This study explored the views of guardians and research nurses about the practical aspects of seeking valid informed consent across different study designs and settings in hospital based paediatric research studies. Our study identified challenges about the informed process that were expressed by both guardians and research nurses in paediatric research involved in consenting. The challenges identified were related to the health care context or environment, culture and research procedures and varied across study types and setting. We found that motivation to participate in the study was influenced by the personal benefits participants anticipated or experienced after enrolment in a study in this context. Misunderstandings of the consent process were associated with peer influence and inappropriate timing of consent in the acute setting. The need to involve the head of the family (men) in decision-making affected informed consent processes. Poor staff communication techniques due to limited time also affected the consent process.
Health care context or environment
Both staff and guardians who participated in clinical trials in acute and non-acute study settings and observational studies prioritised the ethics of care over research ethics codes of practices. Access to better health care was associated with better health outcomes. Our findings are similar to studies conducted in high-income countries like France and the United States [40, 41]. These studies reported that parents and patients participating in clinical trials who had life-threatening illnesses perceived that enrolment in hospital-based clinical research was beneficial because of the access to innovative treatment and care. These findings reveal that irrespective of health care contexts, what participants in research require, desire, or care about the most is to receive superior and effective treatment and a cure. Similar to Caldwell’s study in Australia, guardians stated that their child would be better monitored when he/she was in a research study [42]. This is likely more influential on decision-making and consent, especially when the local quality and standard of care is lower than the standard received when participating in research, as in many LMIC settings. It is not surprising in a setting like Malawi that high levels of illiteracy [43] and insufficient awareness of human and medical rights [34] may affect understanding of research concepts by guardians. Other studies in LMICs have also reported that the high societal status of physicians prevents patients from questioning their doctors and that poor access to medical services [26] increases the likelihood of being enrolled in a study.
Medical benefits are difficult to define as there are no guidelines on how they should be described in consent forms or during the consent process. The participants may face frustrations if these anticipated benefits are not met during the study [44]. Studies are needed to define the level of ancillary care in this setting and how it should be incorporated in the consent process.
The danger of undue inducement also needs to be considered. On a similar note, we recommend that research staff should ensure that privacy is maintained during individual consent rather than taking place in front of others, as reported in this study, to prevent peer influence which could also lead to undue inducement. However, it is important for staff obtaining informed consent to clearly state that refusal to participate will not jeopardise access to standard of care. Although this is unlikely in acute settings where the child is severely ill, the desire for enhanced care is likely to always dominate decisions on consent and encourage parents to pay less attention to risks; especially when the standard of care is perceived as suboptimal, as is often the case in LMIC settings [17, 24, 45].
Furthermore, poor and inaccurate recall of medical information provided is often related to the patient’s age and levels of anxiety [46]. Patients tend to focus on diagnosis-related information and fail to register instructions on treatment [46]. Our participants were given information at a time when their children were sick, and it is highly likely that their anxiety might have affected retention and recall of information. A study in Malawi which explored the effectiveness of rectal suppositories in children with moderately severe malaria, reported that parents with severely ill children struggled to comprehend large amounts of information due to the stress they felt about their child’s condition [31]. Participants need adequate information about the study to give informed consent. Omitting some of the information might compromise the credibility of the study and the ability of participants to make an informed decision, but there may be ways of focusing the key information so as not to overwhelm guardians at a stressful period. Re-consenting at a later period may also help with this.
Culture
Despite differences in household hierarchies between ethnic groups in Malawi, either patrilineal (wife lives in husbands home) or matrilineal (husband lives in wife’s home), men are generally still the main decision-makers in Malawi regarding the health care of the family and household decisions in general [47]. In patrilineal societies, the husband and his relatives are the main decision makers while in matrilineal societies, the wife’s brothers are the main decision makers. In contrast to the underlying cultural gender norms, this study identified that mothers or female guardians who had accompanied the child to the hospital generally made the decisions in acute and emergency settings. As a result, this decision-making practice bears the risk of causing conflict in families. However, this was different from non-acute settings where female guardians had a chance to consult their families or spouses before making decisions. Similarly, research staff from acute settings from both clinical trials and observational studies faced some challenges in consenting mothers in the absence of their partners. Respecting the underlying gendered decision-making process often resulted in low recruitment numbers of participants.
The study findings confirm the important role that cultural background plays in health care research. In many African contexts, individuals decide important issues in consultation with family, friends, and community members. This approach is related to an Ubuntu perspective [48], where decision-making with regard to medical interventions is often based on collective rather than individual processes [48]. In contrast, an individualistic approach to decision-making in Western culture is based on the concept of individual autonomy, where choices and actions are based on personal beliefs and values. [49]. This approach clashed with some guardians as they felt uncomfortable that their cultural perspective was not respected. Balancing the scale between individual consent and cultural dynamics in order to improve ethical conduct in research requires careful consideration. In some communitarian cultures, many do not necessarily prioritise the principle of individual autonomy because the emphasis is on communal decision-making, which is perceived as in the best interest of the group, family or society. Studies that have taken this approach into account in the Malawian setting and have pursued a collective consent approach have been successful [50].
