ArticlesObtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study
Introduction
It is normal practice for informed consent to be obtained from parents for research on newborn infants. For consent to be valid, parents must be deemed to be mentally competent, to have received appropriate information, to be able to understand the information, and to give consent voluntarily.1 However, the research may need to be carried out urgently, may be potentially life-saving or complex (eg, a randomised controlled trial), and there could be significant risks. Some commentators have suggested that the process undertaken does not always lead to valid informed consent; indeed, it has been described as a ritual2 and a sham.3 Nonetheless, it is legally necessary in Europe4 and is widely seen as ethically vital.5
We present an examination of the validity of obtaining informed consent for neonatal research across Europe. We report on the experience of parents asked for consent and of clinicians seeking it. The paper is part of a larger project funded by the European Union, the Euricon study,6 which also sought to investigate legal and ethical guidelines on the obtaining of informed consent for neonatal research across Europe, the structure of research ethics committees, and their views on this subject. The project aimed to suggest practical improvements if necessary. Such Europe-wide studies are necessary in view of the increasing need for international recruitment to clinical trials so that sufficient statistical power can be achieved to answer research questions as quickly as possible.
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Participants
Between January, 1997, and September, 1998, we undertook semi-structured interviews with parents of 200 infants who had been asked to consent for their baby to take part in a trial and with 107 neonatologists in nine European countries (table 1). The sample of countries was designed to be geographically representative; accordingly, neonatologists of the European Neonatal Brain Club (an informal organisation) were invited to take part in the study. The participating countries represented
Discussion
Inevitable limitations arose from the large-scale design and size of this study. For example, there was no in-depth observation of the actual consent process, so neither the information conveyed to each parent nor the interactions involved were accessible. There was variability in the trials for which consent was sought, and babies varied in the severity of their illness. However, lack of depth in the data may be offset by the gain in breadth from this cross-cultural study and, therefore, in
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Cited by (0)
Co-authors and study organisation given at the end of the paper