Realization of ethical principles by study participants in communities starts with researchers as they draw out the proposed protocol. These are upheld or authenticated by the ethics committees through reviewers as the study protocol goes through assessment and the approvals process. Further, data safety and monitoring boards (DSMBs) try to observe that ethical guidelines are maintained and there is no prejudice while testing the study hypotheses. While the regulatory authorities (e.g. Medicines Control Authorities, Medical Research Councils, etc.) verify that ethical principles are adhered to and practised during the conduct of the studies. However, governments through the ministry of health and other ministries overseeing research, sometimes take advantage of the research activities to fulfil their own political promises using resources supposed to be research incentives. Very often it is not rare to find some policy makers twisting the regulations to achieve certain goals for the communities. While rarely advocacy groups including NGOs represent the community leaders and the voiceless participants.
Lack of empowerment exposes African research participants and even African researchers and institutions to exploitation, coercion, enticement and inducement that would compromise overall voluntariness, and even upholding fairness is research studies. The sponsor and the investigator must take every effort to ensure that the research is responsive to the health needs and priorities of the population or community in which it is to be carried out. If the capacity is lacking, steps must be taken to strengthen the oversight mechanisms [4]. Usually, some key players are easily identified with major responsibilities in research, however, the concern in determining the respect for the research participant is often over looked. Most guidelines refer to research participants as mere study components to be protected disregarding the need for rewards and individual benefits. The hierarchy in research authority and all responsible overseers should understand the demands and needs of the communities they protect. Research in resource limited areas need to have prescriptive guidelines that accounts for individual desires for rewards. The research participant is a living individual from whom a researcher obtains data and specimens. The investigation is performed on the research participant that means the individual is central to the activities. Researchers and all responsible authorities have ethical and legal obligations to protect and satisfy human participants universally [3, 13].
The fundamental ethical principle of justice requires fairness or entitlement that is giving to each what is due. Human beings are morally equal and should be treated as such regardless of colour, creed, race or religion including economic status. This principle of justice demands fairness in treatment of individuals and communities as such there should be equitable distribution of the burden and benefits of research. Important implications for such issues include rewards to participants during the study and post-study benefits. Generally, the communities in resource-constrained areas still do not enjoy the fruits of study participation at an individual level. The fundamental principle of autonomy requires that the wishes and choices of an individual be respected [2]. Individuals in research studies must be their own masters and can act or make free choices and take decisions without constraint of another. This is rare where no individual opportunity is given to make an informed decision to ask if not demand for reward, rather level and the regulatory authorities presume the type of reward, and very often the principle of divide and rule is applied. No discussion is permitted even though consent is obtained. Most resource-constrained communities do not exercise their demand rights but are entangled in mob participation that is taken advantage of by the area regulatory authorities under the pretext of representing the participants.
Most communities involved in studies or clinical trials are presumed to understand the essence of research. Even with these assumptions, participants should be given adequate information and explanation hence this implies that they volunteer to be objects of some experiments. Even though being aware that it is not an obligation to participate in the research, most resource constrained communities and individuals flow together without demanding or exercising the right of being free to refuse participation. The success of research is highly dependent on the willingness and cooperation of the participants during the protocol activities, by providing information or specimens. Informed consent plays an important part in this regard [1, 2, 7]. The responsibilities often are weighted on the investigator even though there are considerable responsibilities on the research participant. In most instances, community representatives are a major player in decision making in as far as research participation. Researchers and trial sponsors need to consult communities through transparent and meaningful participatory process that involve participants during the early stages in the design, development, implementation and monitoring of the study activities [18]. Consultations maybe arranged through local community leaders such as headmen, chiefs, community health workers and local civic leaders. Most communities where research activities have been conducted, certain mechanisms have been established for community engagement by establishing community advisory boards.
