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Legal framework: organ donation

VCA Donation: legal framework and NEOB experience Alexandra K. Glazier, JD MPH VP & General Counsel New England Organ Bank. Legal framework: organ donation. Uniform Anatomical Gift Act (UAGA) State law For specific purposes Transplantation, research, education Based on gift law principles.

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Legal framework: organ donation

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  1. VCA Donation: legal framework and NEOB experienceAlexandra K. Glazier, JD MPHVP & General CounselNew 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. Legal Basis of Deceased Donation • 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

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

  5. Legal Basis of Deceased Donation • UAGA is notbased 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

  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

  11. 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

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

  13. 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

  14. NEOB Future Considerations • VCAs designated as “organs” • Regulatory • Allocation • Sharing • Priority • Authorization practices may change

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