[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: 21CFR50.27]

[Page 290]
 
                        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. 50.27  Documentation of informed consent.

    (a) Except as provided in Sec. 56.109(c), informed consent shall be 
documented by the use of a written consent form approved by the IRB and 
signed and dated by the subject or the subject's legally authorized 
representative at the time of consent. A copy shall be given to the 
person signing the form.
    (b) Except as provided in Sec. 56.109(c), the consent form may be 
either of the following:
    (1) A written consent document that embodies the elements of 
informed consent required by Sec. 50.25. This form may be read to the 
subject or the subject's legally authorized representative, but, in any 
event, the investigator shall give either the subject or the 
representative adequate opportunity to read it before it is signed.
    (2) A short form written consent document stating that the elements 
of informed consent required by Sec. 50.25 have been presented orally to 
the subject or the subject's legally authorized representative. When 
this method is used, there shall be a witness to the oral presentation. 
Also, the IRB shall approve a written summary of what is to be said to 
the subject or the representative. Only the short form itself is to be 
signed by the subject or the representative. However, the witness shall 
sign both the short form and a copy of the summary, and the person 
actually obtaining the consent shall sign a copy of the summary. A copy 
of the summary shall be given to the subject or the representative in 
addition to a copy of the short form.

[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]

[[Page 291]]