Protection of research subjects with emphasis on protocols involving radiation.
Approval by an institutional review board (IRB) or human studies committee must be obtained prior to conducting human subject research. Historically this was not the case, and human subjects were injured as a result. Because there has been and still remains an inevitable conflict of interest for researchers, instititions that perform human research must follow regulations designed to protect human subjects contained in the Code of Federal Regulations, if the research is federally funded. Two federal agencies provide oversight for IRB activities: the Food and Drug Administration (FDA) and a National Institutes of Health Office for Human Research Protection (OHRP), formerly the Office for Protection from Research Risks (OPRR). These agencies are charged with the implementation of rules related to ethical and legal obligations of researchers and their institutions. The institution's role, by means of an IRB, is to adhere to principles of the Belmont Report and to set forth ethical principles, policies, and procedures for protecting the rights and welfare of human subjects. The researchers' role is to conduct their research ethically while maximizing benefits and minimizing harm. Studies involving radiation exposure of human subjects add another level of risk that must be evaluated by an IRB with assistance of a radiation expert or radiation safety committee (RSC). This paper will look at regulatory aspects of human research, IRB responsibilities overall and as they relate to radiation exposure of subjects, and the role of the RSC.
Classic
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KL
Mayo Clinic Rochester, MN 55905, USA. classic.kelly@mayo.edu
Porter
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DiMagno
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D002648:Child; D002985:Clinical Protocols / Q000592:standards*; D004992:Ethics, Medical; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D011367:Professional Staff Committees / Q000592:standards; D011832:Radiation Injuries / Q000517:prevention & control*; D012106:Research / Q000331:legislation & jurisprudence* / Q000592:standards*; D012306:Risk; D014481:United States