[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.100]

[Page 111]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
              Subpart E--Responsibilities of Investigators
 
Sec. 812.100  General responsibilities of investigators.


    An investigator is responsible for ensuring that an investigation is 
conducted according to the signed agreement, the investigational plan 
and applicable FDA regulations, for protecting the rights, safety, and 
welfare of subjects under the investigator's care, and for the control 
of devices under investigation. An investigator also is responsible for 
ensuring that informed consent is obtained in accordance with part 50 of 
this chapter. Additional responsibilities of investigators are described 
in subpart G.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]