The human subject research law in the United States can be traced to the early 20th century. Research on human subjects in the United States is largely unregulated until the 20th century, like the rest of the world, until the formation of various rules and codes of government and professional conduct. Notable - and in some cases, famous - human subjects experiments conducted in the US including Tuskegee syphilis experiments, human radiation experiments, Milgram obedience experiments and Stanford prison experiments and the MKULTRA Project. With increasing public awareness of such experiments, and the evolution of professional ethical standards, such research becomes regulated by various laws, especially those that introduce and then empower institutional review boards.
Video Human subject research legislation in the United States
Initial research and laws
Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 which prohibits the sale of some narcotic drugs, there is no federal regulatory control that ensures the safety of new drugs. Thus a preliminary call for setting up a drug-related human experiment, and in particular, testing of a new pharmaceutical drug and its release on the market.
In 1937, a drug known as Elixir Sulfanilamide was released without clinical trials. Reports in the media about potentially deadly side effects caused public outcry. Investigations by the American Medical Association show that toxic compounds, diethylene glycol, are present in the drug. The AMA concluded that the drug caused more than a hundred deaths - but contemporary law does not require the company that released it to test it (existing legislation only requires that the drug be clearly labeled, no false claims are made about it, and that it does not polluted). A new law is proposed by the Secretary of Agriculture to address this issue but is weakened after being opposed by business interests. It was eventually included in the Federal Food, Drug, and Cosmetic Act of 1938.
In the aftermath of World War II, and what was recognized as a highly unethical human experiment conducted by the Nazis, the Nuremberg Code - the ethical principles governing international human experimentation - was established. This code highlights 3 key elements (voluntary informed consent, profitable risk/benefit analysis, and the right to pull without reactions) which later became the basis for further human regulatory research. However, neither the Nuremberg Code nor the Federal Food, Drug and Cosmetic Act of 1938 prevented the "thalidomide tragedy" in the early 1960s. Thalidomide was introduced in 1958, and there are reports that it is unsafe for certain groups, such as pregnant women and young children; however, even though the Food and Drug Administration does not agree to be marketed, existing regulations allow unlimited drug testing. This leads to the abuse of approved drug testing as a means to advance promotional marketing strategies. This was overcome by the Drug Amendment Act of 1962, which introduced the requirements for a series of animal tests before continuing with human experiments, and a total of three phases of human clinical trials before the drug could be approved for the market. The inability of the 1938 and 1962 acts was revealed by revelations in the 1960s and 1970s.
Maps Human subject research legislation in the United States
60 and 70s: Beecher's research and Tuskegee syphilis experiment
Another milestone came with the research of Henry K. Beecher in 1966 as published in the New England Journal of Medicine . His studies became instrumental in the implementation of federal rules on human experiments and informed consent. Beecher's study listed more than 20 major research cases in which subjects were subjected to experiments without being fully informed of their status as research subjects, and without knowledge of the risks of such participation in the study. Some research subjects died or were permanently paralyzed as a result of the study. One of the cases analyzed is the Willowbrook State School Case, where mentally ill children are deliberately infected with hepatitis, disguising the vaccination program.
Beecher's findings are not alone. Evidence emerged that immediately after the introduction of nuclear weapons, soldiers and civilians were subjected to potentially harmful radiation levels - without consent - to test their health effects (see Advisory Committee on Human Radiation Experiments and human radiation experiments in the United States).
While much of the controversy about unethical research is focused on biomedical science, there is also controversy involving behavioral, psychological, and sociological experiments such as: Milgram obedience experiments, Stanford prison experiments, Tearoom Trade studies, and others. There are also ethical issues related to the CIA MKULTRA Project.
The Tuskegee syphilis experiment may be the most famous case of unethical medical experimentation in the United States. Beginning in 1932, researchers recruited 399 poor African-American farmers with syphilis for research related to the natural development of untreated diseases, hoping to justify a treatment program for blacks. By 1947, penicillin had been the standard treatment for syphilis, but Tuskegee scientists decided to withhold penicillin (and information about it) from patients. This study continued under many supervisors until 1972, when leaks to the press resulted in his termination. The victims included a number of men who died of syphilis, their wives who contracted the disease, and some children born with syphilis. Even when the results are published, the initial reaction of the medical scientific community is to free the research and criticize the popular press for disrupting research.
