21 CFR § 312.60 - General responsibilities of investigators.

---
identifier: "/us/cfr/t21/s312.60"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.60 - General responsibilities of investigators."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.60"
section_name: "General responsibilities of investigators."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 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 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]