You are on page 1of 16

The Tuskegee Timeline

The Study Begins


In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record
the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called
the "Tuskegee Study of Untreated Syphilis in the Negro Male."
The study initially involved 600 black men 399 with syphilis, 201 who did not have the
disease. The study was conducted without the benefit of patients' informed consent. Researchers
told the men they were being treated for "bad blood," a local term used to describe several
ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper
treatment needed to cure their illness. In exchange for taking part in the study, the men received
free medical exams, free meals, and burial insurance. Although originally projected to last 6
months, the study actually went on for 40 years.
What Went Wrong?
In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led
the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to
review the study. The panel had nine members from the fields of medicine, law, religion, labor,
education, health administration, and public affairs.
The panel found that the men had agreed freely to be examined and treated. However, there was
no evidence that researchers had informed them of the study or its real purpose. In fact, the men
had been misled and had not been given all the facts required to provide informed consent.
The men were never given adequate treatment for their disease. Even when penicillin became
the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory
panel found nothing to show that subjects were ever given the choice of quitting the study, even
when this new, highly effective treatment became widely used.
The Study Ends and Reparation Begins
The advisory panel concluded that the Tuskegee Study was "ethically unjustified"--the
knowledge gained was sparse when compared with the risks the study posed for its subjects. In
October 1972, the panel advised stopping the study at once. A month later, the Assistant
Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study.
In the summer of 1973, a class-action lawsuit was filed on behalf of the study participants and
their families. In 1974, a $10 million out-of-court settlement was reached. As part of the
settlement, the U.S. government promised to give lifetime medical benefits and burial services to
1 | Page

all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide
these services. In 1975, wives, widows and offspring were added to the program. In 1995, the
program was expanded to include health as well as medical benefits. The Centers for Disease
Control and Prevention was given responsibility for the program, where it remains today in the
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. The last study
participant died in January 2004. The last widow receiving THBP benefits died in January 2009.
There are 15 offspring currently receiving medical and health benefits.
Timeline

1895 Booker T. Washington at the Atlanta Cotton Exposition,


outlines his dream for black economic development and gains support of northern
philanthropists, including Julius Rosenwald (President of Sears, Roebuck and Company).
1900 Tuskegee educational experiment gains widespread support. Rosenwald Fund provides
monies to develop schools, factories, businesses, and agriculture.
1915 Booker T. Washington dies; Robert Motin continues work.
1926 Health is seen as inhibiting development and major health initiative is started. Syphilis is
seen as major health problem. Prevalence of 35 percent observed in reproductive age population.
1929 Aggressive treatment approach initiated with mercury and bismuth. Cure rate is less than
30 percent; treatment requires months and side effects are toxic, sometimes fatal.
1929 "Wall Street Crash"--economic depression begins.
1931 Rosenwald Fund cuts support to development projects. Clark and Vondelehr decide to
follow men left untreated due to lack of funds in order to show need for treatment program.
1932 Follow-up effort organized into study of 399 men with syphilis and 201 without. The men
would be given periodic physical assessments and told they were being treated. Motin agrees to
support study if "Tuskegee Institute gets its full share of the credit" and black professionals are
involved (Dr. Dibble and Nurse Rivers are assigned to study).
1934 First papers suggest health effects of untreated syphilis.
1936 Major paper published. Study criticized because it is not known if men are being treated.
Local physicians asked to assist with study and not to treat men. Decision was made to follow
the men until death.
1940 Efforts made to hinder men from getting treatment ordered under the military draft effort.
1945 Penicillin accepted as treatment of choice for syphilis.
2 | Page

