Statement ofInformed Consent for Form
Informed Consent Form
Surgery with Placental Allograft Tissue
I have been informed by Dr. ____________________ of my current condition. As part of the treatment human placental allograft tissue will be used as a wound covering. The placental tissue used in this membrane has been procured and processed according to regulations established by the United States Food and Drug Administration and the standards of the American Association of Tissue Banks. All tissue is donated under full informed consent from mothers undergoing elective cesarean section surgery. A thorough medical and social history of the donor is also obtained, including detailed family history. All recovered tissue meets stringent specifications during donor screening and laboratory testing to reduce the risk of transmitting infectious disease. An additional assurance of safety is achieved by terminally sterilizing each allograft. This allograft has been designated as a Human Cell, Tissue and Cellular and Tissue-Based Product (HCT/P) as established in 21 CRF part 1271 and is regulated under section 361 of the Public Health Service Act (42 U.S.C. 264) and various state-specific laws and regulations. As with any human allograft product, the potential risks include the possibility of disease transmission. The risks for the surgery include but are not limited to possible bleeding, swelling, infection, scarring, pain, altered sensation, and or the need for retreatment.
I am eighteen years of age or older. I have read the foregoing information, or it has been read to me, and I understand its content. I have been provided an opportunity to ask questions and have had all of my questions answered. I understand that reactions to allograft placental tissue may occur. With this possibility in mind, I have elected to undergo surgery using placental allograft tissue.
Patient Signature: ________________________________ Date: ______________________
Patient Name: ________________________________
Clinician Signature: ________________________________ Date: ______________________
Clinician Name: ________________________________
Witness Signature: ________________________________ Date: ______________________
Witness Name: ________________________________
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Snoasis Medical has prepared this informed consent form template to ensure patients receive proper disclosure prior to treatment with Snoasis Medical placental tissue based-products. Snoasis makes no representation as to the adequacy of this consent or disclosure provided. This informed consent should be reviewed and approved under relevant state and federal laws prior to its use. This text box should be deleted or augmented to reflect the appropriate consent, disclosure and/or regulations of its user.
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