CODE OF FEDERAL REGULATIONS

TITLE 45

PUBLIC WELFARE

Departmenc of Health and Human Services

National Institutes of Health

Office for Protection from Research Risks

PART 46 - PROTECTION OF HUMAN SUBJECTS


SUBPART A - BASIC HHS POLICY FOR PROTECTION OF HUMAN RESEARCH SUBJECTS

Sections:
46.101 To what do these regulations apply?
46.102 Definitions.
46.103 Assurances.
46.104
46.105
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.
46.121 Investigational new drug or device 30-day delay requirement.
46.122 Use of federal funds.
46.123 Early termination of research funding; evaluation of subsequent 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

Sections:
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

Sections:
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

Sections:
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; sec. 474(a), 88 Stat. 352 (42 U.S.C. 289l-3(a)). 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.