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(i) Unless otherwise required by law, classes or research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the Department or Agencyhead shall forward advance notices of these actions to the Office for Protection from Research Risks, National Institutes of Health, Department or Agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or Department of Health and Human Services (DHHS), and shall also publish them in the Federal Register or in such other manner as provided in Department or Agency procedures.1
1 Institutions with DHHS-approved assurances on file will abide by provisions of Title 45 CFR Part 46 Subparts A-D. Some of the other departments and agencies have CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, incorporated all provisions of Title 45 CFR Part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization, Subparts B and C. The exemption at 45Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
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