Informed consent is defined in ICH as:
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written signed and dated informed consent form.
This SOP describes the procedure for obtaining written informed consent from a subject in a Clinical Trial of an Investigational Medicinal Product (CTIMP) study. The Regulations define informed consent as follows:-
“A person gives informed consent to take part in a clinical trial only if his decision:
The same definition also applies to the giving of informed consent by a person with parental responsibility, or a legal representative, on behalf of the trial subject.
This SOP applies to all investigators and research team members involved in the conduct of Clinical Trials (as defined in the Regulations) sponsored or co-sponsored by King’s Health Partner Organisations and will be followed in accordance with each Partner NHS Organisations’ local policy for consent.
The informed consent process will be monitored for compliance with the Regulations and this SOP by the KHP CTO Quality Team.
SOP: Obtaining Informed Consent for Clinical Trials (.pdf 7000Kb)