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Overview of European legislation on informed consent for neonatal research
  1. S MASON
  1. A B GILL
  1. S REITER-THEIL on behalf of the Euricon Study Group
  1. Medical School, University of Athens, Greece
  2. Northern and Yorkshire Clinical Trials and Research Unit, University of Leeds, UK
  3. Department of Philosophy, University of Leeds, UK
  4. Department of Nursing, University of Sheffield, UK
  5. Department of Pediatrics, University Hospital, Trondheim, Norway
  6. Department of Neonatology, Leeds, UK
  7. University College, Cork, Ireland
  8. Faculty of Law, University of Leeds, UK
  9. Centre for Ethics in Medicine and Law, University of Freiburg, Germany

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Euricon, a European Union funded study,1 had the objective of examining the issue of obtaining informed consent for neonatal research across Europe. As part of that project, legal representatives from these countries (see acknowledgements) were invited to a colloquium to report, discuss, and analyse European legal frameworks governing informed consent for neonatal research. The first author (PDV) presented a general overview of European law, which is the basis for this report. Furthermore, specific supplemental information from different countries was given by legal representatives from these countries, and is summarised in table 1.

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Table 1

Summary of legal requirements in Europe for research in neonates

Legally and ethically, informed consent of the subject is a requirement for biomedical research. However, there are differing interpretations in European Law of this requirement for neonatal research. Increasingly, to answer many neonatal research questions, there is a need for multinational recruitment to randomised controlled trials and studies, and thus a need for investigators to be aware of the differing, relevant, national legislation.

The aim of this paper is to discuss areas of consistency and inconsistency in the law or practice governing informed consent for neonatal research in ten European countries (Denmark, Finland, France, Germany, Greece, Ireland, Norway, Spain, Sweden, and the United Kingdom). In particular, the following areas are examined: whether there is specific law governing informed consent for research and, if so, what it is; the ethical review system, whether there are specific requirements for consent, whether benefit for the individual child is a specific requirement, and whether research of no direct benefit (so called non-therapeutic research) is legally permitted in minors—for example, the taking of extra blood samples purely for research purposes.

The law governing neonatal research across Europe

A variety of laws and a plethora of ethical and professional guidelines govern the conduct of research within individual countries and …

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