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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of December 18, 2009
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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| 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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