe good Community Engagement Practice is not only crucially important for the participants to take part in the process, but acceptance of the process as well is significant7.
It therefore suffice to say, Community Engagement involves dynamic symbiotic synergy that consequently facilitates dialogue between community members and biomedical researchers. Collaboration with and participation of community representatives and other stakeholders in the research process helps to build trust, contributes to the acceptability and use of the intervention, and increases the likelihood that affected communities are invested in and supportive of the research being done5. The relationship comes in varying degrees in terms of community and biomedical researchers’ involvement, decision-making, and control. In public health, Community Engagement efforts aim at promoting the mutual exchange of information, ideas, and resources between community members and the biomedical researcher 8. With tremendous strides covered in the field of public health, the success of biomedical research “necessarily relies on successful recruitment of human participants in order to yield meaningful results,” 9. Consequently, this entails that human subjects are central in any biomedical research if accurate, relevant and useful data is to be attained 9.
For any study, and for it to have human subjects at the centre, how a researcher enters the community eventually obtaining an informed consent that helps to recruit participants is crucial 9–12. A number of studies have established that acquiring an effective “informed consent from participants is a prerequisite to the conduct of an ethically sound study.” 12. There is, however, the continued need for an effective Community Engagement approach if biomedical studies are to reduce different and diverging perceptions from the participants taking part in the research. Different and diverging views are emerging due to Community Engagement process that has jumped some of the steps resulting in misunderstanding of the whole study 9–12. Due to the search for an effective Community Engagement that can reduce misunderstandings and misconceptions that triggered this study to attempt to evaluate Community Engagement from the perspective of the community.
1.1.2 Community Perception towards Community Engagement in biomedical studies
Ethical issues in biomedical studies and Community Engagement have historically gone hand in hand. However, the debate on the extent of engagement that “Community Engagement” brings has always been an issue that has consequently opened areas of international research opportunities131415. The main purpose of Community Engagement is to deal with ethical concerns, which include demonstrating respect for, protecting and empowering participating communities and individuals thereby strengthening research processes16. Community Engagement may not always be crucial in some settings; however, studies continue to prove that the potential importance of involving communities is particularly recognised in international health research. One of the most important factors for biomedical research to succeed in recruiting community members including children is for potential participants to be willing to enroll 17.
While the objectives of research are to attain a specific goal and recruiting potential participants, at the same time striving to make it clear to the study participants to feel part of the process, studies have shown that there has been the emergence of divergent views. It is the divergent views that have resulted in participants and guardians of participants bringing forth what motivated them to take part or not in biomedical studies. Unfortunately, the diverging views have resulted in people enrolling in the study for the reason that is not in tandem with the goal of the study.
A study conducted in Korogwe district, North-Eastern Tanzania demonstrated that majority of community members had positive perceptions of the malariometric surveys and services provided. The availability of free health services was the major determining factor for community members’ participation in malariometric surveys17. The fact that community members would gain something from the study is supported by another study carried out in Malawi. The study, why do individuals agree to enroll in clinical trials? A Qualitative study of health research participation in Blantyre, Malawi established that participants enrolled in a study as a way of “obtaining a better quality treatment made available through the Clinical Trials as ancillary care” 11. The perception by community members that they would gain something was a determinant for their participation.
The above perception is supported by another study in Australia showed that parents were able to balance risks and benefits when deciding whether their children should take part in the biomedical study 11. The perceived risks included potential side effects such as rashes, being randomized to ineffective treatments and the inconvenience of participation. Also, a study that was carried out in United States of America (USA) revealed that most parents were afraid of their children “being treated as guinea pigs”, but were willing to allow their children to participate in research if asked by their own doctors 12.
One of the most important factors for biomedical research to succeed in recruiting community members including children is for potential participants to be willing to enroll 17. The decision to participate in biomedical research depends on several factors such as perceived benefits like free treatment, suffering from the disease under investigation, monetary reimbursement and altruism (sacrificing something for someone other than the self)18. Apart from individual gains some people may volunteer to participate in biomedical studies in order to contribute to science or improve the health of others or having interest in goals of the study, meeting other people or just out of curiosity 19. However, studies have shown that there is need to find a middle point as altruism, coercion and incentive while being used as tools for engagement, they also raise ethical issues. As argued in most studies instead of participants taking part in a study for the reason of the study, they take part in those studies for “other” reasons other than the goal of the study.
Despite a number of varying determinants that trigger people to participate in biomedical studies, how the community is engaged remains paramount. The willingness to participate may depend on the nature of engagement between researchers and the researched community, which can help to create an environment that is conducive for smooth research activities and enhancing a sense of research ownership20.
While a number of studies have attempted towards identifying the motivational factors as to why they take part in biomedical studies, there is little literature that establishes the perception of community members towards biomedical studies. In a study, why do people refuse to take part in biomedical research studies? Evidence from a resource-poor area, adequate Community Engagement should involve Community Consultation, Community Sensitization, Community Ownership and Feedback which have a potential to minimize refusal9.
