When the Institution is engaged in non-exempt human subjects research conducted or supported by HHS, the Institution will comply with the requirements of subparts B, C, D, and E of the HHS regulations at Title 45 Code of Federal Regulations part 46, when applicable, for research involving pregnant women, fetuses, and neonates prisoners and children, respectively. federal department or agency which conducts or supports the research and any other applicable federal, state, local, or institutional laws, regulations, and policies. federal department or agency head determines that the procedures prescribed by the Institution afford protections that are at least equivalent to those provided by the Common Rule, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided above, consistent with the requirements of section 101(h) of the Common Rule.įor any research to which the FWA applies, the Institution also will comply with any additional applicable human subjects regulations and policies of the U.S. Federal Policy for the Protection of Human Subjects. federal departments and agencies which have adopted the U.S. Other standard(s) for the protection of human subjects recognized by U.S.The current Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects or.The current Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.The current Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects.The current International Conference on Harmonization E-6 Guidelines for Good Clinical Practice.Food and Drug Administration regulations at 21 CFR parts 50 and 56 When the Institution becomes engaged in research to which the FWA applies, the Institution and IRBs upon which it relies for review of such research at a minimum will comply with one or more of the following: federal department and agency which has adopted the Common Rule:ħ CFR part 1c – Department of Agricultureġ4 CFR part1230 – National Aeronautics and Space Administrationġ6 CFR part 1028 – Consumer Product Safety CommissionĢ2 CFR part 225 – Agency for International DevelopmentĢ4 CFR part 60 – Department of Housing and Urban Developmentģ8 CFR part 16 – Department of Veterans AffairsĤ0 CFR part 26 – Environmental Protection AgencyĤ5 CFR part 46, subpart A – Department of Health and Human ServicesĤ5 CFR part 46, subpart A – Central Intelligence Agency (by Executive Order 12333)Ĥ5 CFR part 46, subpart A – Department of Homeland Security (by federal statute)Ĥ5 CFR part 690 – National Science FoundationĤ9 CFR part 11 – Department of Transportation
Code of Federal Regulations is shown below for each U.S. When the Institution becomes engaged in research to which the FWA applies, the Institution and institutional review boards (IRBs) upon which it relies for review of such research will comply with the Common Rule. Compliance with Laws, Regulations, Policies, and Guidelines (For guidance on the meaning of “engaged,” see OHRP’s guidance at. federal department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance. federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a U.S. These terms apply whenever the Institution becomes engaged in human subjects research conducted or supported* by any U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research), or (b) a statement formulated by the institution itself. This statement of principles may include (a) an appropriate existing code, declaration (such as the World Medical Association’s Declaration of Helsinki), or statement of ethical principles (such as the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. Human Subjects Research Must Be Guided by a Statement of PrinciplesĪll of the Institution’s human subjects research activities, regardless of whether the research is subject to the U.S.