Informed consent, clinical trials responsibility

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

The IRB s oversight responsibility is highlighted by this amendment, which was enacted to ensure that an informed consent is obtained before any trial-related clinical procedures are performed. 

Academic, cultural (including religious), ethical and medical attitudes also diverge within the EEA. For example, with the exception of clinical trial participation, in many European countries a requirement for written informed consent is seen as unethical no informed consent means no therapy, and therefore the patient may be under duress, or provide uninformed consent in order to gain access to medical treatment. Furthermore, the notion that some of the burden of responsibility for drug exposure could shift to the patient can also be seen as an abrogation of the responsibility of the prescriber or pharmacist. 

Freely given informed consent should be obtained from every subject prior to clinical trial participation. Informed consent of a subject includes informing the subject that the trial involves research, their participation is voluntary, and they may refuse to participate or withdraw at any time without penalty or loss of benefits. The subject is also informed of the purpose of the trial and the probability of being assigned to each treatment in the trial, the trial procedures to be followed, and the subject s responsibilities in the trial. The subject is informed of any reasonably foreseeable risks and potential benefits of the study and any alternative courses of treatment other than participation in the study. 

Informed consent was first formulated under international law through the Declaration of Helsinki, and in response to the atrocities of the Second World War. The principles of informed consent are under continuous review and discussion (e.g. Marsh, 1990). This is to be expected when reasonable standards of informed consent are dependent not only upon the design of a particular study, but also on environmental factors, the current state of medicine, and particular local characteristics of clinical trials populations, all of which are themselves continuously changing. 

In the case of an emergency, and when the person with parental responsibility is not contactable prior to the inclusion of the participant in the trial, a legal representative for the minor can give informed consent. In the UK, that will be someone other than the person involved in the conduct of the trial, who by virtue of his or her relationship with that minor is suitable to act as a legal representative for the pnrposes of the trial and is available and willing to act for those pnrposes. When no such person is available, a doctor who is primarily responsible for the medical treatment provided to the child, and is not connected to the clinical trial, can act as a professional representative. It is possible, however, that it would still be unlawful if the research were not expected to benefit the child in question. 

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