C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart D—Responsibilities of Sponsors and Investigators

21 C.F.R. § 312.60

General responsibilities of investigators

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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]
Notes of Decisions
Cited in 5 cases (1 in the last 5 years), 2005–2026 · leading case: Edward Abney, Barbara Allen, James Day, Robert Green, Delbert Jackson, James Pugh, Roger L. Thacker, & Daniel Hunter Webster v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006).
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Edward Abney, Barbara Allen, James Day, Robert Green, Delbert Jackson, James Pugh, Roger L. Thacker, & Daniel Hunter Webster v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006). “See 21 C.F.R. § 312.60 (indicating that in a clinical drug trial “[a]n investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investi-gational plan, and applicable regulations; for protecting the rights,…”
Suthers v. Amgen, Inc., 372 F. Supp. 2d 416 (S.D.N.Y. 2005). · cites it 2× “The Clinical Trial Agreement between Amgen and NYU makes clear’ that Hutchinson and NYU performed as independent contractors, and not as agents of Amgen: In the activities connected with the Study, Institution agrees to act as an independent contractor without the capacity to…”
Graw (E.D. Mo. 2026). · cites it 3× “” 21 C.F.R. § 312.60 ; see also Kernke v. The Menninger Clinic, Inc.”
Darke ex rel. Est. of Darke v. Est. of Isner, 20 Mass. L. Rptr. 419 (Mass. Super. Ct. 2005). · cites it 2× “21 C.F.R. §312.60 . In light of these enumerated responsibilities, VGI, as sponsor, did not directly owe specific duties to Mr.”
Abney v. Amgen (6th Cir. 2006). “See 21 C.F.R. § 312.60 (indicating that in a clinical drug trial “[a]n 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,…”
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