Human Subjects Protection and the IRB Process
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Human Subjects Protection and the IRB Process |
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| What we have learned from history... | |
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.” World-Events Leading to Human Subject Protections 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 principles of informed consent and minimizing harm are the focus of the Nuremberg Code. 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. The Kefauver-Harris Bill requires researchers to inform all subjects about potential risks and benefits of experimental drugs and to obtain consent from participants prior to taking part in the study. 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. The Declaration of Helsinki requires surrogate consent for minors and adults who lack cognitive ability or emotional maturity to understand potential risk or harm associated with research participation. The Evolution of the IRB 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 National Research Act established the IRB process that requires formal peer review and approval of all Department of Health and Human Services (DHHS) research involving human subjects. 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. The ethical principles in the Belmont Report, Respect for Persons, Beneficence, and Justice, are the standards on which current federal laws and regulations governing human subjects research are based and ethical practices of research studies are evaluated. 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).
Title 45 CFR 46 which was adopted by 17 Federal agencies is known as the Common Rule because the rules are “common” to a wide range of federal departments and agencies conducting human subjects research. 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 Department of Justice policy to protect human subjects research establishes the essential rules that all juvenile justice professionals must follow when conducting Federally funded research activities. This discussion represents a general framework for integrating Federal human subject protection requirements into juvenile justice practice and research. Federal human subject protection laws are supplemented by other Federal, state, and local regulations. This guide also reviews relevant youth-related protection regulations in situations related to information sharing. Please note: Juvenile justice professionals who are uncertain about their legal responsibilities for human subject protection should seek advice from local legal authorities and from experts at federal, state, and local government offices. |
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