We conducted the present REA to understand the potential ethical challenges relevant to the study area and to develop a tailored consent process before the conduct of a large-scale longitudinal study. A good understanding of the basic concept of research among people approached is essential to secure authentic consent. The REA found out that the community in SIlti Zone has inadequate understanding of the concept of research. In studies conducted in Southern and Northern Ethiopia, a similar finding was noted [9, 14, 15]. Ethiopian health researchers and regulators also shared the insights that the community’s awareness about research and research ethics elements are not well developed [6, 21]. These may have led to the therapeutic misconception of health research, the belief that participation in research will result in some medical benefits to the participants [21]. The misconceptions of health research with medical interventions, aids, and other immediate benefits were reported in many studies conducted in resource-poor countries [6, 10, 14, 15, 23]. We found a similar finding where most of the community members understood research equating it to medical care while others related research with planning and doing some beneficial interventions.
In line with similar studies, our study demonstrated that the low level of societal literacy and their limited familiarity with the research works was among the major reason for the inadequate level of research understanding [13]. Indeed, education is one of the most important aspects of social and economic development. However, educational attainment in Ethiopia is generally low especially among rural residents where 54% of females and 39% of males have no education. In Southern Ethiopia where our study is being conducted, only 1.7% of females and 2.2% of males completed primary education [17]. Nevertheless, some level of understanding regarding the concept of research among inadequately educated participants who had familiarity with health research was noted [10, 24]. In a study conducted among people who had mostly no formal education, the difference in the research understanding among those who have experienced agricultural studies with those who had no experience was noted [14]. Some researchers working with illiterate communities argued against the notion that illiteracy is a barrier to research understanding and comprehension except for the understanding of abstract scientific concepts [24]. Bhutta also put a favorable argument advising to never consider illiteracy to mean that a potential participant is unable to comprehend complex information suggesting the value of presenting the information differently for these populations [3]. These findings suggest that the lack of experience and familiarity with research work could have a pivotal role in shaping the research understanding of the given community. In consideration of the fact that illiteracy is widespread in most resource-poor countries particularly in the poorest areas, devising an appropriate mechanism that assists illiterate people to have a basic understanding of research before the consent process could be important.
The tendency to approach the individual study subjects directly without considering the existing community structure may be difficult in some communities as individuals might lack trust in the outsiders and become reluctant to participate. In Silti Zone, it was found out to be important to involve and get the permission of key and influential peoples such as the kebele managers, and religious and community leaders who have a meaningful role in the formal and informal community-based administration before approaching individuals. The role these people may have and their level of influence might vary based on the culture, religion, and the structure of the community in a given area. For example, in Cameroon, the fon (local traditional authority) plays a very important role as the entry point to the community [23]. In South-Eastern Tigray, religious leaders were the most accepted people to reach the community [14]. While in East Gojjam, kebele leaders and law enforcement were identified as the keys to approaching the community [5]. Considering the value of respecting the community and creating a good relationship, seeking the involvement of these people before reaching the potential study subjects could have a meaningful place for the smooth conduct of the planned research.
Conducting community sensitization and giving collective information through public and religious gatherings was also suggested before approaching the study subjects. Using Mosques for community sensitization, which was specific to our study, was meaningful given that nearly all of the community members follow Muslim Religion in the study area. Other studies also recognized the value of community sensitization and group information provision using community gatherings such as churches and market places [14, 15, 24]. The REA threw valuable light to using the community sensitization and individual consent process as an opportunity to discuss the concepts of research with the community, which could improve their awareness and address the existing misunderstanding. The benefit of community sensitization in educating the community about research, enhancing the level of individuals' comprehension and clear misunderstandings was well documented [10, 15, 23].
The social relationships of an individual within families, institutions, and communities may influence the assumption of informed consent for a self-determined choice of individual study subjects [21, 26]. Therefore, the understanding of the decision-making tradition in a given community is important to devising appropriate strategies that balance respecting the individual autonomy for a self-determined choice against respecting the community-based decision-making tradition. In the study area, the permission of key and influential community members such as Kebele managers, religious and community leaders who are working in various hierarchies of the formal and informal community-based administration is essential. It is a common phenomenon in some societies in resource-poor countries where it would be culturally inappropriate to ask individuals for research participation without consulting the community or getting permission from community leaders [21]. In the context of rural Ethiopia for example, any important decision has to involve significant other people including community elders and religious leaders [5]. Given the intimate and shared living arrangement in these settings, recognizing the value of involving all concerned bodies before initiating any community-based activities including research work may be necessary. Based on the international guidelines that suggested the significance of accommodating the cultural context of a given population, the permission requirement of these people before approaching potential individual participants could be ethically sound as far as it does not compromise the requirement for an individual’s voluntary informed consent.
