---
kind: "section"
citation: "21 C.F.R. § 312.60"
title: "21"
number: "312.60"
heading: "General responsibilities of investigators."
url: "https://uscodex.org/cfr/21/312.60"
---

# §312.60. General responsibilities of investigators.


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](/cfr/21/part50.md) of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts [50](/cfr/21/part50.md) and [56](/cfr/21/part56.md) of this chapter.


## Notes

### Amendments

[88 FR 88248, Dec. 21, 2023]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

### Amendments

[88 FR 88248, Dec. 21, 2023]