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Tuskegee Syphilis Study: HE Uskegee Imeline
Tuskegee Syphilis Study: HE Uskegee Imeline
Nearly 65 years after the U.S. Public Health Service Syphilis Study at Tuskegee began;
President Clinton apologized for the U.S. government's role in the research study,
which was carried out in Macon County, Alabama, from 1932 to 1972.
The United States Public Health Service, in trying to learn more about syphilis and
justify treatment programs for blacks, withheld adequate treatment from a group of
poor black men who had the disease, causing needless pain and suffering for the men
and their loved ones.
In the wake of the U.S. Public Health Service Syphilis Study at Tuskegee and other
studies, the federal government took a closer look at research involving human
subjects and made changes to prevent the moral breaches that occurred in Tuskegee
from happening again.
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.
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 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,
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.
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.
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.
2009 The last widow receiving THBP benefits dies on January 27.
"Bad Blood:"
A Case Study of the Tuskegee Syphilis Project
THE DISEASE
Syphilis is a venereal disease spread during sexual intercourse. It can also be passed from mother to child during pregnancy. It is
caused by a corkscrew-shaped bacterium called a spirochete, Treponema pallidum. This microscopic organism resides in many
organs of the body but causes sores or ulcers (called chancres) to appear on the skin of the penis, vagina, mouth, and occasionally
in the rectum, or on the tongue, lips, or breast. During sex the bacteria leave the sores of one person and enter the moist
membranes of their partner's penis. vagina, mouth, or rectum.
Once the spirochetes wiggle inside a victim, they begin to multiple at an amazing rate. (Some bacteria have a doubling rate of 30
minutes. You may want to consider how many bacteria you might have in 12 hours if one bacterium entered your body doubling at
that rate.) The spirochetes then enter the lymph circulation, which carries them to nearby lymph glands that may swell in response
to the infection.
This first stage of the disease (called primary syphilis) lasts only a few weeks and usually causes hard red sores or ulcers to develop
on the genitals of the victim, who can then pass the disease on to someone else. During this primary stage, a blood test will not
reveal the disease but the bacteria can be scraped from the sores. The sores soon heal and some people may recover entirely
without treatment.
Secondary syphilis develops two to six weeks after the sores heal. Then flu-like symptoms appear with fever, headache, eye
inflammation, malaise, and joint pain, along with a skin rash and mouth and genital sores. These symptoms are a clear sign that the
spirochetes have traveled throughout the body by way of the lymph and blood systems, where they now can be readily detected by
a blood test (e.g., the Wassermann test). Scalp hair may drop out to give a "moth-eaten" look to the head. This secondary stage
ends in a few weeks as the sores heal.
Signs of the disease may never reappear even though the bacteria continue to live in the person. However, in about 25% of those
originally infected, symptoms will flare up again in a late or tertiary stage syphilis.
Almost any organ can be attacked, such as the cardiovascular system, producing leaking heart valves and aneurysms--balloon-like
bulges in the aorta that may burst, leading to instant death. Gummy or rubbery tumors filled with spirochetes and covered by a
dried crust of pus may develop on the skin. The bones may deteriorate as in osteomyelitis or tuberculosis and may produce
disfiguring facial mutilations as nasal and palate bones are eaten away. If the nervous system is infected, a stumbling foot-slapping
gait may occur or, more severely, paralysis, senility, blindness, and insanity.
The cause of syphilis, the stages of the disease's development, and the complications that can result from untreated syphilis were
all known to medical science in the early 1900s. In 1905, German scientists Hoffman and Schaudinn isolated the bacterium that
causes syphilis. In 1907, the Wassermann blood test was developed, enabling physicians to diagnose the disease. Three years later,
German scientist Paul Ehrlich created an arsenic compound called salvarsan to treat syphilis. Together with mercury, it was either
injected or rubbed onto the skin and often produced serious and occasionally fatal reactions in patients. Treatment was painful and
usually required more than a year to complete.
In 1908, Congress established the Division of Venereal Diseases in the United States Public Health Service. Within a year, 44 states
had organized separate bureaus for venereal disease control. Unfortunately, free treatment clinics operated only in urban areas for
many years. Data collected in a survey begun in 1926 of 25 communities across the United States indicated that the incidence of
syphilis among patients under observation was "4.05 cases per 1,000 population, the rate for whites being 4 per 1,000, and that for
Negroes 7.2 per 1,000."
One of the Fund's major goals was to encourage their grantees to use black personnel whenever possible as a means to promote
professional integration. Thus, the mission of the Fund seemed to fit well with the plans of the PHS. Macon County, Alabama, was
selected as one of five syphilis-control demonstration programs in February 1930. The local Tuskegee Institute endorsed the
program. The Institute and its John A. Andrew Memorial Hospital were staffed and administered entirely by African-American
physicians and nurses: "The demonstrations would provide training for private physicians, white and colored, in the elements of
venereal disease treatments and the more extensive distribution of antisyphilitic drugs and the promotion of wider use of state
diagnostic laboratory facilities."
