Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Safeguards for Children in Clinical Investigations
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§ 50.50 IRB duties.
In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in §50.51, §50.52, or §50.53 and the conditions of all other applicable sections of this subpart D.
