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. Issue 5 (21st May 2021)

• Record Type: Journal Article
• Authors: Pant, Stuti; Elias, Maya Annie; Woolfall, Kerry; Morales, Maria Moreno; Lincy, Bensitta; Jahan, Ismat; Sumanasena, Samanmali P; Ramji, Siddarth; Shankaran, Seetha; Thayyil, Sudhin
• Other Names: author non-byline.; Seeralar Arasar author non-byline.; Kamalarathnam Chinnathambi N author non-byline.; Shivarudhrappa Indramma author non-byline.; Jahan Ismat author non-byline.; Somanna Jagadish author non-byline.; Mondkar Jayashree author non-byline.; Mendoza Josephine author non-byline.; Jayaraman Kumutha author non-byline.; Sundaram Mangalabharathi author non-byline.; Sajjid Mohamed author non-byline.; Shahidullah Mohammod author non-byline.; Sebastian Monica author non-byline.; Baburaj Mythili author non-byline.; Benakappa Naveen author non-byline.; Montaldo Paolo author non-byline.; Bassett Paul author non-byline.; Bandiya Prathik author non-byline.; Vinayagam Prakash author non-byline.; Rodrigo Ranmali author non-byline.; Sujatha Radhika author non-byline.; Chandramohan Rema author non-byline.; Moni Sadeka C author non-byline.; Sumanasena Samanmali author non-byline.; Radha Saritha J author non-byline.; Ramji Siddarth author non-byline.; Shankaran Seetha author non-byline.; Pant Stuti author non-byline.; Thayyil Sudhin author non-byline.; Manerkar Swati author non-byline.; Oliveira Vania author non-byline.;
• Is Part Of: BMJ global health. Volume 6:Issue 5(2021)
• Publication Date: 2021-05-21
• Subjects: child health -- public health -- qualitative study -- randomised control trial -- clinical trial; World health -- Periodicals; 362.105
• DOI: 10.1136/bmjgh-2021-005757
• Languages: English
• ISSNs: 2059-7908

Abstract

Abstract : Introduction: Time-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. Methods: Term 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. Results: A 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. Conclusion: Despite 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.