In 1930, Macon County had 27,000 residents, 82 percent of whom were African-Americans, most living in rural poverty in shacks
with dirt floors, no plumbing, and poor sanitation. This was the target population, people who "had never in their lives been treated
by a doctor." Public health officials arriving on the scene announced they had come to test people for "bad blood." The term
included a host of maladies and later surveys suggest that few people connected that term with syphilis.
The syphilis control study in Macon County turned up the alarming news that 36 percent of the African-American population had
syphilis. The medical director of the Rosenwald Fund was concerned about the racial connotations of the findings, saying "There is
bound to be danger that the impression will be given that syphilis in the South is a Negro problem rather than one of both races."
The PHS officer assured the Fund and the Tuskegee Institute that demonstrations would not be used to attack the images of black
Americans. He argued that the high syphilis rates were not due to "inherent racial susceptibility" but could be explained by
"differences in their respective social and economic status." However, the PHS failed to persuade the Fund that more work could
break the cycle of poverty and disease in Macon County. So when the PHS officers suggested a larger scale extension of the work,
the Rosenwald Fund trustees voted against the new project.
Building on what had been learned during the Rosenwald Fund demonstrations and the four other sites, the PHS covered the nation
with the Wassermann tests. Both blacks and whites were reached with extensive testing, and in some areas mobile treatment clinics
were available.
THE EXPERIMENT
As the PHS officers analyzed the data for the final Rosenwald Fund report in September of 1932, and realizing that funding for the
project would be discontinued, the idea for a new study evolved into the Tuskegee Study of Untreated Syphilis in the Negro Male.
The idea was to convert the original treatment program into a nontherapeutic human experiment aimed at compiling data on the
progression of the disease on untreated African-American males.
There was precedence for such a study. One had been conducted in Oslo, Norway, at the turn of the century on a population of
white males and females. An impressive amount of information had been gathered from these patients concerning the progression
of the disease. However, questions of manifestation and progression of syphilis in individuals of African descent had not been
studied. In light of the discovery that African natives had some rather unique diseases (for example, sick cell anemia--a disease of
red blood cells), a study of a population of African males could reveal biological differences during the course of the disease. (Later,
the argument that supported continuation of the study may even have been reinforced in the early 1950s when it was suggested
that native Africans with the sickle cell trait were less susceptible to the ravages of malaria.)
In fact, Dr. Joseph Earle Moore of the Venereal Disease Clinic of the Johns Hopkins University School of Medicine stated when
consulted, "Syphilis in the Negro is in many respects almost a different disease from syphilis in the white." The PHS doctors felt that
this study would emphasize and delineate these differences. Moreover, whereas the Oslo study was retrospective (looking back at
old cases), the Macon Study would be a better prospective study, following the progress of the disease through time.
It was estimated that of the 1,400 patients in Macon County admitted to treatment under the Rosenwald Fund, not one had
received the full course of medication prescribed as standard therapy for syphilis. The PHS officials decided that these men could be
considered untreated because they had not received enough treatment to cure them. In the county there was a well-equipped
teaching hospital (the John A. Andrew Memorial Hospital at the Tuskegee Institute) that could be used for scientific purposes.
Over the next months in 1932, cooperation was insured from the Alabama State Board of Health, the Macon County Health
Department, and the Tuskegee Institute. However, Dr. J.N. Baker, the state health officer, received one important concession in
exchange for his approval. Everyone found to have syphilis would have to be treated. Although this would not cure them--the nine-
month study was too short--it would keep them non-infectious. Dr. Baker also argued that local physicians be involved.
As Dr. Vonderlehr approached the end of his few months of study, he suggested to his superior, Dr. Clark, that the work continue
for five to 10 years because "many interesting facts could be learned regarding the course and complications of untreated syphilis."
Dr. Clark retired a few months later and in June 1933 Dr. Vonderlehr was promoted to director of the Division of Venereal Diseases
of the PHS.
This promotion began a bureaucratic pattern over the next four decades that saw the position of director go to a physician who had
worked on the Tuskegee Study. Dr. Vonderlehr spent much of the summer of 1933 working out the study's logistics, which would
enable the PHS to follow the men's health through their lifetime. This included gaining permission from the men and their families
to perform an autopsy at the time of their death, thus providing the scientific community with a detailed microscopic description of
the diseased organs.
Neither the syphilitics nor the controls (those men free of syphilis who were added to the project) were informed of the study's true
objective. These men knew only that they were receiving treatment for "bad blood" and money for burial. Burial stipends began in
1935 funded by the Milbank Memorial Fund.
