Ethics in Medical Research

CHAPTER 16 Ethics in Medical Research




Liars, as portrayed on screen and in fiction, are often charming rogues, while statisticians are always persons of infinite dullness. In real life, this is not the way you tell one from the other


—Robert Hooke1


Physicians have always been guided in their profession by a code of ethics. Medical professionals are in the unique position of directing decisions that affect the health and well-being of a trusting public. We make recommendations to folks who have confidence that we will act in their best interest. As early as the fourth century B.C., the Greek physician Hippocrates recognized the importance of the moral responsibility of the physician to the patient. He produced a litany of documents that addressed the basic principle of ethical conduct, “to help and not to harm.” The Hippocratic Oath is a product of this era that emphasizes the importance of respecting the ethical rights of the patient. Parts of this oath are still recited by United States medical school graduates as they receive their degree.


There is the potential for a breach of trust in the physician–patient relationship when medical professionals act in a manner that unduly places the patient at risk of harm. One of the most flagrant examples of a deviation from the basic principle of ethical treatment of humans was the barbaric torture that was inflicted upon concentration camp victims by the Nazis during World War II. These heinous actions included hypothermic “experiments” in which subjects were immersed in tanks of ice water and frozen to death. Others were deprived of oxygen and they slowly asphyxiated. Some of the prisoners were deliberately infected with cholera or suffered through grotesque surgeries that involved transplanted organs or sterilization. These appalling interventions were performed on captive victims against their will and under the guise of “medical experimentation.”


When these inhumane acts were publicly revealed, there was an international outcry for guidelines to direct the ethical treatment of human subjects in medical experimentation. The Nuremberg Military Tribunal that investigated these war crimes, which ultimately led to the execution of the responsible physicians, compiled a list of conditions outlining acceptable ethics in these circumstances. This came to be known as the Nuremberg Code (see Box 16-1). When it was released in 1947, it introduced the world to the era of modern medical ethics. It provided the basic expectations that should be met when experiments on human subjects are performed. It echoed the Hippocratic philosophy of “do no harm” and also stressed the importance of informed consent by the subjects.



BOX 16-1





The Nuremberg Code


Permissible Medical Experiments


The great weight of the evidence before us is to the 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 will justify the performance of the experiment.

Related posts:

  1. Types of Statistical Tests
  2. Populations
  3. Measures of Disease
  4. Mathematical Principles

Stay updated, free articles. Join our Telegram channel
Tags:
Jun 18, 2016 | Posted by in BIOCHEMISTRY | Comments Off on Ethics in Medical Research

Full access? Get Clinical Tree
Get Clinical Tree app for offline access