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Surrogate Consent—Assessing Capacity

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					    Surrogate Consent—Assessing
              Capacity

            Paul S. Appelbaum, MD
Dollard Professor of Psychiatry, Medicine & Law
              Columbia University
        Why Surrogate Consent?
   Some areas of research will be difficult
    or impossible to pursue without the
    participation of subjects who are unable
    to provide consent
   Categories include:
       Children (separate regs, not discussed
        here)
       Adults with impaired capacity
      Alzheimer’s Disease As Paradigm
           for Surrogate Consent
   By 2040, roughly 80 million people
    worldwide will suffer from AD—major public
    health issue
   Impaired decision making appears early in
    the course of the illness, even in mild AD
   Research on diagnosis and treatment will
    often involve persons unable to give
    consent
          Who Will Give Consent for
       Persons with Impaired Capacity?
   Federal regulations provide mechanism for
    surrogate consent, allowing consent by
    “legally authorized representative” (LAR):
    “Legally authorized representative means an
    individual or judicial or other body authorized
    under applicable law to consent on behalf of a
    prospective subject to the subject's participation in
    the procedure(s) involved in the research.”
                Who Can Be An LAR?
   “The issue as to who can be an LAR is determined by the
    laws of the jurisdiction in which the research is conducted
    (e.g., local or state law). Some states have statutes,
    regulations, or common law that specifically address
    consent by someone other than the subject for participation
    in research. Most states have no law specifically addressing
    the issue of consent in the research context. In these
    states, law that addresses who is authorized to give consent
    on behalf of another person to specific medical procedures
    or generally to medical treatment may be relevant if the
    research involves those medical procedures or medical
    treatment.” OHRP FAQs on Informed Consent
        Possibilities for Designation of
              An LAR: 3 Options
   Designation in advance of becoming
    decisionally impaired, i.e., via an advance
    directive designating a surrogate
       Only a small proportion of the population has
        advance directives
       Unclear whether ordinary advance directives
        provide authority for research decisions—
        though OHRP language suggests that they do
             Second Option for LAR
   Designation after becoming decisionally
    impaired, i.e., via default designation in
    that jurisdiction
       Statutory designation via hierarchy
       Common law reliance on familial decision
        making
       But has downside of taking decision out of
        subject’s hands
   Or…
               Third Option for LAR
   When approached for research
    participation
       Possible when subject has lost capacity to
        make research decision, but retains capacity to
        appoint a surrogate or proxy decision maker
       Respects autonomy interest of subject by
        empowering him/her to designate surrogate
       Thus, when possible, may be preferable
        approach, i.e., “concurrent directive”
      When Is Someone Capable of
        Appointing a Surrogate?
   If criteria require that subject fully grasp
    the decision that the surrogate will make,
    not much point in having a surrogate
   Perhaps the key lies in the subject grasping
    the function of the surrogate and the
    potential consequences of the designation,
    and trusting the surrogate with the decision
              Many People Trust Family Members to
             Make Research Participation Decisions—
                Even Against Their Preferences
Views of Older Americans (age 51+), n=1400+            LP     Drug RCT Vaccine GeneRx


Leeway: How much freedom or leeway            None     41.4    33.2     45.2 39.6

would you give [a] close family member
                                              Some     39.3    40.6     37.9 39.2
to go against your preference and instead

[enroll/not enroll] you in the study?         Complete 19.3    26.2     16.9 21.1

(n=1,456)

