Before outlining specifics of these ILDA-identified contraindications, let us start with a brief overview of the ILDA role and purpose and a clarification of what the ILDA is empowered (and, conversely, not empowered or perhaps even qualified) to do. The ILDA serves as an unbiased resource for the prospective donor to learn more about the process and options; explores the prospective donor’s understanding of surgical, medical, psychosocial, and financial risks; affirms understanding of process as well as follow-up recommendations; and confirms desire to proceed or assists with walking away (with the protection of confidentiality for the reasons why she/he does not want to proceed with surgery). Ideally, the ILDA supports and advocates so that all living donors are competent, fully informed, willing, and uncoerced.

To be clear: first, the ILDA role does not interpret medical or psychosocial risk profiles to make candidacy determinations (though if she/he serves in a dual role at the transplant center , these separate recommendations may be appropriate and necessary in the other capacity). Second, the ILDA does not trump prospective living donor autonomy to declare what is in his/her “best” interest (as in theory it would be in every person’s “best” interest to avoid unnecessary surgery). It is not the ILDA, but rather the treating clinician (i.e., living donor surgeon), who formally completes the informed consent prior to surgery.

Individual transplant centers across the United States have operationalized the ILDA role in vastly different ways [25]. Other chapters of this book will explore recommendations for ILDA training, practice, and role throughout the living donation process. Certainly, during the evaluation process, the ILDA can participate in many ways to assist prospective donors throughout the process: via assessment, evaluation, psychoeducation, collaboration with transplant team members, and advocacy, all as central elements of practice.

In the varied and various ways that the ILDA role has been implemented, the ILDA must partner with potential donors to promote rights and understanding as part of the prospective donor’s decision-making process. In so doing, ILDA also identifies barriers to prospective donors’ provision of informed consent [15, 30, 31]. For example, the prospective living donor may not be able to understand or accept risks associated with donation. Essential to the ILDA role , then, is to be empowered to stop the donation process if elements of informed consent have not been met.

Of course, living donor candidacy criteria are defined by individual transplant centers . Previous research has shown broad differences in donor candidacy requirements and processes in the United States [5, 20, 25]. Provided the donor evaluation process is consistent with the Center for Medicare and Medicaid Services (CMS) and the United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) guidelines (and there has been a move within regulatory agencies and transplant professional organizations to increase degree of standardization in this process), individual candidacy decisions and criteria are determined by the transplant facility . Regardless of how contraindications are specifically defined, ILDA review of prospective donor readiness and understanding—including identified contraindications—becomes part of donor candidacy discussion, and should be addressed within teams and at donor selection meetings.

Informed consent for live kidney donation is a prerequisite—essential for living donor transplantation from ethical, legal, and regulatory perspectives. In general, informed consent occurs when a competent person makes an autonomous choice about whether to access medical treatment, armed with adequate information and understanding regarding risks, benefits, and expected outcomes [2]. The patient’s intention to proceed, understanding of process and benefits, and free will to decide are fundamental. However, as Valapour noted, these factors may be present along a continuum of clarity/confusion [32]. Informed consent can also be described as a reciprocal process between clinician and patient of information disclosure, processing, and decision making. Much has been written describing the challenges associated with determining adequacy of informed consent for living organ donation, a procedure lacking medical benefits for the participant and therefore demanding a high standard of careful process and communication. Living donor transplant has the added challenge of being a shared transaction, in which the living donor’s informed consent must also include understanding of the intended benefits, options, and expected outcomes for another (the recipient) [4].

In “Informed consent in living donation : a review of key empirical studies, ethical challenges and future research,” Gordon summarizes goals of the process as follows:

The principle of respect for persons requires that potential LDs be competent and informed, and comprehend the risks to themselves of undergoing the procedure, as well as the risks, benefits and alternatives available to the recipient. The consensus conference on Living Kidney Donor Follow-Up emphasized the critical need to inform donors about risks specific to themselves. Further, potential LDs must be willing to donate and be free from undue pressure to consent to the procedure. Moreover, respect for autonomy means that LDs have the right to determine how much risk they are willing to accept, and conversely, that LDs (and the recipients) have the right to refuse the donation. [9]

In practice, though, living donor informed consent processes have been shown to vary widely across transplant programs in the United States and worldwide, with wild discrepancies noted in standards, consistency, and practice [9, 16, 32, 33]. In separate pieces, both Gordon and Rodrigue et al. identified significant “variability and deficiencies” in the consent process across the spectrum of living donor care [9, 20]. While many of the studies reviewed care prior to implementation of newer living donor safeguards (including OPTN Living Donor Informed Consent Guidelines; provision of follow-up care for living donors for 2 years; and implementation of the ILDA itself), concerns raised about variability in the quality of informed consent process continue to be valid. Regulatory and professional organizations have called for strengthened processes, and for standardized elements of disclosure and education, including separating the consent process for living donor evaluation from consent to proceed with donation (Table 14.2) [9, 15, 16, 27, 30–33].