The ethics of neonatal research: An ethicist's and a parents' perspective.
The ethics of neonatal research are complex because vulnerable new parents are asked to provide consent on behalf of their fragile baby. Whereas clinical neonatal care has evolved to value personalized and shared decision-making, the goal of research ethics is still to standardize the informed consent process and make it as complete and thorough as possible. Ethicists, lawyers and physicians have shaped the field of research ethics and consent for research. The goal of detailed informed consent is to protect participants from harm, but procedures were developed without input from the principal stakeholders: ex-neonatal intensive care unit parents/patients. Empirical investigations examining patient and parental perspectives on research and research ethics are lacking. Rigorous investigations are needed to determine how parents of sick neonates want their families to be protected, knowing that a lack of research is also harmful. Large randomized controlled multicenter trials will always be needed to improve neonatal outcomes. These trials are costly and time-consuming. Currently, the way in which research is funded and regulated and the way in which academic merit is recognized lead to inefficiency and a waste of precious resources. Following a review of the history of research ethics, this article examines and discusses the ethics of research in neonatology. In addition, challenges and opportunities are identified and ideas for future investigations are proposed.
Department of Pediatrics and Clinical Ethics, University of Montreal, Montreal, Canada; Sainte-Justine Hospital Research Center, Montreal, Quebec, Canada. Electronic address: anniejanvier@hotmail.com.
Annie
A
Janvier
The DeVeber Institute for Bioethics and Social Research, North York, Ontario, Canada; Patients for Patient Safety Canada, Canadian Patient Safety Institute, Canada.
Barbara
B
Farlow
D035843:Biomedical Research / Q000941:ethics*; D026822:Ethicists; D006801:Humans; D009359:Neonatology / Q000941:ethics*; D010290:Parents
Confidentiality; Family-centered care; Informed consent; Intensive care; Neonatology; Parent perspectives; Research ethics