The skill of the African-American nurse, Eunice Rivers, and the cooperation of the local health providers (most of them white
males), were essential in this project. They understood the project details and the fact that the patients' available medical care
(other than valid treatment for syphilis) was far better than that for most African-Americans in Macon County. The local draft board
agreed to exclude the men in the study from medical treatment when that became an issue during the early 1940s. State health
officials also cooperated.
The study was not kept secret from the national medical community in general. Dr. Vonderlehr in 1933 contacted a large number of
experts in the field of venereal disease and related medical complications. Most responded with support for the study. The American
Heart Association asked for clarification of the scientific validity, then subsequently expressed great doubt and criticism concerning
the tests and procedures. Dr. Vonderlehr remained convinced that the study was valid and would prove that syphilis affected
African-Americans differently than those of European descent. As director of the PHS Venereal Disease Division, he controlled the
funds necessary to conduct the study, as did his successors.
Key to the cooperation of the men in the Tuskegee Study was the African-American PHS nurse assigned to monitor them. She
quickly gained their trust. She dealt with their problems. The physicians came to respect her ability to deal with the men. She not
only attempted to keep the men in the study, many times she prevented them from receiving medical care from the PHS treatment
clinics offering neoarsphenamine and bismuth (the treatment for syphilis) during the late 1930s and early 1940s. She never
advocated treating the men. She knew these treatment drugs had side affects. As a nurse, she had been trained to follow doctor's
orders. By the time penicillin became available for the treatment of syphilis, not treating these men had become a routine
procedure, which she did not question. She truly felt that these men were better off because of the routine medical examinations,
distribution of aspirin pink pills that relieved aches and pains, and personal nursing care. She never thought of the men as victims;
she was aware of the Oslo study: "This is the way I saw it: that they were studying the Negro, just like they were studying the
white man, see, making a comparison." She retired from active nursing in 1965, but assisted during the annual checkups until the
experiment ended.
By 1943, when the Division of Venereal Diseases began treating syphilitic patients nationwide with penicillin, the men in the
Tuskegee study were not considered patients. They were viewed as experimental subjects and were denied antibiotic treatment.
The PHS officials insisted that the Study offered even more of an opportunity to study these men as a "control against which to
project not only the results obtained with the rapid schedules of therapy for syphilis but also the costs involved in finding and
placing under treatment the infected individuals." There is no evidence that the study had ever been discussed in the light of the
Nuremberg Code, a set of ethical principles for human experimentation developed during the trials of Nazi physicians in the
aftermath of World War II. Again, the study had become routine.
In 1951, Dr. Trygve Gjustland, then the current director of the Oslo Study, joined the Tuskegee group to review the experiment. He
offered suggestions on updating records and reviewing criteria. No one questioned the issue of contamination (men with partial
treatment) or ethics. In 1952, the study began to focus on the study of aging, as well as heart disease, because of the long-term
data that had been accumulated on the men. It became clear that syphilis generally shortened the lifespan of its victims and that
the tissue damage began while the young men were in the second stage of the disease (see tables in Appendix A).
In February of 1969, the PHS called together a blue ribbon panel to discuss the Tuskegee study. The participants were all
physicians, none of whom had training in medical ethics. In addiiton, none of them were of African descent. At no point during the
discussions did anyone remind the panel of PHS's own guidelines on human experimentation (established in February 1966).
According to records, the original study had been composed of 412 men with syphilis and 204 controls. In 1969, 56 syphilitic
subjects and 36 controls were known to be living. A total of 373 men in both groups were known to be dead. The rest were
unaccounted for. The age of the survivors ranged from 59 to 85, one claiming to be 102. The outcome of this meeting was that the
study would continue. The doctors convinced themselves that the syphilis in the Tuskegee men was too far along to be effectively
treated by penicillin and that the men might actually suffer severe complications from such therapy. Even the Macon County Medical
Society, now made up of mostly African-American physicians, agreed to assist the PHS. Each was given a list of subjects,
In the late 1960s, PHS physician, Dr. James Lucas, stated in a memorandum that the Tuskegee study was "bad science" because it
had been contaminated by treatment. PHS continued to put a positive spin on the experiment by noting that the study had been
keeping laboratories supplied with blood samples for evaluating new blood tests for syphilis.
Peter Buxtin, who had left the PHS for law school, bothered by the study and the no-change attitude of the PHS, contacted the
Associated Press. Jean Heller, the reporter assigned to the story, did extensive research into the Tuskegee experiment. When
interviewed by her, the PHS officials provided her with much of her information. They were men who had nothing to hide. The story
broke on July 25, 1972. The study immediately stopped.
