C.F.R. » Title 21 » 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

21 C.F.R. § 50.51

Clinical investigations not involving greater than minimal risk

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

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]
Notes of Decisions
Cited in 1 case, 2015–2015 · leading case: White v. Kennedy Krieger Inst., Inc., 110 A.3d 724 (Md. Ct. Spec. App. 2015).
Sort: Relevance Newest Treatment
White v. Kennedy Krieger Inst., Inc., 110 A.3d 724 (Md. Ct. Spec. App. 2015). · cites it 2× “Instead, the federal regulations classify human research studies based on the type of risk involved: 21 C.F.R. § 50.51 Clinical investigations not involving greater than minimal risk[.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.