Evidence Library

Title: Exception from informed consent for pediatric resuscitation research: Community consultation for a trial of brain cooling after in-hospital cardiac arrest.
Author: Morris, M., Nadkarni, M., Ward, F. & Nelson, R.
Date Published: 2009
Reference: Pediatrics, 114(3), 776-781.
Are service users or carers authors: Yes

Abstract: The researchers in this study carried out a consultation of health care professionals and parents of current and past patients at a children's hospital. The aim was to explore the ethical dilemmas around obtaining consent for their clinical trial. They were hoping to conduct a trial to find out if brain cooling would be beneficial for children as part of the treatment following a cardiac arrest in hospital. The cooling needs to begin within 30 minutes of the cardiac arrest. The parents and health professionals all agreed it would be unethical to try to obtain consent from parents at this traumatic time. The parents also concluded that it would be unethical to ask all parents about the possibility of their child entering the trial at the time of admission. They suggested that the best solution would be to ensure that all families were made aware of the study via posters and leaflets in the hospital, and that parents were given at an opportunity to opt out of the study in the 30 mins before starting treatment.
The consultation thus identified a way of conducting the trial, without the need to obtain informed consent, in a way that was likely to be acceptable to families, health professionals and the institution.

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Related entry: none currently available

Categories: health
impact on research ethics
impact of public involvement
journal article

Date Entered: 2010/09/28

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