Beginning in 1993, the Ethics Committee (the Committee) developed a series of white papers that are
available through the OPTN website. A white paper is an authoritative report or guide that informs readers
concisely about a complex issue and presents the issuing body's philosophy on the matter. It is meant to
help readers understand an issue, solve a problem, or make a decision.
In 2013, the OPTN implemented new informed consent policies (Policy 14.3, Informed Consent
Requirements) for living kidney donors. New informed consent policies for other types of living donors
followed in 2014. These new policies included absolute contraindications (Living Donor Exclusion Criteria)
to living donation.
Some terminally ill patients may desire to be living donors but may not be afforded the opportunity to
donate based on confusion with existing OPTN policies for living donor informed consent, medical
evaluation, and post-donation reporting policy requirements. If a potential living donor patient is
competent and can provide informed consent, a terminal disease should not preclude organ donation and
would not violate existing policy. Based on published and anecdotal reports, members may need
guidance regarding how to handle potential living donors with certain fatal diseases who meet the criteria
to be living donors.
Impact points
- Very small: UNOS implementation effort for all departments
- Immediate to 2 months implementation time for members
- Minimal or no impact to implement and maintain.
- May increase transplant volume and decrease waitlist
- Guidance documents do not contain new member requirements. However, the assumption in estimating fiscal impact is the members will follow guidelines.
Project size/complexity
UNOS
Implementation and ongoing effort among all departments is very small.
MEMBER
Hospital: Minimal cost impact exists to implement and continue to follow the guidance. There is the potential for increased cost if there are additional complications per case or if additional evaluation costs for prospective living donors occur. This is dependent on volume. This guidance may increase transplant volume and decrease the waitlist. The guidance can likely be implemented immediately to within two months.
Lab and OPO: Minimal or no impact.
