Go to The Evergreen State College Human Subjects Review Application
Go to guest lecture by Dennis McBride, PhD: DSHS Institutional Review Board member
Source:http://ncjj.servehttp.com/irb/ National Center for Juvenile Justice
A look at past and present research practices is the framework for understanding the purpose of the regulations that protect the rights and welfare of persons who are the subjects of human research. Past practice was the stimulus for the initial regulations for human subjects research; however ongoing occurrences of ethical misconduct reinforce the value of and continuing need for the Institutional Review Board (IRB) review process.
The following instances of ethical oversights and unethical treatment of human subjects are only a few of the many abuses alleged by some researchers as “necessary” for the advancement of knowledge. Researchers were either oblivious of or unsympathetic to the risks imposed upon study participants. Such risks were rationalized as minor in contrast to the “greater benefit to society.”
The need for ethical standards to protect human subjects in research studies was brought to the forefront during World War II. In the name of medicine and science, Nazi doctors and scientists conducted cruel, harmful, and often deadly experiments on prisoners in war camps.
In 1946, after public awareness and uproar, leading members of the German medical hierarchy were indicted before the war crimes tribunal in Nuremberg , Germany . The trial resulted in the conviction of 16 of the 23 physician defendants, seven of whom were sentenced to death. The tribunal condemned the experiments and classified them as “crimes against humanity.” “Permissible Medical Experiments,” the standards used to judge these German doctors, became known as the Nuremberg Code and remain the basis for ethics codes internationally.
The U.S. Public Health Service was in the process of conducting the Tuskegee syphilis experiments when the Nuremberg Code was enacted. From 1932 to 1973, Tuskegee researchers intentionally withheld penicillin treatment from black males who were unaware of their positive diagnosis of syphilis. Even though informed consent and minimizing harm were the guiding principles of the Nuremberg Code , researchers continued to deceive the men and their families by involving them in research without informing them about the risks involved. By the end of the study, twenty-eight subjects had died, hundreds experienced extreme disabilities from the disease, wives were infected, and nineteen cases of congenital syphilis were documented. In 1973, Congress commissioned a Syphilis Ad Hoc Study panel to investigate the Tuskegee study. The panel immediately stopped the research and recommended federal regulation of human research. The Federal government announced it would compensate the men for all medical expenses until their death and for all medical treatment of spouses and children who had contracted syphilis during the years of the study. In 1997, sixty-five years after the U.S. Public Health Service initiated the Tuskegee syphilis experiments, President William Clinton issued a formal apology to study subjects and their families, calling for renewed emphasis on research ethics.
In the late 1950s, pregnant women in Europe, Canada , and the United States were given thalidomide, an experimental drug prescribed to control nausea. Thalidomide caused severe birth defects in the fetus that resulted in more than 12,000 deformed and limbless infants. Expectant mothers were not informed of the risks associated with thalidomide or that it was an experimental drug. Additionally, patients did not volunteer nor did they give consent to participate in the research. Once again, the Nuremberg principles of informed consent and minimizing harm were not applied to research practice. In response, the Kefauver-Harris Bill was passed in 1962 to ensure greater drug testing safety.
Both the Nuremberg Code and Kefauver-Harris Bill established the requirements that all research participants be fully informed about potential risks or harm that may result from taking part in a study and that, based on this information, they voluntarily agree to participate. These requirements did not address the capacity of minors or adults with limited decision-making skills to make an informed decision. To address this issue, the World Medical Association issued the Declaration of Helsinki in 1964, requiring surrogate consent when the participant is incapable of decision-making. Parental consent is required for all youth under the legal age limit. Youth assent is required if a child has the cognitive and emotional maturity to understand the conditions of the research and to decide whether to participate. Parental consent can only overrule the child's refusal to assent when the research condition is therapeutic.
While the 1947 Nuremberg Code was the world's reaction to Nazi war crimes, the 1974 National Research Act (Public Law 93-348) is the response of the United States to the Tuskegee Study of Untreated Syphilis. Once again, informed consent is a fundamental principle on which human subject protection is established . The legislation also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that, in 1979, issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research . The IRB process, formalized by the Commission, remains the present-day peer review method to ensure compliance with the basic principles of the Belmont Report.
In 1974, the Department of Health and Human Services instituted formal IRB procedures as part of the regulations for the Protection of Human Subjects of Biomedical Research (Title 45 Code of Federal Regulations (CFR) 46, Subpart A).
In 1991, the National Commission recognized the need for a common federal policy and recommended that all federal departments and agencies adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (45 CFR 46). The adoption of these “common” regulations by seventeen Federal departments and agencies became known as the Common Rule.
As with all federal departments and agencies that adopted the Common Rule, the Department of Justice regulations (28 CFR 46) are identical to the core regulations in 45 CFR 46, Subpart A. The purpose of these regulations is to ensure that recipients of federal funding for research involving human subjects have appropriate procedures in place to protect such subjects from undue or unnecessary risks. The regulations address protection of privacy and the assurance of confidentiality along with detailed procedures to establish and operate an Institutional Review Board (IRB). The IRB is responsible for determining whether proposed research projects contain adequate protections for the subjects involved. Accordingly, all recipients of federal funds must submit to IRB review and approval for all research about or directly involving human subjects.
The fundamental responsibility of the IRB review is to assure that the rights and welfare of the human subject are protected.