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Subpart A—Basic HHS Policy for Protection of Human Research Subjects
Sec.
46.101 To what does this policy apply?
46.102 Definitions.
46.103 Assuring compliance with this policy— research conducted or supported by any Federal Department or Agency.
46.104–46.106 [Reserved]
46.107 IRB membership.
46.108 IRB functions and operations.
46.109 IRB review 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.
46.111 Criteria for IRB approval of research.
46.112 Review by institution.
46.113 Suspension or termination of IRB approval of research.
46.114 Cooperative research.
46.115 IRB records.
46.116 General requirements for informed consent.
46.117 Documentation of informed consent.
46.118 Applications and proposals lacking definite plans for involvement of human subjects.
46.119 Research undertaken without the intention of involving human subjects.
46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
46.121 [Reserved]
46.122 Use of Federal funds.
46.123 Early termination of research support: Evaluation of applications and proposals.
46.124 Conditions.
Subpart B—Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization
46.201 Applicability.
46.202 Purpose.
46.203 Definitions.
46.204 Ethical Advisory Boards.
46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization.
46.206 General limitations.
46.207 Activities directed toward pregnant women as subjects.
46.208 Activities directed toward fetuses in utero as subjects.
46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects.
46.210 Activities involving the dead fetus, fetal material, or the placenta.

46.211 Modification or waiver of specific requirements.

Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
46.301 Applicability.
46.302 Purpose.
46.303 Definitions.
46.304 Composition of Institutional Review
Boards where prisoners are involved.
46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
46.306 Permitted research involving prisoners.
Subpart D—Additional Protections for Children Involved as Subjects in Research
46.401 To what do these regulations apply?
46.402 Definitions.
46.403 IRB duties.
46.404 Research not involving greater than minimal risk.
46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
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.
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.
46.408 Requirements for permission by parents or guardians and for assent by children.
46.409 Wards.

AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289. EFFECTIVE DATE NOTE: At 66 FR 3882, Jan. 17, 2001, the authority for part 46 was revised, effective Mar. 19, 2001. At 66 FR 15352, Mar. 19, 2001, the effective date was delayed until May 18, 2001, and at 66 FR 27599, May 18, 2001, the effective date was further delayed until Nov. 14, 2001. For the convenience of the user, the revised text is set forth as follows: AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289(a).

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(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Protection from Research Risks, Department of Health and Human Services (HHS), and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in department or agency procedures.¹

[56 FR 28012, 28022, June 18, 1991; 56 FR 29756, June 28, 1991]

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HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit

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for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, only if the IRB finds that:

(a) The risk is justified by the anticipated benefit to the subjects;

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(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

§ 46.409 Wards.

(a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under § 46.406 or § 46.407 only if such research is:

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