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Code of Federal Regulations Title 21. Food and Drugs § 21.50.51 Clinical investigations not involving greater than minimal risk

Current as of January 02, 2025 | Updated by Findlaw Staff

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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.50.51 Clinical investigations not involving greater than minimal risk - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-50-51/

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