How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India

The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.

An essential requirement for ethical research is that participation in trials should be informed and voluntary. However, operationalization of the principle of informed consent in community settings with low levels of education and research literacy can pose challenges, especially since standardized consent protocols may not be applicable across different social, cultural and economic settings [1–3]. Medical research in children poses particular concerns for informed consent because of children's status as a vulnerable population, legally incompetent to make decisions about their own participation in research studies [4]. A child's parent or legal guardian usually serves as a proxy consenter, making decisions about research participation on behalf of the child. In many countries, including India, only one parent/guardian's signature is legally required to enrol a child in a study. However, household decision-making processes and gender differences in attitudes towards health research mean that researcher decisions about which parent to approach for consent can have implications for the process of informed consent in terms of the amount of information requested by potential research subjects, as well as ultimate decisions about whether or not to participate [5–8].

Researchers have started to work towards developing cross-cultural understandings of research ethics by examining research literacy and the informed consent process in sub-Saharan Africa, North Africa and Asia [5–7, 9–14]. A range of issues have been identified with respect to the transferability of a code of medical ethics across different settings. These include questions around the relative importance of community versus individual consent [6, 15–17], and whether consent can be truly informed amongst populations with low research literacy; for example, it may not be easy to impart key concepts of clinical research such as randomization, placebo and future societal good versus current individual benefits [18]. A further concern is that organizations that conduct research may also provide health care services which create a high level of trust; this can be a barrier to healthy skepticism necessary for asking questions about the aims and consequences of a research project [9, 19]. A related issue is the common phenomenon of 'therapeutic misconception', where research subjects incorrectly interpret the primary purpose of a clinical trial to be therapeutic rather than experimental, sometimes resulting in false hopes about individual outcomes [20, 21].

Recent reviews of the research process in developing country settings have endorsed the importance of community-level participation and subsequent individual consent for research, particularly in rural areas where community level decision-making is more prevalent compared to urban areas [3, 5, 6, 21]. In line with these recommendations, most community research studies in developing countries are preceded by community-wide information sessions and handouts as a first step for raising awareness of the research study and procedures. However, understanding of the nature and purpose of a research study is often low, even where informed consent has been obtained through standardized and approved procedures [22]. Moreover, few questions may be asked during the informed consent process although participants continue to have questions about the study and are provided ample opportunities to clarify any doubts or seek further information [18].

In order to ensure ethical research across different social and cultural contexts, there is a need for more empirical evidence to understand the informed consent process. This is particularly important in developing countries, where the enforcement of codes of medical research ethics may be weaker. The analysis reported in this paper contributes to debates about how to increase researchers' engagement with research participants, by focusing on the process of consent for enrolling children in a community-based prospective study to assess the incidence of pulmonary tuberculosis (TB) in infants in rural South India. We were interested in examining the extent to which individuals giving consent actively participated in the consent process, and identifying the correlates of participation. The proxy measure for participation was whether any question was asked during the consent discussion.

Out of the 4,382 children enrolled in the study, 4,095 (98.6%) of informed consent forms were signed by the child's mother. The child's father signed the consent form for 60 children (1.4%), and a guardian signed for 2 children. In only 287 cases (6%) were both parents present during the informed consent process. Out of these children, the mother signed the consent form for 271 (94.5%) children. In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process.

Other factors that were associated at the p < 0.05 level were religion (with Muslims being more likely to ask questions), caste (socially disadvantaged Dalits were less likely to ask questions), parental occupation, and which parent signed the consent form (more questions were asked when fathers signed). Factors that did not appear to have a statistically significant association with participation during the consent discussion were mother's age, the house construction material (another indicator of socio-economic status), and reported household exposure to TB.

Location had an effect on participation, with residents of low development rural areas least likely to ask questions, and residents of semi-urban areas most likely to ask questions. Education level was important, with those of a higher education level more likely to ask questions than those with a lower education level. The number of parents present during the consent discussion had a large effect on participation, with questions much more likely to be asked if both parents were present (Odds ratio = 7.5). All other variables were not significantly associated with asking questions; possibly because they are collinear with education and their effect is captured in the model by the education variable, or because of the small number of observations.

Institutional and government ethical review boards play an important role in ensuring that clinical and epidemiological research studies have well-defined and documented procedures for obtaining voluntary and informed consent from research participants. However, too often, little attention is paid to how the processes of obtaining consent are conducted. Important indicators of these processes are the extent to which research subjects participate in consent discussions and understand the nature of the research study. In developing countries, a further concern is that many of the principles of medical ethics have been developed within the social context of Europe and North America, and local considerations for obtaining consent may need to be better understood. The conduct of research studies in children poses further questions for how to establish procedures for obtaining parental consent that respect the autonomy of parents as well as protect the interests of the child. This study of participation in consent discussions in a community-based neonatal study contributes to the thinking about research engagement with participants, and consent for vulnerable populations.

