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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of November 19, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 50--PROTECTION OF HUMAN SUBJECTS
Subpart A--GENERAL PROVISIONS
Subpart B--INFORMED CONSENT OF HUMAN SUBJECTS
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| General requirements for informed consent. |
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| Exception from general requirements. |
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| Exception from informed consent requirements for emergency research. |
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| Elements of informed consent. |
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| Documentation of informed consent. |
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Subpart C--[RESERVED]
Subpart D--ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS
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| Clinical investigations not involving greater than minimal risk. |
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| Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. |
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| Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. |
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| Clinical investigations not otherwise approvable that present 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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