Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

IntroductionTime-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in I...

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Published in:	BMJ global health Vol. 6; no. 5; p. e005757
Main Authors:	Pant, Stuti, Elias, Maya Annie, Woolfall, Kerry, Morales, Maria Moreno, Lincy, Bensitta, Jahan, Ismat, Sumanasena, Samanmali P, Ramji, Siddarth, Shankaran, Seetha, Thayyil, Sudhin, Seeralar, Arasar, Kamalarathnam, Chinnathambi N, Shivarudhrappa, Indramma, Somanna, Jagadish, Mondkar, Jayashree, Mendoza, Josephine, Jayaraman, Kumutha, Sundaram, Mangalabharathi, Sajjid, Mohamed, Shahidullah, Mohammod, Sebastian, Monica, Baburaj, Mythili, Benakappa, Naveen, Montaldo, Paolo, Bassett, Paul, Bandiya, Prathik, Vinayagam, Prakash, Rodrigo, Ranmali, Sujatha, Radhika, Chandramohan, Rema, Moni, Sadeka C, Sumanasena, Samanmali, Radha, Saritha J, Manerkar, Swati, Oliveira, Vania
Format:	Journal Article
Language:	English
Published:	London BMJ Publishing Group Ltd 01-05-2021 BMJ Publishing Group LTD BMJ Publishing Group
Subjects:	Babies child health Childrens health clinical trial Cooling Decision making Health administration High income Hypothermia Informed consent Intensive care Intervention Interviews Medical personnel Mixed methods research Newborn babies Original Research Participation Professional ethics Public health Qualitative research qualitative study randomised control trial Sri Lanka Bangladesh India
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Summary:	IntroductionTime-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.MethodsTerm infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.ResultsA total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.ConclusionDespite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2059-7908 2059-7908
DOI:	10.1136/bmjgh-2021-005757