Guardians and research staff experiences and views about the consent process in hospital-based paediatric research studies in urban Malawi: A qualitative study

Abstract

Background Obtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will assist in developing appropriate consent guidelines. Methods We conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software. Results All participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting. Conclusion The health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent. Trial registration Not applicable.

Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research

“…In a study in Ethiopia that explored the perspectives of community members on the procedure to follow to gain consent, participants recommended that researchers approach prospective participants through, or in the presence of, locally trusted individuals ( Tekola et al, 2009 ). This notion was also echoed by participants in Burundi ( Dunin De Skrzynno & Di Maggio, 2018 ), Cameroon ( Kengne-Ouafo et al, 2014 ), Ghana ( Tindana et al, 2006 ), Kenya ( Vreeman et al, 2012a ), Malawi ( Gondwe et al, 2022 ), and Mali ( Diallo et al, 2005 ).…”

“…Rather than forcefully apply the individual-focused IC model, Shaibu (2007) argued that researchers in collectivist social settings should carefully consider a diversified IC model that acknowledges and blends the cultural values and practices of the African people with the science and principles underpinning the standard research ethical codes, as appropriate. That a blended, multi-step approach to IC is more appropriate for much of African communities has also been vociferously advocated in the literature by scholars in Botswana (Ramabu, 2020), Burundi (Dunin De Skrzynno & Di Maggio, 2018), Ghana (Appiah, 2021;Tindana et al, 2006), Eswatini (Moyer et al, 2022), Ethiopia (Gebresilase et al, 2017), Kenya (Vreeman et al, 2012b), Malawi (Gondwe et al, 2022;Nyirenda et al, 2020), Nigeria (Osamor & Kass, 2012;Princewill et al, 2017), and South Africa (Akpa-Inyang & Chima, 2021;Moodley, 2002).…”

“…Subversion of Gatekeepers' Functions. Seven studies reported that the standard IC model, with its emphasis on individualism, essentially neglects the important functions of community leaders and gatekeepers in research, particularly in the rural, socioeconomically disadvantaged settings of Africa (Diallo et al, 2005;Gondwe et al, 2022;Kengne-Ouafo et al, 2014;Molyneux et al, 2005;Tekola et al, 2009;Tindana et al, 2006;Vreeman et al, 2012a). Studies find that gatekeepers, including chiefs and council of elders, Assembly representatives, Unit Committee members (e.g., for health, education, sanitation, etc) are elected, often politically, to govern and preserve the culture of the group, to spearhead developmental activities and well-being of residents, and to protect members from exploitation (Appiah, 2021).…”

“…In a study in Ethiopia that explored the perspectives of community members on the procedure to follow to gain consent, participants recommended that researchers approach prospective participants through, or in the presence of, locally trusted individuals (Tekola et al, 2009). This notion was also echoed by participants in Burundi (Dunin De Skrzynno & Di Maggio, 2018), Cameroon (Kengne-Ouafo et al, 2014), Ghana (Tindana et al, 2006), Kenya (Vreeman et al, 2012a), Malawi (Gondwe et al, 2022), and Mali (Diallo et al, 2005). Despite the reported claim of the functional roles of community leaders and gatekeepers in research in some African contexts, we retrieved three studies that critically questioned the implications of gatekeepers' involvement in research, implicating them, instead, of abuses of power and undue coercion of community members to participate in research.…”

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study

“…The majority (apart from participants from the control group in the observational study) were unwell with scrub typhus at the time of recruitment in hospital, one participant described feeling ‘drowsy’ and that this affected her memory. The potential stress of participants or their children being ill has previously been reported to affect people’s ability to understand and give meaningful (parental) consent [ 27 , 28 ].…”