Codes of Medical and Human Experimentation Ethics

Victoria Berdon

This resource for The Least of My Brothers is intended to familiarize the reader with the historical development of ethical codes for physicians and scientists. Below is a partial chronology of codes of medical ethics over the ages, a more detailed listing with relevant excerpts from the codes, and links to the texts, or relevant portions, of the codes. Close this window when you are ready to return to the Scenario.


Introduction | Short List of Codes | Annotated List of Codes | Sources


Introduction

We have evidence from as far back as about 4000 BCE of physicians practicing medicine. For example, in prehistoric Egypt medical practices included using malachite as an eye salve. There is evidence of dentistry, too: a mandible (jaw bone) was found in a Fourth Dynasty (2900-2750) tomb that had an alveolar process pierced to drain an abscess under the first molar.

Written codes of ethics for doctors may have existed in those times; however, the earliest evidence we have is the Ebers Papyrus from 3,550 years ago. There are Egyptian medical papyri (such as Ebers and Smith) that describe the accepted medical practices and codes of ethics dating from about 2000 to 1090 BCE Imhotep is the earliest recorded name of a physician. When Imhotep died, he was deified as the Egyptian "God of Medicine", and later as a universal God of Medicine. He was so important to the early Egyptians that in honor they built the Temple of Imhotep, the "first hospital", and engraved his picture on the walls.

From even the earliest records through the present, physicians are exhorted to try to end human suffering. They should do this in a disinterested manner, without concern for remuneration, status or personal reputation. Physicians should use all means available to them, and be open to learning more methods from other physicians. Moreover, they should appreciate all life and treat all patients equally. Such exhortations are found not only in ancient Egyptian records, but also in other early records. For example, we know of the 5th Century BCE Greek Oath of Hippocrates and his On Epidemics (the source of the injunction, Primum non nocere!, or "First, do no harm!"), the First Century CE Indian Oath of Initiation, the 12th Century Jewish Daily Prayer of the Physician (Moses Maimonides), and the 16th Century Japanese 17 Rules of Enjuin.

The earliest codes addressed only physicians' obligations to themselves and to their patients; they do not address experimental treatments on the sick, nor are healthy subjects mentioned. Perhaps the earliest documented evidence of concerns about experimental medicine may be in Thomas Percival's code, which appeared in England in 1803. According to this code, the physician may try experimental treatments when all else fails, and when it can serve the public good.

In 1833 in America, William Beaumont's code acknowledged the importance of experimental treatments, but added requirements stipulating that the subject must give voluntary, informed consent and the subject should be able to end the experiment at will. (Note: it is not clear that Beaumont, himself, heeded these requirements.)

Claude Bernard is often regarded as the founder of experimental medicine. In his Introduction to the Study of Experimental Medicine (1865), Bernard wrote that one should never perform an experiment "which might be harmful to [the subject]"; that experiments "that can only harm are forbidden", that "innocent [experiments] are permissible", "and those that may do good are obligatory."

In 1898 in the United States of America, Walter Reed introduced a contract to augment and confirm oral informed consent. More significantly, Reed used healthy volunteer subjects in his medical experiments involving the transmission of Yellow Fever. He was committed to protecting the volunteers as well as possible while also making explicit to the subjects that in spite of the best medical practices they might die.

Increasing medical experimentation highlighted the increasing need for concern for subject consent and safety. In the 1900 Berlin Code, or Prussian Code, capacity to give consent was the central focus. In this code, if a subject is not competent to consent, or doesn't completely understand the information being explained, or does not give unambiguous consent, the experiment may not be performed.

The 1931 Reich Circular reminded physicians that in medical experiments, physicians must be concerned primarily with the consent and well-being of the subjects. The 1947 Nuremberg Code demonstrated increased concern, stating in its first sentence that, "the voluntary consent of the human subject is absolutely essential." Only after that does the code describe what constitutes a permissible medical experiment. One important component of permissibility includes the legal issue of the subject's capacity to give consent. While these were moves in the direction of establishing the practice of obtaining informed consent, actually gaining informed consent was not yet typically incorporated into standard practices.

In 1948, in the Physician's Oath of the Declaration of Geneva, the primary concern returns to that which was expressed in even the most ancient documents: one must put health of the patient first, be unbiased in attitude toward the patient, and have the "utmost respect for human life." In 1954, the World Medical Association produced a set of Principles for Those in Research and Experimentation. Respect -- for the rules of scientific research (constructed by convention) and the subjects -- is presented as central. In the 2000 Declaration of Helsinki, the primacy of patient health and well-being is reasserted. Also made explicit is the vulnerability and resulting need for special protection for research populations, especially for persons who cannot give or refuse consent.

So, while the concerns for human subjects broaden, the fundamental themes remain constant: value life, do no harm, and respect and treat all subjects equally.


Short List

Click on "A" to link to the item's annotation. Click on "S" to link to the item's source.

