| Betterchem |
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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 50 - PROTECTION OF HUMAN SUBJECTS
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| 50-1 | Scope. | ||
| 50-3 | Definitions. | ||
| 50-20 | General requirements for informed consent. | ||
| 50-23 | Exception from general requirements. | ||
| 50-24 | Exception from informed consent requirements for emergency research. | ||
| 50-25 | Elements of informed consent. | ||
| 50-27 | Documentation of informed consent. | ||
| 50-50 | IRB duties. | ||
| 50-51 | Clinical investigations not involving greater than minimal risk. | ||
| 50-52 | Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. | ||
| 50-53 | 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. | ||
| 50-54 | Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. | ||
| 50-55 | Requirements for permission by parents or guardians and for assent by children. | ||
| 50-56 | Wards. | ||