The Nuremberg Code

This is essay that is intended to accomplish a complete evaluation of the significance of the Nuremberg Code and the Belmont report on patient rights. A critical analysis of the events that led to the creation of the Nuremberg Code and the Belmont report and the importance of those events will be done. It also discusses how the creation of the Nuremberg Code and the Belmont report affects the ethical issues surrounding clinical trials today. Finally, the ethical restraints and guidelines that exist for conducting clinical trials and how this relates to special populations like minors, prisoners and persons with mental disabilities among others are examined.

In the 20th century, the well-known cases of human subjects of abuse that were conducted by the Nazis during World War II, a case in point of research involving prisoners which came to light in the Nuremberg Doctors’ Trial led to the Nuremberg Code of ethical conduct for human subjects used in research. In 1948, the Nuremburg Code was set up which advocates that voluntary consent of the human subject is extremely vital; the subjects must give consent and the gains of the research must be more than the risks (UNLV, n.d).

The Tuskegee Syphilis Study led to the United States Congress approving the formation of the National Commission for the Protection of human Subjects in Biomedical and Behavioral Research or the National Commission in 1974 that led to the publishing of the Belmont Report in 1979. Belmont Report is a declaration of the basic ethical principles and guidelines that should assist in determining the ethical problems that surround the conduct of research with human subjects (Bernat, 2008).

Nuremberg Code. On the 9^th of December 1946, a famous episode in the history of research with human subjects started when an American military court opened criminal proceedings against twenty three top German physicians and administrators for willingly participating in war crimes and crimes against humanity. The Germany physicians were accused of conducting medical experiments on thousands of concentration camp prisoners without their permission. Most of the subjects that were used in these experiments were permanently crippled or died at the end of the experiments. At the end of the trial, in the year 1948 the Nuremburg Code was set up which states that the voluntary consent of the human subject is extremely vital; the subjects must give consent and the gains of the research must be more than the risks. Thus the Nuremberg Code was the first international document which supported voluntary participation and informed consent; it was aimed at assuring that research involving human subjects would be carried out in an ethical manner (UNLV, n.d).

The Belmont report. The Belmont Report tries to sum up the basic ethical principles identified by the commission in the course of its deliberations. It is a declaration of the basic ethical principles and guidelines that should assist in determining the ethical problems that surround the conduct of research with human subjects. The major event that led to publishing the Belmont report is the Tuskegee Syphilis Study which is likely the worst case of unethical use human subjects research in the history of the United States. Others events include: the Nazi atrocities in the second world war that drew attention to the lack of international standards on research with human subjects; the thalidomide disaster which led to the adoption of the "Kefauver Amendments" to the Food, Drug and Cosmetic Act, necessitating drug manufacturers to confirm to the FDA the effectiveness of their products before selling them; the Declaration of Helsinki; and finally the National Research Act that codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report (Zimmerman, 1997).

The three basic ethical principles identified in the Belmont Report that underlie all research involving human subjects include: respect for persons, beneficence and justice.

Respect for persons includes two ethical presumptions: the first one is that individuals should be treated as autonomous agents that are capable of making their decisions. Autonomous individuals have the capacity for self-determination. Respect for persons is demonstrated when an individual’s opinions and choices are encouraged and accepted. Lack of respect for persons is demonstrated when information is withheld and individuals are denied to make an informed decision by others.

Secondly, persons with diminished autonomy are entitled to protection. The capacity for self-determination develops during a person’s life, thus children have diminished autonomy. Also, the capacity for self-determination can be lost by some individuals due to physical illness, mental disabilities or situations that restrict personal freedom like military and prisons. Persons with diminished autonomy or restricted are supposed to be protected as human subjects.

This is the practice of treating others ethically by making effort to secure their well being. Beneficence is regularly understood to cover acts of kindness or charity that go beyond strict obligation. Do not harm, and maximize possible benefits and minimize possible harms are the two common rules formulated as complementary expressions of beneficent actions.

The Hippocratic saying "do no harm" is a fundamental principle of medical ethics. It was extended to the realm of research by Bernard who said that one should not injure another person regardless of the benefits that others might get. Even though avoiding harm requires learning what is harmful; in the process of obtaining the information, individuals may be exposed to risk of harm. Subjects may be exposed to a risk of harm without personal gains when a research that will benefit a society is done. An ethical dilemma occurs in research in deciding when it is appropriate to pursue certain gains regardless of the risks involved, and when to forego the gains potential or known risks to the subject (DHEW, 1979).