Clinical Trials Regulations 2004 - Essay Example

The provisions include the establishment of a UK Ethics Committee Authority; the requirements for authorization and ethics committee opinions and provisions for the protection of adults incapable of giving informed consent and who should be able to benefit from research that can improve their condition (Statutory Instrument 2004). Schedule 1 (Regulation 2[1]) 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 to an incapacitated adult (Statutory Instrument 2004).

Article 1.28 of the ICH-GCP guidelines defines informed consent 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 using 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 can benefit from research that can improve their condition. So informed consent at UK hospital sites would have to be taken by a legal representative who is independent of the research team and should act based on the person’s presumed wishes as defined by the Declaration of Helsinki (1964) Part B (21-26). According to Article 5 of Directive 2001/20/EC, this legal representative will be the person with a strong relationship to the subject in the first instance. If they are not available or are unwilling to do then the doctor primarily responsible for treating the subject would act in this capacity. Failing that, then the health care provider would nominate an individual. This differs slightly in Scotland where this trial would fall under the Adults with Incapacity (Scotland) Act 2000 (Statutory Instrument 2004).

The practical considerations of this situation are that information about the trial would need to be readily available to health providers for distribution or to be brought to the attention of those at risk. This information would also need to be available to ambulance crews and accident and emergency staff as they are likely to be first at the scene of a stroke. They would also need to be suitably trained as stated in the Declaration of Helsinki (1964) and ICH GCP (2002). This would also entail health providers such as hospitals setting up standard operating procedures and processes for nominating legal representatives on a per-trial basis. This would mean preparing patient information sheets/leaflets which state what will happen to the subject, when, and where; not providing financial incentives to increase participation. An ethics application would be completed as well to review the appropriateness of the patient information sheets and proposed routes and methods of recruitment.

This would mean that a favorable ethical opinion would need to be acquired before conducting this trial and this would involve submitting the patient information sheets, consent forms, protocol, and other supporting documentation to the research ethics committee. Read More