Additional Safeguards for Children in Clinical Investigations

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Protection of Human Subjects
  7. Additional Safeguards for Children in Clinical Investigations

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Section
50.50

IRB duties.

Section
50.51

Clinical investigations not involving greater than minimal risk.

Section
50.52

Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

Section
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.

Section
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.

Section
50.55

Requirements for permission by parents or guardians and for assent by children.

Section
50.56

Wards.