Epidemics in Western Society: The Tuskegee Syphilis Study

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Jan 14, 2010
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17 Mar 2011
21. The Tuskegee Experiment




Study of Epidemics in Western Society Since 1600 The Tuskegee Syphilis Study, carried out in Macon, Alabama, from 1932 to 1972, is a notorious episode in the checkered history of medical experimentation. In one of the most economically disadvantaged parts of the U.S., researchers deceived a group of 399 black male syphilitics into participating in a study with no therapeutic value.

These "volunteers" were not treated as patients, but rather as experimental subjects, or walking cadavers. Even after the development of penicillin, the Tuskegee group was denied effective treatment. Despite regularly published scholarly articles, forty years passed before there was any protest in the medical community.

The aftereffects of the study, along with the suffering of its victims, include a series of congressional investigations, the drafting of medical ethics guidelines, and the establishment of independent review boards.
  • 00:00 - Chapter 1. Tuskegee Syphilis Study, 1932-72
  • 05:26 -Chapter 2. Origins
  • 26:23 - Chapter 3. Continuation
  • 45:45 - Chapter 4. Legacy
Source: YaleCourses

‘You’ve got bad blood’: The horror of the Tuskegee syphilis experiment​

In the fall of 1932, the fliers began appearing around Macon County, Ala., promising “colored people” special treatment for “bad blood.”
“Free Blood Test; Free Treatment, By County Health Department and Government Doctors,” the black and white signs said. “YOU MAY FEEL WELL AND STILL HAVE BAD BLOOD. COME AND BRING ALL YOUR FAMILY.

Hundreds of men — all black and many of them poor — signed up. Some of the men thought they were being treated for rheumatism or bad stomachs. They were promised free meals, free physicals and free burial insurance.

What the signs never told them was they would become part of the “Tuskegee Study of Untreated Syphilis in the Negro Male,” a secret experiment conducted by the U.S. Public Health Service to study the progression of the deadly venereal disease — without treatment.

On Tuesday, the Tuskegee History Center will mark the 20th anniversary of its founding and President Bill Clinton’s apology to the survivors of the experiment with a day-long program devoted to the fallout of the study. It destroyed the trust many African Americans held for medical institutions — a legacy that persists today.

“These anniversaries offer a unique opportunity for us to remind America and the world of the medical injustice that occurred here in Macon County,” said Fred Gray, the civil rights attorney who brought a class-action lawsuit on behalf of unwitting study participants. “We have to continue to tell their story so that such injustices never happen again.”

The study recruited 600 black men, of which 399 were diagnosed with syphilis and 201 were a control group without the disease. The researchers never obtained informed consent from the men and never told the men with syphilis that they were not being treated but were simply being watched until they died and their bodies examined for ravages of the disease.

Charles Pollard, one of the last survivors, recalled that he heard that men were receiving free physicals at a local one-room schoolhouse, according to the James H. Jones book “Bad Blood: The Tuskegee Syphilis Experiment.”
“So I went over, and they told me I had bad blood,” Pollard remembered. “And that’s what they’ve been telling me ever since. They come around from time to time and check me over and they say, ‘Charlie, you’ve got bad blood.’ ”
In the book, Herman Shaw, a farmer, recounted hearing about the study as a kind of health care program. “People said you could get free medicine for yourself and things of that kind, and they would have a meeting at Salmon Chapel at a certain date.” So he went.

Initially, when the study began, treatment for syphilis was not effective, often dangerous and fatal. But even after penicillin was discovered and used as a treatment for the disease, the men in the Tuskegee study were not offered the antibiotic.

“All I knew was that they just kept saying I had the bad blood — they never mentioned syphilis to me. Not even once,” said Pollard, who added: “They been doctoring me off and on ever since then. And they gave me a blood tonic.”
Shaw explained: “We got three different types of medicine. A little round pill — sometime a capsule — sometime a little vial of medicine — everybody got the same thing.”
Although originally projected to last six months, the study extended for 40 years. “Local physicians asked to assist with study and not to treat men,” the Centers for Disease Control reported in a timeline of the experiment. “Decision was made to follow the men until death.”

