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+
Leeway: How much freedom or leeway
LP
Drug RCT Vaccine GeneRx
None
41.4
33.2
45.2 39.6
Some
39.3
40.6
37.9 39.2
Complete 19.3
26.2
16.9 21.1
would you give [a] close family member
to go against your preference and instead
[enroll/not enroll] you in the study?
(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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