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

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 staf 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.