21 CFR 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]

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 50 after this date.

  • 2013-02-26; vol. 78 # 38 - Tuesday, February 26, 2013
    1. 78 FR 12937 - Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective March 28, 2013.
      21 CFR Parts 50 and 56