1947 USPHS establishes "Rapid Treatment Centers" to treat syphilis; men in study are not
treated, but syphilis declines.
1962 Beginning in 1947, 127 black medical students are rotated through unit doing the study.
1968 Concern raised about ethics of study by Peter Buxtun and others.
1969 CDC reaffirms need for study and gains local medical societies' support (AMA and NMA
chapters officially support continuation of study).
1972 First news articles condemn studies.
1972 Study ends.
1973 Congress holds hearings and a class-action lawsuit is filed on behalf of the study
participants.
1974 A $10 million out-of-court settlement is reached and the U.S. government promised to give
lifetime medical benefits and burial services to all living participants. The Tuskegee Health
Benefit Program (THBP) was established to provide these services.
1975 Wives, widows and offspring were added to the program.
1995 The program was expanded to include health as well as medical benefits.
1997 On May 16th President Clinton apologizes on behalf of the Nation.
1999 Tuskegee University National Center for Bioethics in Research and Health Care hosts 1st
Annual Commemoration of the Presidential Apology.
2001 President's Council on Bioethics was established.
2004 CDC funds 10 million dollar cooperative agreement to continue work at Tuskegee
University National Center for Bioethics in Research and Health Care.
2004 The last U.S. Public Health Service Syphilis Study at Tuskegee participant dies on January
16.
2006 Tuskegee University holds formal opening of Bioethics Center.
2007 CDC hosts Commemorating and Transforming the Legacy of the United States Public
Health Service (USPHS) Syphilis Study at Tuskegee.
2009 The last widow receiving THBP benefits dies on January

3 | Page

TUSKEGEE SYPHILIS STUDY


I dont know what they used us for. I will never understand the study.
~ a survivor ~

4 | Page

In 1933, the U.S Public Health Service in Macon County, Albama began an investigation to chart
the succession of phases syphilis exhibits when left to itself, uncomplicated by other morbid
processes and unmolested by active treatment. 399 African-American men with latent syphilis
and 201 men without disease were enrolled in the study based on the results of a 1930 venereal
diseases control projects survey. This survey had identified Macon County to have the highest
prevalance of syphilis of the six southern States examined. The rural setting of Tuskegee - a
deprived socioeconomic status,high rates of illiteracy and especially a paucity of medical care were exploited by the investigators of the syphilis study who led the poor sharecroppers to
believe they were being treated for "bad blood," a euphemism for syphilis. The study, which
lasted for 40 years included only sporadic clinical reexaminations when a Public
Health physician came to Tuskegee and denied the individuals any form of antisyphilitic therapy. In fact, in 1942 when it was brought to the attention of the then
Assistant Surgeon General, Vonderlehr that some of the syphilitic subjects were being
called for examination prior to induction into the Armed Forces and were being directed to
undergo treatment systematic steps were taken to preserve the investigation. To prevent the
draftees from receiving anti-syphilitic treatment, the investigators provided the Macon County
Selective Service Board with a list of 256 names of men under the age of 45 years who were to
be excluded from the list of draftees needing treatment. The Board agreed to exclude these men.
Furthermore, when the modern-era of anti-syphilitc therapy began in 1943 with the introduction
of penicillin as an effective drug, the Public Health Service did not use the drug on the Tuskegee
participants unless they asked for it. The rationale published by the investigators for their
decision regarding the lack of treatment provided to the infected "Negro" population was,
"...Such individuals seemed to offer an unusual opportunity to study the untreated syphilitic
patients from the beginning of the disease to the death of the infected person. An opportunity was
also offered to compare the syphilitic process uninfluenced by modern treatment, with the results
attained when treatment had been given."(6)
By the time the study was exposed in 1972 and ended on November 16 th of the same year, 28
men had died of syphilis, 100 others were dead due to syphilis related complications, at least 40
wives had been infected and 19 children had contracted the disease at birth.
On July 23rd, eight months after the Tuskegee syphilis study was abandoned, a $1.8 billion class
action suit was filed against the institutions and individuals involved. Prominent civil rights
lawyer, Fred Gray, demanded $3 million in damages for each living participant and the heirs of
the deceased. The case, however, never came to trial and in December 1974 and out of court
settlement was made. The government agreed to the distribution of $10 million, whereby each
survivor received $37,500 in damages and the heirs of the deceased received $15,000.
The most vociferous criticism of the Tuskegee Study has been that the subjects were not
provided with the adequate information needed to willingly consent to participating. The subjects
were not consulted about the research project, its consequences to them and the alternatives
available to them. A program that promised little inconvience and substantial rewards to the
impoverished society of Tuskegee necessarily appealed to the participants of the study.

