1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter A - GENERAL
  5. Part 50 - PROTECTION OF HUMAN SUBJECTS
  6. Subpart D - Additional Safeguards for Children in Clinical Investigations
  7. 21 CFR § 50.51
21 CFR § 50.51
Clinical investigations not involving greater than minimal risk
June 25, 2020
CFR

Any clinical investigation within the scope described in §§50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:

(a) No greater than minimal risk to children is presented; and

(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in §50.55.

[78 FR 12951, Feb. 26, 2013]

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§ 50.50 IRB duties
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§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects

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