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OPTN/UNOS Ethics Committee

OPTN/UNOS Ethics Committee. Spring 2012 Regional Meeting Update Chair, Alexandra Glazier, MPH, JD Vice-Chair, Peter Reese, MD. 2011-12 Activities Update. Jointly sponsored proposed revisions to Policy 6.0 with the Ad Hoc International Relations Committee

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OPTN/UNOS Ethics Committee

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  1. OPTN/UNOS Ethics Committee Spring 2012 Regional Meeting Update Chair, Alexandra Glazier, MPH, JD Vice-Chair, Peter Reese, MD

  2. 2011-12 Activities Update • Jointly sponsored proposed revisions to Policy 6.0 with the Ad Hoc International Relations Committee • Public comment for the proposal ended 1/12/2012 • Met jointly with AHIRC and developed final proposal on March 21, 2012 • Proposed final language will go to the Board of Directors in June 2012

  3. Proposed Activity OPO CommitteeUncontrolled DCD (UDCD or Rapid Organ Recovery) • Ethics Committee will work with the OPO Committee to survey UDCD protocols to develop model elements to be included in the protocols.

  4. DCD Model Elements(redistributed for public comment) • The Committee generally supported the revised proposals and identified several opportunities for clarification, which will be forwarded to the OPO Committee

  5. Concerns with Proposed DCD Model Elements 1/2 • Support the change in use of term circulatory instead of cardiac in Donation by Circulatory Death. • Consent issues remain, including when to contact donor families about potential DCD and first person consent. • Committee does not agree with the OPO approaching the donor family before the decision to withdraw treatment or support.

  6. Concerns with Proposed DCD Model Elements 2/2 • Ethically inappropriate to make the OPTN the arbiter on how to describe circulatory death. • Requirements are clear that the OPO staff should have no role n the end of life care yet common practice currently is not that the patient’s physician obtains consent. Logistical or ethical issue? • The Committee supports the requirement that the evaluation for DCD suitability should occur pre-mortem.

  7. Vascular Composite Allografts (VCA) • Regulation • HHS issued a notice in the Federal Register indicating its intent to designate VCAs as organs within the oversight of HRSA and the OPTN. • OPTN Final Rule has NOT yet been amended for VCA • Committee will assist early stages in the VCA policy development to identify and discuss potential ethical issues.

  8. Vascular Composite Allografts • Will need policies and oversight : • Matching and placement of organs • Organ recovery, distribution, and transplantation • Membership and program qualifications • Data collection and sharing • Compliance • Professional and public education

  9. Questions?

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