A S 2700 BCE - Third Dynasty (Egypt): Have an expectant attitude and trust in nature's healing. Be observant of the patient's condition.
A S 1750 BCE - Code of Hammurabi (Babylon): If the physician succeeds, he gets paid. If he fails, at worst he loses his hands.
A S 400 BCE - Oath of Hippocrates (Greece): Give no deadly medicines, only benefit the sick and maintain confidentiality. Also, in Hippocrates' On Epidemics "First, do no harm!" appears.
A S 1st c. CE - Oath of Initiation (India): Save lives and behave morally. Most of all, have compassion for all creatures.
A S 3rd c. CE - Hebrew Oath of Asaph: Serve the poor and the needy. Heal them.
A S 10th c. CE - Advice to a Physician (Persia): Constantly attend to the sick, pay unremitting attention to them, and inquire frequently about the patient's symptoms.
A S 12th c. CE - Jewish Daily Prayer of a Physician (Egypt): Don't let desire for profit, fame, or admiration interfere with your work. Help the rich and the poor, enemy and friend, equally. See only the human being. Care for the lives and health of all creatures.
A S 14th c. CE - Ming Dynasty (China): Appreciate the value of life. Rescue the dying. Heal the wounded. Use all means available to you. Acknowledge that all patients are equal to the physician.
A S 16th c. CE - The 17 Rules of Enjuin (Japan): Always be kind and devoted to loving people. Keep the art of medicine secret. Form a brotherhood of physicians.
A S 1803 - Percival's Code (England): Use experimental treatments when all else fails, as long as it serves the public good. Percival's Code is the basis for the 1847 first AMA Code of Medical Ethics. However, passages from Percival regarding experimentation are not included in the first AMA code.
A S 1833 - Beaumont's Code (United States): Use experimental treatments when all else fails. Moreover, get voluntary, informed consent form the subject. Stop the experiment if the subject wants you to.
A S 1847 - American Medical Association (AMA) Code of Medical Ethics (United States): The physician should always be ready to respond to the sick, treating all of them with "attention, steadiness, and humanity." Much of the early version of the code discusses the "duties of physicians to each other, and to the profession at large."
A S 1865 - Claude Bernard (France): Use experimental treatments when all else fails. However, first and foremost, do no harm!
A S 1898 - Walter Reed (United States): Introduces the use of consent "contracts" to augment verbal informed consent. Additionally, Reed allows for the use of healthy human subjects in medical experiments.
A S 1900 - Sir William Osler (Canada): "The father of scientific medical practice." Well-known for his textbook The Principles and Practice of Medicine and The Evolution of Modern Medicine. Considered to be a link between Walter Reeds's consent "contracts" and the Berlin Code.
A S 1900 - Berlin Code, or Prussian Code (Germany): One ought not to perform medical experiments when the subject is not competent to give informed consent (minors, etc), in the absence of unambiguous consent, or in the absence of information properly explained to subject.
A S 1931 - Reich Circular (Germany): Acknowledges the need for medical experiments on human subjects. Primarily concerned with consent and well-being of the subjects.
A S 1947 - Nuremberg Code (Germany): The Nuremberg Code is perhaps the most significant code of medical and research ethics to date. The first principle is: "The voluntary consent of the human subject is absolutely essential." In ten principles it codifies the international law. Among other things, the code stipulates that experimenter must intend to produce fruitful results for the good of society, avoid unnecessary physical and mental suffering, protect the subject against against injury, disability, or death, and be sure that the subject should be free to stop participating in the experiment.
A S 1948 (revised 1968, 1983, 1994) - Declaration of Geneva (Switzerland): Always put the health of the patient first. Be unbiased in one's attitude toward one's patients. Maintain the "utmost respect for human life."
A S 1949 (revised 1968, 1983, 1994) - World Medical Association International Code of Medical Ethics: Outlines the "duties of doctors to the sick." Specifically mentions abortion and the physician's duty to abide by his conscience, as well as the national laws. Asserts that doctors are bound to maintain "absolute secrecy" regarding their patients.
A S 1953 - Wilson Memo (United States): Requires voluntary, informed consent in writing from subjects participating in medical research. Use experimental treatments only when other methods have failed. (The Wilson Memo was top secret until the 1970s.)
A S 1954 - World Medical Association Principles for Those in Research and Experimentation: Requires respect for rules of scientific research, and for subjects involved. May use healthy subjects. Subjects must be fully informed.
A S 1957 - American Medical Association Revision of Code of Medical Ethics (United States): Increases the emphasis on the physicians' obligations to the patients; decreases the emphasis on other members of the profession.
A S 1964 (revised 1975, 1983, 1989, 1996, 2000) - Declaration of Helsinki (Finland): Extends concerns of medical ethics set forth in the Declaration of Geneva and the International Code of Medical Ethics to issues in biomedical research, especially with respect to its hazards for the subjects.
A S 1979 - Belmont Report (United States): The foundational document for research on human subjects in the United States. Outlines three principles for research with human subjects (respect for persons, beneficence, and justice) and applications for the principles.
A S 1980 - American Medical Association Revision of Code of Medical Ethics (United States): A more streamlined code--intended as "a body of ethical statements developed primarily for the benefit of the patient." Limits references to others in the profession to those, which ultimately affect the patients' care.
A S 1991 - Council for International Organizations of Medical Sciences (CIOMS) Guidelines for Ethical Review of Epidemiological Studies (Switzerland): "Guidelines for the application of the principles of the Declaration of Helsinki." Outlines "General Ethical Principles," i.e. respect for persons, beneficence, non-maleficence, and justice, and includes a lengthy section on informed consent.
A S 1994 - Revision of the World Medical Association International Code of Medical Ethics: Augments the previous code's explanation of informed consent, and establishes more rigorous standards for informed consent.
A S 2000 - Most Recent Revision of the Declaration of Helsinki (Finland): Emphasizes the primacy of patient health and well-being. Acknowledges that research populations, as well as those who cannot give or refuse consent for themselves, are often vulnerable and need special protection.
A S 2001 - American Medical Association Revision of Code of Medical Ethics (United States): This version of the code augments the 1980 version, adding two clauses, which further strengthen the emphasis on the patient.


Annotated List

Click on the item to link to its source.

2700 BCE - Third Dynasty (Egypt)

Egyptian medical papyri describe the accepted medical practices and codes of ethics as early as the Old Kingdom, Fourth Dynasty (2900-2750).

For example, in the Smith papyrus, the physician is told to follow the diagnosis by saying that it is:

  1. "An ailment which I will treat,"
  2. "An ailment with which I will contend," or
  3. "An ailment not to be treated."

