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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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VCA Donation: legal framework and NEOB experienceAlexandra K. Glazier, JD MPHVP & General CounselNew England Organ Bank


Legal framework organ donation
Legal framework: organ donation

  • Uniform Anatomical Gift Act (UAGA)

  • State law

  • For specific purposes

    • Transplantation, research, education

  • Based on gift law principles


Legal basis of deceased donation
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


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


    Legal basis of deceased donation1
    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


  • State law uaga
    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)


    Uaga and vcas
    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


    Donor registries and vcas
    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


    Current neob practice
    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


    Current neob practice1
    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


    Neob experience
    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


    Neob future considerations
    NEOB Future Considerations 

    • Multiple programs approved to perform VCA transplants

    • Regional allocation system being created

    • Matching criteria versus allocation priority


    Neob future considerations1
    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


    Neob future considerations2
    NEOB Future Considerations 

    • VCAs designated as “organs”

      • Regulatory

      • Allocation

        • Sharing

        • Priority

    • Authorization practices may change


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