Regulatory Text
21 C.F.R. § 50.51 — Clinical investigations not involving greater than minimal risk.
§ 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]
Source: ecfr.gov · govinfo.gov — public domain
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BS-CFR21-SEC-522589
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boisestandard.org
Citation
21 C.F.R. § 50.51
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CFR — Code of Federal Regulations
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PRIMARY-SOURCE
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The regulatory text of 21 C.F.R. § 50.51 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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21 C.F.R. — public domain
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