Code of Federal Regulations (Last Updated: November 8, 2024) |
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 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. |