The physician also ought to indicate the period of time during which treatment will occur:

  1. "Until he recovers,"
  2. "Until the period of his injury passes by," or
  3. "Until thou knowest that he has reached a decisive point."

Notice that two things are being recommended:

  1. an expectant attitude and trust in nature's healing powers, and
  2. waiting "until thou knowest that he [the patient] has reached a decisive point". (Later, Hippocrates will say something similar about medical crisis.)

1750 BCE - Code of Hammurabi (Babylon)

Hammurabi's code contains approximately 291 clauses, but only nine regard medical ethics. In short, if the physician "succeeds," he gets paid. If he "fails," he pays. In the worst case, the physician loses his hands. For example:

113. If a physician make a large incision with an operating knife and cure it, or if he open a tumor (over the eye) with an operating knife, and saves the eye, he shall receive ten shekels in money.

115. If a physician make a large incision with the operating knife, and kill him, or open a tumor with the operating knife, and cut out the eye, his hands shall be cut off.

400 BCE - Oath of Hippocrates (Greece)

Hippocrates' Oath indicates what ought to concern a physician and how a physician ought to act with patients.

Note: Nowhere in the Oath of Hippocrates does the familiar "First, do no harm!" appear. Rather, Primum non nocere (First, do no harm!) appears in another of his writings: On Epidemics, Book 1, Section XI. Some sources attribute Primum non nocere to the Roman physician, Galen.

Excerpt from the Oath of Hippocrates:

I will give no deadly medicine to any one if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion. ... Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption; ...Whatever, in connection with my professional service, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.

1st century CE - Oath of Initiation (India)

A section on medical ethics from the "Oath of Initiation" (Caraka Samhita) instructs a physician to do all he can to save life and behave morally:

He who practices medicine out of compassion for all creatures rather than for gain or for gratification of the senses surpasses all. Those who for the sake of making a living make a trade of medicine, bargain for a dust-heap, letting go a heap of gold. No benefactor, moral or material, compares to the physician who by severing the noose of death in the form of fierce diseases, brings back to life those being dragged towards death's abode, because there is no other gift greater than the gift of life. He who practices medicine while holding compassion for all creatures as the highest religion is a man who has fulfilled his mission. He obtains supreme happiness.

3rd century CE - Hebrew Oath of Asaph

The Oath of Asaph is written at the end of the oldest medical text, The Book of Asaph the Physician (Sefer Asaph haRofe).

The Oath states: "ye shall not harden your hearts against the poor and needy, but heal them."

10th century CE - Advice to a Physician (Persia)

The Persian physician Haly Abbas advises:

And of those things which were incumbent on the student of this art (medicine) are that he should constantly attend the hospitals and sick houses; pay unremitting attention to the conditions and circumstances of their intimates, in company with the most astute professors of medicine, and inquire frequently as to the state of the patients and symptoms apparent in them, bearing in mind what he has read about these variations, and what they indicate of good or evil.

12th century CE - Jewish Daily Prayer of A Physician (Egypt)

From the Prayer of Moses Maimonides:

Do not allow thirst for profit, ambition for renown and admiration, to interfere with my profession ... . Preserve the strength of my body and of my soul that they ever be ready to cheerfully help and support rich and poor, good and bad, enemy as well as friend. In the sufferer let me see only the human being. Illumine my mind that it recognize what presents itself and that it may comprehend what is absent or hidden. Let it not fail to see what is visible, but do not permit it to arrogate to itself the power to see what cannot be seen, for delicate and indefinite are the bounds of the great art of caring for the lives and health of Thy creatures.

Let me be contented in everything except in the great science of my profession. Never allow the thought to arise in me that I have attained to sufficient knowledge, but vouchsafe to me the strength, the leisure and the ambition ever to extend my knowledge.

1368-1644 CE - Ming Dynasty (China)

Chinese physicians were expected to keep to the highest Confucian ideals. For example:

  1. Appreciate the value of life, rescue the dying, and heal the wounded by all means available.
  2. Bear the suffering of patients in mind, not one's own material interests.
  3. Improve medical skills and oppose careless styles of working.
  4. Act with decorum, decency, and politeness. ... A prostitute who comes to see a doctor should be treated as if she were a good lady and the physician should not take liberties with even such a woman.
  5. Acknowledge that all patients are equal before the physician.
  6. Respect other people's achievements and abide by academic ethics.

In feudal China, people of the same occupation despised one another, so these moral requirements showed the great courage of physicians in pursuing medical ethics.

16th century CE - The 17 Rules of Enjuin (Japan)

Included in the 17 Rules, are admonishments to physicians to: "Always be kind to people and devoted to loving people," to "keep the Art secret," and to "form a brotherhood." See a more extensive citation at: http://zobell.biol.tsukuba.ac.jp/~macer/sg/SG4.html.

1803 - Percival's Code (England)

According to Percival, as long as it serves the public good, physicians should use experimental treatments to try to heal a patient when other methods have failed. However, one must first consult with his colleagues.

Percival's Code retained the core of the Hippocratic tradition (Percival 1803, Waddington 1975). The principal concern is with professional etiquette, cautioning physicians to display respect for one another, avoid criticism of colleagues, and to conceal any professional differences with other physicians from the public as this would lead to a degrading of the medical profession. In addition to being healers, doctors should work to enhance public respect for the entire medical profession.

Percival's code of medical ethics was the source for the first American Medical Association Code of Ethics in the United States in 1847.

An excerpt from Percival's Code:

New methods of chirurgical treatment should be devised but, in the accomplishment of the salutary purpose, the gentlemen of the faculty should be scrupulously and conscientiously governed by sound reason, just analogy, or well-authenticated facts. And no such trials should be instituted without a previous consultation of the physicians or surgeons according to the nature of the cause.

1833 - Beaumont's Code (United States)

Beaumont's Code, like Percival's Code, acknowledges the importance of experimental treatments on patients who don't respond to conventional ones, and requires conscientious, responsible use of sound methods. There is, however, one significant difference between the two. Beaumont stresses the necessity of getting voluntary, informed consent from the subject, and that the experiment should be stopped if the subject is distressed.

Excerpts from Beaumont's Code:

  1. There must be recognition of an area where experimentation in man is needed.
  2. Some experimental studies in man are justifiable when the information cannot otherwise be obtained.
  3. The investigator must be conscientious and responsible ... for a well considered, methodological approach is required so that as much information as possible will be obtained whenever a human subject is used. No random studies are to be made.
  4. The voluntary consent of the subject is necessary.
  5. The experiment is to be discontinued when it causes distress to the subject.
  6. The project must be abandoned when the subject becomes dissatisfied.

1847 - American Medical Association (AMA) Code of Medical Ethics (United States)

Note: Percival's Code of medical ethics (1803) was the source for this code.

The 1847 AMA Code hardly mentions the patient or the patient's well-being. It is primarily concerned with doctors' professional issues. The code, its original cover intact, can be viewed as a .pdf file on the World Wide Web at http://www.ama-assn.org/ama/upload/mm/369/1847code.pdf.

Excerpt from the AMA Code of Medical Ethics:

Chapter I, Article I: Duties of Physicians to their Patients

Section 4: A physician should not be forward to make gloomy prognostications because they savour of empiricism, by magnifying the importance of his services in the treatment or cure of the disease. But he should not fail, on proper occasions, to give friends of the patient timely notice of danger, when it really occurs; and to the patient himself, if absolutely necessary.

1865 - Claude Bernard (France)

Bernard was consistent with Percival in advocating the use of experimental medical treatments to save a life when other treatments had failed. Also, Bernard emphasized the familiar medical exhortation, "First, do no harm."

In his Introduction to the Study of Experimental Medicine (1927), Bernard wrote:

It is our duty and our right to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit. The principle of medical and surgical morality, therefore, consists in never performing on man an experiment which might be harmful to him in any extent, even though the result might be highly advantageous to science, i.e., to the health of others ... Christian morals forbid only one thing, doing ill to one's neighbor. So, among the experiments that might be tried on man, those that can only harm are forbidden. Those that are innocent are permissible, and those that may do good are obligatory.

1898 - Walter Reed (United States)

Walter Reed did experimental work on humans in which he proved that Yellow Fever was transmitted by mosquitoes and not by contact with infected people or their belongings. Notably, Reed introduced using consent contracts to indicate informed consent. He wanted volunteers to know what sorts of risks they faced, that he would control the environment as best he could, that he would make medical assistance immediately available, and that in spite of this, they might die.

The source for the above information is Joan Echtenkamp Klein, Assistant Director for Historical Collections and Services at the University of Virginia's Health Sciences Library.

1900 - Sir William Osler (Canada)

Sir William Osler "is regarded as the father of scientific medical practice." He is especially well-known for his textbook, The Principles and Practice of Medicine (New York: D. Appleton and Company, 1892) as well as for The Evolution of Modern Medicine (New Haven: Yale University Press, 1921).

Osler may be a link between Walter Reed's Yellow Fever study consent contracts and the Berlin Code. In an unpublished talk, A Brief History of the Army's Contributions to Ethical Standards for Research Involving Human Subjects, Arthur O. Anderson proposes a connection. What follows is a summary of the events as Anderson thinks they may have happened:

In the 1890s, Osler worked in Berlin in Rudolph Virchow's lab along with William Welch. Virchow had been on the Berlin City Council in the mid-1880s, and by 1900 he had a higher government position in Berlin. While all three were in Berlin, there was a medical scandal: Dr. Neiser had inoculated unsuspecting subjects with serum from patients with syphilis. Because Neiser had not obtained consent from the subjects, there was an enormous controversy to which the Berlin City Council would respond officially in writing. Virchow probably still communicated with members of the City Council. In addition to working together, Virchow, Welch and Osler shared an interested in medical ethics. It's quite likely that Virchow spoke with them about the Council's discussions of the Neiser scandal.

In 1893, Walter Reed and William Carroll were appointed by Army Surgeon General George Sternberg to the Yellow Fever Commission in order to study the mode of transmission of Yellow Fever. Sternberg had worked in Welch's laboratory, and Reed had replaced Sternberg. So, Welch, Sternberg and Reed could have discussed the matter among themselves.

In the Yellow Fever studies, Reed introduced a consent "contract" in an attempt to make clear express consent of the volunteers. One consent contract is dated November 26, 1900. This date is approximately one month prior to the December 29, 1900 date of the Berlin Code.

Virchow may have discussed the Berlin Council's deliberations for a response with Welch and Osler. Osler may have discussed the topic with Sternberg , who then spoke with Reed. Reed may have liked and therefore included much of the content being considered by the Berlin City Council for their response to the Neiser scandal. Therefore, Osler may have contributed, albeit indirectly, to the Berlin Code.

1900 - Berlin Code, or Prussian Code (Germany)

The Berlin Code emphasizes when one ought not perform medical "interventions for other than diagnostic, healing, and immunization." For example, it excludes minors or those otherwise not competent and argues against medical "interventions" in the absence of unambiguous consent or properly explained information given to the subject.

In an unpublished talk, A Brief History of the Army's Contributions to Ethical Standards for Research Involving Human Subjects, Arthur O. Anderson writes that there may be a connection between the Walter Reed consent contracts discussed above and the Berlin Code:

The Berlin Code is dated 29 December 1900, a later date than that on the Yellow Fever consent document. So, how can there be a connection between the Yellow fever consents and the Berlin Code? The connection may have originated when Drs. William Osler and William Welch were fellows with Rudolf Virchow in Berlin during the decade preceding 1900. These important founding members of the Johns Hopkins Medical School also were present in Berlin when extreme controversy broke out over Neiser's unethical experiments where unsuspecting subjects were inoculated with convalescent serum from patients with syphilis. Because consent was not obtained the controversy led to an official written response by the Berlin City Council.

1931 - Regulations on New Therapy and Human Experimentation, or The Reich Circular (Germany)

The Reich Circular acknowledges the need for medical experimentation with human subjects, and outlines the conditions under which this may be done. It focuses on the consent and well being of the subject.

The regulations were "published originally as a Circular of the Reich Minister of the Interior dated February 28, 193 1. The guidelines remained in force until 1945, but were not included in the Reich Legislation validated at the end of World War II. It is interesting to note the disjunction between the guidelines and the practice of the Nazi researchers."

Excerpts from the 14 points of the Reich Circular:

1. In order that medical science may continue to advance, the initiation in appropriate cases of therapy involving new and as yet insufficiently tested means and procedures cannot be avoided. Similarly, scientific experimentation involving human subjects cannot be completely excluded as such, as this would hinder or even prevent progress in the diagnosis, treatment, and prevention of diseases.

5. Innovative therapy may be carried out only after the subject or his legal representative has unambiguously consented to the procedure in light of relevant information provided in advance. Where consent is refused, innovative therapy may be initiated only if it constitutes and urgent procedure to preserve life or prevent serious damage to health and prior consent could not be obtained under the circumstances.

7. Exploitation of social hardship in order to undertake innovative therapy is incompatible with the principles of medical ethics.

1947 - Nuremberg Code (Germany)

Unlike the 1847 AMA Code, or other representative codes of medical ethics, the Nuremberg Code puts concern for the patient at the fore. More significantly, the first sentence of the first paragraph states: "The voluntary consent of the human subject is absolutely necessary."

Excerpts from the Nuremberg Code:

Directives for Human Experimentation
NUREMBERG CODE

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.

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 will 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 ... .

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage.

1948 (revised 1968, 1983, 1994) - Declaration of Geneva (Switzerland)

While the Declaration of Geneva's Physician's Oath is not a code of medical ethics, it does spell out the general obligations of the physician. The patient does not receive the primary focus in this oath.

CIRP Introduction:

The World Medical Association is an association of national medical associations. This oath seems to be a response to the atrocities committed by doctors in Nazi Germany. Notably, this oath requires the physician to "not use [his] medical knowledge contrary to the laws of humanity." This document was adopted by the World Medical Association only three months before the United Nations General Assembly adopted the Universal Declaration of Human Rights (1948) which provides for the security of the body.

Physician's Oath:

At the time of being admitted as a member of the medical profession:

I solemnly pledge myself to consecrate my life to the service of humanity;

I will give to my teachers the respect and gratitude which is their due;

I will practice my profession with conscience and dignity; the health of my patient will be my first consideration;

I will maintain by all the means in my power, the honor and the noble traditions of the medical profession; my colleagues will be my brothers;

I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient;

I will maintain the utmost respect for human life from the time of conception, even under threat, I will not use my medical knowledge contrary to the laws of humanity;

I make these promises solemnly, freely and upon my honor.

Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994.

1949 (revised 1968, 1983, 1994) - World Medical Association International Code of Medical Ethics

Adopted by the Third General Assembly of the World Medical Association at London in October 1949.

Excerpts from the International Code of Medical Ethics:

Duties of Doctors to the Sick

A doctor must always bear in mind the obligation of preserving human life from conception. Therapeutic abortion may only be performed if the conscience of the doctors and the national laws permit.

A doctor owes to his patient complete loyalty and all the resources of his science. Whenever an examination or treatment is beyond his capacity he should summon another doctor who has the necessary ability.

A doctor shall preserve absolute secrecy on all he knows about his patient because of the confidence entrusted in him.

A doctor must give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care.

A doctor must observe the principles of The Declaration of Geneva approved by The World Medical Association.

1953 - Wilson Memo (United States)

On February 26, 1953, Secretary of Defense Charles Wilson issued a memo establishing the Nuremberg Code as Department of Defense policy. While not itself a code of medical ethics, the Memo stressed the importance of the subject signing a statement which explained the experiment and the dangers it might present to the subject. This document was not declassified until 1975.

Excerpts from the Memo:

By reason of the basic medical responsibility in connection with the development of defense of all types against atomic, biological and/or chemical warfare agents, Armed Services personnel and/or civilians on duty at installations engaged in such research shall be permitted to actively participate in all phases of the program ... .

1954 - World Medical Association Principles for Those in Research and Experimentation

Excerpt from the Principles for Those in Research and Experimentation:

5. It should be required that each person who submits to experimentation be informed of the nature of, the reason for, and the risk of the proposed experiment. If the patient is irresponsible, consent should be obtained from the individual who is legally responsible for the individual. In both instances, consent should be obtained in writing.

1957 - American Medical Association Revision of Code of Medical Ethics (United States)

The revised code was stated more succinctly. Significantly, all ten paragraphs concern the physicians' obligations to the patients; emphasis on the other members of the profession is greatly diminished.

Excerpts from AMA Revision of Code of Medical Ethics:

Section 1: The principle objective of the medical profession is to render service to humanity with full respect for the dignity of man.

Section 2: Physicians should strive continually to improve medical knowledge and skill, and should make available to their patients and colleagues their professional attainments.

Section 4: [Physicians] should expose, without hesitation, illegal or unethical conduct of fellow members of the profession.

