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When we ask people to take part in a clinical trial, what information do they need in order to make up their minds? And after they have consented, what information would we like them to know as participants to ensure the trial runs smoothly and efficiently? Suppose the trial involves the testing of a new unlicensed medicine – would that change what we tell potential participants? Can we be sure that they will understand the days and times of their planned blood test visits? We provide the participant with written information – the ‘participant information sheet’ – so that they know about all these things. The information sheet plays an essential role in the process of obtaining consent from a participant.
The Declaration of Helsinki – first adopted in 1964 and revised several times since – lays out the requirements for recruiting participants to clinical research (1). Participants should be given written information to allow them to make an informed decision about whether or not to participate. They should also have access to a clinician when giving consent – someone who will answer their questions and provide clarification, if required. |