Researchers or investigators have mammoth responsibilities that include extreme caution on the vulnerable populations. The Helsinki Declaration mentions the observation of the benefits to the community [1]. The Investigator must make evaluation on the benefits to the communities and or individual. The sponsor or investigator should make every effort to ensure the work is responsive to the health needs and the priorities of the population or community in which the study is being conducted. After the study or intervention, the knowledge generated should be made available for the benefit of the population or community [1–4, 7].
One challenge of assessing the effectiveness of biomedical field research implementation is the lack of a reliable, unbiased and accepted indicator to measure participation. Compliance with the biomedical research programme and intervention (e.g. epidemiology project, clinical trials or testing clinical tools) is an important indicator of a successful implementation strategy. To our knowledge, none of the several studies that measured study participation in relation to compensation and giving out incentives as effectiveness to improve participation assessed determinants of compliance directly. To date, the most common end-points used to assess compliance rely on statistics deducted from successful follow-up as the indirect observation of willingness to participate and these indicators are often assessed once, usually at the end of the intervention, and the reliability of these indicators is unknown. Self-reported compliance in the context of an interview is known to produce inflated results due to reporting bias. In this study we use six measures of direct observation and researcher tallying attendance from sample availability to create a score to classify participation according to 'willingness to participate' by being present at examination and interview day, and 'provision of samples' as required on appropriate days. However, this approach to participation and availability of sample classification uses components that can readily indicate magnitude of willingness. Agreeing to be part of the study forces the investigator to subjectively determine the acceptance of the study by the community. There is a need for objective methods to classify participants into distinct willing groups and also to consider views of the CABs and other community leaders.
In this article we present a detailed analysis of research study compliance among participants from resource limited settings who participated in different community based studies in rural Zimbabwe. The assessment detected a highly statistically significant demand for incentive in school children and in adults with an overall compliance of above 80% based on both community- health worker assessment and the research staff. Here, we use research data collected over a number of studies whose participant compliance was monitored by CABs and the study researchers to objectively deduce participation. We then use the classified groups to describe the participation determinants that are associated with the general researcher-participant attitude in resource-constrained setting.
Systematic reviews of biomedical studies and clinical interventions in developing countries reveal that majority of the global inhabitants have somehow been reached by certain forms of research programme that demand their participation. Further, from empirical research data, the world is now becoming a village in as far as being accessed by study programs is concerned. The global research events indicate that it is becoming increasingly difficulty to isolate communities from what was practiced in other areas during conduct of research programs. Even justification for grossly different levels of incentives, compensation or reimbursement can no longer continue, as the world becomes a global village. There is need for collective consideration of both personal and community rewards in future studies to be conducted in resource-constrained communities. Information available indicates a projected fear that recruitment in future may be a challenge, now that almost every community has somehow been reached and participated in some form of research studies. A major concern is that study participation rewards should be internationally pegged regardless of different economic status of the individuals or communities.
The challenge for incentives, compensation or even reimbursement is addressed unequally between regions and development status of the community or country. Resource constrained communities welcome many forms of studies regardless of the exploitation levels, due to poverty. Most of these communities are not empowered to air out their demands. Further, in such communities there is no recourse to challenge irrational health research policies and administrative decisions. If research intellectual and legal rights can be shared equitably between researchers and their institutions - what is preventing individualized benefits to study participants? We characterized six distinct participation groups in studies conducted over 6 years among participants of school- and community-based studies in rural Zimbabwe. Participation characteristics that were most strongly associated with the categorized groups include giving incentives, the level of compensation or reward for time taken to participation. These three forms of study participant benefit were strongly associated with participation. Promotion of efforts to give the study participants something would more easily encourage participation, and presumably reduce recruitment time.
