Determining Capacity to Consent to Research in Cognitively Impaired Individuals Presentation

1. Determining Capacity to Consent
to Research in Cognitively
Impaired Individuals
David J. Moser, Ph.D.
Department of Psychiatry
University of Iowa
Carver College of Medicine
Bioethics Forum
March 3, 2006

2. Informed Consent
 The most basic ethical component of
research
 Assures the the subject receives
information, understands it, and makes a
voluntary (uncoerced) choice regarding
participation

3. Balancing Act
Freedom vs. Protection

4. Competence
 Technically speaking, this is a legal term
 What we assess as clinicians and
researchers is decisional capacity

5. Incompetence
 “Incompetence constitutes a status of the
individual that is defined by functional
deficits (due to mental illness, mental
retardation, or other mental conditions )
judged to be sufficiently great that that
person currently cannot meet the demands
of a specific decision-making situation,
weighed in light of its potential
consequences.” (Grisso & Appelbaum, p.
27).

6. What does “cognitively
impaired” mean?
 When should I check the Cognitively Impaired
box on the IRB form?
 Will this cause a SWAT team to knock on my
door and audit my study?
 How can I enroll cognitively impaired
people into my study while providing them, and
myself, with adequate protection?

7. What might impair decisional
capacity?
 Mental illness (but not always)
 Many forms of medical illness
 Acute stress
 Medications / drugs

8. Findings from our research…
80% of people with schizophrenia are able to
provide informed consent to research studies
In these subjects, decisional capacity was
strongly associated with cognitive function, and
only weakly associated with symptoms such as
hallucinations and delusions
(Moser DJ et al. Am J Psychiat 2002;159:1201-7)

9. Findings from our research…
This capacity did not change significantly after
discontinuation of antipsychotic medications
(Moser DJ, et al. Am J Psychiat 2005;162:1209-1211)
In a sample of 30 mentally ill prisoners, all but one
demonstrated adequate decisional capacity
(Moser DJ, et al. Compr Psychiat 2004;45(1):1-9)

10. How to assess decisional capacity?
 Thorough discussion during consent
process
 Specific tests of decisional capacity
 Neuropsychological testing

11. MacArthur Competence
Assessment Tool
 Treatment and Clinical Research versions
 Semi-structured interview
 Information presented piece by piece, with
questions following each major element
 Quantitative ratings made by examiners

12. Understanding
 Can the individual comprehend the
information that you are providing?
 This includes such things as procedures,
risks, benefits, alternatives, what to do if
wanting to discontinue participation, etc.

13. Appreciation
 Can s/he understand the consequences of
participating or not on a personal level
(e.g. how this decision will affect him or
her person specifically?).

14. Reasoning
 Can s/he weigh the pro’s and con’s of
participation in a rational and organized
manner?
 Can s/he explain this reasoning process to
you, indicating the advantages and
drawbacks of participation?

15. Expression of Choice
 Can s/he come to a decision and express
it?
 Is this decision relatively stable or is there
a significant amount of ambivalence?

16. Verbal Expression

17. Nonverbal Expression

18. MacCAT Pro’s
 Very thorough assessment of decisional
capacity
 Allows for quantitative ratings
 Helps determine specific aspects of
decisional capacity that may be impaired

19. MacCAT Con’s
 Time consuming
 Domains cannot be combined to form a
Total Score
 Does not result in a specific outcome (e.g.
competent vs. not competent)

20. Where do I get the MacCAT-CR?
 Appelbaum PS, Grisso T. MacCAT-CR.
Sarasota FL Professional Resource
Press;2001

21. Evaluation to Sign Consent
(DeRenzo EG, et al. J Health Care Law Polic 1998;1:66-87)
 Much quicker, more practical than
MacCAT-CR
 But also less detailed, less informative
regarding various aspects of capacity
 Typically accepted by our IRB
 Copy available on the Human Subjects
Office website (research.uiowa.edu/hso)