Eunice Rivers, a local nurse, was recruited by doctors to serve as a recruiter and conduit between researchers and the men. Nurse Rivers, as she became known, kept records of the men and drove them to government doctors when they visited the community. She took them to doctors’ appointments in “a shiny station wagon with the government emblem on the front door, according to “Bad Blood.” On one occasion, she followed a man to a private doctor to make sure he did not receive treatment.

In 1945, according to the CDC timeline, penicillin was “accepted as treatment of choice for syphilis.” The U.S. Public Health Services created what they called “rapid treatment centers” to help men afflicted with syphilis — except the men in the Tuskegee study.
In 1966, a public health service investigator raised concerns about the study. Peter Buxtun wrote to the director of the U.S. division of venereal diseases about the ethics of the experiment. But the agency ignored Buxtun’s concerns.

Buxtun eventually leaked information about the study to an Associated Press reporter named Jean Heller, who years later called it “one of the grossest violations of human rights I can imagine.” On July 26, 1972, Heller’s story appeared on the front page of the New York Times, revealing that the men had deliberately been left untreated for 40 years.

The study was finally brought to a halt, and the following year, a congressional subcommittee held hearings on the Tuskegee experiment.

In 1973, a class-action lawsuit was filed on behalf of the men in the study by Gray, the civil rights lawyer who had represented Rosa Parks. Pollard was among those he represented.

A $10 million out-of-court settlement was reached in the case. “The U.S. government promised to give lifetime medical benefits and burial services to all living participants,” the CDC reported.
In 1974, Congress passed the National Research Act, which was aimed at preventing the exploitation of human subjects by researchers.

On May 16, 1997, President Bill Clinton issued an apology to the eight remaining survivors of the experiment:
“The United States government did something that was wrong — deeply, profoundly, morally wrong,” Clinton said. “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.”

Source : https://www.washingtonpost.com/news...e-horror-of-the-tuskegee-syphilis-experiment/
 

WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS​


Preamble​

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3. The Declaration of Geneva of the WMA 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 in the patient’s best interest when providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies involving human subjects.
6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm to the environment.
12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.
20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21. 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 adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and Confidentiality

24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed consent, 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, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome and results of the study.
27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions​

34. In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. Source : WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
9th July 2018
 
''Miss Evers' Boys.''

First, Do No Harm: a Nurse And the Deceived Subjects Of the Tuskegee Study​

The film, based on an examination of one of modern America's darkest chapters of medical research and racial exploitation.
HISTORY as docudrama revisits television on Saturday in the HBO presentation ''Miss Evers' Boys.''

The film, based on a Pulitzer Prize-nominated play of the same name, is an examination of one of modern America's darkest chapters of medical research and racial exploitation.

The movie, its producers say, is a fictionalized interpretation of the true story of the Tuskegee Study of Untreated Syphilis in the Negro Male, a 40-year project in which the United States Government tracked the deadly course of the venereal disease in hundreds of infected poor black men living in or around Tuskegee, Ala.

Essential to the study, which was started by the United States Public Health Service, was to withhold treatment -- even penicillin when it proved a cure in the 1940's -- to the diseased men, all in the late and most devastating stages of syphilis.

Brushing aside ethical questions, researchers hoped, according to letters and articles detailing the study, that science would learn the precise nature of how the disease ravishes the body by examining the men over time. Death, autopsies and funerals were routine features of the program, which ran from 1932 to 1972.

Some doctors were curious to know whether black men apart from their skin were significantly different from whites. A point of reference was a similar syphilis study conducted from 1891 to 1910 on white men in Norway.

In the Tuskegee experiment, 399 of the men were infected with syphilis and 201 were in a healthy control group. Many of the participants died prematurely when they could have been saved.

