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
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
Competence Technically speaking, this is a legal term What we assess as clinicians and researchers is decisional capacity
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).
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?
What might impair decisional capacity? Mental illness (but not always) Many forms of medical illness Acute stress Medications / drugs
Findings from our research…80% of people with schizophrenia are able toprovide informed consent to research studiesIn these subjects, decisional capacity wasstrongly associated with cognitive function, andonly weakly associated with symptoms such ashallucinations and delusions(Moser DJ et al. Am J Psychiat 2002;159:1201-7)
Findings from our research…This capacity did not change significantly afterdiscontinuation of antipsychotic medications(Moser DJ, et al. Am J Psychiat 2005;162:1209-1211)In a sample of 30 mentally ill prisoners, all but onedemonstrated adequate decisional capacity(Moser DJ, et al. Compr Psychiat 2004;45(1):1-9)
How to assess decisional capacity? Thorough discussion during consent process Specific tests of decisional capacity Neuropsychological testing
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
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.
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?).
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?
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?
MacCAT Pro’s Very thorough assessment of decisional capacity Allows for quantitative ratings Helps determine specific aspects of decisional capacity that may be impaired
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)
Where do I get the MacCAT-CR? Appelbaum PS, Grisso T. MacCAT-CR. Sarasota FL Professional Resource Press;2001
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)
Evaluation to Sign Consent1) Is the subject alert and able to communicate with the examiner2) 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
Evaluation to Sign Consent4) 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
So your subject lacks adequatedecisional capacity…now what?
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)
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
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
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)
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.
Not all subjects can benefit sufficiently from such interventions. So now what?
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
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
AssentEven though incompetent to consent, thecognitively impaired person must assent toparticipateAssent cannot be passiveThere are some circumstances in whichassent is not absolutely requiredAssent does not overrule dissent from anLAR
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
Vignette 1An elderly man with AD is clearlyunable to provide informed consent,but agrees to be in your researchstudy. He and his ex-wife are onamicable terms and, in fact, theyresumed living together two yearsago. She agrees that he should be inthe study. Can she serve as hisLAR?
Vignette 2A patient is able to fully understand all ofthe procedures, risks, and benefits ofbeing in your study. He states that hedoesn’t really want to participate, but heknows 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 feltcertain that God wanted him toparticipate?
Recommended Reading Assessing Competence to Consent to Treatment. Thomas Grisso & Paul Appelbaum, 1998, Oxford University Press.
Need Help? Suzanne BentlerIRB Administrator 335-6910
Questions or Comments?David J. Moser, Ph.D.Department of PsychiatryPhone: 319-353-4360Email: firstname.lastname@example.org