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Improved procedures may improve informed consent for neonatal research

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Obtaining truly informed consent for neonatal research under difficult circumstances may be more achievable with new approaches. These originate from discussions of European neonatologists, ethicists, sociologists, and legal experts—all participants in the Euricon trial.

Urgent or emergency situations when parents are asked to consent to research treatment for their child are especially difficult. Most doctors would probably suspect that here informed consent is compromised by circumstances that hinder parents absorbing and processing complex information.

Alternatives to current process might seek consent in a stepwise or a continuous process—with information initially given by the doctor and later chances to withhold or withdraw consent. Both would allow more time for parents to deal with complex information. A stepwise process would see parents deciding from core information, with more detailed information given later, and a continuous process with them deciding from all information given up front, repeated at later stages, sparing them the realisation that they might have withheld consent at the outset, had they understood the full picture.

Importantly, parents should not assume that responsibility for their child’s welfare is theirs alone—it extends to researchers, grant awarding body, senior hospital staff, and research ethics committee. They may be reassured if they know that the research has committee approval, though this should not be allowed to interfere with their decision, and great care must be used to avoid coercive language.

At worst the Helsinki declaration would permit research treatment without parental consent, but this would be a rare event, occasioned by an extreme situation.