Valid informed consent and decision-making capacity in clinical trials

Valid informed consent and decision-making capacity in clinical trials
Discussion
Vittoria Sorice, Louise Burton, Amy Neal, Jodie Bradder
Nursing Times, 1 August 2022; 118(8)
Abstract
There are ethical and legal requirements involved in the consent process for research involving human participants. The Mental Capacity Act 2005 introduced a framework outlining how choices should be made by, and on behalf of, people lacking decision-making capacity. This ensures vulnerable groups are protected from being enrolled into clinical studies without their informed consent, and gives people access to studies that are of benefit to themselves and the field of clinical research.