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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).
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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
What problem will the proposal solve? • The proposal will also: • Clarify some related KPD policy requirements • Remove some outdated Bylaw requirements
Key Proposed Clarifications/Changes to Current Policy • Professional Societies’ consensus-based recommendations call for disclosures • Requirement to address concepts – details of disclosures left to recovery hospital
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