In 1976, the National Institutes of Health (NIH) Office for Protection of Research Subjects (OPRR) was created, and issued the Policy for the Protection of Human Subjects which recommended the establishment of an independent review board, which was then called the institutional review board.
Rise of IRB
In 1969, Kentucky Court of Appeals Court, Samuel Steinfeld disagreed in Strunk v. Strunk, 445 S.W.2d 145 , and makes the first legal suggestion that the Nuremberg Code should apply to American jurisprudence.
In the early 1970s, cases like the Willowbrook State School and the Tuskegee syphilis experiment were being raised in the US Senate. As controversy over ongoing human experiments, public opinion criticizes research in which science appears to be valued for the good of the subject.
In 1974, Congress passed a National Research Act that established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (CPHS) and mandated that the Public Health Service come with regulations that would protect the rights of human research subjects. The Commission's work from 1974-1978 resulted in 17 reports and annexes, most notably the Institutional Review Board Report and Belmont Report ("Ethical Principles and Guidelines for the Protection of Human Subjects of Research"). The IRB Report supports the establishment and functioning of Institutional Review Board institutions, and the Belmont Report, the Commission's final report, identifies the "basic ethical principles" applicable to human subject experiments that serve as the modern guidelines for ethical medical research: "respect for people," "good" and "justice".
In 1975, the Department of Health, Education and Welfare (DHEW) drafted a regulation incorporating the recommendations contained in NIH's 1966 Policy for the Protection of Human Subjects . Title 45 of the Code of Federal Regulations, known as the "General Regulations," requires that the institutional review board (IRB) supervises experiments using human subjects.
Beyond IRB
The National Commission was replaced by the Ethical Advisory Board (EAB), which was in turn supplanted in 1980 by the Presidential Commission for the Study of Ethical Issues in Biomedical and Behavioral Research (PCEMR). EAB focuses on the problem of in vitro fertilization and prohibits the creation of the fetus for research purposes; and PCEMR issued recommendations on subjects such as brain death, access to health care, withdrawal of life support systems, and testing related to genetic diseases.
In 1980 the FDA made prisoners ineligible to be the subject of new drug testing in clinical trials (21 CFR 50.44).
On January 15, 1994, President Bill Clinton formed the Advisory Committee for Human Radiation Experiment (ACHRE). The committee was created to investigate and report on human use as a test subject in experiments involving the effects of ionizing radiation in federal government-funded research. The Committee seeks to determine the cause of the experiment, and the reason why proper supervision is absent, and makes some recommendations to help prevent similar events in the future. In 1995 (or 1996 - varied sources), the National Bioethics Advisory Committee was established, argued on issues such as human cloning, and research involving mentally disabled persons. In 2001, the Presidential Council on Bioethics was established to consider the issue of bioethics, such as stem cell research. The review of the research committee has become a standard part of America's attitude toward ethical issues in science. In 2009, the Obama administration replaced this body with the Presidential Commission for the Study of the Problem of Bioethics.
Research that does not require IRB review
Some provisions of medical research regulations allow specific research projects to proceed without IRB reviews. For example, in the United States, studies using electronic medical records of dying patients do not require IRB reviews.
References
Further reading
- Christine Grady, "Clinical Trial," in From Birth to Death and Clinic to Clinic: Introduction to Holistic Bioethics Center for Journalists, Policy Makers, and Campaigners, ed. Mary Crowley (Garrison, NY: The Hastings Center, 2008), 21-24.
- Jay Katz, Human Experimentation Rules in the United States: A Personal Odyssey , IRB: Human Ethics and Research, Vol. 9, No. 1 (Jan. - Feb., 1987), pp.Ã, 1-6, JSTOR
- Eileen Welsome, Plutonium files: secret American medical experiments in the Cold War , Dial Press, 1999, ISBNÃ, 0-385-31402-7
- Harriet A. Washington, Medical Apartheid: Dark History of Medical Experiments on Black Americans from Colonial Period to Current , Random House, Inc., 2008, ISBNÃ, 0-7679-1547-X
External links
- IRB: Ethics & amp; Journal of Human Research
- Belmont Reports
Source of the article : Wikipedia
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