5 | Page

"...various methods were used to maintain and stimulate their


interest. Free medicines, burial assistance or insurance, free hot
meals on the days of examination, transport to and from the hospital
and an opportunity tp stop in town on the return trip...all helped."
(7)
Bearing in mind the low educational status of the patients and the
tendency of the average African-American man to willingly agree
with a perceived authoritarian figure such as the Public Health Service physician the men from
Tuskegee became the unassuming victims of an unethical scientific undertaking.

"...The county health officer shall require persons


infected with venereal disease to report for treatment to
a reputable physician and continue treatment until such
disease, in the judgment of the attending physician is no
longer communicable..." (8)
This was stated in the venereal disease law enacted by
the Alabama Legislature in 1927. Notwithstanding the
law the officials of a Federal Agency, the Public Health
Service, were successful in withholding therapy from the participants of the Tuskegee Study, and
the physicians did not detect an ethical dilemma.
Although there were no guidelines in 1930 to influence the formulation of a prospective study of
patients with an untreated chronic disease, when the Judiciary Council of the American Medical
Association issued a report, on December 10th, 1946, on the ethics of experiments involving
human subjects the investigators of the Tuskegee Study took no steps to revise or terminate their
investigation. The Tuskegee Syphilis Study was in violation of all three requirements proposed
by the Judiciary: (1) the voluntary consent of the person on whom the experiment is to be
performed must be obtained, (2) the danger of each experiment must be previously investigated
by animal experimentation, (3) the experiment must be performed under proper medical
protection and management.
In the aftermath of the Tuskegee Study the government reevaluated its research practices to
prevent another Tuskegee. The National Research Act was signed in 1974, which created the
National Commission for the Protection of Human Subjects of Biomedical and Behavioural
Research. The group identified the basic principles of research conduct and suggested ways to
ensure those principles were followed.
Furthermore, regulations were passed that required all studies using human subjects be reviewed
by an Institutional Review Board, which read the study protocols and decided whether they met
ethical standards.

6 | Page

THE NUREMBERG CODE


Wartime Experiments on the Inmates of Nazi Concentration Camps
The idea of, "state before individual" was typical of the Nazi era and physicians began to lose
sight of their moral obligations as they were swept into the dehumanizing Nazi political culture.
The slew of exotic diseases and afflictions, a condition of the war environment, were seen as a,
"national threat," and it was to these "threats" that German doctors began to assume the
responsibility of acting on behalf of the state in order to improve the health of the nation. On the
basis of national thought and utilitarianism doctors no longer acted as caretakers but as puppets
of a government obsessed with racial and genetic purity. Medical experiments committed under
the disguise of scientific research fell into three basic categories: (1) Medico-Military Research;
(2) Miscellaneous, Ad Hoc Experiments; and (3) Racially Motivated Experiments. (1)
Dr. Josepf Mengele, more familiarly known as the 'Angel of death,' is probably
the most famous of the Nazi doctors who used the prisoners in Nazi
concentration camps for medical experimentation. Mengele sought to unlock the
genetic basis for a superior race and conducted goulish experiments with
precision going even beyond the limits of scientific inquiry. He was fanatical
about twin studies, obsessing over the differences between twins, and would
make them sit together in the nude for hours while he personally examined them leaving no bady
part untouched. Furthermore, drawing blood from identical twins was routine, which often left
them bleeding to death. Mengele was also involved in other studies that sought to design better
equipment for the Nazi soldiers, and for this purpose naked prisoners were placed in ice cold vats
to determine the lowest possible temperature in which a human could survive. However,
Mengele wasn't alone in his medical exploits, many German doctors made trips to Nazi
concentration camps where they could use the large potential subject pool without concern for
the harm of the subjects.

