Human subject research legislation in the United States
Encyclopedia
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics
. Notable - and in some cases, notorious - human subject experiments performed in the USA include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment
and Stanford prison experiment
s and Project MKULTRA
. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the Institutional Review Board
s.
of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs. Thus the early calls for regulation of human experimentation concerned medicine, and in particular, testing of new pharmaceutical drug
s and their release on the market.
In 1937, a drug known as Elixir Sulfanilamide was released without any clinical trial
s. Reports in the press about potentially lethal side effect
s led to a public outcry. Investigation by the American Medical Association
showed that a poisonous compound, diethylene glycol
, was present in the drug. The AMA concluded that the drug caused more than a hundred deaths - yet the contemporary law did not require the company that released it to test it (the existing laws required only that a drug be clearly labeled, no false claims be made about it, and that it was not adulterated). A new legislation was proposed by the Secretary of Agriculture to address the issue but was weakened after opposition from business interests. It was finally included in the Federal Food, Drug, and Cosmetic Act
of 1938.
In the aftermath of World War II
, and what became recognized as deeply unethical
human experimentation carried out by the Nazis
, the Nuremberg Code
- ethical principles governing international human experimentation
- were founded. Neither the Nuremberg Code nor the Federal Food, Drug and Cosmetic Act of 1938 prevented the "thalidomide tragedy" of the early 1960s. Thalidomide
was introduced in 1958, and there were reports of it being unsafe for certain groups, such as pregnant women and young children; however, although the Food and Drug Administration
did not approve it for market, the existing regulations allowed relatively unrestricted testing of the drug. This led to the abuse of approved drug testing as the means to further a promotional marketing
strategy. This was addressed by the Drug Amendments legislation of 1962, which introduced a requirement for a series of animal tests before proceeding with human experimentation, and a total of three phases of human clinical trials before a drug can be approved for the market. The inadequacy of the 1938 and 1962 acts was exposed by revelations in the 1960s and 1970s.
's 1966 study as published in the New England Journal of Medicine
. His study became instrumental in the implementation of federal rules on human experimentation and informed consent. Beecher's study listed over 20 cases of mainstream research where subjects were subject to experimentation without being fully informed of their status as research subjects, and without knowledge of the risks of such participation in the research. Some of the research subjects died or were permanently crippled as a result of that research. One of the cases analyzed was the Willowbrook State School
Case, in which mentally defective children were deliberately infected with hepatitis
, under disguise of a vaccination
program.
Beecher's findings were not alone. Evidence emerged that soon after the introduction of nuclear weapons, soldiers and civilians were subjected to potentially dangerous levels of radiation - without consent - to test its health effects (see Advisory Committee on Human Radiation Experiments
and human radiation experiments in the United States).
While most major controversies about unethical research were focused on biomedical sciences, there were also controversies involving behavioral, psychological, and sociological experiments such as: the Milgram obedience experiment
, Stanford prison experiment
, Tearoom Trade
study, and others. There were also ethical issues related to the CIA's Project MKULTRA
.
The Tuskegee syphilis experiment is probably the most infamous case of unethical medical experimentation in the United States. Starting in 1932, investigators recruited 399 impoverished African-American sharecroppers with syphilis for research related to the natural progression of the untreated disease, in hopes of justifying treatment programs for blacks. By 1947, penicillin had become the standard treatment for syphilis, but the Tuskegee scientists decided to withhold penicillin
(and information about it) from the patients. The study continued under numerous supervisors until 1972, when a leak to the press resulted in its termination. Victims included a number of men who died of syphilis, their wives who contracted the disease, and some children who were born with syphilis. Even when the results were made public, the initial reaction of the medical scientific community was to exonerate the study and criticize the popular press for interfering with the research.
In 1966, the National Institutes of Health
(NIH) Office for Protection of Research Subjects (OPRR) was created, and issued its Policies for the Protection of Human Subjects which recommended establishing independent review bodies, later called institutional review boards.
Judge Samuel Steinfeld
dissented in Strunk v. Strunk, 445 S.W.2d 145, and made the first judicial suggestion that the Nuremberg Code
should apply to American jurisprudence
.
