e-CFR data is current as of January 21, 2021
TITLE 45—Public Welfare
Subtitle A—DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A—GENERAL ADMINISTRATION PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart A—BASIC HHS POLICY FOR PROTECTION OF HUMAN RESEARCH SUBJECTS
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| To what does this policy apply? |
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| Definitions for purposes of this policy. |
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| Assuring compliance with this policy—research conducted or supported by any Federal department or agency. |
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| IRB functions and operations. |
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| Criteria for IRB approval of research. |
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| Suspension or termination of IRB approval of research. |
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| General requirements for informed consent. |
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| Documentation of informed consent. |
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| Applications and proposals lacking definite plans for involvement of human subjects. |
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| Research undertaken without the intention of involving human subjects. |
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| Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. |
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| Early termination of research support: Evaluation of applications and proposals. |
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Subpart B—ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN, HUMAN FETUSES AND NEONATES INVOLVED IN RESEARCH
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| To what do these regulations apply? |
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| Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. |
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| Research involving pregnant women or fetuses. |
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| Research involving neonates. |
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| Research involving, after delivery, the placenta, the dead fetus or fetal material. |
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| 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. |
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Subpart C—ADDITIONAL PROTECTIONS PERTAINING TO BIOMEDICAL AND BEHAVIORAL RESEARCH INVOLVING PRISONERS AS SUBJECTS
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| Composition of Institutional Review Boards where prisoners are involved. |
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| Additional duties of the Institutional Review Boards where prisoners are involved. |
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| Permitted research involving prisoners. |
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Subpart D—ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS SUBJECTS IN RESEARCH
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| To what do these regulations apply? |
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| Research not involving greater than minimal risk. |
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| Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
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| 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. |
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| Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. |
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| Requirements for permission by parents or guardians and for assent by children. |
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Subpart E—REGISTRATION OF INSTITUTIONAL REVIEW BOARDS
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| What IRBs must be registered? |
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| What information must be provided when registering an IRB? |
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| When must an IRB be registered? |
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| How must an IRB be registered? |
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| When must IRB registration information be renewed or updated? |
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