21 CFR Subpart D
Additional Safeguards for Children in Clinical Investigations
June 25, 2020
§
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