By the early 1970s, cases like the Willowbrook State School and the Tuskegee syphilis experiments were being raised in the U. S. Senate. As controversy over human experiments continued, the public opinion criticized research where the science seemed to be valued over the good of the subjects.
In 1974, Congress passed the National Research Act
which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
(CPHS) and mandated that the Public Health Service come up with regulations that would protect the rights of human research subjects. The Commission work from 1974-1978 resulted in 17 reports and appendices, of which the most important were the Institutional Review Board Report and the Belmont Report
("Ethical Principles and Guidelines for the Protection of Human Subjects of Research"). The IRB Report endorsed the establishment and functioning of the Institutional Review Board
institution, and the Belmont Report, the Commission's last report, identified "basic ethical principles" applicable to human subject experimentation that became modern guidelines for ethical medical research: "respect for persons", "beneficence" and "justice".
In 1975, the Department of Health, Education and Welfare (DHEW) created regulation which included the recommendations laid out in the NIH's 1966 Policies for the Protection of Human Subjects. Title 45 of the Code of Federal Regulations
, known as "The Common Rule," requires that institutional review boards (IRBs) oversee experiments using human subjects.
es for research purposes; and PCEMR issues recommendation on subjects such as brain death
, access to health services, withdrawal of life-support systems, and testing in regards to genetic disease.
In 1980 the FDA prohibited made prisoners illegible to be subjects of new drug testing in clinical trial
s (21 CFR 50.44).
On January 15, 1994, President Bill Clinton
formed the Advisory Committee on Human Radiation Experiments
(ACHRE). This committee was created to investigate and report the use of human beings as test subjects in experiments involving the effects of ionizing radiation in federally funded research. The committee attempted to determine the causes of the experiments, and reasons why the proper oversight did not exist, and made several recommendations to help prevent future occurrences of similar events. In 1995 (or 1996 - sources vary) a National Bioethics Advisory Commission was established, opining on issues such as cloning
of humans, and research involving mentally disabled. In 2001, The President's Council on Bioethics
was founded to consider bioethics issues, such as stem cell research. Committee review of research has since then become a standard part of American attitude to ethical issues in science. In 2009, the Obama administration replaced this body with the Presidential Commission for the Study of Bioethical Issues
.
Ethical code
An ethical code is adopted by an organization in an attempt to assist those in the organization called upon to make a decision understand the difference between 'right' and 'wrong' and to apply this understanding to their decision...
. Notable - and in some cases, notorious - human subject experiments performed in the USA include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment
Milgram experiment
The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that...
and Stanford prison experiment
Stanford prison experiment
The Stanford prison experiment was a study of the psychological effects of becoming a prisoner or prison guard. The experiment was conducted from August 14th-20th, 1971, by a team of researchers led by psychology professor Philip Zimbardo at Stanford University...
s and Project MKULTRA
Project MKULTRA
Project MKULTRA, or MK-ULTRA, was the code name for a covert, illegal CIA human experimentation program, run by the CIA's Office of Scientific Intelligence. This official U.S. government program began in the early 1950s, continued at least through the late 1960s, and used U.S...
. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
s.
Early research and legislation
Aside from the Pure Food and Drug ActPure Food and Drug Act
The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...
of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs. Thus the early calls for regulation of human experimentation concerned medicine, and in particular, testing of new pharmaceutical drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s and their release on the market.
In 1937, a drug known as Elixir Sulfanilamide was released without any clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s. Reports in the press about potentially lethal side effect
Side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequences of the use of a drug.Occasionally, drugs are...
s led to a public outcry. Investigation by the American Medical Association
American Medical Association
The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...
showed that a poisonous compound, diethylene glycol
Diethylene glycol
Diethylene glycol is an organic compound with the formula 2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent...
, was present in the drug. The AMA concluded that the drug caused more than a hundred deaths - yet the contemporary law did not require the company that released it to test it (the existing laws required only that a drug be clearly labeled, no false claims be made about it, and that it was not adulterated). A new legislation was proposed by the Secretary of Agriculture to address the issue but was weakened after opposition from business interests. It was finally included in the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
of 1938.
