Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in department or agency procedures. In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research. (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects. (d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy. (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. * * * Subpart A - Basic HHS Policy for Protection of Human Research SubjectsĪuthority: 5 U.S.C. For further information see 47 FR 9208, Mar. 289(a).Įditorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost-sharing, such as deductibles, copayment and coinsurance, in the Medicaid program. §46.123 Early termination of research support: Evaluation of applications and proposals.Īuthority: 5 U.S.C. §46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. §46.119 Research undertaken without the intention of involving human subjects. §46.118 Applications and proposals lacking definite plans for involvement of human subjects. §46.117 Documentation of informed consent. §46.116 General Requirements for Informed Consent. §46.113 Suspension or Termination of IRB Approval of Research. §46.111 Criteria for IRB approval of research. §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. §46.103 Assuring compliance with this policy-research conducted or supported by any Federal department or agency. §46.102 Definitions for purposes of this policy. Basic HHS Policy for Protection of Human Research Subjects General Compliance date is January 21, 2019 Revised January 19, 2017, and Amended Januand June 19, 2018
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