CFR section
21 CFR 50.25(c): Elements of informed consent
PART 50-PROTECTION OF HUMAN SUBJECTS · Subpart B-Informed Consent of Human Subjects
Key facts
| Citation | 21 CFR 50.25(c) |
|---|---|
| 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) | (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: “A description of this clinical… |
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.