Section 5: A physician may choose whom he will serve. In an emergency, however, he should render service to the best of his ability. ... He should not solicit patients.

Section 7: [A] physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients. His fee should be commensurate with the services rendered and the patient's ability to pay.

Section 9: A physician may not reveal the confidences entrusted to him in the course of medical attendance, or the deficiencies he may observe in the character of the patients, unless he is required to do so by law or unless it becomes necessary in order to protect the welfare of the individual or of the community.

Section 10: The honored ideals of the medical profession imply that the responsibilities of the physician extend not only to the individual, but also to society where these responsibilities deserve his interest and participation in activities which have the purpose of improving both the health and the well-being of the individual and the community.

1964 (revised 1975, 1983, 1989, 1996, 2000) - Declaration of Helsinki (Finland)

This declaration augments the Declaration of Geneva and the International Code of Medical Ethics. This code extends concerns of medical ethics to issues in biomedical research, especially with respect to its hazards for the subjects. It stipulates the principles human subjects research should follow, and the conditions under which the research ought to be performed. Issues of subject consent and their ability to adequately give it are included, but not until late in the document in paragraphs 9 and 10.

Significantly, this code is in sharp contrast with the Nuremberg Code (1947) in which the importance of the subjects' informed consent and other considerations of the subjects' agency are not only addressed, but extensively defined in the first paragraph of the code. When the Helsinki Declaration arrives at the topic in paragraph 9, first mentioned is the importance of informing the subject of the possible hazards. Next, the issue of consent arises in a form much weaker than in the Nuremberg Code. Compare:

He or she should be informed that he or she is at liberty to abstain from the study and that he or she is free to withdraw his or her consent to participation at any time. (Declaration of Helsinki, Section I, paragraph 9)

The voluntary consent of the human subject is absolutely essential. (The Nuremberg Code, paragraph 1)

Excerpts from the Declaration of Helsinki:

Introduction

The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration" and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

I. Basic Principles

3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.

6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.

9. [E]ach potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. ... [the subject] should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw visor her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing.

10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who isn't engaged in the investigation and who is completely independent of this official relationship.

11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.

12. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present declaration are complied with.

II. Medical Research Combined with Professional Care (Clinical Research)

5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (1, 2).

6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

III. Non-Therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research)

2. The subjects should be volunteers- either healthy persons or patients for whom the experimental design is not related to the patient's illness.

4. In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.

1979 - Belmont Report (United States)

The Commission proposed several basic ethical principles that "should underlie the conduct of biomedical and behavioral research involving human subjects:"

  1. the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
  2. the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
  3. appropriate guidelines for the selection of human subjects for participation in such research, and
  4. the nature and definition of informed consent in various research.

Excerpts from the Belmont Report:

B. Basic Ethical Principles

Three basic principles ... are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence, and justice.

1. Respect for Persons. [F]irst, individuals should be treated as autonomous agents, and second, ... persons with diminished autonomy are entitled to protection. ... An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. ... Not every human being is capable of self-determination. ... Some persons are in need of extensive protection.

Respect for persons demands that subjects enter into the research voluntarily and with adequate information.

2. Beneficence. Two general rules have been formulated as complementary expressions of beneficent actions in this sense:

  1. do no harm and,
  2. maximize possible benefits and minimize possible harm.
C. Applications

Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.

1. Informed Consent. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. There is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness."

Information. Most codes of research establish specific items for disclosure: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research.

Comprehension. Special provisions may need to be made when comprehension is severely limited. For example, by conditions of immaturity or mental disability. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored ... . Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm.

Voluntariness. Requires conditions free of coercion and undue influence.

2. Assessment of Risks and Benefits.

The Systematic Assessment of Risks and Benefits. Assessment of the justifiability of research should reflect at least:

  1. Brutal or inhumane treatment of human subjects is never morally justified.
  2. Risks should be reduced to those necessary to achieve the research objective ... .
  3. When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk ... .
  4. When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. [One should consider] the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits.
  5. Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

1980 - American Medical Association Revision of Code of Medical Ethics (United States)

This revision is more streamlined than previous versions and is intended as "a body of ethical statements developed primarily for the benefit of the patient." The references to others in the profession are limited to those which ultimately effect the patients' care: exposing "those physicians deficient in character or competence, or who seek to engage in fraud or deception," "use the talent of other health professionals when indicated," and "recognize a responsibility to participate in activities contributing to an improved community."

1991 - Council for International Organizations of Medical Sciences (CIOMS) Guidelines for Ethical Review of Epidemiological Studies (Switzerland)

International Guidelines for Ethical Review of Epidemiological Studies

In 1982, the Council for International Organizations of Medical Sciences (CIOMS) issued Proposed International Guidelines for Biomedical Research Involving Human Subjects. "These are guidelines for the application ... of the principles of the Declaration of Helsinki, adopted by the World Medical Association in 1964 and amended in 1975, 1983 and 1989." Respect for persons, especially as regards informed consent, is the central concern and is addressed in the first parts of the code.

Excerpts from the International Guidelines for Ethical Review of Epidemiological Studies:

General Ethical Principles

Respect for persons incorporates at least two other fundamental ethical principles ... :

  1. autonomy: ... those who are capable of deliberation about their personal goals should be treated with respect for their capacity for self-determination; and
  2. protection of persons with impaired or diminished autonomy: ... those who are dependent or vulnerable be afforded security against harm or abuse.

Beneficence is the ethical obligation to maximize possible benefits and to minimize possible harms and wrongs.

Non-maleficence ("Do no harm.") ... guards against avoidable harm to research subjects.

Justice requires that cases considered to be alike be treated alike, and that cases considered to be different be treated in ways that acknowledge the difference.

