IV. Informed Choice
The forces that influence a donor are numerous and complex. The donor must be free to make an informed independent choice. The informed choice process refers to that part of the donation decision that helps to focus on the technical elements of the donation, surgery, recovery, and on the unknown and unforeseeable consequences that might in the short-or long-run change the patient’s life, health, employment, or emotional situation. The person who gives consent to be a live organ donor should be:
- willing to donate;
- free from coercion;
- medically and psychosocially suitable;
- fully informed of the risks and benefits as a donor;
- fully informed of the risks, benefits, and alternative treatment available to the recipient; and
- likely to benefit in a specific, nonmonetary way. The benefits to both the donor and the recipient must outweigh the risks associated with the donation and transplantation of the living donor organ.
A. Informed Understanding
- Written and verbal presentations should be in lay language, in accordance with the person’s educational level, and in a language he or she can understand.
- The potential donor should be able to demonstrate that he or she understands the essential elements of the donation process, especially the risks associated with the procedure.
- Adequate time should be allowed for the potential donor to understand and assimilate the information provided, ask questions, and have questions answered. This may require several consultations for the donor to absorb the information and formulate questions.
- Written material provided to the potential donor should not only serve as a basis for consent but also as future reference for the donor.
- The donor’s family/ loved ones should be given the opportunity to openly discuss their concerns in a safe and nonthreatening environment.
- The potential donor should understand, agree to, and commit to the need for postoperative, longterm follow-up and testing by the transplant center.
- The transplant team and the independent donor advocate team should disclose their institutional affiliations to the potential donors.
- The relationship of the donor and the recipient should not alter the level of acceptable risk.
- There should be a two-week period of reflection and reaffirmation of the decision to donate subsequent to the completion of the medical work-up and final approval to proceed by the independent donor advocate team before the potential donor signs the consent for the donation procedure.
- Non-English speaking candidates and hearingimpaired candidates must be provided with a nonfamily interpreter who understands their language and culture.
- A member of the independent donor advocate team should witness the potential donor signing the consent document for the donor hemihepatectomy.
The overall donation process and experience should be explained to the potential donor and should include:
- donor evaluation procedure;
- surgical procedure;
- recuperative period;
- short-and long-term follow-up care;
- alternative donation and transplant procedures;
- potential psychological benefits to donor;
- transplant center and surgeon-specific statistics of donor and recipient outcomes;
- confidentiality of the donor’s information and decision;
- donor’s ability to opt out at any point in the process;
- information about how the transplant center will attempt to follow the health of the donor for life.
Risks should be fully explained to the potential donor.
- potential for surgical complications including risk of donor death;
- potential for liver failure and the need for liver transplant;
- potential for other medical complications including long-term complications;
- abdominal and/or bowel symptoms such as bloating and nausea.
- potential for problems with body image;
- possibility of recipient death;
- possibility of recipient rejection and need for retransplantation;
- possibility of adjustment disorder postsurgery;
- impact on donor’s family;
- impact on recipient’s family;
- potential impact of donation on lifestyle.
- out-of-pocket expenses;
- child care costs;
- possible loss of employment;
- potential impact on ability to obtain future employment;
- potential for disability benefits and need for assistance completing relevant paperwork;
- impact on ability to obtain health and life
insurance (may be denied or have higher future premiums).
- Determine, to the extent possible, that there is no monetary enrichment for the donor.
- Determine that there is no coercion to donate by family or others.
- Assist donor with a general statement of unsuitability for donation if requested by donor. Medical information regarding the donor should not be falsified to provide the donor with an excuse to decline donation.
- Ensure that the donor is intellectually and emotionally capable of participation in a balanced discussion of potential risks and benefits.
- Provide adequate information to the recipient to ensure his or her understanding regarding the risks to the donor.
- Educate donor about recipient’s options for cadaveric transplant, including risks and outcomes.
- Ensure the donor understands that he or she may decline to donate at any time.
- Disclosure and consent process should be documented.
- Donor should have a medical record separate and distinct from the recipient’s to protect donor confidentiality.
- Once the independent donor advocate team determines the suitability of the donor, then, further evaluative processes may proceed: medical assessment, psychological assessment, assessing the family dynamics, and assessing the level of social support.
F. Decision to Donate
- Before the independent donor advocate team presents its decision to the potential donor, the team should discuss the decision with the transplant team.
- If the potential donor wishes to donate, but the independent donor advocate team does not agree, the donation should not occur. The reasons for the independent donor advocate team’s objections to donation should be explained to the donor. For example, the donor may have an inability to assimilate or process the information provided to him or her, the donor may be unable to integrate the degree of risk pertinent to his or her situation, or there may be a lack of equipoise between the risk to the potential donor and potential benefits to the recipient.
- If the independent donor advocate team and the potential donor agree to donate, final review rests with the transplant team.