PART 50 SUBPART D
Subpart D - Additional Safeguards for Children in Clinical Investigations
- 21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
- Source: 45 FR 36390, May 30, 1980, unless otherwise noted.
|21:188.8.131.52.184.108.40.206||SECTION 50.50||50.50 IRB duties.|
|21:220.127.116.11.18.104.22.168||SECTION 50.51||50.51 Clinical investigations not involving greater than minimal risk.|
|21:22.214.171.124.126.96.36.199||SECTION 50.52||50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.|
|21:188.8.131.52.184.108.40.206||SECTION 50.53||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.|
|21:220.127.116.11.18.104.22.168||SECTION 50.54||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.|
|21:22.214.171.124.126.96.36.199||SECTION 50.55||50.55 Requirements for permission by parents or guardians and for assent by children.|
|21:188.8.131.52.184.108.40.206||SECTION 50.56||50.56 Wards.|