APPENDIX A
The following are a variety of data sets compiled from later publications of the Tuskegee study.
http://ublib.buffalo.edu/libraries/projects/cases/blood.htm
The story finally broke in the Washington Star on July 25, 1972, in an article by Jean Heller of the Associated Press. Her source was
Peter Buxtun, a former PHS venereal disease interviewer and one of the few whistle blowers over the years. The PHS, however,
remained unrepentant, claiming the men had been “volunteers” and “were always happy to see the doctors,” and an Alabama state
health officer who had been involved claimed “somebody is trying to make a mountain out of a molehill.”
Under the glare of publicity, the government ended their experiment, and for
the first time provided the men with effective medical treatment for syphilis. The PHS did not accept the media's
Fred Gray, a lawyer who had previously defended Rosa Parks and Martin comparison of Tuskegee with the
Luther King, filed a class action suit that provided a $10 million out-of-court experiments performed by Nazi doctors
settlement for the men and their families. Gray, however, named only whites on Jewish victims during World War II.
and white organizations as defendants in the suit, portraying Tuskegee as a Yet the PHS offered the same defense
black and white case when it was in fact more complex than that—black offered at the Nuremberg trials — they
doctors and institutions had been involved from beginning to end. were just carrying out orders.
The PHS did not accept the media's comparison of Tuskegee with the appalling experiments performed by Nazi doctors on their
Jewish victims during World War II. Yet in addition to the medical and racist parallels, the PHS offered the same morally bankrupt
defense offered at the Nuremberg trials: they claimed they were just carrying out orders, mere cogs in the wheel of the PHS
bureaucracy, exempt from personal responsibility.
The study's other justification—for the greater good of science—is equally spurious. Scientific protocol had been shoddy from the
start. Since the men had in fact received some medication for syphilis in the beginning of the study, however inadequate, it thereby
corrupted the outcome of a study of “untreated syphilis.”
In 1990, a survey found that 10 percent of African Americans believed that the U.S. government created AIDS as a plot to
exterminate blacks, and another 20 percent could not rule out the possibility that this might be true. As preposterous and paranoid
as this may sound, at one time the Tuskegee experiment must have seemed equally farfetched.
Who could imagine the government, all the way up to the Surgeon General of the United States, deliberately allowing a group of its
citizens to die from a terrible disease for the sake of an ill-conceived experiment? In light of this and many other shameful episodes
in our history, African Americans' widespread mistrust of the government and white society in general should not be a surprise to
anyone.
THE PRESIDENT: Ladies and gentlemen, on Sunday, Mr. Shaw will celebrate his 95th
birthday. (Applause.) I would like to recognize the other survivors who are here today
and their families: Mr. Charlie Pollard is here. (Applause.) Mr. Carter Howard.
(Applause.) Mr. Fred Simmons. (Applause.) Mr. Simmons just took his first airplane
ride, and he reckons he's about 110 years old, so I think it's time for him to take a
chance or two. (Laughter.) I'm glad he did. And Mr. Frederick Moss, thank you, sir.
(Applause.)
I would also like to ask three family representatives who are here -- Sam Doner is
represented by his daughter, Gwendolyn Cox. Thank you, Gwendolyn. (Applause.)
Ernest Hendon, who is watching in Tuskegee, is represented by his brother, North
Hendon. Thank you, sir, for being here. (Applause.) And George Key is represented by
his grandson, Christopher Monroe. Thank you, Chris. (Applause.)
I also acknowledge the families, community leaders, teachers and students watching
today by satellite from Tuskegee. The White House is the people's house; we are glad to have all of you here today. I thank Dr.
David Satcher for his role in this. I thank Congresswoman Waters and Congressman Hilliard, Congressman Stokes, the entire
Congressional Black Caucus. Dr. Satcher, members of the Cabinet who are here, Secretary Herman, Secretary Slater, members of
the Cabinet who are here, Secretary Herman, Secretary Slater. A great friend of freedom, Fred Gray, thank you for fighting this
long battle all these long years.
The eight men who are survivors of the syphilis study at Tuskegee are a living link to a time not so very long ago that many
Americans would prefer not to remember, but we dare not forget. It was a time when our nation failed to live up to its ideals,
when our nation broke the trust with our people that is the very foundation of our democracy. It is not only in remembering that
shameful past that we can make amends and repair our nation, but it is in remembering that past that we can build a better
present and a better future. And without remembering it, we cannot make amends and we cannot go forward.
So today America does remember the hundreds of men used in research without their knowledge and consent. We remember them
and their family members. Men who were poor and African American, without resources and with few alternatives, they believed
they had found hope when they were offered free medical care by the United States Public Health Service. They were betrayed.
Medical people are supposed to help when we need care, but even once a cure was discovered, they were denied help, and they
were lied to by their government. Our government is supposed to protect the rights of its citizens; their rights were trampled upon.
