[Code of Federal Regulations][Title 42, Volume 1, Parts 1 to 399]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50]
[Page 171-176]
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. 50.201 Applicability.
The provisions of this subpart are applicable to programs or
projects for health services which are supported in whole or in part by
Federal financial assistance, whether by grant or contract, administered
by the Public Health Service.
Sec. 50.202 Definitions.
As used in this subpart:
Arrange for means to make arrangements (other than mere referral of
an individual to, or the mere making of an appointment for him or her
with, another health care provider) for the performance of a medical
procedure on an individual by a health care provider other than the
program or project.
Hysterectomy means a medical procedure or operation for the purpose
of removing the uterus.
Institutionalized individual means an individual who is (1)
involuntarily confined or detained, under a civil or criminal statute,
in a correctional or rehabilitative facility, including a mental
hospital or other facility for the care and treatment of mental illness,
or (2) confined, under a voluntary commitment, in a mental hospital or
other facility for the care and treatment of mental illness.
Mentally incompetent individual means an individual who has been
declared mentally incompetent by a Federal, State, or local court of
competent jurisdiction for any purpose unless he or she has been
declared competent for
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purposes which include the ability to consent to sterilization.
Public Health Service means the Office of the Assistant Secretary
for Health, Health Resources and Services Administration, National
Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse
and Mental Health Administration and all of their constituent agencies.
The Secretary means the Secretary of Health and Human Services and
any other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
Sterilization means any medical procedure, treatment, or operation
for the purpose of rendering an individual permanently incapable of
reproducing.
[43 FR 52165, Nov. 8, 1978, as amended at 49 FR 38109, Sept. 27, 1984]
Sec. 50.203 Sterilization of a mentally competent individual aged 21 or
older.
Programs or projects to which this subpart applies shall perform or
arrange for the performance of sterilization of an individual only if
the following requirements have been met:
(a) The individual is at least 21 years old at the time consent is
obtained.
(b) The individual is not a mentally incompetent individual.
(c) The individual has voluntarily given his or her informed consent
in accordance with the procedures of Sec. 50.204 of this subpart.
(d) At least 30 days but not more than 180 days have passed between
the date of informed consent and the date of the sterilization, except
in the case of premature delivery or emergency abdominal surgery. An
individual may consent to be sterilized at the time of premature
delivery or emergency abdominal surgery, if at least 72 hours have
passed after he or she gave informed consent to sterilization. In the
case of premature delivery, the informed consent must have been given at
least 30 days before the expected date of delivery.
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.
(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.
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(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.
Sec. 50.205 Consent form requirements.
(a) Required consent form. The consent form appended to this subpart
or another consent form approved by the Secretary must be used.
(b) Required signatures. The consent form must be signed and dated
by:
(1) The individual to be sterilized; and
(2) The interpreter, if one is provided; and
(3) The person who obtains the consent; and
(4) The physician who will perform the sterilization procedure.
(c) Required certifications. (1) The person obtaining the consent
must certify by signing the consent form that:
(i) Before the individual to be sterilized signed the consent form,
he or she advised the individual to be sterilized that no Federal
benefits may be withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized.
(2) The physician performing the sterilization must certify by
signing the consent form, that:
(i) Shortly before the performance of the sterilization, he or she
advised the individual to be sterilized that no Federal benefits may be
withdrawn because of the decision not to be sterilized,
(ii) He or she explained orally the requirements for informed
consent as set forth on the consent form, and
(iii) To the best of his or her knowledge and belief, the individual
to be sterilized appeared mentally competent and knowingly and
voluntarily consented to be sterilized. Except in the case of premature
delivery or emergency abdominal surgery, the physician must further
certify that at least 30 days have passed between the date of the
individual's signature on the consent form and the date upon which the
sterilization was performed. If premature delivery occurs or emergency
abdominal surgery is required within the 30-day period, the physician
must certify that the sterilization was performed less than 30 days but
not less than 72 hours after the date of the individual's signature on
the consent form because of premature delivery or emergency abdominal
surgery, as applicable. In the case of premature delivery, the physician
must also state the expected date of delivery. In the case of emergency
abdominal surgery, the physician must describe the emergency.
