Elsevier

The Lancet

Volume 356, Issue 9247, 16 December 2000, Pages 2045-2051
The Lancet

Articles
Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study

https://doi.org/10.1016/S0140-6736(00)03401-2Get rights and content

Summary

Background

Questions have been asked about whether the process of obtaining informed consent from parents to clinical trials on neonates leads to valid consent. We undertook a study in nine European countries to assess this issue and to seek any practical improvements.

Methods

Semi-structured interviews were conducted with parents of 200 babies who had been asked for consent to neonatal trials and 107 neonatologists seeking consent. Analysis assessed the validity of the consent process against four components: parental competence; information given; parental understanding; and voluntariness of consent.

Findings

59 of the 200 parents had given valid consent or refusal but the remainder had problems in one or more of the component areas (42 for competence, 43 for information, 44 for understanding, and 21 for voluntariness). The proportions with impaired consent were greatest for research in an emergency situation and for that associated with risk or discomfort greater than standard treatment. Information sheets were little used by parents in deciding whether to consent. Parents highly valued their involvement in the informed consent process, and clinicians generally agreed on the value of the process.

Interpretation

Current standards of informed consent to neonatal research projects could be improved. Research personnel should receive guidance on legal and ethical constraints governing the process. Oral and written information should be given at the same time. Parents could be made aware that research projects have been examined by research ethics committees. Little support was found for the argument that informed consent should be relinquished for the parents' own good. Further study is needed to identify which elements of the process are valued by parents and clinicians in a process that has some unavoidable limitations.

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.

Section snippets

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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