[Code of Federal Regulations]

[Title 10, Volume 4]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 10CFR745.117]



[Page 417-418]

 

                            TITLE 10--ENERGY

 

                    CHAPTER III--DEPARTMENT OF ENERGY

 

PART 745_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 745.117  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:



[[Page 418]]



    (1) A written consent document that embodies the elements of 

informed consent required by Sec. 745.116. 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. 745.116 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 

0990-0260.)



[56 FR 28012, 28018, June 18, 1991, as amended at 70 FR 36328, June 23, 

2005]