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Le département de l'Human Research Protection (en anglais : Office of Human Research Protections ou OHRP) est un petit département au sein du ministère de la Santé et des Services sociaux des États-Unis (DHHS) qui a pour objet de surveiller, selon des critères éthiques, les recherches cliniques menées par le ministère, la plupart du temps en passant par le National Institutes of Health. (fr) The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH). The office's primary duty is the implementation of 45 CFR 46, a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule". Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ethics, and advises the HHS Secretary on issues of medical ethics. (en) |
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Le département de l'Human Research Protection (en anglais : Office of Human Research Protections ou OHRP) est un petit département au sein du ministère de la Santé et des Services sociaux des États-Unis (DHHS) qui a pour objet de surveiller, selon des critères éthiques, les recherches cliniques menées par le ministère, la plupart du temps en passant par le National Institutes of Health. (fr) The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH). (en) |
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Office for Human Research Protections (fr) Office for Human Research Protections (en) |
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