CFR section

21 CFR 50.25(a)(6): Elements of informed consent

PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart B-Informed Consent of Human Subjects

Key facts

Citation 21 CFR 50.25(a)(6)
Section Elements of informed consent
Part PART 50-PROTECTION OF HUMAN SUBJECTS
Subpart Subpart B-Informed Consent of Human Subjects
Subchapter 21 CFR A General
Product types cited Devices, Drugs, General
Regulation text (excerpt) (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

At a glance

  • 10–99 Inspections citing this section
  • 1–9 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About CFR sections cited by the FDA

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA