Advocacy Informed Consent OPTN

Informed Consent for the Living Kidney Donor – Public Comment for OPTN

Here is my third and final public comment for this batch of OPTN’s proposed policies. Deadline is Friday, December 23rd, so you still have time to write and submit your own. In fact, I recommend you do; things will never change unless we make our voice heard.

This missive is in regards to Proposed Policy 293, Informed Consent of the Living Kidney Donor.

It’s understandable why a LKD would seek graft & recipient survival information during evaluation, but of more importance to their well-being is the center’s LIVING DONOR mortality and morbidity stats. OPTN has collected short term data for over ten years(1), records which could easily be shared. Yet they are not. A prospective LKD has a right to know how a program performs and if it is compliant with federal reporting mandates. After all, the purpose of Informed Consent is to protect the patient, not ‘sell’ living donation or hide a transplant program’s flaws.

While the policy advocates ‘semi-quantitative’, ‘data-based estimates’, it is unclear on the details. Telling a potential LKD that 50% of transplanted kidneys survive 15 years may be true, but it is also disingenuous when more specific data is available from USRDS and SRTR.

– It is not enough to say “Current practice is to prioritize prior living donors who become transplant candidates”. It should be explained that prior LKDs are given four-points of LOCAL priority, equivalent to approximately one year of wait-time(2).

– It is inaccurate to define LKD’s surgical risks as “scars, pain, fatigue & other consequences typical of any surgical procedure”. Laparoscopic donor nephrectomies carry unique risks: hernias, nerve damage, testicular swelling requiring surgical intervention, adrenal dysfunction, chylous ascites and pancreatitis(3). Not informing LKDs of such possibilities could delay symptom recognition and timely treatment, resulting in adverse consequences and perhaps lawsuits.

– An LKD should not be told their remaining kidney will ‘grow’ but should be educated on hyperfiltration, hypertrophy, and glomerular hypertension. Do not assume s/he is unable to understand.

The authors admit that LKDs lose 25-40% of their renal function. However, A 10% reduction in GFR has been shown to significantly increase risk of cardiovascular morbidity and death(4). Most patients in the early stages of CKD won’t progress to kidney failure because they’ll die of a heart-related ailment(5). Yet only approximately 30% of transplant professionals discuss cardiovascular issues with potential donors(6). Policy 293 ignores the subject completely.

The proposed change to the Independent Donor Advocate description, that they not be involved with “recipient evaluation or the decision to transplant the recipient” is far from the original “must not be involved in transplantation activities on a routine basis” dictum set forth by CMS Final Rule 2007(7). OPTN has consistently ignored this provision of the IDA, allowing Transplant (or Living Donor) Coordinators to serve in this capacity. The purpose of the IDA is to provide a prospective LD with an advocate who does not financially or otherwise benefit from their donation, and who is not beholden to the transplant center for their livelihood. For Coordinators to assume this role is clearly a conflict of interest.

Because living donors receive no benefit for themselves, their informed consent process must be more rigorous than that of other surgical interventions(8), more closely resembling that of human research subjects. Ethically, it should always err on the side of too much information rather than too little. As a prospective LKD recently pointed out to me, it is impossible to fact-check a transplant center’s living donor pamphlet because of its overwhelming vagueness. If relinquishing a kidney is as safe as the transplant industry insists, there is no reason for subterfuge. Tell the public the truth.



(3) Merlin TL, et al. The safety and efficacy of laparoscopic live donor nephrectomy: Transplantation. 2000 Dec 27;70(12):1659-66.

Vallancien G, et al. Complications of transperitoneal laparoscopic surgery in urology: review of 1,311 procedures at a single center. J Urol. 2002 Jul;168(1):23-6.

Handschin AE, et al. Laparoscopic donor nephrectomy. Br J Surg. 2003 Nov;90(11):1323-32.

Gruters, G. Living Donors: Process, Outcome and Ethical Questions. Work Group paper for the September 2006 meeting of the President’s Council on Bioethics.

(4) Tonelli M. Should CKD be a coronary heart disease risk equivalent? Am J Kidney Dis 2007: 49: 8.

Emara M, Ragheb A, Hassan A, Shoker A. Evidence for a need to mandate kidney transplant living donor registries. Clin Transplant 2008: 22: 525–531.

(5) Brenner, B. Brenner and Rector’s The Kidney, 8th edition. Saunders, 2008.

(6) Housawi, A.A. Transplant Professionals Vary in the Long-Term Medical Risks They Communicate to Potential Living Kidney Donors: an international survey. Nephrol Dial Transplant (2007) 22: 3040–3045.



2 replies on “Informed Consent for the Living Kidney Donor – Public Comment for OPTN”

Is there anywhere else we can get things done? It seems to me that that the OPTN is the fox in control of the hen house. Laws need to be changed. How else can we go about this?

I unfortunately didn’t see this in a timely fashion; past deadline.

1. Our informed consent should be required to be completely in writing and able to be read at home for a period of time (not some dr. mumbling quickly as if a 30 second commercial disclaimer, and then having a form signed that says we were informed).

2. There should be a completely unbiased database collecting complete information. (my center called by phone as followup… I asked them to please send me the questions in writing, as there was too much to say over the phone. I never heard from them again… assume all lost people are negative info… of the worst type.)

3. Living donors should be told that medicare only covers 3 years of the lifelong antirejection medications needed for the recipient… so while they claim it can help a recipient live longer; they are taking away any advantage they may have had when they take away the medications. (this should be part of the informed consent, as it significantly lessens the value of the donation compared to the risk taken).

4. Personally, I think that until these things are done, living donations should be outlawed.

5. Change medicare to cover anti-rejection meds for lifetime of recipient.

OPTN is indeed “the fox watching the henhouse”; the membership of OPTN is comprised primarily of transplant centers and other persons and organizations that benefit, financially and otherwise, from transplants. They’ve opposed every movement to increase protections for living donors.

Don’t worry about missing this deadline; OPTN posts proposed policies up for public comment multiple times per year. You can sign up for their email list and stay informed if you’d like.

A couple of other options:

– ACOT ( – click ‘legislation’) serves as a sort of liaison between OPTN and DHHS (Dept of Health and Human Services), which provides what little oversight there is for OPTN. Like OPTN, ACOT has meetings, which are open to the public, and even if one can’t attend, they have a ‘public comment’ section wherein anyone can pen a missive and ask for it to be read during the meeting.

– Also, individual states have a lot of latitude in implementing healthcare related policy. NY and NC passed extensive policies governing living liver donors after two separate incidents wherein lie liver donors died. OPTN took much of NY’s policy and implemented it on a national level. That occurred, unfortunately, only after the details of Mike Hurewitz’ death went public.

– Transplant recipients are tracked for ten years in a govt funded registry. ODRIA, passed in 2004, gave the Sec of Health the authority to develop a similar database for living donors. Yet the funds have never been allocated. If you’re up to the task, you can attempt to rally folks around such a project, start a petition, etc. and see if you can’t make it reality. (Neither OPTN nor any transplant associations have lifted a finger in this regard).

The reason for the three year limit on anti-rejection meds was the assumption that once a patient underwent a transplant s/he would regain their health and be able to rejoin the workforce *and* obtain private insurance. This has turned out not to be the case. The passage of the ACA should make it more affordable for individuals to procure private insurance but how that will all shake out is anyone’s guess.

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