45 CFR 46 (Protection of Human Subjects) TITLE 45 CODE OF FEDERAL REGULATIONS PART 46 PROTECTION OF HUMAN SUBJECTS * * * Revised June 18, 1991 Effective August 19, 1991 * * * Subpart A Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) Source: 56 FR 28003, June 18, 1991. The HHS regulations, 45 CFR part 46, include four subparts: All Titles Title 45 Chapter A Part 46 Subpart A - Basic HHS Policy for Protection of Human Research Subjects. 289 is section 491 of The Public Health Service Act, 42 U.S.C. The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. In order to understand the regulatory text of the revised Common Rule, OHRP recommends reviewing the preamble and regulatory text from: Subpart A of 45 CFR Part 46 . Note: 42 U.S.C. Subpart A of 45 CFR part 46 is often referred to as the Common Rule. Source: 82 FR 7259, 7273, Jan. 19, 2017, unless otherwise noted. 289a-1 is section 492a of The Public Health Service Act, and . 45 CFR Subpart A - Basic HHS Policy for Protection of Human Research Subjects . (2) 2018 Requirements. Many other federal departments and agencies have also codified the text of the Common Rule in their own sections of the Code of Federal Regulations (CFR). (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. 46.117 Documentation of informed consent. 45 CFR Part 46 Subpart A 1) Applicability of the Common Rule Federal funds cannot be used for research involving human subjects if the requirements of the Common Rule have not been satisfied.19 The department or agency head may impose additional requirements on research for the purpose of protecting human subjects.20 a. Definitions21 CFR ; prev | next § 46.101 To what does this policy apply? § 46.117 Documentation of informed consent. § 46.102 Definitions for purposes of this policy. 42 U.S.C. §46.101 To what does this policy apply? View all text of Subpart A [§ 46.101 - § 46.124] ... For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations. (a) Except as detailed in §46.104, this policy applies to all research involving human subjects conducted, supported, or 289g … In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. The "Common Rule" was published in 1991, based on the Belmont Report, and codified in separate regulations by 15 Federal departments. This is explained in the transition provision (45 CFR 46.101(l), as amended June 19, 2018). § 46.103 Assuring compliance with this policy - research conducted … (Note: Section 46.102(g) becomes Section 46.102(i) in Title 45 CFR Part 46 as revised on June 18, 1991.)