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

2. OPTN 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. OPTN  Ethics Committee will work with the OPO Committee to survey UDCD protocols to develop model elements to be included in the protocols. Proposed Activity OPO Committee Uncontrolled DCD (UDCD or Rapid Organ Recovery)

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

5. OPTN Concerns with Proposed DCD Model Elements 1/2 1. Support the change in use of term circulatory instead of cardiac in Donation by Circulatory Death. 2. Consent issues remain, including when to contact donor families about potential DCD and first person consent. 3. Committee does not agree with the OPO approaching the donor family before the decision to withdraw treatment or support.

6. OPTN Concerns with Proposed DCD Model Elements 2/2 4. Ethically inappropriate to make the OPTN the arbiter on how to describe circulatory death. 5. 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? 6. The Committee supports the requirement that the evaluation for DCD suitability should occur pre-mortem.

7. OPTN 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. OPTN 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. OPTN Questions?