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Developed by:
U-MIC

2. Cognitively impaired subjects
and Legally Authorized Representatives
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U-MIC
University of Michigan IRB Collaborative

3. Cognitive impairment Consent capacity
ability to understand information
relevant to informed, voluntary decision whether to participate
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U-MIC

4. Cognitive impairment Cognitive impairment
inability/limited ability to provide consent due to impairment of
memory
understanding
reason
may be fixed
developmental disorders
may fluctuate
some mental illnesses
may worsen over time
Alzheimer’s disease
may improve
some brain injuries
affects ability to protect one’s own interests
may be compounded by circumstances that limit freedom of choice
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U-MIC

5. Cognitive impairment Cognitive impairment
not limited to psychiatric and neurological diseases
may result from
stroke
trauma
drug/alcohol use
other causes
effect on consent capacity depends on
nature of information
complexity of information
single blood draw
versus
more complex research
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U-MIC

6. Cognitively impaired subjects
Cognitive impairment
Cognitively impaired subjects
may face extra vulnerabilities
inadequate understanding of their impairments
stigma
discrimination
IRB members/consultants
expertise relevant to
study design
difficulties faced by cognitively impaired individuals
judge appropriateness of impaired subjects’ involvement
assess subject population’s consent capacity
evaluate appropriateness of LAR involvement
recommend extra protections tailored to subjects’ impairments
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U-MIC

7. Cognitively impaired subjects
Cognitive impairment
Cognitively impaired subjects
generally acceptable to involve cognitively impaired subjects in research that
meets criteria for IRB approval
poses no more than minimal risk
includes provisions for
LAR’s consent
subject’s assent (as appropriate)
subject’s affirmative agreement to participate
generally not acceptable to involve cognitively impaired subjects in research that
poses more than minimal risk
unless it offers potential for direct benefit
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U-MIC

8. evaluating consent capacity
Cognitive impairment
evaluating consent capacity
varies by risk level
no more than minimal risk
study team’s judgment that subject understands and wishes to participate
higher-risk studies
formalized evaluation procedures
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U-MIC

9. Legally authorized representatives (LARs)
Cognitive impairment
Legally authorized representatives (LARs)
authorized under state law to consent on behalf of cognitively impaired subjects
should base decision on
knowledge of potential subject’s wishes
familiarity with potential subject’s
beliefs
values
past decisions
potential subject’s interests
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U-MIC

10. Legally authorized representatives (LARs)
Cognitive impairment
Legally authorized representatives (LARs)
when LAR provides consent
Cognitively impaired individual should provide assent (as appropriate).
Cognitively impaired individual’s objection should be honored.
If subject enrolled with LAR consent gains consent capacity during participation
Subject should be asked to consent to continued participation.
Developed by:
U-MIC

11. Legally authorized representatives (LARs)
Cognitive impairment
Legally authorized representatives (LARs)
laws vary from state to state
consult
legal counsel
state agency
UM IRBs work with Office of the Vice President and Legal Counsel.
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U-MIC

12. Cognitive impairment IRB
may require study team member obtaining consent to sign document
indicating that they believe the subject and/or LAR understood study information
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U-MIC

13. Researchers enrolling cognitively impaired subjects
Cognitive impairment
Researchers enrolling cognitively impaired subjects
consider additional components
study team well-experienced with population
study information tailored to subjects’ needs
monitoring consent/assent capacity and willingness to participate
involvement of
family member or friend
clinician to monitor subjects’ physical and mental well-being
LAR
during the consent process
throughout study
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U-MIC

14. Cognitively impaired subjects
Cognitive impairment
Cognitively impaired subjects
and legally authorized representatives (LARs)
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U-MIC

15. Thank you. Adam Mrdjenovich IRB-HSBS Judith Birk IRBMED Developed by:
U-MIC