At the household level, a man has a dominant role in decision making on the behalf of other family members including the women to participate in research by culturally accepted status as the head of the family. A similar finding was reported in Cameroon where most women even advocated for male responsibility in giving consent for research participation [23] and in some areas of Uganda as well [21]. This is particularly relevant in Muslim communities where the permission of the husbands must be sought and obtained before accessing women for surveys [26]. Furthermore, it was rarely mentioned that the mothers in law who usually lives with her son when she is alone has also an influence on the household level decision including for research participation of individual members. In South Asian regions, the mothers-in-law commonly exert power over daughters-in-law to the extent that the women may not be able to express personal opinions on even minor household matters including research participation [21]. In such circumstances, the decision-making status of women could in part be the possible barrier to voluntary participation in research [9]. The situation where another person including the male family head customarily has the authority to make decisions on behalf of others on whether they will participate in research is challenging considering the recommendation of the universal ethical standard of informed consent. However, attitudes have been changing dramatically in much of Africa, where many women, especially in non-Muslim societies, are now cultivating a more assertive position concerning healthcare [21]. For example, in a study conducted in Northern Ethiopia, women reported their individualized decision-making role in any aspect of their life including for research participation [14]. Until it becomes practical in similar settings, researchers, therefore, need to take time to work with all concerned bodies at the various stage of the research and take culturally sensitive measures to secure authentic informed consent from women participants to the greatest extent possible. Despite this, considering the nature of the planned research that requires long-term follow-up, repeated home visits, and family involvement, a sound argument to involve the male head of the household was proposed.
The ethical procedures that are designed based on the specific attributes of the population in high-income countries may be ineffective for implementation in some resource-poor countries because of the significant differences in cultural and social environments [21]. Considering this, the Ethiopian Research Ethics Review Guideline suggested that the content of the information sheet should consider the local culture and values, as well as the level of understanding and competence of the research participant [2]. About 95.4% of Ethiopian researchers, regulators, and IRB members also thought that the internationally recognized consent process and the elements of information sheet are often inappropriate in some societies demanding contextualization to the given setting [6]. A similar finding was reported in Northern Ethiopia [5]. In this REA, similar views were shared mentioning that the consent process should be adapted to the local setting considering the existing situation of the study subject, the community, and the cultural issues.
The requirements for informed consent assume that individuals are autonomous agents with the capacity for expressing a self-determined choice after information on the purpose, risks, benefits, and alternatives are thoroughly described and understood [25]. However, various challenges were reported in the provision of information to the potential participants in different settings. In a study conducted in Ethiopian universities and health research centers, consent-related problems including the provision of inadequate information, lack of clarity of the information, the use of inappropriate language, and terminologies were documented [6]. In other studies, the tendency of stressing more on information related to the potential benefit and de-emphasizing information on the potential risks of participation was noted [8, 14, 15, 24, 28]. The reluctance of researchers to provide all the relevant information in a way that is understandable and appropriate, in particular disclosing the risk related information might be intentional due in part to the fear that it might frighten the study subjects with the potential to deter participation [28]. Moreover, the frustration of the researchers regarding the lengthy and complex disclosure requirements for informed consent and the tendency of focusing more on the consent than on informed consent, which is based on prior information and comprehension was also noted [6, 26]. Our study found similarly finding where most of the experts often expressed the difficulties of communicating information based on the recognized ethical requirement in some communities. The consideration of the existing local situations of the community such as the low level of literacy and the lack of familiarity with the concept and procedure of research that possibly influences the comprehension level of the potential participants was suggested. The nature of the planned research where it was assumed to have minimal risk was also mentioned as a favorable argument. Yet, a meaningful argument was shared underscoring that the researchers usually focus on recruiting as many as possible study subjects and getting the required data quickly than giving complete information that is relatively time-intensive. It was also suggested that even illiterate subjects could understand the information as far as it is customized for the level of their understanding and literacy level of a given population. This concern is consistent with the universal ethical standard of informed consent that requires the information provided to research participants should be analyzed in terms of containing the basic elements of information which should be communicated accurately and in an understandable and appropriate way [1, 3, 4]. In communities where there is a low level of literacy, it is common to see the tendency of preferring oral consent to written consent (8,9,10, 24). The study subjects may also hesitate to sign (using thumbprints) on the consent form although they agreed to take part in the study. For example, in Ethiopia, several studies reported the difficulty of obtaining the written signature [8, 10]. The commonest reason appeared to be the fear of legal issues and accountabilities associated with signing on the document. The past experiences of the study subjects such as losing the land by signing papers and the fear of any other adverse repercussions such as stigmatization could have made people suspicious of signing documents [22, 26]. In contrary to most of the studies, it was worth noting that, signing on documents including for research participation is not a problem in the Silti community, although we noted the preference for the information to be communicated orally. In explaining this, the flexible nature of the community, their frequent experience in signing on documents, and the long-existing trusting relationship were repeatedly mentioned.