In the aftermath of World War II
Aftermath of World War II
After World War II a new era of tensions emerged based on opposing ideologies, mutual distrust between nations, and a nuclear arms race. This emerged into an environment dominated by a international balance of power that had changed significantly from the status quo before the war...
, and what became recognized as deeply unethical
Ethics
Ethics, also known as moral philosophy, is a branch of philosophy that addresses questions about morality—that is, concepts such as good and evil, right and wrong, virtue and vice, justice and crime, etc.Major branches of ethics include:...
human experimentation carried out by the Nazis
Nazi human experimentation
Nazi human experimentation was a series of medical experiments on large numbers of prisoners by the Nazi German regime in its concentration camps mainly in the early 1940s, during World War II and the Holocaust. Prisoners were coerced into participating: they did not willingly volunteer and there...
, the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
- ethical principles governing international human experimentation
Human experimentation
Human subject research includes experiments and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, nursing, psychology, and all other social sciences. Humans have been participants in research since the earliest studies...
- were founded. Neither the Nuremberg Code nor the Federal Food, Drug and Cosmetic Act of 1938 prevented the "thalidomide tragedy" of the early 1960s. Thalidomide
Thalidomide
Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
was introduced in 1958, and there were reports of it being unsafe for certain groups, such as pregnant women and young children; however, although the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
did not approve it for market, the existing regulations allowed relatively unrestricted testing of the drug. This led to the abuse of approved drug testing as the means to further a promotional marketing
Marketing
Marketing is the process used to determine what products or services may be of interest to customers, and the strategy to use in sales, communications and business development. It generates the strategy that underlies sales techniques, business communication, and business developments...
strategy. This was addressed by the Drug Amendments legislation of 1962, which introduced a requirement for a series of animal tests before proceeding with human experimentation, and a total of three phases of human clinical trials before a drug can be approved for the market. The inadequacy of the 1938 and 1962 acts was exposed by revelations in the 1960s and 1970s.
60s and 70s: Beecher's study and the Tuskegee syphilis experiment
Another milestone came with Henry K. BeecherHenry K. Beecher
Henry Knowles Beecher was an important figure in the history of anesthesiology and medicine, receiving awards and honors during his career. His 1966 article on unethical practices in medical experimentation within the New England Journal of Medicine was instrumental in the implementation of...
's 1966 study as published in the New England Journal of Medicine
New England Journal of Medicine
The New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It describes itself as the oldest continuously published medical journal in the world.-History:...
. His study became instrumental in the implementation of federal rules on human experimentation and informed consent. Beecher's study listed over 20 cases of mainstream research where subjects were subject to experimentation without being fully informed of their status as research subjects, and without knowledge of the risks of such participation in the research. Some of the research subjects died or were permanently crippled as a result of that research. One of the cases analyzed was the Willowbrook State School
Willowbrook State School
Willowbrook State School was a state-supported institution for children with intellectual disabilities located in the Willowbrook neighborhood of Staten Island in New York City from the 1930s until 1987....
Case, in which mentally defective children were deliberately infected with hepatitis
Hepatitis
Hepatitis is a medical condition defined by the inflammation of the liver and characterized by the presence of inflammatory cells in the tissue of the organ. The name is from the Greek hepar , the root being hepat- , meaning liver, and suffix -itis, meaning "inflammation"...
, under disguise of a vaccination
Vaccination
Vaccination is the administration of antigenic material to stimulate the immune system of an individual to develop adaptive immunity to a disease. Vaccines can prevent or ameliorate the effects of infection by many pathogens...
program.
Beecher's findings were not alone. Evidence emerged that soon after the introduction of nuclear weapons, soldiers and civilians were subjected to potentially dangerous levels of radiation - without consent - to test its health effects (see Advisory Committee on Human Radiation Experiments
Advisory Committee on Human Radiation Experiments
The Advisory Committee on Human Radiation Experiments was established in 1994 to investigate questions of the record of the United States government with respect to human radiation experiments. The special committee was created by President Bill Clinton in Executive Order 12891, issued January 15,...
and human radiation experiments in the United States).