Informed Consent

Individual Consent

1. Consent is informed when it is given by a person who understands the purpose and nature of the study, what participation in the study requires the person to do and to risk, and what benefits are intended to result from the study.

2. An investigator who proposes not to seek informed consent has the obligation to explain to an ethical review committee how the study would be ethical in its absence: it may be impractical to locate subjects whose records are to be examined, or the purpose of some studies would be frustrated.

Community Agreement

5. When it is not possible to request informed consent from every individual to be studied, the agreement of a representative of a community or group may be sought. ... Approval given by a community representative should be consistent with general ethical principles.

8. It will be more difficult to ensure group representation, and all the more important to obtain subjects' free and informed consent to participate.

Selective Disclosure of Information

9. In epidemiology, an acceptable study technique involves selective disclosure of information, which seems to conflict with the principle of informed consent. For certain epidemiological studies non-disclosure is permissible, even essential, so as to not influence the spontaneous conduct under investigation, and to avoid obtaining responses that the respondent might give in order to please the questioner.

Undue Influence

10. Prospective subjects may not feel free to refuse requests from those who have power or influence over them. Therefore the identity of the investigator ... must be made known to them. It is ethically questionable whether subjects should be recruited from among groups that are unduly influenced by persons in authority over them or by community leaders.

Confidentiality

26. Unlinked information, which cannot be linked, associated or connected with the person to whom it refers; as this person is not known to the investigator, confidentiality is not at stake and the question of consent does not arise.

Linked information, which may be:

  • anonymous, when the information cannot be linked to the person to whom it refers except by a code or other means known only to that person, and the investigator cannot know the identity of the person;
  • non-nominal, when the information can be linked to the person by a code (not including personal identification) known to the person and the investigator; or
  • nominal or nominative, when the information is linked to the person by means of personal identification, usually the name.

Balancing Personal and Social Perspectives

39. [While] at the personal level it is essential to ensure individual informed and free consent, such consent alone may not be sufficient to render a study ethical if the individual's community finds the study objectionable. Social values may raise broad issues that affect future populations and the physical environment.

1994 - Revision of the World Medical Association International Code of Medical Ethics

This revision adds to the statement of the 1994 revision to the Declaration of Geneva.

United States of America, Title 45, Public Welfare, October 1, 1999 Revision (Original: 1981)
National Archives and Records Administration, Code of Federal Regulations
.

Excerpts:

Title 45--Public Welfare, Subtitle A: Department of Health and Human, Part 46: Protection of Human Subjects.

Subpart A--Basic HHS Policy for Protection of Human Research Subjects. Sec. 46.116. General requirements for informed consent.

(a) Basic elements of informed consent: Except as provided in paragraph (c) or (d).

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional elements of informed consent.

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

2000 - Most Recent Revision of the Declaration of Helsinki (Finland)

This is a further revision of the 1964 code of ethics stipulated for biomedical research with human subjects. The focus of this revision is the primacy of patient health and well-being, with special attention to those "research populations are vulnerable and need special protection" as well as for "those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care."

Important to notice is that this revision puts even less emphasis on informed consent of subjects than the 1964 version (which did not discuss this issue until paragraphs 9 and 10, and first addresses problems of consent with "economically and medically disadvantaged" subjects. Thus, the concerns in this code are even further from the primary concerns of the Nuremberg Code.

Compare:

The voluntary consent of the human subject is absolutely essential. (Nuremberg Code, paragraph 1)

He or she should be informed that he or she is at liberty to abstain from the study and that he or she is free to withdraw his or her consent to participation at any time. (Declaration of Helsinki, 1964, Section I, paragraph 9)

Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, [or] for those who may be subject to giving consent under duress. (Declaration of Helsinki, 2000, Section I, paragraph 8)

2001 - American Medical Association Revision of Code of Medical Ethics (United States)

This revision increases the focus on the care of the patient and addresses the concept of universal access to medical care.

Sunday, June 17, 2001, the AMA's House of Delegates adopted Revised Principles of Medical Ethics in what represents a rare change to this historic document in the 154 year history of the Association. The revised Principles reflect many of the original tenets that the association has held since its inception, such as "dedication to providing competent medical care," (Principle I) " honesty in all professional interactions" (Principle II) and the "safeguard of patient confidences" (Principle IV).

These revised Principles now emphasize a physician's "responsibility to participate in activities contributing to ... the betterment of public health" (Principle VII), and state that "a physician shall, while caring for a patient, regard responsibility to the patient as paramount" (new Principle VIII) and that "a physician shall support access to medical care for all people" (new Principle IX).


Sources

Return to Short List | Return to Annotated List

2700 BCE

Third Dynasty (Egypt)
http://www.levity.com/alchemy/islam22.html;
Eubios Journal of Asian and International Bioethics 10 (2000), 40-44.

1750 BCE Code of Hammurabi (Babylon)
http://www.wsu.edu:8080/~dee/MESO/CODE.HTM
400 BCE Oath of Hippocrates (Greece)
http://en.wikipedia.org/wiki/Hippocratic_Oath
1st c. CE Oath of Initiation (India)
http://zobell.biol.tsukuba.ac.jp/~macer/EJ102/ej102e.html
3rd c. CE Hebrew Oath of Asaph
Pines, S. "The Oath of Asaph the Physician and Yohanan ben Zabda -- Its Relation to the Hippocratic Oath and the Doctrina Duarum Viarum of the Didache." Proceedings of the Israel Academy of Sciences and Humanities, English Series, 5:9 (1975).
10th c. CE Advice to a Physician (Persia)
http://www.islam-usa.com/im4.html
12th c. CE

Jewish Daily Prayer of a Physician (Egypt)
http://www.us-israel.org/jsource/Judaism/mdprayer.html;
Friedenwald, Harry, trans. Bulletin of the Johns Hopkins Hospital 28 (1917), 260-261.
Copyright 1999: The American-Israeli Cooperative Enterprise.

