alexandra k. glazier, jd, mph why gift law matters: the law and ethics of donor designation
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Alexandra K. Glazier, JD, MPHWhy Gift Law Matters: The Law and
Ethics of Donor Designation
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Why gift law matters: the law and ethics of
donor designationAlexandra K. Glazier, JD, MPH
VP General Counsel, New England Organ Bank
Chair, OPTN/UNOS Ethics CommitteeFaculty, Boston University School of Law
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Legal Basis of Deceased Donation in the U.S.
The Uniform Anatomical Gift Act (UAGA)
Primary legal authority for organ and tissue donation
Model legislation enacted as state law
First drafted in 1968, revised in 1987 and 2006
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Legal Basis of Deceased Donation in the U.S.
State lawConsent a reserved power of the states
Federal regulation of transplantation
Every state passed original UAGA
47 states have now enacted the 2006 version
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True or False ?The law requires informed consent for deceased organ donation.
A. TrueB. False
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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
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Legal Basis of Deceased Donation
Other decisions do not fall under the informed consent legal principles
advanced directives
burial / cremation
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Legal Principles of Gift law
Gift defined:
A gift is a voluntary and legallybinding uncompensated transfer
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Legal Basis of Deceased Donation
Gift law as primary legal principle in UAGA
Gift law requires 3 elements:○ Intent○ Transfer○ Acceptance
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Legal Basis of Deceased Donation
The gift is conditionalDeathClinical suitability
The gift is limitedTransplant / therapyResearchEducation
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First Person Authorization
Adult individuals have the right to make a legally
binding anatomical gift prior to death.
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Legal Basis of First Person Authorization
Under the UAGA an anatomical gift can be made:By an adult prior to death
By a surrogate decision-maker at death
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UAGA: First Person Authorization
Document of gift
Satisfies first legal element of gift law
Signed by adult prior to death
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Which of the following are legally recognized ways to make an anatomical gift?
A. Signing up for the donor registry at the DMV
B. Written statement in a will
C. Verbal statement D. All of the aboveE. A and B but not C
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Approximately how many registered donors in the U.S.?
A. 5 millionB. 25 millionC. 50 millionD. Over 100 million
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0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
Donor Designation in the United States
110,277,329 as of 3/31/13
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19%
25%28%
33%36%
40%
27% 27%30%
37%
42%45%
33%38%
42% 42%
48%
0%
10%
20%
30%
40%
50%
60%
2007 2008 2009 2010 2011 2012
Organ Donors Tissue Donors Eye Donors
Impact on Donation, 2007-2012 Designated Donors Among Recovered Donors
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UAGA: First Person Authorization
Disclosure of donor designation to familyRequired by some state laws CMS regulationsOPO practice
Coordination of donationLegal permission is the floor not the ceilingFamilies are an integral part of carrying out the
donor’s gift
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Ethical Basis of First Person Authorization
Self-determination concept that adult individuals should be able to make their own decisions about donation of organs after their death
Consistent with ethical principles behind other advanced directives
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True or False ?Family can revoke donor designation at the time of a patient’s death.
A. TrueB. False
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What happens when families object?
LawFirst person authorization is a legally
binding anatomical gift that family cannot over-ride
Gift can be accepted or declined
Legally protected and granted immunity from liability if follow UAGA in good faith.
EthicsRespect the autonomy rights of the
donorMaximize the potential good (lives
saved)
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How to move forward Hospital staff knowledge of the law
Escalation protocol in placebasis of family objectiontransplant potential
Coordinated decision between OPO and Hospital
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“A ship is safe in the harbor, but that's not what ships are for.”
- William Shedd
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4 things to know about the legal and ethical principles of donation
The Uniform Anatomical Gift Act is the law that governs deceased donation in the U.S.
It is based on gift law principles not informed consent
Adults can make their own legally binding donation decision prior to death
The ethical principle of autonomy supports first person authorization