Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60; 21 CFR 50.20; 21 CFR 50.27; 21 CFR 50.52; 21 CFR 50.55].
Passage 2You failed to adhere to these requirements. Protocol **(b)(4)** was a clinical trial involving children and adolescents, ages ≥6 to <18 years. The IRB determined that Protocol **(b)(4)** was a research study that meets the criteria found in the risk category described in 21 CFR 50.52. As a result, you were required to obtain the permission of a parent or guardian, which must be documented in accordance with and to the extent required by 21 CFR 50.27.
Passage 3You failed to obtain legally effective written consent from two subjects before their enrollment in Protocol **(b)(4)**, because you did not obtain permission from the subjects’ parent or guardian before the subjects’ enrollment in the study. Specifically:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 312.60
- 21 CFR 312
- 21 CFR 50.27
- 21 CFR 50
- 21 CFR 50.20
- 21 CFR 50.52
- 21 CFR 50.55
- 21 CFR 50.23
- 21 CFR 50.24
- 21 CFR 50.52(c)
- 21 CFR 50.55(f)
- 21 CFR 56.109(c)