The Aftermath
Following World War II, leading Nazi doctors were brought to justice before the International
Military Tribunal at Nuremberg. 20 doctors (unfortunately Dr. Josepf Mengele was not among
these twenty. He fled Auschwitz in 1945, before the liberation of the camps by the Americans.),
were charged with War Crimes and Crimes Against Humanity. The Nuremberg trial of doctors,
which began in 1946, revelaed evidence of sadistic human experiments conducted at the Dachau,
Auschwitz, Buchenwald and Sachsenhausen concentration camps.
7 | Page

The Nuremberg Code is the most important document in the history of the ethics of medical
research and the first of its kind to ensure the rights of subjects. Formulated 50 years ago, in
August 1947, by the American judges heading the trial of Nazi
doctors accused of conducting macabre human experiments in the
concentration camps. During the course of the trial the judges at
Nuremberg correctly recognized that more than the Hipporatic
ethics and the maxim premium non nocere, were necessary to
ensure and protect the rights of human research subjects. Thus the
judges defined a set of 10 research principles that were centered
on the research subject rather than the physician. The judges were
emphatic about the necessity and quality of the subject's consent,
explicitly adding the subjects right to withdraw from the
experiment. The Nuremberg Code insists that the medical
investigators alone cannot set the rules for the ethical conduct of
research, even when guided by beneficence and the Hippocratic
ethics. In the traditional doctor-patient relationship, the silent and dutiful patient trusted the
physician to act in their best interests or at least do no harm. However, more often than not
scientific research lies outside the beneficent context of the physician-patient relationship
whereby the physician's primary goal is now motivated by a scientific hypothesis and not to treat
the patient. This breach of trust led the judges heading the Nuremberg trials to merge Hippocratic
ethics and the protection of human rights into a single code.

From "Trials of War Criminals Before the Nuremberg Military Tribunals Under Control
Council Law No. 10", Vol. 2, Nuremberg, October 1946 - April 1949. (Washington,
DC: US Government Printing Office, 1949). pp 181-182.
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.
8 | Page

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.
1. 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.
2. 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 problems under study that the
anticipated results will justify the performance of the experiment.
3. The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
4. 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.
5. 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.
6. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
7. 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.
8. 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.
9. 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.

9 | Page

THE HELSINKI DECLARATION


Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by
the
29th
WMA
General
Assembly,
Tokyo,
Japan,
October
1975
35th
WMA
General
Assembly,
Venice,
Italy,
October
1983
41st
WMA
General
Assembly,
Hong
Kong,
September
1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000
Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002
Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004
INTRODUCTION
1. The World Medical Association has developed the Declaration of Helsinki as a statement of
ethical principles to provide guidance to physicians and other participants in medical research
involving human subjects. Medical research involving human subjects includes research on
identifiable human material or identifiable data.
2. It is the duty of the physician to promote and safeguard the health of the people. The
physician's knowledge and conscience are dedicated to the fulfillment of this duty.
3. 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."
4. Medical progress is based on research which ultimately must rest in part on experimentation
involving human subjects.
5. In medical research on human subjects, considerations related to the well-being of the human
subject should take precedence over the interests of science and society.
10 | P a g e

6. The primary purpose of medical research involving human subjects is to improve


prophylactic, diagnostic and therapeutic procedures and the understanding of the etiology and
pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic
methods must continuously be challenged through research for their effectiveness, efficiency,
accessibility and quality.
7. In current medical practice and in medical research, most prophylactic, diagnostic and
therapeutic procedures involve risks and burdens.
8. Medical research is subject to ethical standards that promote respect for all human beings and
protect their health and rights. 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, 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.
9. Research Investigators should be aware of the ethical, legal and regulatory requirements for
research on human subjects in their own countries as well as applicable international
requirements. No national ethical, legal or regulatory requirement should be allowed to
reduce or eliminate any of the protections for human subjects set forth in this Declaration.

BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH


10. It is the duty of the physician in medical research to protect the life, health, privacy, and
dignity of the human subject.
11. Medical research involving human subjects must conform to generally accepted scientific
principles, be based on a thorough knowledge of the scientific literature, other relevant
sources of information, and on adequate laboratory and, where appropriate, animal
experimentation.
12. Appropriate caution must be exercised in the conduct of research which may affect the
environment, and the welfare of animals used for research must be respected.
13. The design and performance of each experimental procedure involving human subjects
should be clearly formulated in an experimental protocol. This protocol should be submitted
for consideration, comment, guidance, and where appropriate, approval to a specially
appointed ethical review committee, which must be independent of the investigator, the
sponsor or any other kind of undue influence. This independent committee should be in
conformity with the laws and regulations of the country in which the research experiment is
performed. The committee has the right to monitor ongoing trials. The researcher has the
obligation to provide monitoring information to the committee, especially any serious
adverse events. The researcher should also submit to the committee, for review, information
regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and
incentives for subjects.
11 | P a g e

