In line with GCP and ICH guidelines, the participants must be given a patient information sheet detailing the study which must be introduced and discussed with a GCP qualified person, usually the doctor in charge of the participant or a research nurse. This must also include informing the participant of any pain implications or about possible risks or side effects as well as discussing any possible alternative treatment. The participant must have ample time to consider the study and should be advised to talk it through with members of their family. Once they have had time to answer any questions then with the GCP delegated person the consent form can be signed.
The original consent form must be filed in the Investigator Site File together with a copy of the patient information sheet in recruitment order, with a copy for the participant and a copy in the participant’s medical records.
This process needs to be clearly documented in the medical records including the full study title (avoiding the sole use of acronyms).
In cases where the participant is unable to read or write or speaks another language, then a witness should be available to ensure that the participant has been informed and has had time to consider the study and ask questions. As well as the participant or the legal representative the witness should also sign and date the consent form to confirm that the information was accurately explained and that the informed consent was given.
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Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB
Telephone: 0117 4149330
Email: research@nbt.nhs.uk