Surrogate Consent—Assessing Capacity

Paul S. Appelbaum, MDDollard Professor of Psychiatry, Medicine &

LawColumbia 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

Leeway: How much freedom or leeway

would you give [a] close family member

to go against your preference and instead

[enroll/not enroll] you in the study?

(n=1,456)

None

Some

Complete

41.4

39.3

19.3

33.2

40.6

26.2

45.2

37.9

16.9

39.6

39.2

21.1

LP Drug RCT Vaccine GeneRxViews of Older Americans (age 51+), n=1400+

(Kim et al, Neurology 2009)

Many People Trust Family Members to Make Research Participation Decisions—Even Against Their

Preferences

Among those willing to participate in research based on decision by a surrogate, 76% would allow some or complete leeway.

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)

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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.

Copyright restrictions may apply.

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

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Distribution of MMSE scores (0-30)

Distribution of CAPA Scores (0-28)

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Copyright restrictions may apply.

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.

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