Among those willing to participate in research based on decision by a surrogate,
76% would allow some or complete leeway. (Kim et al, Neurology 2009)
          How To Decide On Specific Criteria
           for Capacity to Appoint a Proxy?
   Gradual development with attention to
    process
       Establish provisional criteria
       Test in the field
       Remain open to revisions based on
        experience/results
   Study that follows conducted by Scott Kim
    (UMich) and colleagues (Arch. Gen. Psychiatry, Feb.
    2011)
                                                    11
                   Goal
   To determine to what extent a person
    with dementia who lacks the capacity to
    consent to a research study might have
    the capacity to delegate the
    responsibility for a consent decision by
    appointing a research proxy
                Methods of Study - 1
   Subjects recruited from 3 AD clinics with
    possible or probable AD, stratified by MMSE
   Two MacCAT-CRs to assess capacity to
    consent to research for 2 different studies:
       Randomized clinical trial testing a new
        medication for AD
       Randomized placebo-controlled (sham surgery)
        neurosurgical clinical trial of cell transplantation
        for AD
           Methods of Study - 2
   Also receive instrument to assess capacity
    to appoint a proxy (CAPA)
   All interviews done in subjects’ homes over
    2 visits and videotaped
   5 experienced clinicians (C/L psychiatrists
    who regularly do competence
    assessments) were trained to review tapes
    and make categorical determinations of
    capacity on CAPA and MacCAT-CRs
            Approach to Assessment of
        Capacity to Appoint a Research Proxy
   Approach
       In the absence of consensus criteria, use
        of inclusive criteria, based on MacCAT-CR
         Nature of research (3)
         Nature of research proxy (5)

         Pros and cons of having a proxy (2)

         Performance-related elements (4)

     Disclosure precedes questions
     Semi-structured, 14 items, score 0-28.
                 Items in Capacity to Appoint a
                    Proxy Assessment (CAPA)
                                       Topics Covered in CAPA
Understanding
1. Research creates knowledge to develop treatments and preventions for AD.
2. Research is primarily intended to benefit others with AD rather than those who participate.
3. Research can involve risks, from common minor ones to rare but major ones such as death.
4. Symptoms of AD can prevent some people from giving their own consent for research.
5. By appointing someone as a research proxy, they can choose someone else to decide for them.
6. Research proxy goes into effect when the person with AD becomes incapable.
7. Being a research proxy can be a burdensome task.
8. Talking with one’s proxy ahead of time makes the proxy’s job easier.
9. One benefit of appointing a proxy is that one gets to choose who speaks for oneself.
10. There is no guarantee that the proxy will do what one would have wanted.
Choice, Appreciation, and Reasoning
11. Subject him/herself may not be able to make his/her own research decisions in the future.
12. Subject is able to express whether he/she would or would not appoint a research proxy.
13. Reasoning about why the subject would or would not appoint a proxy.
14a. If the subject would choose a proxy, who the proxy would be and why that person is chosen.
14b. If the subject would not choose a proxy, what they think might happen if they ever reached the point
of incapacity.
                                    Kim, S. Y. H. et al. Arch Gen Psychiatry 2011;68:214-219.



Copyright restrictions may apply.
Distribution of MMSE scores (0-30)




                                     18
Distribution of CAPA Scores (0-28)




                                     19
                     Kim, S. Y. H. et al. Arch Gen Psychiatry 2011;68:214-219.

Copyright restrictions may apply.
               Kim, S. Y. H. et al. Arch Gen Psychiatry 2011;68:214-219.

Copyright restrictions may apply.
         Conclusions from Study - 1
   Capacity to appoint a research proxy better
    preserved than the capacity to consent for a
    drug RCT, which was better preserved than
    the capacity to consent to a higher-risk
    neurosurgical RCT
   Experts appear to apply a sliding-scale to
    competence determinations based on
    complexity and risk
         Conclusions from Study - 2
   Valid informed consent for research requires
    subjects to learn new, technical information
    about research design, a particularly difficult
    task for persons with AD.
   Appointing a proxy, requires trusting
    someone else to make a decision, a familiar,
    relationship-based concept. Subjects will
    have had a close relationship for years with
    most proxies.
           Conclusions from Study - 3
   Most important of all, there is a window in
    AD during which subjects are incapable of
    consenting to research, but capable of
    appointing a proxy
       38% of those incapable of consenting to the
        drug RCT and 55% of those incapable of IC for
        neurosurgical RCT still have capacity to appoint
        a research proxy
       91.7% of those with MMSE 24 or higher were
        capable of appointing a research proxy
        Future of Surrogate Consent
   For disorders with partial retention of
    decision making capacity (i.e., AD but not
    coma), option of asking subjects to appoint
    surrogate appears viable
    Further development of consensus on
    criteria will be helpful

				
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