In Northern India, a study involving drawing of blood for testing malaria in children showed that some parents were less willing to allow their children to participate than they were themselves because they were afraid of unknown side effects while others believed that their children had not enough blood 19. Participation in medical research is also influenced by decision-making power in the family and society. Pressure from village leaders, the research team, village elders and spouses have been reported to influence participation in research21 2223.
While literature continue to show that there are reasons why people take part in the Community Engagement process at the same time community members having a pressure on how one participate in Community Engagement, the areas of evaluating the Community Engagement process is silent. The potential contribution of Community Engagement to addressing ethical challenges for biomedical research is well described, but there is relatively little-documented experience of members in relation to the process of engagement used. Do community members feel that the way they were engaged was really empowering and most effective? The emergence of diversity in terms of how people see the biomedical intervention, and the reasons for their participation in the biomedical intervention, is the result of how the participants were engaged.
1.1.3 History and the Process of Community Engagement
Community Engagement is not a new strategy in public health discourse. Since 20th Century, Community Engagement has played a crucial role. Public health experts have taken the lead in determining the priority health issues and solutions through the use of Community Engagement. At that time, public health used Community Engagement strategies primarily to control communicable diseases by mobilizing people to participate in mass immunization, sanitation and hygiene programs8.
Through the continued change, the general understanding of what constitutes Community Engagement has greatly evolved. The need for Community Engagement has attracted increased attention in recent years due to high vocal demands of health activists, the recognition that inclusion and transparency are ethical responsibilities. It is no wonder that there is overwhelming evidence that shows that not involving participants well results in research results that “can threaten the viability of trials.” 24.
1.1.4 Evolving history of Community Engagement
People that are serving as research participants and those in the communities hosting research are people that are largely absent from the beginning of the research process as well as the crucially significant decision-making process. However, while institutions have had the perception that the participants are just “subjects”, seen as the potential users of the end product24, huge change started to materialize through the emergence of women’s health movement in the 1970s, and HIV and AIDS in 1980s824.
1.1.5 The years 1970s to 1990s
In the 1970s, women’s health advocates began to protest the inadequate inclusion of women in biomedical research and to demand a role in decision making regarding research on contraception, pregnancy, hormone replacement therapies, and a host of other women’s health issues. By early 1980s, the call by women was picked up and taken to another level by AIDS activists mostly in North America and Europe. In an effort to fast-track the search for treatment to combat HIV/AIDS, many people demanded to be involved. All of the sudden the biomedical field was faced with “well-informed, energized community of activists demanding to be involved.” Most of AIDS activists were relatively affluent, well-educated and had to prepare themselves for this engagement244.
In response to their demands, the establishment of Community Advisory Boards – composed primarily of non-scientists who advise on research protocols and help to educate communities about research taking place – became the requirement of US and European donors. It was then exported, through donor requirements, to international research sites. Throughout the 1990s, the number CABS in Africa and Asia expanded as the major research sponsors began requiring their use244.
The definition of CAB has its core built in the “community” 25. Defining the term CAB, it requires understanding the term community, which is understood differently. The term community has over the years been understood “to refer to people who share a common identity, history, symbols, language and culture”25. While a number of scholars define the term differently the term focuses on members of the community sharing a common trait. The CABs are made of members of the community. The roles that have been documented in the literature for the Community Advisory Boards (CABs) include functioning as a liaison between the researchers and the community, providing information to the community about the study including their rights to consent, generally improving the informed consent process, ensuring human subjects protection, advocacy for fair compensation for trial-related injuries, protection of minorities and involvement in disseminating results to communities 26.
While CAB members may share a common interest, identity, illness experience, history, language, and culture; there is a challenge. As there is no standard definition of a community and the same can be said of CABs, because it is now accepted that those who live in the same geographical locality do not necessarily share the same perspectives, history, and language, culture or value system 26.
Currently, there are a number of biomedical research institutions in Malawi such as Johns Hopkins University Research Project (JHP-Malawi), the University of North Carolina Project (UNC-Malawi), and the Malawi-Liverpool Wellcome Trust (MLW) that have established their own CABs. The view is to have the CABs to support their biomedical research activities. The only major challenge that is in the field is that Malawi does not have regulatory or legal requirements or guidelines for the establishment of CABs 26.
1.1.6 Why Community Engagement
The principle of respect for persons requires the treatment of individuals as autonomous agents, who are capable of making their own independent decisions regarding their personal goals and choices. However, some research projects (namely, those that are population-based, or that are concerned with issues of public health) target entire communities rather than individuals, and the conventional methods that are usually used for obtaining consent might have to be modified in such research27.
