1. Informed Consent for Kidney Paired Donation
Kidney Transplantation Committee
Fall 2014

2. The Problem
Participants in KPD programs must be advised of the benefits and risks
Policy does not include informed consent section for KPD participants
Kidney paired donation programs offer candidates with willing but incompatible donors the opportunity for a living donor transplant by finding matches within a larger pool of living donors. Though informed consent policies for living donors already exist, there are no policies for informed consent, specifically for donors and candidates participating in KPD. There are unique benefits and risks associated with KPD that are not covered by living donor policy, and therefore we are recommending new requirements for informed consent for KPD candidates.

3. Goal of the Proposal Inform participants of risks and benefits
Inform participants of logistical aspects
Ensure consent of non-directed donors and bridge donors is based on full understanding of benefits and consequences
This proposal is a result of the efforts put forth by a joint societies work group, comprised of representatives from NATCO, AST and ASTS, as well as the OPTN/UNOS Kidney Committee. The Joint Societies Work Group (JSWG) was charged to “provide recommendations to OPTN/UNOS regarding the development of informed consent policies for paired donors, candidates and non-directed donors entering the OPTN/UNOS KPD program. The KPD JSWG should provide recommendations regarding the risks and benefits of participating in the KPD program, the KPD matching process, and confidentiality and sharing of protected health information. We are developing the KPD informed consent policies in addition to existing informed consent policies that already apply to all candidates and living donors.”

4. How the Proposal will Achieve its Goal
Apply KPD informed consent policies to participants in all KPD programs
Advise participants of risks of shipping kidneys
Explain remedy for a failed exchange
Provide elements of informed consent specific to non-directed donors and bridge donors
It is important to note that the proposed new informed consent requirements would apply to candidates in all KPD programs, not just the OPTN KPD program. This includes KPD programs operated within one hospital. This was a recommendation from the Joint Societies Workgroup and we agree because KPD policy is viewed as an extension of living donor policy, which applies to every living donor program. This will provide consistency for all transplant programs participating in KPD and should ease the burden on transplant programs that participate in more than one KPD program.
The proposal includes the following new requirements:
As part of the informed consent process, transplant programs would be required to advise KPD candidates and donors of the risks inherent to shipping or receiving shipped kidneys. Data reveal a 1-2% loss of shipped deceased donor kidneys, and it is reasonable to extrapolate that figure to shipping kidneys recovered from KPD donors. Donors should understand the potential consequences of permitting their recovered kidney to be shipped, such as the potential that the donor’s kidney will be lost in transplant, and candidates should understand the consequences of agreeing to accept a shipped kidney, such as the that greater ischemic time could create a greater incidence of delayed graft function or need for dialysis.
2. Transplant programs must inform KPD candidates and donors what will happen in the event of a failed KPD exchange – specifically if the paired donor’s kidney is recovered, but his or her paired candidate never receives the matched donor’s kidney. We are not requiring a specific remedy or that all KPD programs provide the same recourse. Instead, transplant programs must inform the candidates and donors of the remedies available, if applicable, within the KPD program in which they’re enrolled. If the transplant program enrolls the candidate and donor in more than one KPD program, then it must advise them of the remedies in each KPD program.
3.The proposal also contains sections specific to non-directed donors (NDD) and bridge donors. NDDs and bridge donors play very valuable roles in KPD exchanges because they can help find harder to reach matches and can help extend chains. Because of their value, NDDs and bridge donors also require additional protection from undue coercion. The proposal therefore requires transplant programs to inform NDDs of all of their options, including participating in KPD, donating to the deceased donor waiting list, or any other options available in their DSA. In addition, bridge donors must be informed of the potential for another medical evaluation in the future, the potential that they’ll have to provide multiple blood samples, and be told how the KPD programs decides whether to end a chain with a bridge donor. Finally, bridge donors are permitted to assert the amount of time they are willing to wait to be a bridge donor, and will verbally consent to remain a bridge donor when they are involved in an accepted KPD chain or exchange.

5. Supporting Evidence
Feedback from March 2012 public comment proposal for KPD policy
March 2012 KPD Consensus Conference recommendations for donor evaluation and care
The informed consent section of KPD policy was originally distributed for public comment in March Though the informed consent section was removed from the KPD policy proposal that ultimately went to the Board of Directors in November 2012, the comments that were submitted specifically in response to the KPD section provided the Kidney Committee with valuable insight for its future proposal. For example, the original proposal did not include a section for bridge donors.
There was also a KPD Consensus Conference in March 2012 that produced numerous recommendations for informed consent for KPD participants. Many of the proposed elements of informed consent in this policy proposal were informed by the recommendations of the Consensus Conference, such as advising candidates and donors of the risks of shipping kidneys, and advising candidates and donors of the risks of a failed exchange.

6. What Members will Need to Do
Incorporate these elements into your informed consent process
Comply with the elements of informed consent for non- directed donors and bridge donors as applicable
Understand and communicate specific aspects of the KPD program in which the member participates
Matching requirements
Remedies for failed exchanges
Rules for meetings between matched donors and recipients
Transplant programs that enroll participants in any KPD program will be responsible for complying with the elements of informed consent in this proposal. Members enrolling a bridge donor or NDD must also comply with those specific sections of the proposed policy. Additionally, all members must become familiar with specific aspects of the KPD program in which they are enrolling their candidates and donors, such as the KPD program’s matching requirements, the KPD program’s rules for facilitating meetings between matched donors and recipients, and the KPD program’s remedies for failed KPD exchanges.

7. Questions?
Richard Formica, MD Committee Chair
Regional representative name (RA will complete) Region X Representative address
Gena Boyle, MPA Committee Liaison