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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 23, 2014

Title 45Subtitle ASubchapter APart 46


TITLE 45—Public Welfare

Subtitle A—DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL ADMINISTRATION

PART 46—PROTECTION OF HUMAN SUBJECTS

rule

Subpart A—BASIC HHS POLICY FOR PROTECTION OF HUMAN RESEARCH SUBJECTS

§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.
rule

Subpart B—ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN, HUMAN FETUSES AND NEONATES INVOLVED IN RESEARCH

§46.201
To what do these regulations apply?
§46.202
Definitions.
§46.203
Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
§46.204
Research involving pregnant women or fetuses.
§46.205
Research involving neonates.
§46.206
Research involving, after delivery, the placenta, the dead fetus or fetal material.
§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.
rule

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.
rule

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.
rule

Subpart E—REGISTRATION OF INSTITUTIONAL REVIEW BOARDS

§46.501
What IRBs must be registered?
§46.502
What information must be provided when registering an IRB?
§46.503
When must an IRB be registered?
§46.504
How must an IRB be registered?
§46.505
When must IRB registration information be renewed or updated?


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