Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

Abstract

BackgroundPediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians.MethodologyAn empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice.ResultsAnalysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents.ConclusionDue to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes.

Recruiting ethnic minority participants to a clinical trial: a qualitative study

“…The difficulty some parents had in distinguishing clinical treatment from research reflects previous reports, [8][9][10][11] while the finding about parental reassurance and sense of control are in line with earlier work relating to consent by proxy. [7][8][9][10][11] Studies on lay understanding of the purpose of genetic sampling have also found a lack of concern about this. 14 15 Implications for the conduct of research We concur with the view that representative ethnic minority participation in trials is feasible if researchers take appropriate steps to facilitate this.…”

“…7 Significant elements include parents' poor comprehension of the trial process, 8 the parental emotional turmoil related to paediatric illness and confusion born of the blurring of ethical boundaries between clinical and research practice. [9][10][11] Parent study The current study is embedded within a randomised controlled trial (the parent study) of the genetic determinants of the efficacy of intermittent montelukast in preschool wheeze (PSW) and provides an opportunity to investigate the perspectives of the parents of trial participants. It was hypothesised that a genetically determined subgroup of patients (with higher urinary inflammatory mediators) would respond better to montelukast (have reduced unscheduled medical attendance) than their peers.…”

Making research central to good paediatric practice

“…If you add to this some ‘bad apple’ stories of when the experience of healthcare professionals of research being unwieldy, impractical and unusable in the ’real world' of clinical practice along with ethical knots that may be tied20 there is a chunky barrier to overcome. It can be possible though—and there are several examples to demonstrate that it is practical.…”

International clinical trials, cardiovascular disease and treatment options in the Russian Federation: Research and treatment in practice

“…The rationale for differentiating research and treatment in RCT conduct, as elaborated within an influential strain of predominantly bioethics literature, lies in the potential conflict between the treatment aim of enhancing the wellbeing of an individual patient and the research aim of producing generalizable knowledge to guide the care of future patients (Appelbaum, 2010;Belmont Report, 1979;Miller, 2004;Miller and Brody, 2003;Morreim, 2005;de Melo-Martín and Ho, 2008;de Vries et al, 2011). Healthcare professionals provide patients with individualized diagnostic procedures and treatments, guided by the patients' best interests.…”