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

Abstract

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.

Need for more evidence in the prevention and management of perinatal asphyxia and neonatal encephalopathy in low and middle-income countries: A call for action

“…The supportive care for neonatal units that do not have basic neonatal care as in sub-Saharan Africa [ 50 ] would be very different to the situation in south Asian neonatal units with good neonatal intensive facilities, and no generalizations should be made. If a hospital has no facility for basic neonatal care, it would be prudent to establish this first before introducing novel neuroprotective interventions [ 51 ].…”

“…Consistently high scores were obtained under these domains indicating adequate quality of informed consent, i.e., appropriate information was provided to parents. Subsequently, qualitative interviews with parents and professional were conducted to explore their views about the research participation [ 51 ]. Thematic analysis of the data suggested that the parental decision to participate was primarily based on an unreserved trust in the treating doctors, therapeutic misconception, and the opportunity to have an expensive treatment free of cost.…”

“…Most parents did not understand the concept of a clinical trial nor the nature of the intervention, despite detailed explanations about the study. Interviews with professionals (prior to the data analysis of the HELIX trial) showed a strong bias towards cooling therapy, as this was already a standard therapy in HICs and in most hospitals in LMICs [ 51 ].…”

Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial

“…Neonatal clinical trials in low and middle-income countries (LMICs) recruiting underprivileged population are challenging and require different approaches to high-income countries. In particular, parental consent rates of almost 100% in neonatal drug trials in LMICs raise concerns about the quality of informed consent 10 11. The high consent rates may be related to a wide range of factors including a genuine trust in treating clinicians,11 therapeutic misconception,11 lucrative financial incentives, especially in pharmaceutical trials managed by contract research organisations,12 13 or even complete unawareness about trial participation 14.…”

“…In particular, parental consent rates of almost 100% in neonatal drug trials in LMICs raise concerns about the quality of informed consent 10 11. The high consent rates may be related to a wide range of factors including a genuine trust in treating clinicians,11 therapeutic misconception,11 lucrative financial incentives, especially in pharmaceutical trials managed by contract research organisations,12 13 or even complete unawareness about trial participation 14. Hence, careful monitoring and transparent reporting of these issues are important to enhance the credibility of clinical trials in LMICs.…”