Almost all of those stricken suffered horribly as they were systematically deceived by Government doctors, most of whom were white. Many of these black men, mostly uneducated and unsophisticated, were lured to the study by promises of free meals, cheap burials, medical care (for minor ailments only) and special recognition.

In 1958, each black man who had participated in the study for 25 years was presented with a certificate signed by the Surgeon General, plus $1 for each year of service.

The men were also misled by an industrious, devoted black nurse known in the movie as Miss Evers. Much of the utter cruelty of the study is forcefully depicted in the film.

''The Tuskegee experience gives light to the fact that our Government has a sunny, lofty side that we should appreciate, and a moonlit side that we should deplore,'' said Russell Adams, chairman of the department of Afro-American Studies at Howard University. ''We don't like to talk about that in the same breath.''

Yet while ''Miss Evers' Boys'' attempts to illuminate its story with the glare of authenticity, questions of factual fidelity always arise -- as with Oliver Stone's ''Nixon,'' or Ron Howard's ''Apollo 13'' -- when pages of history books are rewritten into pages of a director's script. This is no less true for the cinematic retelling of the Tuskegee study, a sensitive subject that is still creating reverberations, including a willingness among some blacks to consider maladies like AIDS and crack addiction part of a genocidal conspiracy against them by whites.



James H. Jones, author of ''Bad Blood,'' an exhaustively researched 1981 book about the Tuskegee study, said in a recent interview that the syphilis experiment had become a kind of ''trump card.''
''It sort of provides proof to many people that things which you think are outrageous and could never happen not only can happen but have happened,'' said Dr. Jones, a professor of history at the University of Houston.

So what did happen?
In the movie, Eunice Evers, played with thunder and tears by Alfre Woodard, was in real life, Eunice Rivers Laurie. She was a constant, complex presence in the study, seeing it through from its modest inception to its demise after it was reported in the press and denounced by the public. Nurse Rivers was the only full-time staff member of the study, Dr. Jones notes in his book, and played a crucial role as a masterful agent of human relations and trusted bridge between the men and medical staff.

The film is faithful to her skill at keeping the men in the program, at assuaging their fear of painful spinal taps by calling them ''back shots.'' Dr. Jones, writing of Nurse Rivers's influence in the study, pointed out that ''more than any other person, she made them believe that they were receiving medical care that was helping them.'' He said one of the syphilis subjects recalled Nurse Rivers, who was a product of the all-black Tuskegee Institute, reassuring him that he merely suffered from ''bad blood and we is trying to help you.''


Dr. Jones said Nurse Rivers, who died in 1984, once characterized her work with the 600 men as ''the joy of my life.''
In the film, she has an affectionate, bittersweet relationship with a syphilitic field hand who announces his love for her. The field hand, played by Laurence Fishburne, who is also an executive producer for the movie, eventually learns the truth about the study when he runs off to join the Army.


That never happened, according to Fred Gray, a longtime resident of Tuskegee and the lawyer who represented the survivors and their heirs in a $1.8 billion class action suit against the state and Federal governments. Eventually Mr. Gray accepted a $9 million settlement from the Government for his clients.

Mr. Gray said he had not seen the film, but he ''understands that some scenes in it are not accurate.'' A chief element he considers problematic is turning the story on the black nurse and reducing the characters representing governmental power and the medical establishment into little more than a blur of white faces.


''I think she was as much a victim as the men themselves were victims,'' Mr. Grey said of Nurse Rivers. ''Nobody could expect one black woman in Alabama in 1932, when the Federal Government is employing her, to do something. How could she resist and say, 'I'm not going to do it.'?''
Robert Benedetti, an executive producer of the film, which was made by HBO New York City and Ted Danson's Anasazi Productions, countered: ''I think the movie is fundamentally accurate. There are certainly no misrepresentations in it.''

He acknowledged, however, that the film focused on the personal story of Miss Evers for the sake of drama. Other characters are ''composites,'' he said, including the field hand played by Mr. Fishburne and a black doctor played by Joe Morgan who was influential in keeping the study alive.

