FIRST-PERSON CONSENT FAMILY CONSENT DONOR REGISTRY LIVING INFORMED CONSENT STATUTORY AUTHORIZATION UAGA PRESUMED CONSENT ANATOMICAL GIFTING.
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1 FIRST-PERSON CONSENT FAMILY CONSENT DONOR REGISTRY LIVING INFORMED CONSENT STATUTORY AUTHORIZATION UAGA PRESUMED CONSENT ANATOMICAL GIFTING DuBois 1
2 INCONSISTENCIES IN CONSENT FOR ORGAN DONATION: Are Different Standards Appropriate To Different Donation Contexts? James M. DuBois, PhD, DSc
3 DISCLOSURE Presenter has no financial conflicts of interest to report Laws provide boundaries for ethical behavior in transplant and will be discussed Presenter is not a lawyer; in discussing laws he does not render legal advice DuBois 3
4 OPPOSITE EXTREMES Some people want more rigorous consent procedures They say we should: Meet legal standards of informed consent Have separate consents for standard donation, DCD, and UDCD Disclose controversies over death criteria DuBois 4
5 OPPOSITE EXTREMES Others think We don t need expressed consent for deceased donation Presume consent have an opt out system DuBois 5
6 OVERVIEW I will argue that our current practices often: Are inconsistent Do not meet standards of informed consent DuBois 6
7 OVERVIEW They should be inconsistent because We have 2 legal frameworks for donation The context of procedures matters ethically and legally Living vs. deceased donors Pre-mortem vs. postmortem interventions Controlled vs. uncontrolled settings Organ donation vs. organ preservation DuBois 7
8 WHY IS PERMISSION IMPORTANT IN SOCIAL RELATIONSHIPS? Educating children Sexual Financial investing Health care Why and how do we give permission in these contexts? school.discoveryeducation.com DuBois 8
9 INTERSECTING LEGAL DOCTRINES IN ORGAN DONATION Gift Law Organ donation is uncompensated Once given, the organ/tissue is subject to gift law Essential element: Donation intent Informed Consent Law Governs physicianpatient relationship Applies to medical interventions on a living patient See Glazier 2009 * See Downie, Shea, (2008) DuBois 9
10 WHAT IS THE DOCTRINE OF INFORMED CONSENT? What is informed consent? When is it necessary? Who can grant consent? DuBois 10
11 WHAT ARE THE OBJECTIVE COMPONENTS OF INFORMED CONSENT? What healthcare providers must do: Inform Procedures / alternatives Risks / benefits of each Avoid coercing Request permission Sometimes obtain a signature on a form DuBois 11
12 WHAT ARE THE SUBJECTIVE COMPONENTS OF INFORMED CONSENT? Decisional capacity requires: Understanding Appreciation Reasoning Expressing a choice DuBois 12
13 THE KINDS OF DONATION PROTOCOLS Objective & subjective consent practices vary by context Living Standard (neurological) Controlled DCD Uncontrolled DCD DuBois 13
14 CONSENT IN THE CONTEXT OF LIVING DONATION Informed Consent Process Disclosure E.g., procedures, risks (medical, financial), expected outcomes (for self and recipient), follow up, expenses Capacity/understanding Voluntariness Independent donor advocate Debates Quality of long-term outcomes data Can living related donors freely say no? Can we lie to provide an out? See Consensus Statement (2000) DuBois 14
15 CONSENT IN THE CONTEXT OF STANDARD DECEASED DONATION Gifting Model Via Registry or Family Consent Disclose basic info about: Uses of gift Financial impact Funeral impact Determine intent to donate & scope Debates Are registry donors well informed? Pre-mortem optimization procedures Will advanced directives be honored? Why do families usually get more information than 1 st person donors? DuBois 15
16 CONSENT IN THE CONTEXT OF CONTROLLED DCD Mixed Model Similar to standard deceased donation, but Patient is alive when Consent is obtained or disclosure to family is made Pre-mortem interventions begin (e.g., heparin) Debates What needs to be disclosed? Death criteria? Heparin use or use and alleged risks? Comfort measures? So informed consent is needed for medical interventions DuBois 16
17 CONSENT IN THE CONTEXT OF UNCONTROLLED DCD 2 Authorizations Authorization for organ preservation* Cooling or Sustained CPR or ECMO Consent to organ donation Debates Is routine organ preservation ok given UAGA State statutes, or Community engagement?** * No circulation at time of death **Arrest occurs in field family are often absent DuBois 17
18 SUMMARY OF KINDS OF AUTHORIZATION Stronger First-person informed consent, assessment of capacity & voluntariness Disclosure of procedures, risks, alternatives, etc Documentation of intent to donate (1 st person or proxy) With proxy consent following limited consent information about pre-mortem medical interventions Weaker Documentation of intent to donate (1 st person or proxy) Without informed consent for medical procedures Statutory authorization Waives need for consent or intent to donate DuBois 18
19 FACTORS INFLUENCING THE KIND OF AUTHORIZATION REQUIRED Key Questions Why? Is the donor living or deceased? Affects the kind of risks and autonomy rights Are we preserving or procuring organs? Who is consenting? Affects the degree of intervention on the deceased Proxies may need reassurance DuBois 19
20 WHAT ABOUT PRESUMED CONSENT? Can we presume consent? Is that what advocates mean? Is an opt out system really that different? Is an opt out system a good fit with the US? What would it accomplish? DuBois 20
21 WE PRESUME NEUTRALITY UAGA allows refusal to donate This bars further requests Accommodates mistrust, moral and religious objections Failure to join registry does not imply unwillingness to donate Some data suggest MOST such persons support donation Request is thus appropriate (legally mandated) See DuBois, Waterman (2009) DuBois 21
22 Consent transforms medical assault into a meaningful gift SUMMARY: CONSENT IS MAGICAL DuBois 22
23 SUMMARY: INCONSISTENCY IS OUR FRIEND Consent may be granted in many ways Donation authorization may involve both gifting and informed consent for medical procedures Contexts matter! DuBois 23
24 INCONSISTENCIES IN CONSENT FOR ORGAN DONATION: Are Different Standards Appropriate To Different Donation Contexts? James M. DuBois, PhD, DSc
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