Resource explains KPD informed consent requirement changes
Published on: Saturday, October 10, 2015
As of December 1, 2015, all U.S. kidney paired donation (KPD) programs are required to inform candidates and donors of the risks and benefits of participating in the program and the logistics of the matching process. These changes were approved by the OPTN/UNOS Board of Directors in June 2015.
An informational resource is available to explain the changes. For any KPD exchange, the paired donor’s transplant hospital is responsible for obtaining and documenting informed consent from the paired donor according to Policy 14.3: Informed Consent Requirements. If a different transplant hospital performs the organ recovery, that hospital must also obtain and document informed consent.
Participating transplant hospitals should consult their legal department for further guidance on informed consent documentation. Evidence of informed consent must be maintained in the donor and candidate medical records.
In addition to the informed consent requirements in Policy 13 (Kidney Paired Donation), programs that perform living donor transplants also must fulfill informed consent requirements in Policy 14 (Living Donation) and Policy 3 (Candidate Registrations, Modifications and Removals). Refer to these policies to ensure that your program informs donors and candidates, that you obtain their consent, and that you provide documentation.
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