After explaining the procedures of the planned research (the detail was presented elsewhere) [15], the procedure was found to be acceptable for the potential study subjects. However, the importance of considering community-based events such as the market and the prayer days of the community was suggested for consideration while scheduling activities with the potential study subjects. In the REA conducted in Addis Ababa, participants confirmed as there is no problem with repeated interviews, but emphasized the importance of making an allowance for the home and outdoor responsibilities of the women in deciding the timing of the interview [9]. The value of small incentives to motivate the potential study subjects was also suggested to ensure effective participation. The pivotal role of incentives to achieve effective recruitment and retention was also recognized in similar studies [8, 10, 15]. International ethical guidelines also recognized the value of incentive as far as it is large or extensive enough to induce study subjects to consent to participate against their better judgment [29]. In the light of the local circumstances, the incentives proposed by the respondents could be appropriate to motivate the potential study subjects without causing the significant ethical concerns of influencing the individuals' informed decision to take part in the research. In our view, the finding regarding the incentive expectation of community leaders and community works for their engagement in the community mobilization efforts which was also reported in similar studies was also meaningful [9, 27].
The REA identified some of the potential barriers that could deter the study subjects from taking part in the planned research. The suspicious view of the community to the outsiders and the associated wrong rumors that may easily arise and disseminate in the course of the research was mentioned perilous with the possible potential to influence participation. Similar studies conducted in different parts of Ethiopia also reported the distrust of the community to the newcomers and the potential of false rumors in creating misconceptions in the community [8, 9]. The tendency of ethnic bigotry and the existing wave of insecurity in Ethiopia contributed to the mentioned phenomena [30]. In line with the finding of similar studies, garnering the support of all concerned stakeholders, a prior community sensitization to disseminate the right information, and ensuring a clear understanding of the nature of the research was suggested [8, 31]. Respect for cultural norms builds a foundation of trust between researchers, study subjects, and the local community [25]. The value of respecting the cultural norms of the community including the religious ideologies and practices were also repeatedly suggested, as the lack thereof potentially dissatisfy the study subjects and become the barrier to participation. In similar studies, the understanding of the culture, religion, and livelihood of the people approached and the circumstance of the study subjects was mentioned as essential [10, 15]. Therefore, we were cautious in selecting the play activities and materials, in selecting home visitors who were recruited from the local community with a good understanding of cultural norms and religious issues of the community including the dressing codes. Due attention was also given to the interaction happening with mothers/fathers with an opposite-sex research team.
To mention some of the limitations, we used the referral of local people in the selection of respondents. For example, at the community level, FGD discussants were selected by HEWs while at the health service providers selected mothers/fathers of children with SAM. Similarly, health facility managers, Kebele managers, and the Research Office head of Worabe University selected the health workers, community-level IDI respondents, and researchers respectively. Consequently, we are not quite certain whether the respondents selected for the study actuality represents the variability of the community and the selection process is free from the potential selection bias. The study was conducted in the Silti community, a Muslime community in Southern Ethiopia and our findings may not fit the realities of other settings given the remarkable diversity across regions, religions, and ethnicities of Ethiopia.