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Living liver donors might benefit from standardized consent forms

Standardized donor evaluation consent forms could help address gaps in efforts to inform potential living liver donors about the possible risks and complications of donation, according to a recent study.

Researchers at the section of transplantation and immunology, Yale School of Medicine reported that 57% of donor centers that shared their patient consent forms included the nine elements required by CMS. Seventy-eight percent used at least two-thirds of the elements suggested by the Organ Procurement and Transplantation Network (OPTN).

In addition data indicated that just 17% of those consent forms allowed for a patient alibi — a generic statement that the donor did not meet requirements for donation — which OPTN guidelines indicate are a method to help ensure potential donors are not subjected to undue pressure to donate.

“Our study is the first to systematically examine written informed consent for living liver donor evaluation donation in the US,” Carrie Thiessen, MD, Yale School of Medicine, said in a press release. “Our findings reinforce the need for standardization of living liver donor liver evaluation consent forms.”

Researchers looked at consent forms obtained from 26 of the 37 centers that evaluate potential living liver donors, which account for about 4% of the 7,000 US donations annually. The most-omitted CMS elements included a statement of the possibility of future health problems related to donation not being covered by insurance (26%) and a description of the surgery (13%). The most-omitted OPTN elements included advice for donors to consider vaccinations for hepatitis A and B (100%) and the disclosure that additional testing and treatments could become the donor’s financial responsibility (74%).

The researchers suggested centers could make the donation process more transparent by comparing their living liver donor consent forms to their living kidney donor consent forms.

“The development of a standardized living liver donor evaluation consent form by either OPTN or the Joint Societies Working Group could further streamline this process and reduce elements that are ambiguous to transplantation centers and donors,” they wrote.

Disclosure: The researchers report no relevant financial disclosures.