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The Development of Informed Consent Regulations

Although it is well accepted that the regulation and theory of informed consent in the medical field arose to a large degree independently in medical research ethics and clinical practice and treatment ethics [Faden & Beauchamp, 1986,Appelbaum et al., 1987], most of the major internationally recognised movements for standards and regulation occurred in medical research, in response to events which affected many people, such as human experimentation in World War II, the Tuskegee syphilis trials (as elaborated on later in this chapter), and other horrific medical experiments carried out in the name of research. I am interested particularly in the establishment of these international guidelines and standards as an exercise in implementation of worldwide governance standards that were then adapted and adopted by various countries as law.

An investigation into the history of informed consent theory usually begins with the result of the Nuremberg Trials [Faden & Beauchamp, 1986,Appelbaum et al., 1987], which is generally accepted as being the first official statement made in medical research ethics specifically on the topic of informed consent. The trials arose from the reaction to the atrocities committed by Nazi physicians in World War II, where human beings had been used against their will in experiments in the name of medical research. One of the main outcomes was to establish the Nuremberg Code, which called for the requirement for medical research subjects to exercise ``free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion'' [U.S. Government, 1949]. This code formed the basis for subsequent informed consent theory, and although not formally established as part of US or German law, was used in the creation of separate law governing medical research on human subjects in the United States [United States Department of Health and Human Sciences, 2000], and has been referred to since by most documents pertaining to informed consent theory and practice.

The Nuremberg Code, however, focusses mainly on providing guidelines for medical research ethics in specific response to the crimes committed by the doctors in World War II. One of the more famous examples of these guidelines is from the first point of the code, that ``the voluntary consent of the human subject is absolutely essential'' [U.S. Government, 1949]. It offers no justifications for the values embedded in the Code and provides no specific definitions of some of the requirements that could be interpreted in a wide variety of ways, such as the definitions of ``coercion'', ``voluntary'', ``legal capacity for consent'', and ``free power of choice'' as used in the Code, or what tests are to be done in order to ensure these conditions are met, etc. in order to know that the subject is giving the ``enlightened decision'' required [U.S. Government, 1949]. Some of these concerns were brought up at the time and have persisted in their controversy, especially the concerns about competence, such as dealing with the mentally ill and the problems of explaining complex medical procedures to the non-medically trained (Appelbaum et al. 1987, p. 59). Despite the problems inherent within the Code, however, it provided a starting point for world-wide discussion about informed consent requirements and theory.

The next major development world-wide in the establishment of informed consent requirements was the Declaration of Helsinki, founded out of increasing international awareness of the importance of informed consent in research and medical practice. In 1964 it was adopted by the World Medical Association, and has been a primary referenced document for issues pertaining to treatment of research subjects. The Declaration sets out a list of principles for medical research and medical research combined with medical care. These principles range from the requirement that the research being conducted is registered in a publicly accessible database through to dealing with privacy of the research subjects. On informed consent in research, it requires that:

...each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. [World Medical Association, 2004]

The Declaration was developed as an international answer to the United Kingdom Medical Research Council's ethics statement, and is still in common use today. The UK MRC statement was based directly on the Nuremberg Code, and distinguished between the two main areas of medical experimentation: therapeutic and non-therapeutic research. Despite these progressions in identification and formalisation of guidelines for conduct of researchers, the regulation of such guidelines, at least in the United States of America, was not well established until 1966 when the Public Health Service, parent body of the National Institutes of Health, required grant recipients to ensure that informed consent was obtained from subjects who were aware of the risks and benefits [Appelbaum et al., 1987]. Over the years these clauses were expanded following discoveries of ongoing experiments in which the subjects were treated inhumanely, such as the following example of the Tuskegee syphilis trials, and the Declaration of Helsinki itself was revised as recently as 2004 [World Medical Association, 2004].

The Tuskegee syphilis trials ran from 1932 to 1972. It was a trial in which poor, mostly illiterate, black sharecroppers in the southern United States were used as case studies for documentation of the progression of untreated syphilis, even after penicillin had been a readily available and safe treatment. The physicians in the study told the subjects they were being treated for ``bad blood'', and after treatment was available, went to great lengths to prevent the subjects obtaining the treatment. The doctors say they believed that they were truly helping the families, however, claiming that they would have otherwise died from the disease and that they were provided with regular medical checkups (and care for non-syphilis-related issues), free meals, and, somewhat ironically, free burial insurance (a full history is detailed by Jones (1993)). The fallout of the revelations of this and other similarly horrific experiments were even more refinements to regulations for experimental study in the United States [Appelbaum et al., 1987], such as the National Research Act of 1974 and the 1978 Belmont Report, both of which were drafted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research as a direct response to the Tuskegee incident.

The Belmont Report (1978) outlines some ethical values in experimental research. The ``Basic Ethical Principles'' in the document outline principles that focus on the autonomy of subjects, with requirements for ``respect for persons'', treating individuals as ``autonomous agents'', and protecting ``persons with diminished autonomy'' (NCPHSBBR, 1978). The right to autonomy as indicated here is one of the grounding principles upon which modern informed consent theory is based, and this, among the other principles, will be discussed in section 1.2.1.

next up previous contents
Next: Informed Consent Regulations Today Up: History of Informed Consent Previous: History of Informed Consent   Contents
Catherine Flick 2010-02-03