Clinical Trials and People who lack capacity to consent to participating

We’ve heard some examples of people being entered into COVID-19 related clinical trials.  There is specific guidance covering situations where people lack the mental capacity to consent to this in The Medicines for Human Use (Clinical Trials) Regulations 2004, which can be found here. Schedule 1, Part 5 covers conditions and principles which apply in relation to an incapacitated adult.   Further information is available on Health Research Authority Webpages here.

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