1.2 Guidelines & Regulations
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1.2 Guidelines & Regulations |
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The Nuremberg Code is a set of principles for human experimentation set as a result of the Nuremberg trials at the end of the Second World War. Specifically, they were in response to the inhumane Nazi human experimentation carried out during the war by individuals such as Dr. Josef Mengele. In August 1947, the judges delivered their verdict in the "Doctors' Trial" against Karl Brandt and several others. They also delivered their opinion on medical experimentation on human beings. Several of the accused had argued that their experiments differed little from pre-war ones and that there was no law that differentiated between legal and illegal experiments. In April of the same year, Dr. Leo Alexander had submitted to the Counsel for War Crimes six points defining legitimate medical research. The trial verdict adopted these points and added an extra four. The ten points constituted the "Nuremberg Code". Although the legal force of the document was not established and it was not incorporated directly into either the American or German law, the Nuremberg Code and the related Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Volume 46, which are the regulations issued by the United States Department of Health and Human Services governing federally funded research in the United States. In addition, the Nuremberg code has also been incorporated into the law of individual states such as California, and other countries. The Nuremberg code includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants. The ten points are: 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, over-reaching, 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 reasonable 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 will 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. THE NUREMBERG CODE [from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.] The code can be viewed HERE The
Universal Declaration of Human Rights was adopted by the General Assembly
of the United Nations in 1948. To give the Declaration legal as well
as moral force, in 1966, the General Assembly adopted the International
Covenant on Civil and Political Rights. Article 7 of the Covenant states
" ... no one shall be subjected without his free consent to
medical or scientific experimentation." |
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The Declaration of Helsinki is the code developed by the World Medical Association for the medical community in response to Nuremberg. The Declaration made an important distinction between therapeutic and non-therapeutic research and, like the Nuremberg Code, it made informed consent a central requirement for ethical research, but allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. However, the Declaration states that research with these groups should only be conducted when the research is necessary to promote the health of the population represented, and when this research cannot be performed on legally competent persons. It further states that when the subject is legally incompetent, but able to give assent to decisions about participation in research, then assent must be obtained in addition to the consent of the legally authorized representative The Declaration has been revised six times, most recently in October 2008, and includes in its 32 principles the statement that "the benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods." Although it says that this does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic, or therapeutic method exists, this stipulation is very controversial since some interpret it to mean that a placebo should never be used whenever effective therapy is available, regardless of the seriousness of the condition being studied. The
Declaration is important in the history of research ethics as the first
significant effort of the medical community to regulate itself. |
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The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949. CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research. CIOMS promulgated guidelines in 1993 entitled International Ethical Guidelines for Biomedical Research Involving Human Subjects. These 15 guidelines address issues including informed consent, standards for external review, recruitment of participants, and more. For further information about CIOMS and its guidelines, refer to http://www.cioms.ch/ The 15 guidelines include: International Ethical Guidelines for Biomedical Research Involving Human Subject International Guidelines for Ethical Review of Epidemiological Studies |
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In the 1950's and 1960's, US federal funding for biomedical research increased dramatically but at the same time there was increasing public concern expressed about research reports such as Tuskegee and other biomedical abuses. In response to this public outcry, US Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974 to make recommendations for the conduct of research involving humans. The primary task of the National Commission was to identify the ethical principles that would guide all research involving humans. In 1979, the National Commission wrote The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects, which serves as the cornerstone upon which Federal regulations for the protection of human research participants are based. The
Belmont Report identified three fundamental principles essential to the
ethical conduct of research with humans: These three principles formed the foundation for the conduct of research, including guidelines for obtaining informed consent, respect for privacy and confidentiality, and risk/benefit assessment. RESPECT
FOR PERSONS - GUIDING PRINCIPLES 1.
Individuals should be treated as autonomous agents. Prospective research participants must be given the information they need to determine whether or not to participate in a study. There should be no pressure to participate and ample time to decide. Respect for persons demands that participants enter into the research voluntarily and with adequate information, this is called informed consent. 2.
Persons with diminished autonomy may need additional protections. BENEFICENCE The principle of beneficence obligates the researcher to maximize possible benefits and minimize possible harm. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the involved harms or risks. Balancing risks and benefits is an important consideration. The goal of much research is societal benefit, however, in the interest of securing societal benefits; no individual shall be intentionally injured. JUSTICE Justice is a difficult and complex ethical issue. Attempts must be made at all times in the study to distribute the risks and benefits fairly and without bias. Also, unless there is clear justification, research should not involve persons from groups that are unlikely to benefit from subsequent applications of the research. The concept of justice may be questioned when deciding who will be given an opportunity to participate, who will be excluded, and the reason for exclusion. When making such decisions, the researcher must ask: Are some classes of persons being selected simply because of their availability, their compromised position, or their vulnerability - rather than for reasons directly related to the problem being studied? |
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