22. Evaluation to Sign Consent
1) Is the subject alert and able to
communicate with the examiner
2) Ask the subject to name at least 2
potential risks of participating in the study.
3) Ask the subject to name at least 2 things
that he/she will be expected to do in the
study

23. Evaluation to Sign Consent
4) Ask the subject to explain what he/she
would do if he/she no longer wanted to
participate in the study.
5) Ask the subject to explain what he/she
would do if he/she experienced distress or
discomfort during the study.
Evaluator’s Signature: It is my opinion
that the subject is alert, able to
communicate, and gave acceptable
answers to the questions above

24. So your subject lacks adequate
decisional capacity…now what?

25. Can decisional capacity be
improved?
 Simplified consent forms
(Bjorn E, et al. J Med Ethics 1999;25:263-7)
 Interactive computerized learning aides &
repeated exposure to material
(Carpenter WT, et al. Arch Gen Psychiat 2000;57:533-8)
 Multimedia (e.g. video)
(Fureman I, et al. AIDS Educ Prev 1997;9:330-341)

26. Can decisional capacity be
improved?
 Enhanced interviewing with corrective
feedback
(Dunn LB et al., Am J Psychiat 2001;158-1911-13)
 Review paper:
Dunn LB et al., Neuropsychopharmacol 2001;24:595-607

27. Improving Decisional Capacity
 We used a semi-tailored intervention
to significantly improve decisional
capacity in schizophrenia
 20 – slide PowerPoint presentation
 Discussion of all MacCAT-CR items
on which the subject did not earn
maximal credit

28. Improving Decisional Capacity
 Subjects with baseline MacCAT-CR
Understanding scores < 23 showed
significant improvement (Cohen’s d = .6, p
< .05).
(Moser DJ et al., Schiz Bull 2006;32(1):116-120)

29. Isn’t this just teaching to the
test?
 To some degree yes, but that’s okay.
You’re not trying to improve the subject’s
general cognitive functioning – just his or
her capacity to consent to a particular
study.
 Important to have the subject use his or
her own words when conveying
understanding of the study. Don’t allow
him or her to simply parrot back your
words.

30. Not all subjects can benefit
sufficiently from such
interventions.
So now what?

31. Legally-Authorized Representatives
 Designated proxy (e.g. durable power of attorney for
healthcare)
 Court appointed guardian
 Spouse (NOT including common law spouse)
 Adult child
 Parent
 Adult sibling

32. If you can’t find Mr. Right, is it
okay to settle for
Mr. Right Now?
NO
From the list of potential LAR’s, the first existing
person must be consulted, even if another person
on the list is more conveniently available.*
* There are some exceptions to this, but err on the side of caution

33. Assent
Even though incompetent to consent, the
cognitively impaired person must assent to
participate
Assent cannot be passive
There are some circumstances in which
assent is not absolutely required
Assent does not overrule dissent from an
LAR

34. Assessing capacity is a
process, not a snapshot
 Consent process should be ongoing
and interactive
 Re-assessment can be important in
longitudinal studies
 Designating a proxy at the start of a
longitudinal study is often helpful

35. Vignette 1
An elderly man with AD is clearly
unable to provide informed consent,
but agrees to be in your research
study. He and his ex-wife are on
amicable terms and, in fact, they
resumed living together two years
ago. She agrees that he should be in
the study. Can she serve as his
LAR?

36. Vignette 2
A patient is able to fully understand all of
the procedures, risks, and benefits of
being in your study. He states that he
doesn’t really want to participate, but he
knows that Larry Mullin (U2’s drummer)
wants him to, so he would like to enroll.
What to do?
What if, instead of Larry Mullin, he felt
certain that God wanted him to
participate?

37. Recommended Reading
 Assessing Competence to Consent to
Treatment. Thomas Grisso & Paul
Appelbaum, 1998, Oxford University Press.

38. Need Help?
Suzanne Bentler
IRB Administrator
335-6910

39. Questions or Comments?
David J. Moser, Ph.D.
Department of Psychiatry
Phone: 319-353-4360
Email: david-moser@uiowa.edu