Living Donor Committee Modifications to Informed Consent Requirements for Potential Living Donors Living Donor Committee

What problem will the proposal solve? Current living donor informed consent policies were implemented in 2013 (kidney donors) and 2014 (other organ donors). Subsequent developments support the need to update or clarify the existing policies in several areas: Important new evidence on outcomes; resulting consensus-based recommendations from professional societies Feedback from audits on unclear policy language Current living donor informed consent policies were implemented in 2013 for kidney donors, and extended to other living organ donors in 2014. Subsequent developments support the need to update the policies: New published evidence on outcomes and consensus-based recommendations from professional societies regarding this evidence Feedback from living donor program site surveyors that living donor recovery programs frequently have questions about what transplant candidate health information can be shared with the potential living donor.  

What problem will the proposal solve? The proposal will also: Clarify some related KPD policy requirements Remove some outdated Bylaw requirements This proposal also includes minor clarifications to Policy 13 on Kidney Paired Donation. These clarifications are needed to make KPD match run eligibility requirements for potential KPD donors consistent with Policy 14: Living Donation for required cancer screening. These clarifications will require programming to change labels in UNet. The changes to KPD policy only apply to the OPTN KPD program.   The proposal includes some related clarifications and elimination of OPTN Bylaws addressing living donor informed consent and independent living donor advocate requirements. The Bylaws are now outdated and are superceded by current living donor informed consent and ILDA policies so those bylaws are no longer needed; the information is contained elsewhere. (additional information for presenter; you do not need to say this: Historically, recovery hospitals were required to develop and follow center-specific protocols for living donor informed consent and independent living donor advocates (ILDAs). Both of these requirements are now superseded by current living donor informed consent and ILDA policies.)

Key Proposed Clarifications/Changes to Current Policy Proposed Change Rationale Require disclosure that transplant candidate selection process is based on hospital-specific guidelines, practices or clinical judgment Response to member feedback Gives general information on candidate selection process; reassures donors that candidates are suitable for transplant Clarify what transplant candidate information can be shared with the potential donor Clarifies privacy law restrictions and circumstances under which candidate health information may/may not be shared First Proposed Change Disclosure on how the transplant program selects transplant candidates would be a new requirement. It is based on reports from committee members that donors have not understood the transplant candidate approval process and want reassurance that their organ is going to an appropriate candidate. The new requirement would reassure donors that candidate selection is based on hospital-specific guidelines and clinical judgment. Please note that this change does NOT require centers to develop any new protocol; it is only a disclosure about what they already do. Second Proposed Change UNOS living donor program site surveyors report that hospitals have misunderstood existing requirements about what transplant candidate health information can be shared with the potential donor. The proposal will clarify what can be disclosed. Specifically, Information about transplant candidates can be disclosed only with permission of the candidate, including: Personal health information collected during the transplant candidate’s evaluation, which is confidential and protected under privacy law. This includes reasons for a transplant candidate’s increased likelihood of adverse outcomes NOTE TO PRESENTERS: The following was deleted from the slide. Here is it plus the script in case anyone asks you about it at the end of your presentation. Proposed change: Clarify that transplant candidates may have risks of adverse outcomes (a) that exceed local/national averages but do not prohibit transplant, and (b) are not disclosed to the donor Rationale: This is a clarification in response to member feedback Original wording unclear An understanding of the transplant candidate selection process is especially relevant when explaining to donors that some candidates may have risks for adverse outcomes that could exceed expected averages but that do not necessarily prohibit transplantation. To that end, the proposed policy also clarifies existing policy that already requires general disclosure of increased risk for some transplant candidates. Transplant center feedback has indicated that the current policy language is unclear. The language in this proposal is in response to that feedback.

Key Proposed Clarifications/Changes to Current Policy Proposed Change Rationale Inform potential kidney donors of updated information on ESRD risk after donation Update of existing requirement New research shows that ESRD risk in kidney donors may exceed healthy nondonors’ risk Inform potential kidney donors of the risk of pregnancy complications after donation New research finds higher risks of gestational hypertension or preeclampsia in donors compared to healthy nondonors The proposal would also update an existing policy requirement regarding living kidney donor ESRD risk. Several important studies have now found that donors’ risk of ESRD may exceed that of equally healthy persons who did not donate. Professional societies’ consensus-based recommendations now call for this disclosure. Please note that the proposed change does NOT require disclosure of specific statistics or risk estimates (which could become rapidly outdated). Instead, the requirement calls for recovery hospitals to address the concept with donors. Disclosing the risk of living donation on future pregnancies would be a new requirement. It is based on recent evidence of higher risks of gestational hypertension or preeclampsia in women after kidney donation compared with healthy non-donors. (YOU MAY NOT NEED TO SAY THIS: Rates of gestational hypertension or preeclampsia in this recent research were similar to prior studies comparing pregnancy outcome in groups of women after vs before donation.) This disclosure is also a response to feedback from donors who emphasize that this information is highly relevant to women of childbearing age who are considering donation. It is also responsive to professional societies’ call for disclosure of this information. The proposed change does not require disclosure of a specific statistic or risk estimate. Instead, the requirement calls for recovery hospitals to address the concept with donors. Professional Societies’ consensus-based recommendations call for disclosures Requirement to address concepts – details of disclosures left to recovery hospital

Proposed Changes – New Disclosures Rationale Inform potential donors about the recovery hospital’s living donor follow-up rates The SRTR has added live donor follow-up rates to PSRs; this information is publicly available but may not be known to donors Finally, the disclosure of the recovery hospitals’ living donor follow-up rates would be a modification of existing policy on required disclosures. The SRTR recently added live donor follow-up rates to Program Specific Reports. This is public information. But it may not be known to most potential living donors. This could create an inequity across donors if only those able to find the information are aware of it. See FAQ document for ADDITIONAL POINTS TO MAKE IF FOLLOW-UP ISSUE IS RAISED AS A PROBLEM

How will members implement this proposal? Living donor recovery hospitals will update informed consent policies or procedures to address the new or modified informed consent requirements

How will the OPTN implement this proposal? Board review date – December 2016 Programming –Proposed changes to KPD policy would require changing field labels in Unet Implementation if approved – March 2017 Monitoring – UNOS staff will continue to review all elements of the informed consent process

Questions? Krista Lentine, M.D., Ph.D. Committee Chair lentinek@slu.edu Lee Bolton, M.S.N., ACNP Committee Liaison Lee.Bolton@Unos.org