Participation in neonatal clinical trials is often viewed as risky, ethically challenging, burdensome for parents, and a favor that altruistic families are performing for future generations of babies.1,2 Views such as “valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain” are common.3 However, neonatal research need not be viewed through such a negative lens. Parents who have participated in clinical trials may view their research involvement very differently, as an exciting opportunity rather than a burden.4 Participation can have benefits for the newborn child and the family, even if the infant is not assigned by chance to a therapy that proves to be superior after completion of the trial.5,6
Collectively, as a group of research nurses and clinical investigators, we have discussed research participation with >900 families. We have found that when done well, conversations about consent to...
Comments
The need to understand the context of developing countries during consent discussions
In context of what has very aptly been stated by DeMauro et al[1] with respect to obtaining consent for clinical trials, we highlight the important aspects to be considered in developing country setting like India.
First; in many instances of government institutions, poor infrastructure, low doctor-patient ratio and overburdening of systems and processes by the huge number of people seeking care at these institutions[2], makes care-seeking quite a painful process. To make families understand the utility of research and ask for their participation when they are literally struggling for optimal clinical care, can be a demanding task.
In such scenario, the support committed to participant as part of research during consent seeking cannot often be limited to research work alone. It means providing comprehensive support services unrelated to research context not only to individual child, but even to siblings/relatives at times. We routinely encounter requests ranging from getting unrelated investigations done free of cost, to getting the enrolled patients siblings/relatives shown in OPDs or admitted at referral institutes. Though such support may be provided on merit, the person seeking consent should make sure that the family understands the research perspective and does not participate simply for sake of better access to clinical services.
Second is the issue of "courtesy bias". Very often in limited resource settings, research team is the same as clinical team. The aura of treating physician makes people at times agree to whatever he is asking, without a second thought. The most common statement encountered is, "If you are suggesting it, it must be best for the child". It is therefore important that the uncertainty of research be discussed honestly and the family be provided ample time to think and discuss about the potential benefits and risks of research to their child. The family should take informed decision assuming full responsibility, without putting onus for participation on the person seeking consent.
Next important consideration is the different social milieu of countries like India. Here, in many instances, parents, especially the mother, may not be the decision makers even when it comes to their own child. Rather, related elders of family decide what should be done, for reasons varying from the value system to financial dependence [3]. It is therefore important for any person seeking consent, to try and understand family dynamics and roles of different family members. We have encountered instances wherein written informed consent given by well-educated mother was withdrawn by the father on instigation of mother-in-law; where mother was sent back to her parents house because of her autonomy in taking decision to enroll their child in research; and another where only grandparents brought the child for health care visits and subsequently consented for enrolment in research without asking his parents. Though it might not be possible to predict such situations, it is advisable to refrain from taking consent from the vulnerable member only, who may later be penalized by the family for her decision- one needs to intricately balance patient confidentiality and family involvement.
References 1. DeMauro SB, Cairnie J, D'Ilario J, Kirpalani H, Schmidt B. Honesty, trust, and respect during consent discussions in neonatal clinical trials. Pediatrics 2014 Jul;134(1):e1-3. doi: 10.1542/peds.2013-3720. Epub 2014 Jun 9.
2. Bajpai V. The Challenges Confronting Public Hospitals in India, Their Origins, and Possible Solutions. Advances in Public Health, vol. 2014, Article ID 898502, 27 pages, 2014. doi:10.1155/2014/898502
3. Sen M, Rastogi S, Vanneman R. Disempowered by whom? Gender vs. generation in family decision making. Paper presented at the Annual Meeting of the Population Association of America; Los Angeles. March.2006
Conflict of Interest:
None declared