21 CFR 312.60
General responsibilities of investigators
21 CFR 312.60 is the regulation titled “General responsibilities of investigators” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 44 FDA warning letters have cited it.
- Letters citing it
- 44 since 2021
- Jan 1 to Oct 30, 2026
- 10 against 8 on the same dates in 2025
- Most often cited with
- 21 CFR 50.20, in 12 letters
- Closed out
- 7% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (40 of 44). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.60 most often, as written in the letters.
- 31 lettersYou failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]
- 8 lettersYou failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20]
- 1 letterFailure to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations; failure to protect the rights, safety, and welfare of subjects…
The regulation
Read the text of 21 CFR 312.60 (eCFR, as of Sep 1, 2026)
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall obtain the informed consent of each human subject to whom the drug is administered, in accordance with part 50 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.
[88 FR 88248, Dec. 21, 2023]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.60.
- 21 CFR 50.20General requirements for informed consent12 letters cite both
- 21 CFR 312.62Investigator recordkeeping and record retention8 letters cite both
- 21 CFR 50.23Exception from general requirements8 letters cite both
- 21 CFR 50.24Exception from informed consent requirements for emergency research7 letters cite both
- 21 CFR 312.66Assurance of IRB review5 letters cite both
- 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”4 letters cite both
- 21 CFR 312.2Applicability3 letters cite both
- 21 CFR 312.20Requirement for an IND3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 312.60 that FDA posted most recently.
- DrugsView Maria E. De La Torre Silva, M.D.investigational drugIssuedJul 27, 2026PostedAug 4, 2026
- DrugsView Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.investigational drug (b)(4)IssuedJul 10, 2026PostedJul 21, 2026
- DrugsView Jose M. Carpio, M.D.investigational drug (b)(4)IssuedMay 28, 2026PostedJun 9, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.