It encompasses the ethical and scientific aspects to be considered when planning, performing, documenting and reporting all phases of the clinical trial. The regulations and guidelines in conducting these trials are set forth in order to safeguard the rights, safety and overall well-being of trial subjects.
In the process of obtaining human subjects for the clinical trial, it is necessary to procure a written informed consent from the persons involved. The Nuremberg Code of 1947 states that, "voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.” " (Mitscherlich et. al., par. 2)
In cases where an individual is considered unable to give informed consent, such as in the case of unconscious patients, children, and/or mentally ill patients, another person is generally authorized to give consent on their behalf. This is permissible only if the necessity of having this particular set of subject has been established and that there are no other alternatives otherwise.
Also, the subject should be duly informed of his right to terminate his participation in the experiment at any given time, provided that he informs the investigator of his intentions to withdraw from the study and his reason for doing so.
The ICH GCP guideline on informed consent maintains that, "The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject's consent. Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favourable opinion in advance of use. The subject or the subject's legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject's willingness to continue participation in the trial. The communication of this information should be documented." (ICH GCP 4.8.2, page 20)
The written approval or favorable opinion of the written consent form and other written information to be given to the subjects should be obtained from the IRB/IEC before starting the clinical trial. (ICH GCP 4.8.1, page 20)
Question #2: Can the testing of medicines in healthy volunteers be justified according to the