1. VCA Donation: legal framework and NEOB experience Alexandra K. Glazier, JD MPH VP & General Counsel New England Organ Bank

2. Legal framework: organ donation  Uniform Anatomical Gift Act (UAGA)  State law  For specific purposes Transplantation, research, education  Based on gift law principles

3.  Gift law as primary legal principle in UAGA  Gift law requires 3 elements: ○ Intent ○ Transfer ○ Acceptance  A gift is a voluntary and legally binding uncompensated transfer Legal Basis of Deceased Donation

4.            

5.  UAGA is not based on informed consent principles ○ authorization ○ legal permission  Informed consent is a legal principle that applies to healthcare treatment decisions risks and benefits to the patient doctor patient fiduciary relationship Legal Basis of Deceased Donation

6. State Law: UAGA  Authorization based on Donor’s decision (first person consent) ○ Donor registries ○ Irrevocable gift upon death Surrogate decision ○ In absence of first person consent ○ Priority list (agent, next of kin)

7. UAGA and VCAs  Anatomical Gift broadly defined A donation of all or part of a human body to take effect after death  VCAs fall under definition of “part” organ, eye or tissue

8. Donor Registries and VCAs  Donor Registries “any needed organ or tissue” specific donation  Experimental VCA protocols may be considered “research” Some donor registries include use of the gift for research and some do not

9. Current NEOB Practice  Permission from Agent/Next of Kin Unique privacy considerations Newness of VCAs Research context of VCA transplant  Approach families after organ donation Prioritize organ donation Self-select families who are inclined to donate

10. Current NEOB Practice  Specialized form  VCA form includes: Description of graft(s) to be donated Need for photos prior to recovery Altered appearance of donor post-recovery Media attention on recipient likely Donor’s identity may be revealed

12. NEOB Experience  VCA donations coordinated: 4 facial graft donations/ transplants 2 sets of hand graft donations / transplants  VCA consent rate: More than 50%  VCA post-donation donor family issues: None

13. NEOB Future Considerations  Multiple programs approved to perform VCA transplants  Regional allocation system being created  Matching criteria versus allocation priority

14. NEOB Future Considerations  Matching Criteria ABO HLA size gender age range skin tone range  Allocation Priority 0 antigen mismatch Bilateral need for extremities Waiting time

15. NEOB Future Considerations  VCAs designated as “organs” Regulatory Allocation ○ Sharing ○ Priority  Authorization practices may change