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American Association of Tissue Banks
Association of Organ Procurement Organizations
Eye Bank Association of America
The following list of "basic elements of informed consent" is intended to highlight the information that may be considered critical to informed decision making by a family member or other legally authorized person who is being approached for consent to organ and/or tissue donation. This listing, whether communicated verbally or included on consent forms, is not intended to pre-empt any applicable federal, state, or local laws or regulations that may require more or less information to be disclosed for informed consent to be legally effective.
In seeking informed consent, the following information should be provided to the person(s) being approached for consent:
• A confirmation/validation of the donor’s identity and his or her clinical terminal condition.
• A general description of the purposes (benefits) of donation.
• Identification of specific organs and/or tissues (including cells) that are being requested for donation (with subsequent information provided on specific gifts recovered).
• An explanation that the retrieved organs/tissues may be used for transplantation, therapy, medical research, or educational purposes.
• A general description of the recovery process (including timing, relocation of donor if applicable, contact information, etc.).
• An explanation that laboratory tests and a medical/social history will be completed to determine the medical suitability of the donor, including an explanation that blood samples from the donor will be tested for certain transmissible diseases.
• An explanation that the spleen, lymph nodes, and blood may be removed, and cultures may be performed, for the purpose of determining donor suitability and/or used to determine compatibility of donor and recipient.
• A statement granting access to the donor’s medical records, and that the medical records may be released to other appropriate parties.
• An explanation that costs directly related to the evaluation, recovery, preservation, and placement of the organs and tissues will not be charged to the family.
• An explanation regarding the impact the donation process may have on burial arrangements and on appearance of the body.
• Any additional information required by federal, state, and/or local laws and/or regulations.
• American Association of Tissue Banks, McLean, VA — www.aatb.org.
• Association of Organ Procurement Organizations, Falls Church, VA — www.aopo.org.
• Eye Bank Association of America, Washington, DC — www.restoresight.org.
Source: Informed Consent in Tissue Donation: Expectations and Realities. U.S. Department of Health and Human Services Office of Inspector General, OEI-01-00-00440.