Forty years, hundreds of men betrayed, along with their wives and children, along with the community in Macon County, Alabama,
the City of Tuskegee, the fine university there, and the larger African American community.
The United States government did something that was wrong -- deeply, profoundly, morally wrong. It was an outrage to our
commitment to integrity and equality for all our citizens.
To the survivors, to the wives and family members, the children and the grandchildren, I say what you know: No power on Earth
can give you back the lives lost, the pain suffered, the years of internal torment and anguish. What was done cannot be undone.
But we can end the silence. We can stop turning our heads away. We can look at you in the eye and finally say on behalf of the
American people, what the United States government did was shameful, and I am sorry. (Applause.)
The American people are sorry -- for the loss, for the years of hurt. You did nothing wrong, but you were grievously wronged. I
apologize and I am sorry that this apology has been so long in coming. (Applause.)
To Macon County, to Tuskegee, to the doctors who have been wrongly associated with the events there, you have our apology, as
well. To our African American citizens, I am sorry that your federal government orchestrated a study so clearly racist. That can
never be allowed to happen again. It is against everything our country stands for and what we must stand against is what it was.
The legacy of the study at Tuskegee has reached far and deep, in ways that hurt our progress and divide our nation. We cannot be
one America when a whole segment of our nation has no trust in America. An apology is the first step, and we take it with a
commitment to rebuild that broken trust. We can begin by making sure there is never again another episode like this one. We need
to do more to ensure that medical research practices are sound and ethical, and that researchers work more closely with
communities.
Today I would like to announce several steps to help us achieve these goals. First, we will help to build that lasting memorial at
Tuskegee. (Applause.) The school founded by Booker T. Washington, distinguished by the renowned scientist George Washington
Carver and so many others who advanced the health and well-being of African Americans and all Americans, is a fitting site. The
Department of Health and Human Services will award a planning grant so the school can pursue establishing a center for bioethics
in research and health care. The center will serve as a museum of the study and support efforts to address its legacy and
strengthen bioethics training.
Second, we commit to increase our community involvement so that we may begin restoring lost trust. The study at Tuskegee
served to sow distrust of our medical institutions, especially where research is involved. Since the study was halted, abuses have
been checked by making informed consent and local review mandatory in federally-funded and mandated research.
Still, 25 years later, many medical studies have little African American participation and African American organ donors are few.
This impedes efforts to conduct promising research and to provide the best health care to all our people, including African
Americans. So today, I'm directing the Secretary of Health and Human Services, Donna Shalala, to issue a report in 180 days about
how we can best involve communities, especially minority communities, in research and health care. You must -- every American
group must be involved in medical research in ways that are positive. We have put the curse behind us; now we must bring the
benefits to all Americans. (Applause.)
Third, we commit to strengthen researchers' training in bioethics. We are constantly working on making breakthroughs in
protecting the health of our people and in vanquishing diseases. But all our people must be assured that their rights and dignity will
be respected as new drugs, treatments and therapies are tested and used. So I am directing Secretary Shalala to work in
partnership with higher education to prepare training materials for medical researchers. They will be available in a year. They will
help researchers build on core ethical principles of respect for individuals, justice and informed consent, and advise them on how to
use these principles effectively in diverse populations.
Fourth, to increase and broaden our understanding of ethical issues and clinical research, we commit to providing postgraduate
fellowships to train bioethicists especially among African Americans and other minority groups. HHS will offer these fellowships
beginning in September of 1998 to promising students enrolled in bioethics graduate programs.
And, finally, by executive order I am also today extending the charter of the National Bioethics Advisory Commission to October of
1999. The need for this commission is clear. We must be able to call on the thoughtful, collective wisdom of experts and
community representatives to find ways to further strengthen our protections for subjects in human research.
We face a challenge in our time. Science and technology are rapidly changing our lives with the promise of making us much
healthier, much more productive and more prosperous. But with these changes we must work harder to see that as we advance
we don't leave behind our conscience. No ground is gained and, indeed, much is lost if we lose our moral bearings in the name of
progress.
The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They
forgot their pledge to heal and repair. They had the power to heal the survivors and all the others and they did not. Today, all we
can do is apologize. But you have the power, for only you -- Mr. Shaw, the others who are here, the family members who are with
us in Tuskegee -- only you have the power to forgive. Your presence here shows us that you have chosen a better path than your
government did so long ago. You have not withheld the power to forgive. I hope today and tomorrow every American will
remember your lesson and live by it.
In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. The group identified basic principles of research conduct and suggested ways to ensure those
principles were followed.
In addition to the panel's recommendations, regulations were passed in 1974 that required researchers to get voluntary informed
consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They
also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards, which read study
protocols and decide whether they meet ethical standards.
The rules and policies for human subjects research have been reviewed and revised many times since they were first approved.