Our findings suggest that the motivation to provide samples and to participate; even for treatment requires some form of rewards. In addition, higher compliance and obtaining samples was associated with the frequency of issuing out some token of appreciation to promote individual attendance at sample collection time point. It is likely that eager participants providing the biological samples are more interested in participating at the related promotional events and with incentives. Applying the theory and belief of due influence if incentives are used, has no place in designing studies in the modern research programme. These coherent findings on the motivating factors for participation underscore the importance of determining form and level of incentive for the participants prior to implementing the project. In combining objective indicators that measured visible signs of willing participation (e.g. provision of biological samples or being present to give the samples especially blood samples for immunological work) with proxies indicative of responsive to CABs encouragement and the presence of the biological samples collected at the required time point increased the quality of measurement and reduced the potential for reporting bias. The CABs evaluation on compliance generated much lower willingness rates than research staff on actual sample availability observation. This underscores the potential for bias in situations where community based staff as members of the CABs evaluate their own work through compliance after mobilization. Our results highlight the importance of choosing independent staff and a valid and responsive indicator to assess willingness and compliance and to draw conclusions about the need or effectiveness of incentives in intervention programme.
Despite an intensive baseline and continuous mobilization campaign carried out by research teams and CABs members, we observed 35% overall compliance without any reward given out at subsequent follow-up time point. However, when incorporating a simple token or reward in the form of dried fish and cooking oil, participation increased to over 70%. While during the follow-up when the rewards were not available, there was a reasonable response to participation on the first day but when participant realized that nothing was being given out, the attendance dropped drastically. Introduction of a small token or reward during follow-up showed an increase to treatment uptake, even when giving out treatment with sweetened orange crush juice to a sector of school children from a religious group that does not accept treatment. Our findings suggest that biomedical research programme would benefit from reassessing the core requirement for compliance. According to information from resourced communities, there are stark differences in marketing messages and approaches to reach the critical fraction of the population to participate in such studies. Our analysis identified some characteristics associated with increased willingness to participate, after receiving a small token or reward, indicating the potential to draw community members to the study. Most of the concerns can be assessed and addressed during the writing up of the protocols and incorporated during marketing and promotion strategies targeting the participants and informing on the personal benefits and rewards from participation. Based on the characteristics that we measured, it was clear to differentiate the willing participant from 'incentive driven participation (Table 2). In the study, the population of the participant groups included the most marginalized rural communities by observable characteristics: they were poor, lived further from health services centres, rarely had enough daily resources, the communities have high prevalence of neglected tropical diseases. We give evidence of the need to include individual token of appreciation. But the agents involved in designing and reviewing the protocols rarely would agree to reward participants in whatever form that the communities would appreciate.
In the resource constrained areas context, programme planning may benefit from assessing easy measurable factors like the individual desires and community expectations, a large proportion of population subgroups in these poor communities that can be targeted for biomedical research sites do not have excessive demands for compensation or rewards at individual level. Those insights supported by our data are consistent with recommendations for a successful rollout of clinical trials programme deriving from other previous studies. Central government suggested levels of appreciation for the communities are not in line with what the community and individuals expect and sometimes rarely would the communities receive these contributions from the researchers. Normally, it is not uncommon that resources from research programme get diverted or replaces government responsibilities, hence individual senior government officials mat benefit from such confusion. Individual benefits should be considered separate from government responsibilities where these are required. As a result, regulatory authorities very often propose making use of community rewards from study programme for community developments, thereby portraying differences to studies conducted in resourceful areas. The difference in not permitting the rewards to an individual is beyond any reasonable thinking besides among those who wish to deny these communities their dues from participation in studies.
There are limitations to this study. The participating communities were not homogenous regarding preexisting infrastructures, previous exposure to research campaigns and biomedical programme, as well as political support to participate in the study. Finally, data on the willing to participate and comparable time points where a reward was introduced, may somehow differ because (i) the indicator was implemented by different groups, and (ii) availability of samples and presence to uptake treatment in non-invasive biomedical studies. We believe such measurements somehow enhanced the reliability of willingness to participate due to a direct visible benefit and none invasiveness of the study procedure.
