[Code of Federal Regulations]
[Title 40, Volume 1]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR26.117]

[Page 292-293]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
               CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
 
PART 26_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Sec. 26.117  Documentation of informed consent.

    (a) Except as provided in paragraph (c) of this section, informed 
consent shall be documented by the use of a written consent form 
approved by the IRB and signed by the subject or the subject's legally 
authorized representative. A copy shall be given to the person signing 
the form.
    (b) Except as provided in paragraph (c) of this section, the consent 
form may be either of the following:
    (1) A written consent document that embodies the elements of 
informed

[[Page 293]]

consent required by Sec. 26.116. 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; or
    (2) A short form written consent document stating that the elements 
of informed consent required by Sec. 26.116 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 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.
    (c) An IRB may waive the requirement for the investigator to obtain 
a signed consent form for some or all subjects if it finds either:
    (1) That the only record linking the subject and the research would 
be the consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern; or
    (2) That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may 
require the investigator to provide subjects with a written statement 
regarding the research.

(Approved by the Office of Management and Budget under control number 
9999-0020)