Only a small fraction (13.5%) of parents asked any questions during the informed consent process. One possible reason for low participation could have been that a significant number of doubts and concerns were clarified during the prior community information sessions (n = 196). Community sessions had been held in schools and village meeting spaces, and were attended by students, teachers and parents. However, when we analysed the focus of the 176 questions that has been recorded over the course of the community information sessions, the majority of these (61.3%) were related to doubts about signs and symptoms of TB. The relatively few questions asked about the study procedures indicate that the community information sessions are not likely to be a major explanatory factor for low participation in the informed consent process. Another possible reason for low participation is that the study was being conducted under the auspices of an organization that has provided charitable health services in the community for more than 30 years; this may have led to an implicit trust in the beneficence of any study being conducted, associated with lower likelihood of expressing doubt or seeking clarification.

If participation is taken as an indicator of the extent to which consent is informed, it is a matter of some concern that so few questions were asked during the informed consent discussions, despite significant efforts being made on the part of the research team to encourage open discussion and questioning, and allow households to be involved in the consent process. This may well result in poor understanding of the nature of the research study, as found in other settings [10, 18, 22]. The analysis identified location, education level and both parents being present during the consent process as the most important factors affecting participation in the consent process. Those in more developed areas (rural areas with high development and semi-urban areas) were more likely to ask questions, perhaps indicating a greater exposure to health education, media and information about research. This could be associated with greater ability to formulate questions and confidence to ask them. The effect of education may be related both to those who are educated having a better understanding of research processes (and therefore having a better idea of which questions to ask), and having greater confidence to ask questions. A study of the quality of informed consent in South Africa reported similar findings with regard to education [13].

The fact that more questions were asked in our study when both parents were present may indicate a greater confidence to ask questions in a group setting. However, some of this effect may also be gender-related, with fathers more likely to ask questions to researchers than mothers (in the vast majority of cases where only one parent was present, this was the mother). This effect may be even more pronounced in our study, since all of the study team members obtaining consent were male. These findings suggest that further research is needed to understand the extent to which participation in informed consent discussions is influenced by the gender of both the research participant and study team members.

There are some limitations to this study. First, asking questions during the consent process is taken as an indicator of the extent to which consent is informed; this may not necessarily correspond with actual knowledge and understanding of the research process. Second, we made the assumption that field supervisors were equally likely to write down any questions asked during the consent process. It is possible, however, that the likelihood of recording questions asked was related to the ability/interest of fieldworkers. We believe that the periodic supervision by the project coordinator of field supervisors for the consent process and recording of questions strengthens the validity of data. Another issue is the possible relationship between fieldworker characteristics and parents' comfort asking questions. In bi-variate analysis, we found an association between the fieldworker who took the consent and whether any question was asked; however, we did not have sufficient information on fieldworker characteristics (such as communication style, educational background, previous experience with research) to conduct further analysis of this important area. Given that previous research in South Africa found that the quality of informed consent was better when consenters had more experience [13], and other authors have suggested that research workers do not always have the necessary communications skills to encourage open discussion and questioning of a research project. [7], this is an important area for future research. A final limitation is that the findings are limited to one study. However, the number of cases is large (n = 4382), and the data can be said to be broadly representative of rural India.

Our findings provide two important lessons for planning the process of informed consent for enrolling children in research studies in developing country settings. First, given that socio-economic status and education are significant predictors of whether any questions were asked during the informed consent process, it is critical to put more effort into considering innovative approaches for making discussions during the consent process more interactive. This may involve including pictures, stories, and some test of understanding of the study aims and procedures. A primary concern for researchers should be to make the process more accessible and meaningful for research participants of all socio-economic groups, and to raise the level of research literacy within the community. Apart from carefully considering the content of informed consent procedures, the impact of training research team members in communication skills (for example, limited jargon and pausing after every sentence to allow opportunities for questions) on research subjects' participation and comprehension should be examined in future research. The collection of data on participation can also serve as a useful monitoring indicator for quality of informed consent processes within research studies.

A second issue for consideration in conducting research with children is the amount of effort that should be put into seeking two parents' participation in the consent process, where possible. Although mothers are the primary caregivers of children and are likely to be easier to reach in a household study, our analysis showed that fathers were much more likely to ask questions during the informed consent process. In order to promote consent that is truly informed, it may be desirable to create more opportunities for fathers to discuss research studies with research workers. Given that fathers are harder to reach during working hours, this could increase the costs of the consent process significantly, which can be a deterrent where research funds are constrained. If mothers are targeted as the primary consenters for children's studies, participation in consent may be increased by having female research workers conduct the consent discussion; it would be valuable to conduct further research to test this hypothesis.

Finally, this research points to the importance of generating more empirical evidence on consent and understanding of informed consent in different settings, and of building quality assurance of these procedures into research protocols. With the growing volume of health research being conducted across different social, cultural and economic settings, it is critical for researchers to continue to introspect on ethical aspects of their work and increase their engagement with research participants.