(3) If an interpreter is provided, the interpreter must certify that
he or she translated the information and advice presented orally, read
the consent form and explained its contents and to the best of the
interpreter's knowledge and belief, the individual to be sterilized
understood what the interpreter told him or her.
Sec. 50.206 Sterilization of a mentally incompetent individual or of an
institutionalized individual.
Programs or projects to which this subpart applies shall not perform
or arrange for the performance of a sterilization of any mentally
incompetent individual or institutionalized individual.
Sec. 50.207 Sterilization by hysterectomy.
(a) Programs or projects to which this subpart applies shall not
perform or arrange for the performance of any hysterectomy solely for
the purpose of rendering an individual permanently incapable of
reproducing or where, if there is more than one purpose to the
procedure, the hysterectomy would not be performed but for the purpose
of rendering the individual permanently incapable of reproducing.
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(b) Except as provided in paragraph (c) of this section, programs or
projects to which this subpart applies may perform or arrange for the
performance of a hysterectomy not covered by paragraph (a) of this
section only if:
(1) The person who secures the authorization to perform the
hysterectomy has informed the individual and her representative, if any,
orally and in writing, that the hysterectomy will make her permanently
incapable of reproducing; and
(2) The individual or her representative, if any, has signed a
written acknowledgment of receipt of that information.
(c)(1) A program or project is not required to follow the procedures
of paragraph (b) of this section if either of the following
circumstances exists:
(i) The individual is already sterile at the time of the
hysterectomy.
(ii) The individual requires a hysterectomy because of a life-
threatening emergency in which the physician determines that prior
acknowledgment is not possible.
(2) If the procedures of paragraph (b) of this section are not
followed because one or more of the circumstances of paragraph (c)(1)
exist, the physician who performs the hysterectomy must certify in
writing:
(i) That the woman was already sterile, stating the cause of that
sterility; or
(ii) That the hysterectomy was performed under a life-threatening
emergency situation in which he or she determined prior acknowledgment
was not possible. He or she must also include a description of the
nature of the emergency.
[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]
Sec. 50.208 Program or project requirements.
(a) A program or project must, with respect to any sterilization
procedure or hysterectomy it performs or arranges, meet all requirements
of this subpart.
(b) The program or project shall maintain sufficient records and
documentation to assure compliance with these regulations, and must
retain such data for at least 3 years.
(c) The program or project shall submit other reports as required
and when requested by the Secretary.
Sec. 50.209 Use of Federal financial assistance.
(a) Federal financial assistance adminstered by the Public Health
Service may not be used for expenditures for sterilization procedures
unless the consent form appended to this section or another form
approved by the Secretary is used.
(b) A program or project shall not use Federal financial assistance
for any sterilization or hysterectomy without first receiving
documentation showing that the requirements of this subpart have been
met. Documentation includes consent forms, and as applicable, either
acknowledgments of receipt of hysterectomy information or certification
of an exception for hysterectomies.
[43 FR 52165, Nov. 8, 1978, as amended at 47 FR 33701, Aug. 4, 1982]
Sec. 50.210 Review of regulation.
The Secretary will request public comment on the operation of the
provisions of this subpart not later than 3 years after their effective
date.
Appendix to Subpart B of Part 50--Required Consent Form
Notice: YOUR DECISION AT ANY TIME NOT TO BE STERILIZED WILL NOT
RESULT IN THE WITHDRAWAL OR WITHHOLDING OF ANY BENEFITS PROVIDED BY
PROGRAMS OR PROJECTS RECEIVING FEDERAL FUNDS.
Consent to Sterilization
I have asked for and received information about sterilization from
______________ (doctor or clinic). When I first asked for the
information, I was told that the decision to be sterilized is completely
up to me. I was told that I could decide not to be sterilized. If I
decide not to be sterilized, my decision will not affect my right to
future care or treatment. I will not lose any help or benefits from
programs receiving Federal funds, such as A.F.D.C. or medicaid that I am
now getting or for which I may become eligible.
