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e-CFR data is current as of September 24, 2020

Title 21Chapter ISubchapter APart 50Subpart D → §50.51


Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Safeguards for Children in Clinical Investigations


§50.51   Clinical investigations not involving greater than minimal risk.

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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