Whoever is at the center of the story, the film's cautionary lesson is the same, Ms. Woodard said. ''Most of the time, conspiracies are not well thought out,'' she said of the study's veil of deception. ''They kind of occur when somebody bends the rules at one point and people don't say, 'Wait a minute.' They take on a life of their own.''

Source : First, Do No Harm: a Nurse And the Deceived Subjects Of the Tuskegee Study (Published 1997)
 
17 Mar 2011
21. The Tuskegee Experiment




Study of Epidemics in Western Society Since 1600 The Tuskegee Syphilis Study, carried out in Macon, Alabama, from 1932 to 1972, is a notorious episode in the checkered history of medical experimentation. In one of the most economically disadvantaged parts of the U.S., researchers deceived a group of 399 black male syphilitics into participating in a study with no therapeutic value.

These "volunteers" were not treated as patients, but rather as experimental subjects, or walking cadavers. Even after the development of penicillin, the Tuskegee group was denied effective treatment. Despite regularly published scholarly articles, forty years passed before there was any protest in the medical community.

The aftereffects of the study, along with the suffering of its victims, include a series of congressional investigations, the drafting of medical ethics guidelines, and the establishment of independent review boards.
  • 00:00 - Chapter 1. Tuskegee Syphilis Study, 1932-72
  • 05:26 -Chapter 2. Origins
  • 26:23 - Chapter 3. Continuation
  • 45:45 - Chapter 4. Legacy
Source: YaleCourses

‘You’ve got bad blood’: The horror of the Tuskegee syphilis experiment​

In the fall of 1932, the fliers began appearing around Macon County, Ala., promising “colored people” special treatment for “bad blood.”
“Free Blood Test; Free Treatment, By County Health Department and Government Doctors,” the black and white signs said. “YOU MAY FEEL WELL AND STILL HAVE BAD BLOOD. COME AND BRING ALL YOUR FAMILY.

Hundreds of men — all black and many of them poor — signed up. Some of the men thought they were being treated for rheumatism or bad stomachs. They were promised free meals, free physicals and free burial insurance.

What the signs never told them was they would become part of the “Tuskegee Study of Untreated Syphilis in the Negro Male,” a secret experiment conducted by the U.S. Public Health Service to study the progression of the deadly venereal disease — without treatment.

On Tuesday, the Tuskegee History Center will mark the 20th anniversary of its founding and President Bill Clinton’s apology to the survivors of the experiment with a day-long program devoted to the fallout of the study. It destroyed the trust many African Americans held for medical institutions — a legacy that persists today.

“These anniversaries offer a unique opportunity for us to remind America and the world of the medical injustice that occurred here in Macon County,” said Fred Gray, the civil rights attorney who brought a class-action lawsuit on behalf of unwitting study participants. “We have to continue to tell their story so that such injustices never happen again.”

The study recruited 600 black men, of which 399 were diagnosed with syphilis and 201 were a control group without the disease. The researchers never obtained informed consent from the men and never told the men with syphilis that they were not being treated but were simply being watched until they died and their bodies examined for ravages of the disease.

Charles Pollard, one of the last survivors, recalled that he heard that men were receiving free physicals at a local one-room schoolhouse, according to the James H. Jones book “Bad Blood: The Tuskegee Syphilis Experiment.”
“So I went over, and they told me I had bad blood,” Pollard remembered. “And that’s what they’ve been telling me ever since. They come around from time to time and check me over and they say, ‘Charlie, you’ve got bad blood.’ ”
In the book, Herman Shaw, a farmer, recounted hearing about the study as a kind of health care program. “People said you could get free medicine for yourself and things of that kind, and they would have a meeting at Salmon Chapel at a certain date.” So he went.

Initially, when the study began, treatment for syphilis was not effective, often dangerous and fatal. But even after penicillin was discovered and used as a treatment for the disease, the men in the Tuskegee study were not offered the antibiotic.