Beneficence refers to ‘the moral obligation to act for the benefit of others2829. People become benevolent when they act for the benefit of others. The goal of community health research is to produce knowledge that is beneficial to the community. Researchers should ensure that their research participants are protected from harm. Whereas the obligation that researchers have towards individual participants regarding the prevention and minimization of risks and harm is well documented, little attention has, so far, been focused on preventing risks and harm to the community. While the benefits of research are well-documented, the concept of beneficence is understood differently as most participants as studies have shown focus on immediate benefits rather than the long term benefits that the research will bring forth171091112.
Justice is a particularly important principle in the context of Community Engagement, which requires that related benefits and burdens should be fairly distributed among all groups in the community concerned, without allowing such issues as age, gender, culture ethnicity, and socioeconomic status to influence distribution unduly30. Research should not deliberately target vulnerable groups in the community. All research, with the potential to cause psychological, social or physical risk to individuals, communities or groups within the community, must be critically evaluated for the likelihood of such risk.
There are a number of biomedical research institutions engaging communities in Malawi. These institutions use Community Advisory Boards (CABs) as a structure that helps researchers to engage communities. It is the use of the CABs and other community-based Community Engagement structures that this study intends to evaluate. The study employs Mfutso-Bengo’s principles of Community Engagement in evaluating the biomedical research institutions’ CABs or Community-Based Community Engagement Structures Community Engagement practice. On basis of the above information, this research attempted at analyzing biomedical researching Institution’s Community Engagement Practice using Mfutso-Bengo’s Community Engagement Principles.
According to Mfutso-Bengo’s Principles, there are four Community Engagement Principles. These are Community Consultation, Community Sensitization, Community Ownership/Partnership/Involvement and Community Feedback.
Community Consultation is the first step in Community Engagement process. This step involves briefing community leaders (Chiefs, political leaders, and religious leaders among others) about the research project coming into the community. This step aims at obtaining the permission to carry out the research project. Alternatively, other research projects engage communities using Community Advisory Boards (CABs). For both approaches after debriefing, what follows is explaining the coming research project to members of the community9.
Community Consultation is followed by Community Sensitization. Under this principle, community members are informed be it through CABs or traditional leaders on the proposed research that is about to take place in their community. While Community Ownership/Partnership/Involvement the principle examines the extent to which community members are part of the research, are they seen as equal partners? How are they accepting the biomedical research as theirs?
Once the study period elapses, this is where most studies stop. According to Mfutso-Bengo, giving feedback back to the community members is overlooked in most research projects9. Feedback is the last principle of Community Engagement. Under this one community members and participants, including community leaders are given feedback as regards the research findings. Providing feedback to the community is another way of fostering ownership 9.
1.2.0 Justification of the Study
Research has shown that there are already studies where researchers are studying community. With anthropology approach, studies have managed to find out behavior, perception and attitude of people. Anthropology is a long-established ‘discipline’ with some sub-disciplines. Literature shows that anthropology is divided differently. There is what is called social anthropology (for most of Europe) or cultural anthropology (in the USA) or ethnology (in some European countries). It is the study of culture within human populations, and is methodologically based predominantly on ethnography31. Ethnography is a field-based/grounded, inductive method that employs forms of observation and interviewing to investigate social practices and the meanings behind social interaction3132. Thus, a researcher that stays in the community to understand people’s way of live will help the researcher to know them better.
According to LeCompte and Schensul 33, there are seven significant characteristics of ethnography. These include: 1) being carried out in a natural setting, not in a laboratory; 2) involving intimate, face-to-face interaction with participants; 3) presenting an accurate reflection of participant perspectives and behaviors; 4) utilizing inductive, interactive, and recursive data collection to build local cultural theories; 5) using both qualitative and quantitative data; 6) framing all human behavior within a sociopolitical and historical context; and 7) using the concept of culture as a lens through which to interpret study results. On basis of the above-mentioned characteristics it is easier to see the reason why conducting a study that examines people’s characteristics requires an ethnographic approach. Its event more crucial than ever to employ ethnographic approach when examining Community Engagement from the lens of engangee.
These researchers have used Community Engagement in the process. However, there has been hardly a study that has carried out an evaluation of Community Engagement from the perspective of the engagee (community). The study, therefore, has the potential to generate information on Community Engagement Practices of biomedical studies in Malawi. The results should help designing of future research initiatives, policy formulation, and advocacy design among other activities. Such initiatives should help public health interventions in the country.
Chapter Two: Study Objectives
2.1.0 The Broad Objective
To explore the perception that community members have towards biomedical studies’ Community Engagement strategies and practices;
2.2.0 Specific Objectives
Specific objectives are:
To establish community knowledge and understanding of Community Engagement process in biomedical studies;To establish community knowledge and understanding of Community Engagement process in community advisory boards;To establish community perceived benefits of biomedical research Community Engagement;To explore the perceived challenges that communities experience in relation to Community Engagement process for biomedical studies;