Informed consent in ethics usually refers to the idea that a person must be fully informed about and understand the potential benefits and risks of their choice of treatment. A correlate to "informed consent" is the concept of informed refusal. An uninformed person is at risk of mistakenly making a choice not reflective of his or her values or wishes. It does not specifically mean the process of obtaining consent, or the specific legal requirements, which vary from place to place, for capacity to consent. Patients can elect to make their own medical decisions or can delegate decision-making authority to another party. If the patient is incapacitated, laws around the world designate different processes for obtaining informed consent, typically by having a person appointed by the patient or their next of kin make decisions for them. The value of informed consent is closely related to the values of autonomy and truth telling.
The Nuremberg Code has not been officially accepted as law by any nation or as official ethics guidelines by any association. In fact, the Code's reference to Hippocratic duty to the individual patient and the need to provide information was not initially favored by the American Medical Association. The Western world initially dismissed the Nuremberg Code as a "code for barbarians" and not for civilized physicians and investigators. Additionally, the final judgment did not specify whether the Nuremberg Code should be applied to cases such as political prisoners, convicted felons, and healthy volunteers. The lack of clarity, the brutality of the unethical medical experiments, and the uncompromising language of the Nuremberg Code created an image that the Code was designed for singularly egregious transgressions.
However, the Code is considered to be the most important document in the history of clinical research ethics, which had a massive influence on global human rights. The Nuremberg Code and the related Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Part 46, which are the regulations issued by the United States Department of Health and Human Services for the ethical treatment of human subjects, and are used in Institutional Review Boards (IRBs). In addition, the idea of informed consent has been universally accepted and now constitutes Article 7 of the United Nations' International Covenant on Civil and Political Rights. It also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization
The Nuremburg Code 1947
The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects in a new code that is now accepted worldwide.
This judgment established a new standard of ethical medical behavior for the post World War II human rights era. Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body.
This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided.
This code recognizes that doctors should avoid actions that injure human patients.
The principles established by this code for medical practice now have been extened into general codes of medical ethics.
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:
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.
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.
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.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
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.
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.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
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.
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.
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.