VCA Donation: legal framework and NEOB experience

Alexandra K. Glazier, JD MPH

VP & General CounselNew England Organ Bank

Legal framework: organ donation

Uniform Anatomical Gift Act (UAGA)

State law

For specific purposesTransplantation, research,

education

Based on gift law principles

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

UAGA is not based on informed consent principles

○ authorization○ legal permission

Informed consent is a legal principle that applies to healthcare treatment decisionsrisks and benefits to the patientdoctor patient fiduciary relationship

Legal Basis of Deceased Donation

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

Anatomical Gift broadly definedA 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 “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

Permission from Agent/Next of KinUnique privacy considerationsNewness of VCAsResearch context of VCA transplant

Approach families after organ donationPrioritize organ donationSelf-select families who are inclined to

donate

Current NEOB Practice

Specialized form

VCA form includes:Description of graft(s) to be donatedNeed for photos prior to recoveryAltered appearance of donor post-

recoveryMedia attention on recipient likelyDonor’s identity may be revealed

NEOB Experience

VCA donations coordinated:4 facial graft donations/ transplants2 sets of hand graft donations /

transplants

VCA consent rate:More than 50%

VCA post-donation donor family issues:None

NEOB Future Considerations

Multiple programs approved to perform VCA transplants

Regional allocation system being created

Matching criteria versus allocation priority

NEOB Future Considerations Matching Criteria

ABOHLAsizegender age rangeskin tone range

Allocation Priority0 antigen mismatchBilateral need for extremitiesWaiting time

NEOB Future Considerations

VCAs designated as “organs” RegulatoryAllocation

○ Sharing○ Priority

Authorization practices may change