One of the key problems with examining living donor morbidity and mortality is the under-documentation or lack of direct reporting of complications by the transplant centers, leading to a dearth of hard data on which to base transplant decisions and to an to inability to provide potential living donors with true informed consent.The International Liver Transplantation Society 13th Annual International Congress, 2007 (66)
What Is ‘Informed Consent‘?
In short, a person’s written consent to a surgical or medical procedure, other course of treatment (e.g. mental health), or participation in a research study, which occurs after the person demonstrates sufficient understanding of the potential risks, complications and consequences of the treatment (or non-treatment).
While state laws may vary, the elements of informed consent must include:
-the nature of the decision/procedure
-reasonable alternatives to the proposed intervention
-the relevant risks, benefits, and uncertainties related to each alternative
-assessment of patient understanding
-the acceptance of the intervention by the patient, voluntarily without coercion or duress
Some studies take their recommendations further:
“A detailed informed consent should be obtained from high-risk living kidney donor transplant recipients as well as donors and family members after the high perioperative risk potential has been explained to them.” (74)
And “Living Kidney Donors must be informed of a recipient’s potential for morbidity and mortality before they consent to undergo an unnecessary individual surgery” (74)
As mentioned, Informed Consent is not simply about disseminating information but ensuring the would-be patient or research subject comprehends the information given to them. This understanding is the responsibility of the surgeon, researcher or facility, and not the burden of the patient.
However, ensuring that prospective living donors have sufficient understanding of potential complications before giving valid informed consent may be problematic because complications important to living organ donors and long-term risks associated with living organ donation are not known. (127)
How Does it Apply to Living Donors?
Living kidney or liver donation is unique in that it is a purely elective procedure with no medical or psychological benefit to the living donor. In fact, it can actually be medically and psychosocially detrimental to the living donor. Dr. Scantlebury, at a 2007 ACOT meeting, noted that informed consent for a living organ donor is different from informed consent for a general operation, because in every other instance, the surgery will benefit the individuals themselves.(62)
Every state’s courts have determined ‘informed consent’ to be the legal responsibility of the surgeon, and not of the medical facility or auxiliary medical personnel. However, in the case of living donors, the evaluation is done by a team: mental health provider/social worker, a Living Donor Advocate/Coordinator, a nephrologist and a surgeon (at the least) as opposed to other surgical patients who meet only with a surgeon/specialist.
Ironically, most living donors spend the least amount of time with their surgeon. Because of the unique nature of a prospective living donor’s evaluation, other members of the ‘team’ should be held responsible for a living donor’s care and preparation.
How are some Transplant Centers not providing Informed Consent?
1. While CMS Final Rule 2007 requires living donors to be given informed consent, it provides almost complete discretion to transplant centers regarding what information is included and how.
Housawi’s international survey of 203 transplant practitioners in 2007 revealed that:
- 80% of practitioners discussed risks of hypertension, proteinuria, or kidney failure requiring dialysis, which means that 20% do not.
- However, many practitioners do not believe these risks are increased after donation, with surgeons being less convinced of long-term repercussions compared with nephrologists.
- Only approximately 30% of practitioners discuss long-term risks of premature cardiovascular disease or death with potential kidney donors.
The authors of the study admit “There is often a discrepancy between what busy physicians say they do, and what they actually do in real practice, with self-reported results more likely to describe model behavior. Thus, the proportion of practitioners who do not discuss long-term medical risks with potential kidney donors may be even higher than reported here, increasing variability amongst the transplant centers.”(80)
2. Some transplant centers choose to present information in a skewed fashion: “We’ve never lost a living donor” instead of the more factual “Between 2000 and 2009, UNOS data reveals that 2.3 living kidney donors die each year within 90 days of surgery in the US”.
They can omit information regarding other post-op complications, psychosocial consequences or long-term risks or repercussions. Many transplant centers also provide no information on preserving one’s long-term health with one kidney, dietary precautions, or medications/supplements that could be nephrotoxic, even though CMS Final Rule 2007 requires ‘nutritional services and diet counseling services…be available’.
While the government has established Institutional Review Boards (IRBs) to protect the rights of subjects for scientific research, no such review for potential living organ donors exists. The government…has left unregulated and unreviewed the use of living donors for transplant surgery. (93)
3. Before 2013, no living donor specific standards of informed consent existed (226),meaning that each transplant center made their own policies and procedures.Unfortunately, the new policy is minimum and in places incomplete and vague (227).
For example, the policy requires certain discussion about future kidney disease, but says nothing about hypertension or cardiac disease, which are highly correlated with reduced kidney function (See: Risks)
In other words, not every prospective living donor is given the same information, or with the same emphasis. This results in a diminished quality of care for all living donors, and leaves many ignorant and unprepared to deal with a one-kidney life.
4. Informed Consent Forms provided by transplant centers and given to living donors are often written at a college reading level, which is much higher than the recommended 5th-8th grade (228).
And let’s not forget, the transplant industry has NO concrete data on living donor risks, complications, or long-term health or well-being.
– No identifying information collected prior to 1994, so NO data on 40 years of living donors.
