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The challenges of seeking consent from adults to participate in acute research studies
Lookup NU author(s)
Dr Lynne Stobbart
Dr Madeline Murtach
Professor Gary Ford
Dr Tim Rapley
Professor Helen Rodgers
Lecouturier J, Stobbart L, Murtagh MJ, Ford GA, Rapley T, Louw S, Rodgers H
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In this paper the current legislative landscape and the challenges researchers face in obtaining informed consent in acute situations are explored. In such situations, some current guidelines can be difficult or impossible to apply. Capacity should be formally assessed before consent is sought to ensure that vulnerable persons are neither inappropriately recruited to a study nor denied the opportunity to participate. However, there is little guidance in current legislation as to how this should be achieved. When the patient is considered to be unable to provide prospective informed consent other forms are sometimes permissible although all have specific drawbacks. Firstly, we will argue that a brief instrument, suitable for the acute situation, is needed to determine whether patients have the capacity to consent to clinical trials. Secondly, we will argue that there are areas of the informed consent process that require review and suggest ways that improvements could be made.
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