"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 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 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 than the standard definition:

"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)

How Does it Apply to Living Donors?

Living donation is unique in that it is a purely elective procedure with no medical or psychological benefit to the donor. In some cases, it is medically and psychosocially detrimental to the donor. [Dr. Scantlebury, at a 2007 ACOT meeting, noted that informed consent for a living donor is different from informed consent for a general operation, for something that 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?

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. Generally, transplant centers discuss the possibility of death, or conditions that would cause a laparoscopic nephrectomy to become an open procedure, but they often omit information regarding other post-op complications, psychosocial consequences or long-term risks or repercussions. Many transplant centers also provide no information on 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'.

A 2007 international survey of 203 transplant practitioners (63% nephrologists and 27% surgeons) 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 sequelae compared with nephrologists.

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)

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)

Because each transplant center makes their own policies and procedures, there is no standard of care for living donors between centers. 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-kidneyed life.

The Importance of Informed Consent

In one living donor follow-up study, the strongest correlates of donor dissatisfaction included a belief that information given preoperatively had been inadequate. 31% of living donors would've liked more information than was given (4).

Safe donation, both for the donor and the recipient, requires honesty and openness... (76)

A lack of informed consent will result in a greater risk of post-surgical depression, anxiety/stress, anger and PTSD-like symptoms. It will also leave living donors unprepared for the possibility of complications, long absences from work and consequently, financial hardship. It could, in some situations, result in lawsuits against the transplant center and its personnel that could've been avoided.

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 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).

- Detailed explanation of how kidneys function and what changes will occur post-nephrectomy and how it can affect the body's other systems.

Still under BIG construction.....

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