14. The research protocol should always contain a statement of the ethical considerations
involved and should indicate that there is compliance with the principles enunciated in this
Declaration.
15. Medical 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 consent.
16. Every medical research project involving human subjects should be preceded by careful
assessment of predictable risks and burdens in comparison with foreseeable benefits to the
subject or to others. This does not preclude the participation of healthy volunteers in medical
research. The design of all studies should be publicly available.
17. Physicians should abstain from engaging in research projects involving human subjects
unless they are confident that the risks involved have been adequately assessed and can be
satisfactorily managed. Physicians should cease any investigation if the risks are found to
outweigh the potential benefits or if there is conclusive proof of positive and beneficial
results.
18. Medical research involving human subjects should only be conducted if the importance of
the objective outweighs the inherent risks and burdens to the subject. This is especially
important when the human subjects are healthy volunteers.
19. Medical research is only justified if there is a reasonable likelihood that the populations in
which the research is carried out stand to benefit from the results of the research.
20. The subjects must be volunteers and informed participants in the research project.
21. The right of research subjects to safeguard their integrity must always be respected. Every
precaution should be taken to respect the privacy of the subject, the confidentiality of the
patient's information and to minimize the impact of the study on the subject's physical and
mental integrity and on the personality of the subject.
22. In any research on human beings, 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. The subject should be informed of the right to abstain from participation in the
study or to withdraw consent to participate at any time without reprisal. After ensuring that
the subject has understood the information, the physician should then obtain the subject's
freely-given informed consent, preferably in writing. If the consent cannot be obtained in
writing, the non-written consent must be formally documented and witnessed.
23. When obtaining informed consent for the research project the physician should be
particularly cautious if the subject is in a dependent relationship with the physician or may
consent under duress. In that case the informed consent should be obtained by a wellinformed physician who is not engaged in the investigation and who is completely
independent of this relationship.

12 | P a g e

24. For a research subject who is legally incompetent, physically or mentally incapable of giving
consent or is a legally incompetent minor, the investigator must obtain informed consent
from the legally authorized representative in accordance with applicable law. These groups
should not be included in research unless the research is necessary to promote the health of
the population represented and this research cannot instead be performed on legally
competent persons.
25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to
decisions about participation in research, the investigator must obtain that assent in addition
to the consent of the legally authorized representative.
26. Research on individuals from whom it is not possible to obtain consent, including proxy or
advance consent, should be done only if the physical/mental condition that prevents
obtaining informed consent is a necessary characteristic of the research population. The
specific reasons for involving research subjects with a condition that renders them unable to
give informed consent should be stated in the experimental protocol for consideration and
approval of the review committee. The protocol should state that consent to remain in the
research should be obtained as soon as possible from the individual or a legally authorized
surrogate.
27. Both authors and publishers have ethical obligations. In publication of the results of research,
the investigators are obliged to preserve the accuracy of the results. Negative as well as
positive results should be published or otherwise publicly available. Sources of funding,
institutional affiliations and any possible conflicts of interest should be declared in the
publication. Reports of experimentation not in accordance with the principles laid down in
this Declaration should not be accepted for publication.
ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
MEDICAL CARE
28. The physician may combine medical research with medical care, only to the extent that the
research is justified by its potential prophylactic, diagnostic or therapeutic value. When
medical research is combined with medical care, additional standards apply to protect the
patients who are research subjects.
29. The benefits, risks, burdens and effectiveness of a new method should be tested against those
of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude
the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or
therapeutic method exists.1
30. At the conclusion of the study, every patient entered into the study should be assured of
access to the best proven prophylactic, diagnostic and therapeutic methods identified by the
study.2
31. The physician should fully inform the patient which aspects of the care are related to the
research. The refusal of a patient to participate in a study must never interfere with the
patient-physician relationship.

