Abstract

Research is the cornerstone of progress in medicine. Neonatal research, both basic science and the randomized controlled trial (RCT) have demonstrated the positive and negative aspects of new treatments. The RCT is recognized as the gold standard for determining the effectiveness of new treatments. Informed consent is central to any research taking place but in neonatal research this presents a number of problems. By the nature of the subjects, the consent is ‘proxy consent’. In addition, the timing of the consent is often shortly after birth and/or at times of severe emotional distress. Recent research has shown that the quality of the informed consent falls below the requirements expected of it. This appears greatest for research where consent is required urgently and/or the study is considered to have significant risks. Whilst the research ethics committee places great store on the value of the parent information leaflet, parents appear to rely more on the communication by the doctor obtaining the informed consent in their decision making. Improvements to the obtaining and validity of informed consent for neonatal research are possible through improved understanding of the role of all those involved. The meeting with parent(s) to obtain informed consent should be viewed as the first stage of continual involvement of parents and their baby(s) in a research project.

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