by Macey L. Henderson
Living kidney donation can potentially provide a solution for the growing waitlist in the United States, which is now holding steady at over 100,000 people. Through paired donation and kidney chains living donors could realistically be the solution to providing an unlimited number of transplants to those in need throughout the world, but the number of donors has been decreasing since 2004. Why? Leading groups of transplant surgeons and professionals have called for the active pursuit of health policies which achieve financial neutrality for the donor—meaning the donor wouldn’t be any financially worse off after donation than before. Other groups have charted an ethical course for the healthcare system to study financial interventions for living kidney donation with the goal of assessing donor attitudes and perceptions.
The Slow Evolution of Federal Transplant Law
Financial compensation as we understand to be “valuable consideration” under federal law is illegal in the U.S. under the National Organ Transplant Act of 1984 (NOTA) and while certainly possible, change to federal legislation is difficult and time consuming. In 2007 NOTA was modified so that kidney paired donation activities did not constitute illegal or criminal activity by the Charlie W. Norwood Living Organ Donation Act. This change sparked the growth of programs providing algorithms that match incompatible donor pairs in the U.S.
The same legislation was responsible for modifications to a national program providing financial assistance based on donor and recipient income factors as well as other eligibility criteria set forth by the U.S. Department of Health and Human Services Poverty Level Guidelines. In order to file an application for donor travel expense to the transplant center, The National Living Donor Assistance Center (NLDAC) requires the recipient and the donor complete worksheets and forms. It should also be mentioned that NLDAC is not an option for donors participating in large kidney donation chains which often attract great media attention. Recently, the New York Times published an article titled, “The Great American Kidney Swap” which explored the computer software and Nobel prize winning algorithms largely responsible for the often sensationalized success of donor chains but left absent mention of federally designated and financially struggling non-profits like the American Living Organ Donor Fund which often make these large chains possible when in fact federally funded NLDAC cannot assist.
Federal transplant law was last amended in 2013 with the HIV Organ Policy Equity Act (known as the HOPE Act) which removed the ban on HIV+ organ donation, transplant, and research. Things aren’t automatically changing for HIV+ kidney waitlist candidates. At the most recent meeting in June 2015, the UNOS Board of Directors approved policies to facilitate the transplant community’s participation in the federal HOPE Act. These UNOS policies will allow the recovery of organs from HIV positive donors and include patient safety measures intended to assure their use only for candidates known to be HIV positive which is a critical step in the implementation of the HOPE Act. The new UNOS policy requirements build upon recent federal and regulatory changes and provide a pathway for the clinical use of organs from HIV positive donors. The HOPE Act is expected to increase the number of transplants for both HIV positive and HIV negative candidates. With a supply not meeting demand, more transplantable organs for HIV-positive candidates’ means HIV-negative recipients will have greater access to organs from HIV-negative donors. Research criteria development is being led by the National Institute of Allergy and Infectious Diseases for transplant programs that want to utilize HIV positive organs for HIV positive recipients with clinical trials to begin in early 2016.
Transplant Research in a Learning Healthcare System
The transplant community appears to be in a state of clinical equipoise over whether a financial intervention should ethically be tested in a clinical research study to observe its effects on living kidney donation. The Institute of Medicine has already called for our health system to embrace and to identify as a ‘learning healthcare system.’ Would an Institutional Review Board ever approve innovative research requiring a shift in the way benefit and risk are perceived such as in the case of a financial intervention for living kidney donation? A study of financial intervention would require us to adopt a new framework for conducting research ethics review. A new ethical framework for a learning healthcare system has been proposed which requires a departure from traditional clinical and research ethics and is grounded in a moral obligation to conduct continuous learning activities that improve the quality of clinical care and healthcare systems. Research where the intervention would be financial in nature to the study participant (in this case, the living donor) would require implementation from new ethical frameworks.
A Patient-Centered Approach to Understanding the Value of Financial Interventions
How can we continue to discuss what is right and wrong for a group of people until we ask the directly affected group how and what they think? It is often unclear if (and if so, the number and diversity of) living donors included in professional transplant community consensus agenda meetings, conferences, and publications making recommendations on ethical aspects of donation. It would be beneficial to gather empirical evidence as to how living donors think and feel about financial interventions associated with their donation and follow-up care. Posing questions to living donors retrospectively (and prospectively) if they want financial intervention for their donation, if they need financial interventions, and about the impact of financial interventions on their long-term follow-up care needs could help the transplant community understand the significance and possible value of financial incentives as a whole from the patient perspective.
There is ethical justification for asking questions to living donors and patient groups to understand if financial interventions (or incentives) could significantly impact individual donor experiences and increase national donation rates without negative psychological experience for the donor. There is also merit to future investigation into long-term financial impact of living kidney donation. Negative public perception of financial interventions as part of a U.S. regulated system is feared by many. However, as a living donor myself I believe there will be more negative public reaction when the financial distress of some donors garners much needed media attention. In the court of public opinion, I would like data before we continue to make the value judgment that living kidney donation without financial intervention is still ethically permissible.