[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.60]

[Page 79]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
        Subpart D_Responsibilities of Sponsors and Investigators
 
Sec. 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, 
in accordance with the provisions of part 50 of this chapter, obtain the 
informed consent of each human subject to whom the drug is administered, 
except as provided in Sec. Sec. 50.23 or 50.24 of this chapter. 
Additional specific responsibilities of clinical investigators are set 
forth in this part and in parts 50 and 56 of this chapter.

[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51530, Oct. 2, 1996]