[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.20]

[Page 285]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
              Subpart B--Informed Consent of Human Subjects
 
Sec. 50.20  General requirements for informed consent.

    Source: 46 FR 8951, Jan. 27, 1981, unless otherwise noted.


    Except as provided in Secs. 50.23 and 50.24, no investigator may 
involve a human being as a subject in research covered by these 
regulations unless the investigator has obtained the legally effective 
informed consent of the subject or the subject's legally authorized 
representative. An investigator shall seek such consent only under 
circumstances that provide the prospective subject or the representative 
sufficient opportunity to consider whether or not to participate and 
that minimize the possibility of coercion or undue influence. The 
information that is given to the subject or the representative shall be 
in language understandable to the subject or the representative. No 
informed consent, whether oral or written, may include any exculpatory 
language through which the subject or the representative is made to 
waive or appear to waive any of the subject's legal rights, or releases 
or appears to release the investigator, the sponsor, the institution, or 
its agents from liability for negligence.

[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999]