The person obtaining the consent must certify by signing the consent form that:
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withdrawn because of the decision not to be sterilized,
He or she explained orally the requirements for informed consent as set
forth on the consent form, and
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.
The medical care practitioner performing the sterilization must certify by
signing the consent form, that:
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individual to be sterilized that no Federal benefits may be withdrawn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,
He or she explained orally the requirements for informed consent as set
forth on the consent form, and
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
medical care practitioner 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 medical care practitioner 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 medical care practitioner must also state the
expected date of delivery and that the consent was signed more than 30 days
before the estimated date of delivery. In the case of emergency abdominal
surgery, the medical care practitioner must describe the emergency.
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. (42 CFR sec. 50.205)