“All I knew was that they just kept saying I had the bad blood — they never mentioned syphilis to me. Not even once,” said Pollard, who added: “They been doctoring me off and on ever since then. And they gave me a blood tonic.”
Shaw explained: “We got three different types of medicine. A little round pill — sometime a capsule — sometime a little vial of medicine — everybody got the same thing.”
Although originally projected to last six months, the study extended for 40 years. “Local physicians asked to assist with study and not to treat men,” the Centers for Disease Control reported in a timeline of the experiment. “Decision was made to follow the men until death.”

Eunice Rivers, a local nurse, was recruited by doctors to serve as a recruiter and conduit between researchers and the men. Nurse Rivers, as she became known, kept records of the men and drove them to government doctors when they visited the community. She took them to doctors’ appointments in “a shiny station wagon with the government emblem on the front door, according to “Bad Blood.” On one occasion, she followed a man to a private doctor to make sure he did not receive treatment.

In 1945, according to the CDC timeline, penicillin was “accepted as treatment of choice for syphilis.” The U.S. Public Health Services created what they called “rapid treatment centers” to help men afflicted with syphilis — except the men in the Tuskegee study.
In 1966, a public health service investigator raised concerns about the study. Peter Buxtun wrote to the director of the U.S. division of venereal diseases about the ethics of the experiment. But the agency ignored Buxtun’s concerns.

Buxtun eventually leaked information about the study to an Associated Press reporter named Jean Heller, who years later called it “one of the grossest violations of human rights I can imagine.” On July 26, 1972, Heller’s story appeared on the front page of the New York Times, revealing that the men had deliberately been left untreated for 40 years.

The study was finally brought to a halt, and the following year, a congressional subcommittee held hearings on the Tuskegee experiment.

In 1973, a class-action lawsuit was filed on behalf of the men in the study by Gray, the civil rights lawyer who had represented Rosa Parks. Pollard was among those he represented.

A $10 million out-of-court settlement was reached in the case. “The U.S. government promised to give lifetime medical benefits and burial services to all living participants,” the CDC reported.
In 1974, Congress passed the National Research Act, which was aimed at preventing the exploitation of human subjects by researchers.

On May 16, 1997, President Bill Clinton issued an apology to the eight remaining survivors of the experiment:
“The United States government did something that was wrong — deeply, profoundly, morally wrong,” Clinton said. “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.”

Source : https://www.washingtonpost.com/news...e-horror-of-the-tuskegee-syphilis-experiment/
Aise. Historia ya matibabu ina ukiukwaji mkubwa wa Utu, mbali na Haki za binadamu. Historia kama hizi ndio hufanya watu wawe wapinga chanjo au na mashaka na chanjo.

Upande wa pili, madhila yao, yamekuwa faida kwa ulimwengu juu ya ugonjwa huu wa kaswende. Ubinadamu utawakumbuka.

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WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS​


Preamble​

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3. The Declaration of Geneva of the WMA 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 in the patient’s best interest when providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies involving human subjects.
6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm to the environment.
12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.
20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21. 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 adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and Confidentiality

24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed consent, 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, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome and results of the study.
27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions​

34. In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available. Source : WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
9th July 2018
Mambo mengi kabla ya UN kuwepo, yalifanyika ya kinyama sana, sababu hatukuwa na sheria kama hizi. Immanuel Kant alisema, Man must be disciplined, for he is by nature, raw and wild.

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Jimbo lenye weusi wengi la Alabama
Je hali ya maisha, kijamii na kiuchumi leo mwaka 2024 ipo vipi


2 March 2024
Deep in the heart of Alabama is a region known as the Black Belt, a part of the state with the highest Black population. Join me for a road trip today through this fascinating part of America full of juxtapositions and surprises.


View: https://m.youtube.com/watch?v=3F7JCXpw0Ko
Source : Peter Santenello
 
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