Renal Transplantation: Is it Time to Revise Current Informed Consent Protocols?

November 19, 2008
Renal Transplantation: Is it Time to Revise Current Informed Consent Protocols?
By Peter Laird, MD

The informed consent procedure for renal transplantation is the process relating the risks, benefits and alternative treatments of renal transplantation to prospective patients. I recall my own briefings on renal transplantation that I sat through with my wife as we considered a preemptive transplant. To that end, I also endured a colonoscopy and even suffered through a cystoscopy to complete an evaluation for microscopic hematuria caused by my IgA nephropathy. The subsequent diagnosis of a malignant melanoma gained from my youthful days on the beach put this plan on hold.

Privately, I have had the opportunity to discuss renal transplantation with many of my fellow dialyzors; surprisingly I have found a profound lack of understanding in many of these patients even about common renal transplantation risks. One such patient I talked to several months ago is a Caucasian female who enjoys horse back riding in sunny California awaiting a kidney from her son. I asked her if she was familiar with Squamous Cell Carcinoma after renal transplantation and that she would likely have to give up all exposure to the sun since SCCA is deadly in transplant patients. Although I know that she was informed of this risk during her evaluation as I was as well, she did not understand its significance and potential impact on her lifestyle.

I have yet to meet any candidate for renal transplantation in the last two years that could recall the basic cancer risks, the infection risks and even that of depression, anemia, avascular necrosis, and the pervasive cardiovascular risks let alone that of transmissible agents from high risk donors.

The standard of informed consent is not only to deliver the information to the patient but to also certify that they understand the issues that are presented. It is one of the most important aspects of any medical informed consent procedure that must be documented to afford any medical legal protection for the physician should an adverse outcome develop. It is such an important part of the medical legal interaction of patient care that many physicians who routinely perform high risk operations now videotape all informed consent interactions documenting not only content of information but also the patients understanding of these risks. It must also be concurrent with the procedure itself and thus a consent procedure done remotely is updated at the actual time of the operation to meet the legal and fiduciary duties of a physician for their patients to ensure that they understood those risks, benefits and alternatives not only in the office but at the actual time the procedure is performed.

There are some in the renal transplantation community that believe it is better to give a general informed consent procedure at the time a patient is placed on the transplant list and withhold specific information about the donor at the actual time of the transplant. Many patient refuse high risk organs knowing that the donors are at risk of HIV, Hepatitis C and other infectious agents. Some transplant advocates decry the “wasted” organs refused by patients aware of the the complete risk profile of these potential donors. In such, the NEJM published an article on June 26, 2008 arguing for a general, full informed consent at the time of renal wait listing and then not offering patients an option to decline an organ from high risk patients at the time of transplant as one method of increasing the pool of available organs.

However, one of the first lawsuits stemming from transmission of HIV from a high risk renal transplantation is likely to doom this method of informed consent before it is even implemented:

The woman, a former dog groomer known in court papers only as Jane Doe, received the kidney in an operation at University of Chicago Hospital on Jan. 9, 2007.

"She was informed that it was a young healthy organ," Demetrio said. But he said that she was not told at the time of the transplant the donor who was killed in an auto accident had engaged in male-to-male sexual activity.

At the time, she was on kidney dialysis for a non-life threatening condition.

The lawsuit said that if Jane Doe had been informed of the "true nature of the donor's lifestyle and the risks associated with receiving his kidney" she would not have gone ahead with the operation. She already had rejected two other kidneys offered to her because of risks involving the lifestyle of the donors, it said.

It was not until Nov. 1 that Jane Doe was asked to come to the hospital because three other patients who had received organs from the same donor had tested positive for HIV. She then discovered that she had contracted HIV and hepatitis C as well.

The hospital had been told by the donor network before the transplant the donor had engaged in homosexual sex, a "high-risk behavior," according to the lawsuit.

Another unrelated lawsuit involving transmission of malignant melanoma to more than one recipient from the same donor highlights the dilemma transplant surgeons and even primary care physicians must contend with. Numerous medical legal cases have established that referring physicians are legally liable for informed consent at the time of referral for a procedure as well as the specialist performing the procedure. It is my opinion that renal transplantation will soon enter into the arena of lawsuits based on informed consent as do so many other commonly performed operations and procedures.

As a physician, I am no friend of the lawsuit happy lawyer making huge sums on my colleagues who are vulnerable to 20/20 hindsight reviews of all of their actions. Yet as a patient seeking alternative renal replacement therapies other than renal transplantation, my options have been blocked by the universal castigation of all treatment options other than renal transplantation.

However, once an alternative treatment is identified by the legal community, not only must the patient be advised of these options, they must also be given reasonable accommodation to receive the alternative therapies. Thus, it is only a matter of time before the legal community understands what many in the dialysis community already know, daily dialysis survival rivals renal transplantation survival, most especially nocturnal dialysis.

It is my hope that the renal transplantation community will recognize their informed consent obligations to not only discuss in more detail the risks of renal transplantation, but also what was entirely absent in my informed consent procedure, the alternative of daily dialysis that many other nations have already embraced. Perhaps this tragic case of HIV transmission from a high risk donor will end the paternalistic renal transplantation approach where the physician makes the decisions for the patient on which organ is best for which patient. The respect for patient autonomy demands an informed renal transplant patient population still at the helm of decision making authority as it is in all other venues of medicine in this nation.

http://www.billpeckham.com/from_the_sharp_end_of_the/2008/11/renal-transplantation-is-it-time-to-revise-current-informed-consent-protocols.html