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Living Donor Committee Spring 2014

Proposal To Modify Existing or Establish New Requirements for the Informed Consent of all Living Donors. Living Donor Committee Spring 2014. The Problem. OPTN policy has inconsistent requirements for living donor informed consent Kidney donor recovery hospitals must follow OPTN policies

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Living Donor Committee Spring 2014

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  1. Proposal To Modify Existing or Establish New Requirements for the Informed Consent of all Living Donors Living Donor Committee Spring 2014

  2. The Problem • OPTN policy has inconsistent requirements for living donor informed consent • Kidney donor recovery hospitals must follow OPTN policies • Liver donor recovery hospitals must develop and follow center-specific protocols • Hospitals performing living lung, intestine or pancreas donor recovery are not required to follow OPTN policy or develop and follow center-specific protocols

  3. Goal of the Proposal • Establish informed consent requirements for living liver, lung, intestinal, and pancreas donors that mirror existing requirements for informed consent of living kidney donors • Improve informed consent process for all future living donors

  4. How the Proposal will Achieve its Goal • Extend standardized informed consent process to all living donor programs

  5. Additional Background • Proposed requirements are based on recommendations from a Joint Societies Steering Committee • Committee representation from: • American Society of Transplantation (AST); • American Society of Transplant Surgeons (ASTS); • North American Transplant Coordinators Organization (NATCO)

  6. Proposal Summary • All living donor recovery programs would be required to provide an ILDA and develop center specific ILDA protocols • Majority of existing (living kidney donor) informed consent requirements are extended to all categories of living donors • Remaining informed consent requirements specific to living kidney donors remain unchanged

  7. Proposal Summary Includes new informed consent disclosure requirements specific to living liver donors which include: • Acute liver failure • Transient liver dysfunction • Biliary complications • Need for blood products • Liver donation related surgical complications • Abnormal post-donation lab results which could lead to additional testing with associated risks

  8. What Members will Need to Do • Living donor recovery hospitals would be required to follow new policies for the informed consent of living donors

  9. Questions? • Christie Thomas, M.D. Committee Chairchristie-thomas@uiowa.edu • Name Region # Representativeemail address • Lee Bolton Committee Liaisonlee.bolton@unos.org

  10. Supporting Evidence • Several consensus statements* have been published affirming basic principles governing the informed consent of prospective living kidney donors. • *(Adams et al., 2002; Ethics Committee of the Transplantation Society, 2004; Abecassis et al., 2000)

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