Guardians in this study also suggested community sensitisation as a key activity that each study must consider before participant recruitment in this setting. These findings are manifestations of how culture heavily influences the informed consent and decision-making process and differences between African and western cultures need to be understood by researchers and ethical authorities. Researchers in this context must have skills in understanding, appreciating cultural differences and similarities and working with and respecting such diversity during the consent process [51]. More studies are needed to understand how best these two perspectives could be incorporated into the informed consent process without compromising the human rights of individuals and vulnerable groups, especially within the context of acute settings where timely decisions must be made.
Research process
Adequate information and effective communication from research staff are key in the consent process. The findings in this study have shown that it is not always the case that the same sets of principles and procedures on informed consent are equally applicable to research among different groups. With any research, it is necessary for research staff to consider how much information to give during consent, how to give such information, when and how often to give it. When gaining an informed consent, consider vulnerable groups that might be affected with the way informed consent is obtained and consider the types of research that might need different approaches [52].
Consent is considered voluntary if it is given without any internal or external influence [21]. In this study the voluntary nature of participation was not well narrated to participants. While research staff recognised their obligation not to force the participants, they acknowledged limits to their explanations due to the pressure to meet study targets. Similarly, a study on assessing quality of informed consent in Uganda found that a third of participants were not aware that they could withdraw their participation at any time even though all the studies selected had incorporated this section in their consent forms [16].
In this study, most participants from the clinical trial, acute setting, and observational studies from both acute and non-acute settings, were unable to recall specific information that had been communicated to them, particularly that relating to risks and randomisation. This is not surprising, as other studies [9, 32] have reported that participants’ understanding depends on health literacy as well as on the duration of the informed consent process and the skills of the researchers seeking consent. Participants who failed to narrate specific information tended to report that they were not given information leaflets (or had not read them if given), had forgotten the information provided, had received inadequate time and explanations, or cited inappropriate timing of consent and the urgency of their child’s condition as contributing to their inability to recall information. This is in line with other studies indicating that patients’ lack of comprehension of presented information about the research is an obstacle to informed consent, which may be due to unfamiliar terminology, the hospital environment, cultural and language barriers, and low literacy levels [2, 8,9,10]. Participants who have given their consent often do not fully understand their rights as participants and a significant proportion of them do not remember consenting to participation on their own or on behalf of their child [11].
It is well known that participants from LMICs and those with low levels of literacy are less likely to understand some aspects of study information during consenting like randomisation, voluntariness, risks, and the right to withdraw [12, 13]. Other studies have found that not only parents misunderstood these components but also adult patients, adult physicians, and paediatricians [53, 54]. Equally, other studies have reported research staff emphasising issues that they anticipated a participant to understand quickly and downplaying issues that might be difficult for a participant to understand such as study design, randomisation and the selection procedure [29]. The most appropriate time to consent children has been stated as when the child is stable, both in this study, and another conducted in Malawi [17]. The study designs should include adequate time for consent that would prevent research staff rushing through the process. Studies are needed to evaluate innovative ways of obtaining consent in acute settings without compromising study protocols as well as ethics guidelines on the practice of delayed consent process.
Despite efforts to communicate clearly to prospective study participants, it remains a challenge in Sub-Saharan Africa [9, 55]. Recommendations have been made for improving understanding of consent information among participants in resource-limited countries. Corneli et al. [27] demonstrated how formative data were used to develop culturally appropriate counselling cards specifically for trials in Malawi to improve understanding of study information [27]. Other researchers have recommended participants’ information being translated into the local language to enable comprehension of the research and health terms used in research [56]. This was done in the research projects investigated in our study. However, our study has shown that there are still challenges in understanding study information across all study settings and types.
The use of study information leaflets during consenting is universally recognised and is essential to ensure that research participants understand the aims and risks of the study and can voluntarily consent to participation. However, studies have reported that research participants often do not understand the content of the information sheet or the consent form for the study, especially if the consent form is lengthy and includes unfamiliar wording [57, 58]. Some participants may understand information at first contact while others may need to go through the information many times, although some female guardians did not show interest in taking information sheets. However, in the Malawian setting it is mostly women who nurse their sick children. Therefore, there is also a need to design information sheets appropriate for the study setting and study population to facilitate reading, comprehension, and retention.
Our sample contained participants across different study settings and types. We chose to include a wide range of studies to do a comparative analysis of the consenting process. However, we were limited due to the number of studies that met our inclusion criteria.
