[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 42CFR50.205]



[Page 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.  50.205  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benefits may be withdrawn because of the decision not to be sterilized,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withdrawn because of the decision not to be sterilized,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.