OCHSNER HUD OFF-LABEL USE
SURGICAL CONSENT ADDENDUM
Humanitarian Use Device Name:
IRB#______.____.__
HUD User (Your Doctor’s) Name: Dr. ______
Humanitarian Use Devices are FDA approved devices used to treat specific conditions. Because the number of uses per year in the USA are relatively small (less than 4000), the studies that FDA based their approval on have been able to show safety, but only probable benefit for the FDA approved uses (in FDA lingo, “The effectiveness of this device for this use has not been demonstrated”). Because of this, FDA requires that an Institutional Review Board (IRB) at Ochsner approves the use of the device before the manufacturer can ship it to your doctor. The IRB has approved the use of this device by your doctor at Ochsner. The use of this device is treatment, not a research study. When used according to FDA approved uses, the IRB does not normally require any consent form beyond the usual surgical consent.
Your doctor has decided to use this HUD off-label in your case, meaning for a condition not in the FDA approved labeling. This is still treatment of your condition, not a research study. This is allowed under FDA rules, as long as it is not limited by the IRB. In these off-label HUD uses, the IRB requires you read, sign and date this addendum to the surgical consent to assure that you are fully aware of the limited information about off-label HUD use. If there is a patient brochure the manufacturer has for this HUD, your doctor should give you a copy—though the brochure is about FDA approved uses. Discuss with your doctor things you should know about HUD off-label use in your specific situation. FDA draft guidance about this says:
All my questions about the off label use of this HUD in my case have been answered. I freely consent to the off-label use of this HUD.
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Patient Signature Printed Name Date
______
Person Obtaining Consent - Signature Printed Name Date
______
Signature of Legally Authorized Representative Printed Name Date
(when applicable)
______
Authority of Subject’s Legally Authorized Representative or Relationship to Subject
------Use the following only if applicable ------
IMPARTIAL WITNESS STATEMENT (IF APPLICABLE)
If this consent and authorization document is read to the subject because the subject is unable to read the document, an impartial witness (a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject cannot read, and who reads the informed consent and any other written information supplied to the subject) must be present for the consent and sign the following statement:
I attest that the information in this consent and authorization was explained to, and understood by the subject. I also attest that the subject agreed to participate in this research study.
______
Printed Name of Impartial Witness
______
Signature of Impartial Witness Date
Note: This signature block cannot be used for translations into another language. A translated consent form, with the translation approved by the IRB, is necessary for enrolling subjects who do not speak English.
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IRB Version_2012.03.01