While most major controversies about unethical research were focused on biomedical sciences, there were also controversies involving behavioral, psychological, and sociological experiments such as: the Milgram obedience experiment
Milgram experiment
The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that...
, Stanford prison experiment
Stanford prison experiment
The Stanford prison experiment was a study of the psychological effects of becoming a prisoner or prison guard. The experiment was conducted from August 14th-20th, 1971, by a team of researchers led by psychology professor Philip Zimbardo at Stanford University...
, Tearoom Trade
Tearoom Trade
Tearoom Trade is a title of a controversial 1970 Ph.D. dissertation and book "Tearoom trade: a study of homosexual encounters in public places" by Laud Humphreys. The study is an analysis of homosexual acts taking place in public toilets...
study, and others. There were also ethical issues related to the CIA's Project MKULTRA
Project MKULTRA
Project MKULTRA, or MK-ULTRA, was the code name for a covert, illegal CIA human experimentation program, run by the CIA's Office of Scientific Intelligence. This official U.S. government program began in the early 1950s, continued at least through the late 1960s, and used U.S...
.
The Tuskegee syphilis experiment is probably the most infamous case of unethical medical experimentation in the United States. Starting in 1932, investigators recruited 399 impoverished African-American sharecroppers with syphilis for research related to the natural progression of the untreated disease, in hopes of justifying treatment programs for blacks. By 1947, penicillin had become the standard treatment for syphilis, but the Tuskegee scientists decided to withhold penicillin
Penicillin
Penicillin is a group of antibiotics derived from Penicillium fungi. They include penicillin G, procaine penicillin, benzathine penicillin, and penicillin V....
(and information about it) from the patients. The study continued under numerous supervisors until 1972, when a leak to the press resulted in its termination. Victims included a number of men who died of syphilis, their wives who contracted the disease, and some children who were born with syphilis. Even when the results were made public, the initial reaction of the medical scientific community was to exonerate the study and criticize the popular press for interfering with the research.
In 1966, the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH) Office for Protection of Research Subjects (OPRR) was created, and issued its Policies for the Protection of Human Subjects which recommended establishing independent review bodies, later called institutional review boards.
Rise of the IRB
In 1969, Kentucky Court of AppealsKentucky Court of Appeals
The Kentucky Court of Appeals is the lower of Kentucky's two appellate courts, under the Kentucky Supreme Court. Prior to a 1975 amendment to the Kentucky Constitution the Kentucky Court of Appeals was the only appellate court in Kentucky....
Judge Samuel Steinfeld
Samuel Steinfeld
Samuel Steinfeld was the Chief Justice of the Supreme Court of Kentucky. He was elected to the Kentucky Court of Appeals in 1966 and became chief justice in 1972; when the Kentucky courts were reformed in 1975, he became the first chief justice of the newly formed state Supreme Court.-References:...
dissented in Strunk v. Strunk, 445 S.W.2d 145, and made the first judicial suggestion that the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
should apply to American jurisprudence
Jurisprudence
Jurisprudence is the theory and philosophy of law. Scholars of jurisprudence, or legal theorists , hope to obtain a deeper understanding of the nature of law, of legal reasoning, legal systems and of legal institutions...
.
By the early 1970s, cases like the Willowbrook State School and the Tuskegee syphilis experiments were being raised in the U. S. Senate. As controversy over human experiments continued, the public opinion criticized research where the science seemed to be valued over the good of the subjects.
In 1974, Congress passed the National Research Act
National Research Act
The National Research Act was enacted by the 93rd United States Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation in medicine. It was partly a response to the infamous...
which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States....
(CPHS) and mandated that the Public Health Service come up with regulations that would protect the rights of human research subjects. The Commission work from 1974-1978 resulted in 17 reports and appendices, of which the most important were the Institutional Review Board Report and the Belmont Report
Belmont Report
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...