From 1980-1983, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research looked at federal rules for doing research on human subjects to see how well those rules were being followed. An Ethics
Advisory Board was formed in the late 1970s to review ethical issues of biomedical research. In 1991, federal departments and
agencies (16 total) adopted the Federal Policy for the Protection of Human Subjects.
Efforts to promote the highest ethical standards in research are still going on today. In October 1995, President Bill Clinton created
a National Bioethics Advisory Commission funded and led by the Department of Health and Human Services. The commission's task
was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research
volunteers. It was succeeded by the President's Council on Bioethics, which was established in 2001.
The Belmont report has greatly influenced the codes and regulations regarding human subjects’ research that have been
established in the United States by federal and many state governments, universities, professional organizations and by private
research institutions, as well as similar codes and regulations elsewhere in the world.
Issues
An explicit requirement of the Tuskegee study was that the subjects not receive available treatment for a debilitating disease, a
clear violation of normal medical practice. Would any study involving human subjects that violated normal medical practice
necessarily be unethical?
The Tuskegee victims were not informed -- in fact they were deliberately misinformed -- about the nature of the study in
which they were participants. A basic guideline for human subject research, specified in both the Nuremberg Code and
the Belmont Report is the requirement of informed consent. What would have constituted informed consent in the case of
the Tuskegee Study? If such informed consent had been obtained from the subjects, would this remove all questions
about whether the Study was ethical?
In what sense were the premises and the practices of the Tuskegee study racist? An important question to explore when
examining accusations of human rights violations or of prejudicial behavior is whether the standards being applied are
those of the time the action took place, and if not, whether this should affect any judgement about the ethics of the
situation. (Conforming to official social standards does not necessarily imply that you are behaving in an ethical manner.
Most people would consider the medical experiments of the Nazi Doctors to be unethical even though they conformed to
the principles spelled out in the Nazi ideology imposed on Germany by the Third Reich.)
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Eunice Rivers, the African-American nurse who played a vital role by befriending the Tuskegee Study participants and
assuring their cooperation has justified her support for the project in terms of the fact that the attention that she and the
other medical staff gave to the men was more than a non-enrolled, poor, Macon County resident was likely to receive. If
you had been in her place, do you think you would have come to the same conclusion with regard to the ethical choices
available to you.
Ordinarily, one would not think of the media as the proper instrument for enforcing public morality. They had that role
here, but should they have?
The political reaction to the Tuskegee revelations was largely responsible for establishing the committee that wrote the
Belmont report, which set guidelines for experimentation on human subjects. These guidelines have been the basis for
regulations, usually enforced by human subjects research panels, at most public and private institutions that conduct such
research. Is this likely to assure that all future research on human subjects will be conducted in a manner that raises no
ethical concerns?
The Belmont Report proposes three criteria for the evaluation of human subjects research, respect for persons,
beneficence and justice, as described above in the introductory section. In what ways does the Tuskegee Study fail to
conform to each of these criteria.
In experiments on infants, it is obviously impossible to obtain the informed consent of the subject. This is also true in
experiments on senile individuals. Does this mean that ethical considerations preclude using such subjects in any
experiment?
Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the
foundation of freedom, justice and peace in the world,
Whereas disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind,
and the advent of a world in which human beings shall enjoy freedom of speech and belief and freedom from fear and want has
been proclaimed as the highest aspiration of the common people,
Whereas it is essential, if man is not to be compelled to have recourse, as a last resort, to rebellion against tyranny and oppression,
that human rights should be protected by the rule of law,
Whereas the peoples of the United Nations have in the Charter reaffirmed their faith in fundamental human rights, in the dignity and
worth of the human person and in the equal rights of men and women and have determined to promote social progress and better
standards of life in larger freedom,
Whereas Member States have pledged themselves to achieve, in co-operation with the United Nations, the promotion of universal
respect for and observance of human rights and fundamental freedoms,
Whereas a common understanding of these rights and freedoms is of the greatest importance for the full realization of this pledge,
Now, Therefore THE GENERAL ASSEMBLY proclaims THIS UNIVERSAL DECLARATION OF HUMAN RIGHTS as a common
standard of achievement for all peoples and all nations, to the end that every individual and every organ of society, keeping this
Declaration constantly in mind, shall strive by teaching and education to promote respect for these rights and freedoms and by
progressive measures, national and international, to secure their universal and effective recognition and observance, both among
the peoples of Member States themselves and among the peoples of territories under their jurisdiction.
Article 1. All human beings are born free and equal in of the country or territory to which a person belongs, whether
dignity and rights.They are endowed with reason and it be independent, trust, non-self-governing or under any
conscience and should act towards one another in a spirit of other limitation of sovereignty.
brotherhood.
