Institutional review boards are charged with overseeing that human studies research is conducted in accordance with federal and state regulations and with their own policies and procedures, with the goal of minimizing risks to participants and maximizing the quality of the research data. Nutrition research often involves vulnerable populations, including children and the cognitively impaired, for whom there are specific regulations. Ethical issues are common in nutrition research, and both the investigative team and the institutional review board should seek input regarding ethical issues that arise.
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Department of Health, Education, and Welfare. Protection of human subjects; Belmont Report: ethical principles and guidelines for the protection of human subjects of research, report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Fed Regist. 1979;44:23192-23197.
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Office for Human Research Protections. Draft Guidance: Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution. Rockville, MD: Office for Human Research Protections; 2012.
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Department of Health and Human Services. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Washington, DC: Department of Health and Human Services; 2011.
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Executive Order 13563. Improving regulation and regulatory review. Fed Regist. 2011;76:3821-3823.
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EmanuelEJMenikoffJ. Reforming the regulations governing research with human subjects. N Engl J Med. 2011;365:1145-1150.
WinterSM. Terminal nutrition: framing the debate for the withdrawal of nutritional support in terminally ill patients. Am J Med. 2000;109:723-726.
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BrodyHHermerLDScottLDGrumblesLLKutacJEMcCammonSD. Artificial nutrition and hydration: the evolution of ethics, evidence, and policy. J Gen Intern Med. 2011;26:1053-1058.
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PhillipsMMRyanKRaczynskiJM. Public policy versus individual rights in childhood obesity interventions: perspectives from the Arkansas experience with Act 1220 of 2003. Prev Chronic Dis. 2011;8:A96.
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SaarniSIAnttilaHSaarniSE. Ethical issues of obesity surgery—a health technology assessment. Obes Surg. 2011;21:1469-1476.