13 | P a g e

32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods
do not exist or have been ineffective, the physician, with informed consent from the patient,
must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in
the physician's judgement it offers hope of saving life, re-establishing health or alleviating
suffering. Where possible, these measures should be made the object of research, designed to
evaluate their safety and efficacy. In all cases, new information should be recorded and,
where appropriate, published. The other relevant guidelines of this Declaration should be
followed.

Note of clarification on paragraph 29 of the WMA Declaration of Helsinki The WMA


hereby reaffirms its position that extreme care must be taken in making use of a placebocontrolled trial and that in general this methodology should only be used in the absence of
existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if
proven therapy is available, under the following circumstances:
- Where for compelling and scientifically sound methodological reasons its use is necessary to
determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or
- Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor
condition and the patients who receive placebo will not be subject to any additional risk of
serious or irreversible harm.
All other provisions of the Declaration of Helsinki must be adhered to, especially the need for
appropriate ethical and scientific review.
2

Note of clarification on paragraph 30 of the WMA Declaration of Helsinki

The WMA hereby reaffirms its position that it is necessary during the study planning process to
identify post-trial access by study participants to prophylactic, diagnostic and therapeutic
procedures identified as beneficial in the study or access to other appropriate care. Post-trial
access arrangements or other care must be described in the study protocol so the ethical review
committee may consider such arrangements during its review.
Revised: 09/10/2004
Ethical Principles & Guidelines for Research Involving Human Subjects
Scientific research has produced substantial social benefits. It has also posed some troubling
ethical questions. Public attention was drawn to these questions by reported abuses of human
subjects in biomedical experiments, especially during the Second World War. During the
Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging
physicians and scientists who had conducted biomedical experiments on concentration camp
prisoners. This code became the prototype of many later codes(1) intended to assure that research
involving human subjects would be carried out in an ethical manner.

14 | P a g e

The codes consist of rules, some general, others specific, that guide the investigators or the
reviewers of research in their work. Such rules often are inadequate to cover complex situations;
at times they come into conflict, and they are frequently difficult to interpret or apply. Broader
ethical principles will provide a basis on which specific rules may be formulated, criticized and
interpreted.
Three principles, or general prescriptive judgments, that are relevant to research involving
human subjects are identified in this statement. Other principles may also be relevant. These
three are comprehensive, however, and are stated at a level of generalization that should assist
scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in
research involving human subjects. These principles cannot always be applied so as to resolve
beyond dispute particular ethical problems. The objective is to provide an analytical framework
that will guide the resolution of ethical problems arising from research involving human subjects.
This statement consists of a distinction between research and practice, a discussion of the three
basic ethical principles, and remarks about the application of these principles.

Part A: Boundaries between Practice & Research


A. Boundaries between Practice and Research
It is important to distinguish between biomedical and behavioral research, on the one hand, and
the practice of accepted therapy on the other, in order to know what activities ought to undergo
review for the protection of human subjects of research. The distinction between research and
practice is blurred partly because both often occur together (as in research designed to evaluate a
therapy) and partly because notable departures from standard practice are often called
experimental when the terms experimental and research are not carefully defined.
For the most part, the term practice refers to interventions that are designed solely to enhance
the well-being of an individual patient or client and that have a reasonable expectation of
success. The purpose of medical or behavioral practice is to provide diagnosis, preventive
treatment or therapy to particular individuals. (2) By contrast, the term research' designates an
activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or
contribute to generalizable knowledge (expressed, for example, in theories, principles, and
statements of relationships). Research is usually described in a formal protocol that sets forth an
objective and a set of procedures designed to reach that objective.
When a clinician departs in a significant way from standard or accepted practice, the innovation
does not, in and of itself, constitute research. The fact that a procedure is experimental, in the
sense of new, untested or different, does not automatically place it in the category of research.
Radically new procedures of this description should, however, be made the object of formal
research at an early stage in order to determine whether they are safe and effective. Thus, it is the
responsibility of medical practice committees, for example, to insist that a major innovation be
incorporated into a formal research project. (3)
Research and practice may be carried on together when research is designed to evaluate the
safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the
15 | P a g e

activity requires review; the general rule is that if there is any element of research in an activity,
that activity should undergo review for the protection of human subjects.

16 | P a g e