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Cognitively impaired subjects and Legally Authorized Representatives Developed by: U-MIC University of Michigan IRB Collaborative

Cognitive impairment Consent capacity ability to understand information relevant to informed, voluntary decision whether to participate Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

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

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. Developed by: U-MIC

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 Developed by: U-MIC

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 Developed by: U-MIC

Cognitively impaired subjects Cognitive impairment Cognitively impaired subjects and legally authorized representatives (LARs) Developed by: U-MIC

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