Article 3. Everyone has the right to life, liberty and security
Article 2. Everyone is entitled to all the rights and freedoms of person.
set forth in this Declaration, without distinction of any kind,
such as race, colour, sex, language, religion, political or Article 4. No one shall be held in slavery or servitude;
other opinion, national or social origin, property, birth or slavery and the slave trade shall be prohibited in all their
other status. Furthermore, no distinction shall be made on forms.
the basis of the political, jurisdictional or international status
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Article 5. No one shall be subjected to torture or to cruel, Article 17. (1) Everyone has the right to own property alone
inhuman or degrading treatment or punishment. as well as in association with others. (2) No one shall be
arbitrarily deprived of his property.
Article 6. Everyone has the right to recognition everywhere
as a person before the law. Article 18. Everyone has the right to freedom of thought,
conscience and religion; this right includes freedom to
Article 7. All are equal before the law and are entitled change his religion or belief, and freedom, either alone or in
without any discrimination to equal protection of the law. All community with others and in public or private, to manifest
are entitled to equal protection against any discrimination in his religion or belief in teaching, practice, worship and
violation of this Declaration and against any incitement to observance.
such discrimination.
Article 19. Everyone has the right to freedom of opinion
Article 8. Everyone has the right to an effective remedy by and expression; this right includes freedom to hold opinions
the competent national tribunals for acts violating the without interference and to seek, receive and impart
fundamental rights granted him by the constitution or by law. information and ideas through any media and regardless of
frontiers.
Article 9. No one shall be subjected to arbitrary arrest,
detention or exile. Article 20. (1) Everyone has the right to freedom of
peaceful assembly and association. (2) No one may be
compelled to belong to an association.
Article 10. Everyone is entitled in full equality to a fair and
public hearing by an independent and impartial tribunal, in
the determination of his rights and obligations and of any Article 21. (1) Everyone has the right to take part in the
criminal charge against him. government of his country, directly or through freely chosen
representatives. (2) Everyone has the right of equal access
to public service in his country. (3) The will of the people
Article 11.(1) Everyone charged with a penal offence has shall be the basis of the authority of government; this will
the right to be presumed innocent until proved guilty shall be expressed in periodic and genuine elections which
according to law in a public trial at which he has had all the shall be by universal and equal suffrage and shall be held by
guarantees necessary for his defense. (2) No one shall be secret vote or by equivalent free voting procedures.
held guilty of any penal offence on account of any act or
omission which did not constitute a penal offence, under
national or international law, at the time when it was Article 22. Everyone, as a member of society, has the right
committed. Nor shall a heavier penalty be imposed than the to social security and is entitled to realization, through
one that was applicable at the time the penal offence was national effort and international co-operation and in
committed. accordance with the organization and resources of each
State, of the economic, social and cultural rights
indispensable for his dignity and the free development of his
Article 12. No one shall be subjected to arbitrary personality.
interference with his privacy, family, home or
correspondence, nor to attacks upon his honour and
reputation. Everyone has the right to the protection of the Article 23. (1) Everyone has the right to work, to free choice
law against such interference or attacks. of employment, to just and favourable conditions of work and
to protection against unemployment. (2) Everyone, without
any discrimination, has the right to equal pay for equal work.
Article 13. (1) Everyone has the right to freedom of (3) Everyone who works has the right to just and favourable
movement and residence within the borders of each state. remuneration ensuring for himself and his family an
(2) Everyone has the right to leave any country, including his existence worthy of human dignity, and supplemented, if
own, and to return to his country. necessary, by other means of social protection. (4) Everyone
has the right to form and to join trade unions for the
Article 14. (1) Everyone has the right to seek and to enjoy protection of his interests.
in other countries asylum from persecution. (2) This right
may not be invoked in the case of prosecutions genuinely Article 24. Everyone has the right to rest and leisure,
arising from non-political crimes or from acts contrary to the including reasonable limitation of working hours and periodic
purposes and principles of the United Nations. holidays with pay.
Article 15. (1) Everyone has the right to a nationality. (2) No Article 25. (1) Everyone has the right to a standard of living
one shall be arbitrarily deprived of his nationality nor denied adequate for the health and well-being of himself and of his
the right to change his nationality. family, including food, clothing, housing and medical care
and necessary social services, and the right to security in
Article 16.(1) Men and women of full age, without any the event of unemployment, sickness, disability, widowhood,
limitation due to race, nationality or religion, have the right to old age or other lack of livelihood in circumstances beyond
marry and to found a family. They are entitled to equal rights his control. (2) Motherhood and childhood are entitled to
as to marriage, during marriage and at its dissolution. (2) special care and assistance. All children, whether born in or
Marriage shall be entered into only with the free and full out of wedlock, shall enjoy the same social protection.
