Federal (United States) · Regulations
Subpart D
7 sections
7 sections
- 21 C.F.R. § 50.50IRB duties.
- 21 C.F.R. § 50.51Clinical investigations not involving greater than minimal risk.
- 21 C.F.R. § 50.52Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
- 21 C.F.R. § 50.53Clinical 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.
- 21 C.F.R. § 50.54Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- 21 C.F.R. § 50.55Requirements for permission by parents or guardians and for assent by children.
- 21 C.F.R. § 50.56Wards.