1368-1644 CE Ming Dynasty (China)
From "Chinese Confucian Culture And The Medical Ethical Tradition," Guo, Z., J Med Ethics, 21:4 (Aug.1995), 239-46.
Copyright by J Med Ethics. See also http://jme.bmjjournals.com/cgi/content/abstract/21/4/239
1500 CE The 17 Rules of Enjuin (Japan)
http://zobell.biol.tsukuba.ac.jp/~macer/sg/SG4.html
1803

Percival's Code (England)
The Nazi Doctors and the Nuremberg Code. Edited by George J. Annas and Michael A. Grodin. New York: Oxford University Press, 1992. 124.
SHAPING GENES: Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture, Darryl R. J. Macer, Ph.D. Eubios Ethics Institute, 1990.

1833 Beaumont's Code (United States)
The Nazi Doctors and the Nuremberg Code. Edited by George J. Annas and Michael A. Grodin. New York: Oxford University Press, 1992. 125.
1847 American Medical Association (AMA) Code of Medical Ethics (United States)
http://www.ama-assn.org/ama/upload/mm/369/1847code.pdf
1865 Claude Bernard (France)
The Nazi Doctors and the Nuremberg Code. Edited by George J. Annas and Michael A. Grodin. New York: Oxford University Press, 1992. 125-6. (Contains an excerpt from: Introduction to the Study of Experimental Medicine. Claude Bernard. New York: Macmillan, 1927. 101-102.)
1898

Walter Reed (United States)
See also http://www.med.virginia.edu/hs-library/historical/yelfev/pan10.html;
US Army Medical Research Institute of Infectious Diseases: http://www.usamriid.army.mil/

1900 Sir William Osler (Canada)
http://www.geocities.com/artnscience/jm4-primr.html
1900 Berlin Code, or Prussian Code (Germany)
http://www.geocities.com/artnscience/00berlincode.pdf; see also http://ourworld.compuserve.com/homepages/Bulletin_of_Medical_Ethics/news.htm
1931 Regulations on New Therapy and Human Experimentation, or The Reich Circular (Germany)
The Nazi Doctors and the Nuremberg Code. Edited by George J. Annas and Michael A. Grodin. New York: Oxford University Press, 1992. 129-32. This author also provides a discussion of the rules. A translation is also available at http://www.ruhr-uni-bochum.de/zme/Nuernberg.htm#Rl1931-e
1947

Nuremburg Code (Germany)
http://ohsr.od.nih.gov/nuremberg.php3;
Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law 10:2 (1949), 181-182. Washington, D.C.: U.S Government Printing.

1948 Declaration of Geneva (Switzerland)
Revised 1968, 1983, 1994. http://www.cirp.org/library/ethics/geneva/
1949

World Medical Association International Code of Medical Ethics
Revised 1968, 1983, 1994. http://www.cirp.org/library/ethics/intlcode/;
World Medical Association Bulletin 1:3 (1949), 109, 111.

1953 Wilson Memo (United States)
http://tis.eh.doe.gov/ohre/roadmap/achre (See also http://www.eh.doe.gov/ohre/roadmap/achre/chap3_1.html .)
1954 World Medical Association Principles for Those in Research and Experimentation
http://www.iit.edu/departments/csep/PublicWWW/codes/coe/World_Medical_Association_Principles_for_Those_in_Research_1954.html
1957 American Medical Association Revision of Code of Medical Ethics (United States)
There are links to pdf files at http://www.ama-assn.org/ama/pub/category/2503.html for the 1947 original, 1957 revision, and 1980 revision of the AMA codes of medical ethics.
1964

Declaration of Helsinki (Finland)
Revised 1975, 1983, 1989, 1996, 2000. http://www.cirp.org/library/ethics/helsinki;
World Medical Organization. "Declaration of Helsinki." British Medical Journal 313:7070 (Dec. 1996), 1448-1449.

1979

Belmont Report (United States)
http://poynter.indiana.edu/sas/res/belmont.html;
Office of the Secretary, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, National Institutes of Health, Bethesda, Maryland 20892, April 18, 1979.

1980 American Medical Association Revision of Code of Medical Ethics (United States)
There are links to pdf files at http://www.ama-assn.org/ama/pub/category/2503.html for the 1947 original, 1957 revision, and 1980 revision of the AMA codes of medical ethics.
1991 Council for International Organizations of Medical Sciences (CIOMS) Guidelines for Ethical Review of Epidemiological Studies (Switzerland)
http://www.cdc.gov/od/ads/intlgui3.htm
1994 Revision of the World Medical Association International Code of Medical Ethics
http://www.wma.net/e/policy/17-a_e.html
This revision adds the statement of the 1994 Revision to the Declaration of Geneva.
2000 Most Recent Revision of the Declaration of Helsinki (Finland)
http://www.wma.net/e/policy/17-c_e.html
2001 American Medical Association Revision of Code of Medical Ethics (United States)
http://www.ama-assn.org/ama/pub/category/4256.html


Thanks to Victoria Berdon for undertaking the research for this Resource and writing early drafts. Jennifer Flavin edited and prepared the current version.

Indiana University and Wisdom Tools, Inc., have made every effort to secure the necessary permissions and provide appropriate credits for materials used in this WisdomTools ScenarioTM and the related resources. In the event any questions arise as to the use of any material, we express regret for any inadvertent error and will be pleased to make the necessary corrections.

Development of The Least of My Brothers was funded by the Poynter Center for the Study of Ethics and American Institutions, Indiana University-Bloomington, and the National Institutes of Health (Grant Number 1 T15 AI07601).


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