Title 45

PART 46

Part 46 - Protection Of Human Subjects

PART 46 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b). Editorial 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. For further information see 47 FR 9208, Mar. 4, 1982.

45:1.0.1.1.26.1SUBPART A
Subpart A - Basic HHS Policy for Protection of Human Research Subjects
45:1.0.1.1.26.1.1.1SECTION 46.101
   46.101 To what does this policy apply
45:1.0.1.1.26.1.1.2SECTION 46.102
   46.102 Definitions for purposes of this policy.
45:1.0.1.1.26.1.1.3SECTION 46.103
   46.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
45:1.0.1.1.26.1.1.4SECTION 46.104
   46.104 Exempt research.
45:1.0.1.1.26.1.1.5SECTION 46.105-46.106
   46.105-46.106 [Reserved]
45:1.0.1.1.26.1.1.6SECTION 46.107
   46.107 IRB membership.
45:1.0.1.1.26.1.1.7SECTION 46.108
   46.108 IRB functions and operations.
45:1.0.1.1.26.1.1.8SECTION 46.109
   46.109 IRB review of research.
45:1.0.1.1.26.1.1.9SECTION 46.110
   46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
45:1.0.1.1.26.1.1.10SECTION 46.111
   46.111 Criteria for IRB approval of research.
45:1.0.1.1.26.1.1.11SECTION 46.112
   46.112 Review by institution.
45:1.0.1.1.26.1.1.12SECTION 46.113
   46.113 Suspension or termination of IRB approval of research.
45:1.0.1.1.26.1.1.13SECTION 46.114
   46.114 Cooperative research.
45:1.0.1.1.26.1.1.14SECTION 46.115
   46.115 IRB records.
45:1.0.1.1.26.1.1.15SECTION 46.116
   46.116 General requirements for informed consent.
45:1.0.1.1.26.1.1.16SECTION 46.117
   46.117 Documentation of informed consent.
45:1.0.1.1.26.1.1.17SECTION 46.118
   46.118 Applications and proposals lacking definite plans for involvement of human subjects.
45:1.0.1.1.26.1.1.18SECTION 46.119
   46.119 Research undertaken without the intention of involving human subjects.
45:1.0.1.1.26.1.1.19SECTION 46.120
   46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
45:1.0.1.1.26.1.1.20SECTION 46.121
   46.121 [Reserved]
45:1.0.1.1.26.1.1.21SECTION 46.122
   46.122 Use of Federal funds.
45:1.0.1.1.26.1.1.22SECTION 46.123
   46.123 Early termination of research support: Evaluation of applications and proposals.
45:1.0.1.1.26.1.1.23SECTION 46.124
   46.124 Conditions.
45:1.0.1.1.26.2SUBPART B
Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
45:1.0.1.1.26.2.1.1SECTION 46.201
   46.201 To what do these regulations apply
45:1.0.1.1.26.2.1.2SECTION 46.202
   46.202 Definitions.
45:1.0.1.1.26.2.1.3SECTION 46.203
   46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
45:1.0.1.1.26.2.1.4SECTION 46.204
   46.204 Research involving pregnant women or fetuses.
45:1.0.1.1.26.2.1.5SECTION 46.205
   46.205 Research involving neonates.
45:1.0.1.1.26.2.1.6SECTION 46.206
   46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
45:1.0.1.1.26.2.1.7SECTION 46.207
   46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
45:1.0.1.1.26.3SUBPART C
Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
45:1.0.1.1.26.3.1.1SECTION 46.301
   46.301 Applicability.
45:1.0.1.1.26.3.1.2SECTION 46.302
   46.302 Purpose.
45:1.0.1.1.26.3.1.3SECTION 46.303
   46.303 Definitions.
45:1.0.1.1.26.3.1.4SECTION 46.304
   46.304 Composition of Institutional Review Boards where prisoners are involved.
45:1.0.1.1.26.3.1.5SECTION 46.305
   46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
45:1.0.1.1.26.3.1.6SECTION 46.306
   46.306 Permitted research involving prisoners.
45:1.0.1.1.26.4SUBPART D
Subpart D - Additional Protections for Children Involved as Subjects in Research
45:1.0.1.1.26.4.1.1SECTION 46.401
   46.401 To what do these regulations apply
45:1.0.1.1.26.4.1.2SECTION 46.402
   46.402 Definitions.
45:1.0.1.1.26.4.1.3SECTION 46.403
   46.403 IRB duties.
45:1.0.1.1.26.4.1.4SECTION 46.404
   46.404 Research not involving greater than minimal risk.
45:1.0.1.1.26.4.1.5SECTION 46.405
   46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
45:1.0.1.1.26.4.1.6SECTION 46.406
   46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
45:1.0.1.1.26.4.1.7SECTION 46.407
   46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
45:1.0.1.1.26.4.1.8SECTION 46.408
   46.408 Requirements for permission by parents or guardians and for assent by children.
45:1.0.1.1.26.4.1.9SECTION 46.409
   46.409 Wards.
45:1.0.1.1.26.5SUBPART E
Subpart E - Registration of Institutional Review Boards
45:1.0.1.1.26.5.1.1SECTION 46.501
   46.501 What IRBs must be registered
45:1.0.1.1.26.5.1.2SECTION 46.502
   46.502 What information must be provided when registering an IRB
45:1.0.1.1.26.5.1.3SECTION 46.503
   46.503 When must an IRB be registered
45:1.0.1.1.26.5.1.4SECTION 46.504
   46.504 How must an IRB be registered
45:1.0.1.1.26.5.1.5SECTION 46.505
   46.505 When must IRB registration information be renewed or updated