Vaccine Control Group
Study Participant Confirmation

International Code of Medical Ethics (World Medical Association)

The International Code of Medical Ethics drafted by the WMA develops the following principles and obligations:

• Obligation of care: The obligation not to refuse care to those who need it and not to discriminate on financial or other grounds is linked to the obligation to respect life and to consider emergency care as a humanitarian duty. This ethical obligation may also be found in criminal law under the offense of failure to assist a person in danger. The obligation to provide medical care compels doctors to act in the exclusive interest of patients
• Respect of patients’ consent: The obligation to inform the patient and to obtain and respect his or her consent before any act of care is paramount in order to protect the balance in the relationship between the doctor and the patient, and to ensure that the patient’s dignity is respected. This obligation puts the power that the doctor has over the patient into perspective. Even if the doctor must always act in the patient’s best interest, he cannot substitute himself for the patient and decide what the patient wants. This duty is well spelled out in most national laws, and gives rise to compensation before courts.

Source:  https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/

Importance of Informed Consent (UK NHS)

Consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination. The principle of consent is an important part of medical ethics and international human rights law.

Source: https://www.nhs.uk/conditions/consent-to-treatment/

The Nuremberg Code (1947)

Permissible Medical Experiments

The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:

1. The 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.
   The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.