Informed consent for Living Donors

The potential donor must understand all aspects of the donation process and understand the risk and benefit associated with being a living donor as well as certain specific risk factors. The must understand that he/she can stop the evaluation process at any time.

The consent process will include, but is not limited to:

1. The assurance that the potential donor is willing to donate, free from inducement and coercion, and understands that he or she may decline to donate at any time.
2. A psychosocial evaluation of the potential donor completed by someone with mental training which could include a licensed clinical social worker, nurse specialist, psychologist or psychiatrist.
3. Disclosure of alternate procedures or courses of treatment for the potential donor and recipient, including deceased donation. Pre-existing life threatening conditions of the potential recipient should be disclosed to the potential donor prior to obtaining consent.
4. An evaluation of the potential donor’s ability to comprehend the donation process, including procedures employed for both donor and recipient and possible outcomes.
5. Providing printed materials that explain all phases of the living donation process. Materials should be written at an appropriate reading level and provided in the potential donor’s native language. When necessary, independent interpreters should be provided to make certain the potential donor comprehends all phases of living donation and its associated risks and benefits.
6. Ensure that the potential donor has time to reflect after consenting to reflect after consenting to donate.
7. Offer any potential donor a general nonspecific statement of unsuitability for donation should they wish not to proceed with donation.
8. Explain that a decision by the potential donor not to proceed with the donation will only be disclosed after obtaining the consent of the potential donor.
9. An understanding that the donor undertakes risk and receives no medical benefit from the operative procedure of donation
10. A specification of the medical, psychological, and financial risks associated with being a living donor, to include, but not be limited to the following

Potential Medical risks

• Potential for surgical complications including risk of donor death
• Potential for organ failure and the need for a future organ transplant for the donor
• Potential for other medical complications including log-term complications currently unforeseen
• Scars
• Pain
• Fatigue
• Abdominal or bowel symptoms such as bloating and nausea
• Increased risk with the use of over the counter medications and supplement

Potential Psychosocial Risks

• Personal expenses of travel, housing, and lost wages related to live donation might not be reimbursed; however, the potential donor should be informed that resources may be available to defray some donation-related costs
• Child care costs
• Possible loss of employment
• Potential impact on the ability to obtain or afford health, disability, and life insurance
• Health problems experienced by living donors following donation may not be covered by the recipient’s insurance

11. Disclose that transplant centers are required to to report living donor follow- up information for at least two years
12. Centers will specify who is responsible for the cost or follow-up care
13. The agreement of the potential donor to commit to postoperative follow-up testing coordinated by the recipient transplant center for a minimum of two years
14. Disclosure that donors may not receive valuable consideration (including without limitation monetary or material gain) for agreeing to be a donor. In certain cases, donors may be reimbursed for limited travel expenses and may receive subsistence assistance
15. Disclosure that living donor follow-up is the only method for the collection of information on the long term health implications of living donation.
16. The centre will provide data on outcomes to potential donors and recipients