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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2012]
[CITE: 21CFR50.51]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 50 -- PROTECTION OF HUMAN SUBJECTS

Subpart D--Additional Safeguards for Children in Clinical Investigations

Sec. 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 and documents that 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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