I UNDERSTAND THAT THE STERILIZATION MUST BE CONSIDERED PERMANENT AND
NOT REVERSIBLE. I HAVE DECIDED THAT I DO NOT WANT TO BECOME PREGNANT,
BEAR CHILDREN OR FATHER CHILDREN.
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I was told about those temporary methods of birth control that are
available and could be provided to me which will allow me to bear or
father a child in the future. I have rejected these alternatives and
chosen to be sterilized.
I understand that I will be sterilized by an operation known as a
______________. The discomforts, risks and benefits associated with the
operation have been explained to me. All my questions have been answered
to my satisfaction.
I understand that the operation will not be done until at least 30
days after I sign this form. I understand that I can change my mind at
any time and that my decision at any time not to be sterilized will not
result in the withholding of any benefits or medical services provided
by federally funded programs.
I am at least 21 years of age and was born on ____ (day), ____
(month), ____ (year).
I, ______________, hereby consent of my own free will to be
sterilized by ______________ by a method called ______________. My
consent expires 180 days from the date of my signature below.
I also consent to the release of this form and other medical records
about the operation to:
Representatives of the Department of Health and Human Services or
Employees of programs or projects funded by that Department but only
for determining if Federal laws were observed.
I have received a copy of this form.
Signature_______________________________________________________________
Date:___________________________________________________________________
(Month, day, year)
You are requested to supply the following information, but it is not
required:
Race and ethnicity designation (please check)
Black (not of Hispanic origin)__________________________________________
Hispanic________________________________________________________________
Asian or Pacific Islander_______________________________________________
American Indian or Alaskan native_______________________________________
White (not of Hispanic origin)__________________________________________
Interpreter's Statement
If an interpreter is provided to assist the individual to be
sterilized:
I have translated the information and advice presented orally to the
individual to be sterilized by the person obtaining this consent. I have
also read him/her the consent form in ______________ language and
explained its contents to him/her. To the best of my knowledge and
belief he/she understood this explanation.
Interpreter_____________________________________________________________
Date____________________________________________________________________
State of Person Obtaining Consent
Before ______________ (name of individual), signed the consent form,
I explained to him/her the nature of the sterilization operation
______________, the fact that it is intended to be a final and
irreversible procedure and the discomforts, risks and benefits
associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or any benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appears to
understand the nature and consequence of the procedure.
Signature of person obtaining consent___________________________________
Date____________________________________________________________________
Facility________________________________________________________________
Address_________________________________________________________________
Physician's Statement
Shortly before I performed a sterilization operation upon
______________ (name of individual to be sterilized), on __________
(date of sterilization), ______________ (operation), I explained to him/
her the nature of the sterilization operation ______________ (specify
type of operation), the fact that it is intended to be a final and
irreversible procedure and the discomforts, risks and benefits
associated with it.
I counseled the individual to be sterilized that alternative methods
of birth control are available which are temporary. I explained that
sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can
be withdrawn at any time and that he/she will not lose any health
services or benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be
sterilized is at least 21 years old and appears mentally competent. He/
She knowingly and voluntarily requested to be sterilized and appeared to
understand the nature and consequences of the procedure.
(Instructions for use of alternative final paragraphs: Use the first
paragraph below except in the case of premature delivery or emergency
abdominal surgery where the sterilization is performed less than 30 days
after the date of the individual's signature on the consent form. In
those cases, the second paragraph below must be used. Cross out the
paragraph which is not used.)
[[Page 176]]
(1) At least 30 days have passed between the date of the
individual's signature on this consent form and the date the
sterilization was performed.
(2) This sterilization was performed less than 30 days but more than
72 hours after the date of the individual's signature on this consent
form because of the following circumstances (check applicable box and
fill in information requested):
{time} Premature delivery
Individual's expected date of delivery:_________________________________
{time} Emergency abdominal surgery:
(Describe circumstances):_______________________________________________
Physician_______________________________________________________________
Date____________________________________________________________________
[43 FR 52165, Nov. 8, 1978, as amended at 58 FR 33343, June 17, 1993]
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