Risk Management



Informed Consent for Off-label Use of a Drug or Device

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Please review the form, modify it to fit your actual practice, and place on your letterhead.  Please offer the patient a copy of the form. The last page serves to verify that the surgeon has obtained informed consent from the patient; it can be copied and sent to the ambulatory surgery center if needed as verification of consent. This consent form is intended as a sample only and is provided as a risk management service.  It is not intended to constitute a standard of care and should not be relied upon as a source for legal advice.  If legal advice is desired or needed, an attorney should be consulted.
Version 7/1/2004

SAMPLE CONSENT DOCUMENT TEMPLATE FOR DRUG OR DEVICE

When a drug or device is approved for medical use by the Food and Drug Administration (FDA), the manufacturer produces a “label” to explain its use.  Once a device/medication is approved by the FDA, physicians may use it “off-label” for other purposes if they are well-informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects.

[State purpose of the off-label drug/device.]

[State alternatives to the off-label drug or device.]

[State known complications and side effects of the off-label drug/device.]

I understand that [state drug/device]  was approved by the FDA for [state approval purpose/conditions].  Nevertheless, I wish to have [state treatment/procedure] performed on my eye/used in my eye and I am willing to accept the potential risks that my physician has discussed with me.   I acknowledge that there may be other, unknown risks and that the long-term effects and risks of [state drug/device] are not known.

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