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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 50 - Protection of Human Subjects |
| Subpart A - General Provisions |
| § 50.1 - Scope. |
| § 50.3 - Definitions. |
| Subpart B - Informed Consent of Human Subjects |
| § 50.20 - General requirements for informed consent. |
| § 50.21 - Effective date. |
| § 50.22 - Exception from informed consent requirements for minimal risk clinical investigations. |
| § 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. |
| Subpart C - XXX |
| § 50.40 - Applicability. |
| § 50.42 - Purpose. |
| § 50.44 - Restrictions on clinical investigations involving prisoners. |
| § 50.46 - Composition of institutional review boards where prisoners are involved. |
| § 50.48 - Additional duties of the institutional review boards where prisoners are involved. |
| Subpart D - Additional Safeguards for Children in Clinical Investigations |
| § 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. |
| § 50.54 - 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. |