ReviewThe ethics of neonatal research: An ethicist's and a parents' perspective
Introduction
The ethics of neonatal research is complex because new parents, who are generally in a vulnerable position, are asked to consent on behalf of their fragile baby. In the vignette above, illustrating the experience of a new mother, Liam's mother is referring to one of the neonatal trials in which two ranges of oxygen saturation, both of which were within the usual standard of care, were compared [1]. Another of these studies, the SUPPORT trial, has generated controversy because of the nature of the research and the informed consent process [2]. When the parents' experience and perspective is considered, the ethics of neonatal research, especially related to consent, is worthy of discussion. Following a review of the history of research ethics, this article examines and discusses from the parents' and the ethicist's perspectives the consent process and its limitations for parents, their children and researchers. In addition, challenges and opportunities are identified and ideas for future research are proposed.
Section snippets
The birth of research ethics and neonatology
In the 1960s, revelations of abuses of human subjects in biomedical experiments were made public. The Nuremberg Code set out standards for the conduct of medical research. Regulations were developed around the world, designed to protect patients from unethical and potentially harmful research. These included the Belmont Report in 1979, the establishment of the National Human Investigation Board in the USA, and the requirement for establishment of Institutional Review Boards (IRB) across North
Confidentiality
Confidentiality is considered to be essential in both the clinical and research worlds. Indeed, when a project undergoes ethics review, this element is scrutinized thoroughly. We have observed during our family-centered investigations that parents may be harmed by anonymity. For example, in a recent project, we asked 332 parents who lived with children with trisomy 13/18 about their perspectives and their family experience [9], [10]: why they continued their pregnancies after the diagnosis;
Reporting primary outcomes in neonatal research
Many neonatal trials report composite outcomes such as “death or severe retinopathy” [2], “death or bronchopulmonary dysplasia“ [27] or “death or severe disability” [28]. Although it may appear statistically appropriate to combine these competing outcomes together, we should consider how such reporting can affect neonates and their parents. For parents, death and retinopathy are not comparable, nor are any of the composite outcomes stated above. Such use of composite outcomes is considered
Conclusion
Neonatal research is essential in order to continue improving the outcomes of neonates. Currently, empirical investigations examining patient/parental perspectives on research and research ethics are lacking. Rigorous research is needed to examine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. We need to develop innovative ways to approach parents and optimize the consent process, not by making it more complex, nor more
Conflict of interest statement
None declared.
Funding sources
None.
References (35)
- et al.
Do sick newborn infants benefit from participation in a randomized clinical trial?
J Pediatr
(1999) Preterm labor in twins and high-order multiples: update in fetal medicine
Clin Perinatol
(2007)- et al.
Accounting for multiple births in neonatal and perinatal trials: systematic review and case study
J Pediatr
(2010) Prospects for fetal surgery
Early Hum Dev
(2013)- et al.
Toward the ethical evaluation and use of maternal–fetal surgery
Obstet Gynecol
(2001) - et al.
Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial
JAMA
(2013) - et al.
Target ranges of oxygen saturation in extremely preterm infants
N Engl J Med
(2010) Reflections on errors in neonatology: I. The “hands-off” years, 1920 to 1950
J Perinatol
(2003)Oxygen treatment of premature babies and cerebral palsy
Dev Med Child Neurol
(1964)The shared decision-making continuum
JAMA
(2010)
Life and death choices in neonatal care: applying shared decision-making focused on parental values
Am J Bioeth
Short-term outcomes of infants enrolled in randomized clinical trials vs those eligible but not enrolled
JAMA
Our children are not a diagnosis: the experience of parents who continue their pregnancy after a prenatal diagnosis of trisomy 13 or 18
Am J Med Genet A
The experience of families with children with trisomy 13 and 18 in social networks
Pediatrics
What do parents think about enrolling their premature babies in several research studies?
Archs Dis Childh Fetal Neonatal Ed
Multiples and parents of multiples prefer same arm randomization of siblings in neonatal trials
J Perinatol
Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment
Pediatrics
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