("Ethical Principles and Guidelines for the Protection of Human Subjects of Research"). The IRB Report endorsed the establishment and functioning of the Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
institution, and the Belmont Report, the Commission's last report, identified "basic ethical principles" applicable to human subject experimentation that became modern guidelines for ethical medical research: "respect for persons", "beneficence" and "justice".
In 1975, the Department of Health, Education and Welfare (DHEW) created regulation which included the recommendations laid out in the NIH's 1966 Policies for the Protection of Human Subjects. Title 45 of the Code of Federal Regulations
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...
, known as "The Common Rule," requires that institutional review boards (IRBs) oversee experiments using human subjects.
Beyond IRBs
The National Commission was superseded by the Ethical Advisory Board (EAB), which in turn was superseded in 1980 by the President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research (PCEMR). EAB focused on the issues of in vitro fertilization and prohibited the creation of fetusFetus
A fetus is a developing mammal or other viviparous vertebrate after the embryonic stage and before birth.In humans, the fetal stage of prenatal development starts at the beginning of the 11th week in gestational age, which is the 9th week after fertilization.-Etymology and spelling variations:The...
es for research purposes; and PCEMR issues recommendation on subjects such as brain death
Brain death
Brain death is the irreversible end of all brain activity due to total necrosis of the cerebral neurons following loss of brain oxygenation. It should not be confused with a persistent vegetative state...
, access to health services, withdrawal of life-support systems, and testing in regards to genetic disease.
In 1980 the FDA prohibited made prisoners illegible to be subjects of new drug testing in clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s (21 CFR 50.44).
On January 15, 1994, President Bill Clinton
Bill Clinton
William Jefferson "Bill" Clinton is an American politician who served as the 42nd President of the United States from 1993 to 2001. Inaugurated at age 46, he was the third-youngest president. He took office at the end of the Cold War, and was the first president of the baby boomer generation...
formed the Advisory Committee on Human Radiation Experiments
Advisory Committee on Human Radiation Experiments
The Advisory Committee on Human Radiation Experiments was established in 1994 to investigate questions of the record of the United States government with respect to human radiation experiments. The special committee was created by President Bill Clinton in Executive Order 12891, issued January 15,...
(ACHRE). This committee was created to investigate and report the use of human beings as test subjects in experiments involving the effects of ionizing radiation in federally funded research. The committee attempted to determine the causes of the experiments, and reasons why the proper oversight did not exist, and made several recommendations to help prevent future occurrences of similar events. In 1995 (or 1996 - sources vary) a National Bioethics Advisory Commission was established, opining on issues such as cloning
Cloning
Cloning in biology is the process of producing similar populations of genetically identical individuals that occurs in nature when organisms such as bacteria, insects or plants reproduce asexually. Cloning in biotechnology refers to processes used to create copies of DNA fragments , cells , or...
of humans, and research involving mentally disabled. In 2001, The President's Council on Bioethics
The President's Council on Bioethics
The President's Council on Bioethics was a group of individuals appointed by United States President George W. Bush to advise his administration on bioethics. Established on November 28, 2001, by Executive Order 13237, the Council was directed to "advise the President on bioethical issues that may...
was founded to consider bioethics issues, such as stem cell research. Committee review of research has since then become a standard part of American attitude to ethical issues in science. In 2009, the Obama administration replaced this body with the Presidential Commission for the Study of Bioethical Issues
Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues was created by Executive Order 13521 on November 24, 2009, to succeed the disbanded President's Council on Bioethics. The Commission's leadership and members were appointed by President Barack Obama...
.
Further reading
- Christine Grady, “Clinical Trials,” in From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 21-24.
- Jay Katz, The Regulation of Human Experimentation in the United States: A Personal Odyssey, IRB: Ethics and Human Research, Vol. 9, No. 1 (Jan. - Feb., 1987), pp. 1-6, JSTOR
- Eileen Welsome, The plutonium files: America's secret medical experiments in the Cold War, Dial Press, 1999, ISBN 0385314027
- Harriet A. Washington, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, Random House, Inc., 2008, ISBN 076791547X