Informed consent does not exist unless a consent form is completed voluntarily
and in accordance with all the requirements of this [law].
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:
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;
A description of available alternative methods of family planning and
birth control;
Advice that the sterilization procedure is considered to be irreversible;
A thorough explanation of the specific sterilization procedure to be
performed;
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;
A full description of the benefits or advantages that may be expected as
a result of the sterilization; and
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.
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.
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.
A witness chosen by the individual to be sterilized may be present when
consent is obtained.
Informed consent may not be obtained while the individual to be sterilized is:
In labor or childbirth;
Seeking to obtain or obtaining an abortion; or
Under the influence of alcohol or other substances that affect the
individual’s state of awareness.
Any requirement of State and local law for obtaining consent, except one of
spousal consent, must be followed. (42 CFR sec. 50.204)
