Schedule 1 (Regulation 2) Part 1 of the Regulations specifies the application and interpretation of the conditions and principles of Good Clinical Practice (GCP) and also refers to the Declaration of Helsinki adopted by the World Medical Association (WMA) in June 1964. Part 2 of this schedule in the Regulation states the principles and conditions that apply to all clinical trials and that are based on the principles of ICH GCP, whilst Part 5 specifies the conditions and principles which apply in relation to an incapacitated adult (Statutory Instrument 2004).
"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."
As the patients will be unconscious in this trial they will be considered to be physically incapacitated adults under the governing Regulations, and therefore unable to give informed consent. First of all informed consent in this group of subjects can only be considered if the subjects are able to benefit from research that can improve their condition.