Ethical issues in clinical research in neurology
Advancing knowledge and protecting human research subjects
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Neurology is evolving rapidly as research brings to light new knowledge about diseases of the nervous system and novel diagnostic and treatment options. An important ingredient in improving our understanding of neurologic diseases is the conduct of well-designed clinical research studies, including epidemiologic, genetic, and natural history studies, and clinical drug trials. However, some research involving people with neurologic diseases presents serious ethical and regulatory challenges.
As the Decade of the Brain progresses, it is appropriate to give attention not only to the scientific but also the ethical dimensions of neurologic diseases. We give a brief overview of some ethical and regulatory considerations concerning the protection of human subjects in neurologic research.
Ethical guidelines and federal regulations. Biomedical and behavioral research funded or supported by the federal government, including the National Institutes of Health (NIH), is under the purview of regulations for the protection of human subjects (Title 45, Code of Federal Regulations, Part 46).1 Also, in the United States, all clinical trials, regardless of the funding source, involving investigational drugs are under the regulatory purview of the Food and Drug Administration(FDA).2 Both the FDA and the Department of Health and Human Services (DHHS) require that proposed clinical research undergo review by an Institutional Review Board (IRB) whose primary mandate is to protect the rights and safeguard the welfare of the subjects. In their deliberations, IRBs are expected to take into account the nature, content, and design of the research, ethical principles of the Belmont Report,3 and, when appropriate, the regulatory requirements of DHHS and the FDA.
IRBs are important because research investigators have an inherent conflict of interest. As health care professionals, they are dedicated to promoting the welfare of individual patients; as researchers, they seek generalizable knowledge applicable to persons other than their individual patients. …
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