[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

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

[CITE: 42CFR50.204]



[Page 139-140]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents

 

Subpart B_Sterilization of Persons in Federally Assisted Family Planning 

                                Projects

 

Sec. 50.204  Informed consent requirement.



    Informed consent does not exist unless a consent form is completed 

voluntarily and in accordance with all the requirements of this section 

and Sec. 50.205 of this subpart.

    (a) A person who obtains informed consent for a sterilization 

procedure must offer to answer any questions the individual to be 

sterilized may have concerning the procedure, provide a copy of the 

consent form, and provide orally all of the following information or 

advice to the individual who is to be sterilized:

    (1) Advice that the individual is free to withhold or withdraw 

consent to the procedure any time before the sterilization without 

affecting his or her right to future care or treatment and without loss 

or withdrawal of any federally funded program benefits to which the 

individual might be otherwise entitled:

    (2) A description of available alternative methods of family 

planning and birth control;

    (3) Advice that the sterilization procedure is considered to be 

irreversible;

    (4) A thorough explanation of the specific sterilization procedure 

to be performed;

    (5) A full description of the discomforts and risks that may 

accompany or follow the performing of the procedure, including an 

explanation of the type and possible effects of any anesthetic to be 

used;

    (6) A full description of the benefits or advantages that may be 

expected as a result of the sterilization; and

    (7) Advice that the sterilization will not be performed for at least 

30 days except under the circumstances specified in Sec. 50.203(d) of 

this subpart.

    (b) An interpreter must be provided to assist the individual to be 

sterilized if he or she does not understand the language used on the 

consent form or the language used by the person obtaining the consent.



[[Page 140]]



    (c) Suitable arrangements must be made to insure that the 

information specified in paragraph (a) of this section is effectively 

communicated to any individual to be sterilized who is blind, deaf or 

otherwise handicapped.

    (d) A witness chosen by the individual to be sterilized may be 

present when consent is obtained.

    (e) Informed consent may not be obtained while the individual to be 

sterilized is:

    (1) In labor or childbirth;

    (2) Seeking to obtain or obtaining an abortion; or

    (3) Under the influence of alcohol or other substances that affect 

the individual's state of awareness.

    (f) Any requirement of State and local law for obtaining consent, 

except one of spousal consent, must be followed.