– OPTN’s data task force concluded the OPTN database to be ‘woefully incomplete’ and ‘useless’ for research and analysis (136), a fact confirmed by a 2011 OPTN proposed policy for living kidney donor follow-up (176)
– A 2006 assessment of living donor studies revealed small sample sizes, selection bias and many other limitations and liabilities (56), a deficiency corroborated by a 2011 Joint Societies Consensus Document (190).
How many more individuals will agree to donate a kidney with less than full informed consent because the medical information that we should be able to provide them is not available? (203)
The Importance of Informed Consent
In one study, the strongest correlates of living donor dissatisfaction included a belief that information given preoperatively had been inadequate. 31% of living donors would’ve liked more information (4).
Safe donation, both for the living donor and the recipient, requires honesty and openness… (76)
An understanding of the risks guides the need for health promotion, including adopting good lifestyle to reduce long-term risks (95)
“Minimizing the risks…while explaining the procedure to the family, apart from being immoral, will backfire on all doctors involved” (121)
“It is important that living donors receive accurate and unbiased information on the risks of donor surgery.” (124)
A lack of informed consent can result in a greater risk of post-surgical depression, anxiety/stress, anger and PTSD-like symptoms. It can also leave living donors unprepared for the possibility of complications, long absences from work and consequently, financial hardship. This lack of awareness could lead to preventable deaths from cardiac or kidney disease. Inadequate Informed Consent could also result in lawsuits against the transplant center and its personnel, harming the facility’s reputation as well as that of the transplant industry.
What Should Informed Consent for the Living Donor Look Like?
The current living donor evaluation process emphasizes physical and anatomical diagnostics* far more than psychosocial or emotional preparedness. While a prospective living donor endures tests on every major bodily system, s/he only spends 45 minutes with a social worker or other mental health professional and equal time with a Living Donor Coordinator/Advocate. This simply isn’t enough to build rapport, cultivate trust or allow the prospective living donor to process the enormity of the situation.
In fact, there is much evidence that persons contemplating any surgical procedure do not retain or comprehend much of what is said during Informed Consent conversations. For breast cancer patients, an interactive ‘shared decision model’ has been created to test prospective patients on their knowledge and understanding. It was suggested at a May 2007 ACOT meeting that Informed Consent for living donors be dealt with in the same way (62).
1. Detailed explanation of how kidneys function and what changes will occur post-nephrectomy (or biliary system for liver donors). How those changes can affect the body’s other systems.
2. Explanation of the differences between open, hand-assisted laparoscopic, and one-port laparoscopic procedures.
3. How removing the left kidney affects blood flow to the adrenal gland, and the challenges of removing the right kidney.
5. A discussion of the ‘worst-case scenario’; how a donor’s death or incapacitation could affect others in the living donor’s life.
6. Preparation for an extended recovery: budget planning for lost wages, child care, etc.
7. The possible emotional and psychological ramifications of living donation, beyond a simple “Some living donors experience depression….”
8. The unabridged facts about living donor data, both short (inadequate and incomplete) and long-term (non-existent), rather than handing prospective living donors the articles by Ibrahim or Segev as proof that living donation is safe.
9. Potential living donors should be told about the LODN insurance policy, and the possibility that the recipient’s insurance will not pay for complications after a certain date, or over a certain amount. And if the recipient should die, the recipient’s insurance will no longer exist and the living donor will be without coverage.
*Sadly, even after fifty-plus years of living kidney donor transplants, there have been no studies to determine the best way to evaluate a potential living donor to minimize risk of harm (190).
The Recipient’s Responsibilities
The prospective recipient cannot not be excluded from this conversation, since s/he stands to benefit from the living donor’s actions.
As Elliot wrote: “Accepting a sacrifice of great magnitude is not mere passive acquiescence, devoid of any moral import. If I allow someone else to risk his life or health for my sake, I am endorsing his self-sacrifice and agreeing to profit by it.”(129)
Many transplant centers educate recipients on how to have discussions with their loved ones about living donation, and even how to solicit donors via email and the media. But some surgeons have said they refuse to ‘burden’ would-be recipients with information about the risks of being a living donor. Why? Is it out of a misguided need to protect the sick recipient, or is it because the recipient is less willing to take risks with the living donor’s health than the transplant professionals themselves? (189)
In the interest of true and full informed consent (and ethical behavior on the part of the transplant centers), recipients should be required to understand the possible repercussions of their decision to benefit from their living donors’ sacrifices. .
“But while we honor self-sacrifice, we would rightly criticize a person…who willingly took advantage of another person’s sacrifice. And this is what is hard to avoid in many harmful medical procedures: a person who stands to gain from a volunteer’s selflessness. Altruistic acts benefit other people, both directly, as with an organ recipient, and indirectly, as with the clinical researcher whose reputation is made through the fruits of his research. And while it might be admirable to risk harm to oneself, it is not admirable to encourage another person to risk harm to himself for one’s own benefit.” (129)
Recipients have the right to refuse a living donor organ. And transplant centers have the responsibility not to operate if doing so could harm the potential living donor. Patient ‘willingness’ or autonomy does not alleviate any person or organization profiting from the living donor’s sacrifice of their moral obligations.
Last Updated: November 30, 2013.