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Informed Consent, Part 2
(Page 2 of 5) Office of Human Research Protections (OHRP) This OHRP 4, which is part of the U.S. Department of Health and Human Services (DHHS), is responsible for:
These federal regulations set standards for the informed consent process; the formation and function of Institutional Review Boards (see below); the involvement of prisoners, children, and other vulnerable groups in research; and many other protective measures. | ||||||||||||||||||||
The regulations apply to any federally funded research that involves people (which includes NCI-sponsored clinical trials). Participating institutions must provide OHRP with a written assurance that they will comply with the regulations. In addition, many research institutions conducting independent (i.e., not federally funded) trials have volunteered to adhere to these regulations. Human Subject Protection Program, FDA The U.S. Food and Drug Administration (FDA), through its Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Title 21, Parts 50 and 56 of the Code of Federal Regulations; also referred to as 21 CFR 50, 56). The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act -- regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors 6). The American Hospital Association and "The Patient Care Partnership" The American Hospital Association (AHA) first adopted a "patient's bill of rights" in 1973, which was later revised into a brochure called The Patient Care Partnership: Understanding Expectations, Rights and Responsiblities 7. This brochure (available in multiple languages) lists a patient's rights to considerate and respectful care, privacy, confidentiality, information about options, and access to medical records, among others. The AHA expects hospitals to use the brochure to ensure quality care and encourages them to adapt its contents to meet the needs of the communities they serve. Institutional Review Boards Institutions have an Institutional Review Board (IRB) made up of medical specialists, nurses, social workers, medical ethicists, and patient advocates. The IRB reviews all clinical trial protocols and approves only those that address medically important questions in a scientifically and ethically responsible manner. It also reviews all informed consent documents to make sure that they provide clear and complete information for those who may wish to take part. You might be interested in taking a look at the IRB Guidebook 8 issued by the NIH's Office of Human Research Protections. Peer review Before a clinical trial gets under way, it also may be reviewed by experts chosen by the sponsoring organization (such as the National Cancer Institute, the Food and Drug Administration, or pharmaceutical company) for scientific merit, patient safety, and ethical considerations. For more information about peer review at the National Institutes of Health (NIH), including NCI, see the Office of Extramural Research: Peer Review Policy and Issues 9 or the NIH Center for Scientific Review 10. Patient representatives Many hospitals and clinical centers employ patient representatives, who work to make sure that those who receive care (including clinical trial participants) are informed of and understand their rights and responsibilities. Other organizations Groups such as Public Responsibility in Medicine and Research (PRIM&R) 11 help to educate medical personnel and the public about the ethical, legal, and policy issues involved in clinical research. History PThe History of Informed Consent and the System of Protections Over the past half-century, the international and U.S. medical communities have taken numerous steps to protect people who take part in clinical research. The following timeline provides an overview of some of the key events that have contributed to the development of the current system. P1947 - The Nuremberg Code Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the Code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent can be voluntary only if:
The Code also states that researchers should minimize risk and harm, make sure that risks do not significantly outweigh potential benefits, use appropriate study designs, and guarantee participants' freedom to withdraw at any time. The Nuremberg Code was adopted by the United Nations General Assembly in 1948. P1964 - Declaration of Helsinki At the 18th World Medical Assembly in Helsinki, Finland, the World Medical Association adopted 12 principles to guide physicians on ethical considerations related to biomedical research. It emphasizes the distinction between medical care that directly benefits the patient and research that may or may not provide direct benefit. These guidelines were revised at subsequent meetings in 1975 (Tokyo, Japan), 1983 (Venice, Italy), and 1989 (Hong Kong). P1974 - The National Research Act The U.S. Congress signed this act into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was charged with:
About the Author www.nci.nih.gov |
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