consent of the intending spouses. (3) The family is the
natural and fundamental group unit of society and is entitled Article 26. (1) Everyone has the right to education.
to protection by society and the State. Education shall be free, at least in the elementary and
fundamental stages. Elementary education shall be
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compulsory. Technical and professional education shall be Article 29. (1) Everyone has duties to the community in
made generally available and higher education shall be which alone the free and full development of his personality
equally accessible to all on the basis of merit. (2) Education is possible. (2) In the exercise of his rights and freedoms,
shall be directed to the full development of the human everyone shall be subject only to such limitations as are
personality and to the strengthening of respect for human determined by law solely for the purpose of securing due
rights and fundamental freedoms. It shall promote recognition and respect for the rights and freedoms of others
understanding, tolerance and friendship among all nations, and of meeting the just requirements of morality, public order
racial or religious groups, and shall further the activities of and the general welfare in a democratic society. (3) These
the United Nations for the maintenance of peace. (3) Parents rights and freedoms may in no case be exercised contrary to
have a prior right to choose the kind of education that shall the purposes and principles of the United Nations.
be given to their children.
Article 30. Nothing in this Declaration may be interpreted
Article 27. (1) Everyone has the right freely to participate in as implying for any State, group or person any right to
the cultural life of the community, to enjoy the arts and to engage in any activity or to perform any act aimed at the
share in scientific advancement and its benefits. (2) destruction of any of the rights and freedoms set forth
Everyone has the right to the protection of the moral and herein.
material interests resulting from any scientific, literary or
artistic production of which he is the author.
Analysis
Articles 3, 7, 8 & 25 were fully violated in this study. Article 3 states that Everyone has the right to life, liberty and security of
person by which attributing syphilis virus to this group of persons would most likely deprive them from giving them the right to live.
It puts the person’s life at stake for the sake of research purposes. Article 7 states that All are equal before the law and are entitled
without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation
of this Declaration and against any incitement to such discrimination. People in this research were racially discriminated for no white
person were incorporated in this study. The selection of the subjects did not undergo the most equal treatment that they should be
conducting, Article 8 states that everyone has the right to an effective remedy by the competent national tribunals for acts violating
the fundamental rights granted him by the constitution or by law. This article further reinitiates the idea that since there were
violation of human right by the administration of the virus within the subjects and as well as no proper remedy was given to the
clients. Article 25 laments the idea that Everyone has the right to a standard of living adequate for the health and well-being of
himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security
in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his
control. By participating in this research, the standard of living adequate for health was deprived to the persons chosen to
participate in this study.
LEGAL ISSUES
1. The U.S. government violated the constitutional rights of the participants…
2. The government knew the participants had syphilis and failed to treat them.
3. The Public Health Service failed to fully disclose to the participants that they had syphilis, that they were participating in
the study, and that treatment was available for syphilis.
4. The Public Health Service led the participants to believe that they were being properly treated for whatever diseases they
had, when in fact, they were not being meaningfully treated.
5. The Public Health Service failed to obtain the participants’ written consents to be a part of the study.
6. The Study was racially motivated and discriminated against African Americans in that no whites were selected to
participate in the Study…
7. There were no rules and regulations governing the Study.
A class lawsuit was filed in the idea of violation of human rights in this study. A class action or a representative action is a form
of lawsuit in which a large group of people collectively bring a claim to court and/or in which a class of defendants is being sued
The participants in this study used this lawsuit since it dealt in a large group of people. The individuality of the persons who
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participated in this study were most likely expounded in the idea that if several lawsuits were filed, it would place a sluggish manner
of providing justice to the persons who participated in this study.
JURISPRUDENTIAL DOCTRINES
1. Bonus Pater familias
(good father of a family)
“whereby the employer ultimately becomes liable on his own negligence”.
This means that the employer is liable upon a finding that he has been negligent in the selection of his employees ( culpa
in eligiendo) o in the supervision of his employee (culpa in vigilando).
ANALYSIS
The researchers served as the father of the family in this study. Hence, the idea that he was the proponent of this study,
the responsibility is incorporated by which he is liable to the presumptions that conducting this study would most likely
provide the avenue of the worst repercussions. The researchers in this study did not become liable to the repercussions
on the subjects. However, in this case if the researchers were proven ineffective to provide responsibilities to their
subjects, the responsibility should be passed to the government. The subjects were under the sovereignty of the country
and with that, it most likely contributes to the idea that they should provide the due process in the provision of justice to
the research subjects.
ANALYSIS
Since the researchers failed to provide the remedy for their subjects that opened the avenue for mortalities in the
research scenario, there is a breach in the contact that they have provided. This doctrine stated that the researchers are
liable for damages or injuries that the research subjects have obtained. It concludes the idea that whatever law suit that
were given to them, answers and actions should be provided by the one who is liable.
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