Abstract
Rationale
The numbers of older persons with psychiatric disorders are expected to rise rapidly in coming decades, yet most studies of the safety and efficacy of treatments for such disorders have focused on younger adults. A substantial expansion in research involving older patients is needed to meet the treatment needs of this fast growing group. A critical issue in intervention research is ensuring a patient's decision-making capacity. Considerable heterogeneity exists in this regard even within diagnostic groups. Cognitive changes as well as increased complexity of medication regimens in elderly patients may make it particularly difficult for some older persons to fully understand, appreciate, and/or reason about the risks and benefits of participating in any particular study.
Objectives
Empirical research into assessing and possibly improving decisional capacity is warranted in older people with severe mental illness. Such research may be accomplished through collaborations among specialists from various related disciplines and, importantly, with active involvement of community partners.
Methods
We present one model of this type of collaboration, the Bioethics Unit of an Intervention Research Center, comprising a multi-disciplinary team along with a Community Advisory Board.
Results
Preliminary studies in our Center suggest that older individuals with psychotic disorders vary considerably in their decisional capacity, and many subjects appear to be fully capable for consenting to research projects. Furthermore, the patients' level of understanding of the consent material can be improved significantly through repetition and clarification of key elements in the consent form.
Conclusions
The decisional capacity for a given research protocol is not necessarily an unmodifiable trait, but can be enhanced with improvements in consenting procedures, even in older persons with psychotic disorders.
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References
American Psychological Association Ethics Committee (1992) Ethical principles of psychologists and code of conduct. Am Psychol 47:1597–1611
Appelbaum PS (2002) Involving decisionally impaired subjects in research: the need for legislation. Am J Geriatr Psychiatr 10:120–124
Appelbaum PS, Grisso T (1995) The MacArthur treatment competence study. I. Mental illness and competence to consent to treatment. Law Hum Behav 19:105–126
Baker MT, Taub HA (1983) Readability of informed consent forms for research in a Veterans Administration Medical Center. JAMA 250:2646–2648
Beck JC (1988) Determining competency to assent to neuroleptic drug treatment. Hosp Commun Psychiatry 39:1106–1108
Beck JC, Staffin RD (1986) Patients' competency to give informed consent to medication. Hosp Commun Psychiatry 37:400–402
Bjerrum L, Sogaard J, Hallas J, Kragstrup J (1998) Polypharmacy: correlations with sex, age and drug regimen: a prescription database study. Eur J Clin Pharmacol 54:197–202
Carpenter WT, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ, Kovnick J, Appelbaum PS (2000) Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 57:533–538
Christensen K, Haroun A, Schneiderman LJ, Jeste DV (1995) Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatr Law 23:353–365
Doucet J, Chassagne P, Trivalle C, Landrin I, Pauty MD, Kadri N, Menard JF, Bercoff E (1996) Drug-drug interactions related to hospital admissions in older adults: a prospective study of 1000 patients. J Am Geriatr Soc 44:944–948
Dunn LB, Jeste DV (2001) Enhancing informed consent for research and treatment. Neuropsychopharmacology 24:595–607
Dunn LB, Lindamer LA, Palmer BW, Schneiderman LJ, Jeste DV (2001) Enhancing comprehension of consent for research in older patients with psychosis: a randomized study of a novel educational strategy. Am J Psychiatry 158:1911–1913
Dunn LB, Lindamer LA, Palmer BW, Golshan S, Schneiderman LJ, Jeste DV (2002) Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. Am J Geriatr Psychiatry 10:142–150
Fins JJ, Miller FG (2000) Enrolling decisionally incapacitated subjects in neuropsychiatric research. CNS Spect 5:32–42
Grisso T, Appelbaum PS (1995) The MacArthur Treatment Competence Study. III. Abilities of patients to consent to psychiatric and medical treatments. Law Hum Behav 19:149–174
Grisso T, Appelbaum PS, Mulvey EP, Fletcher K (1995) The MacArthur Treatment Competence Study: II. measures of abilities related to competence to consent to treatment. Law Hum Behav 19:127–148
Grossman L, Summers F (1980) A study of the capacity of schizophrenic patients to give informed consent. Hosp Commun Psychiatry 31:205–206
Herz DA, Looman JE, Lewis SK (1992) Informed consent: Is it a myth? Neurosurgery 30:453–458
Hutson MM, Blaha JD (1991) Patients' recall of preoperative instruction for informed consent for an operation. J Bone Joint Surg 73-A:160–162
Irwin M, Lovitz A, Marder SR, Mintz J, Winslade WJ, Van Putten T, Mills MJ (1984) Psychotic patients' understanding of informed consent. Am J Psychiatry 142:1351–1354
Jeste DV (2000) Tardive dyskinesia in older patients. J Clin Psychiatry 61:27–32
Jeste DV, Alexopoulos GS, Bartels SJ, Cummings J, Gallo JJ, Gottlieb GL, Halpain MC, Palmer BW, Patterson TL, Reynolds CF, Lebowitz BD (1999a) Consensus statement: the upcoming crisis in geriatric mental health: challenges and opportunities. Arch Gen Psychiatry 56:848–853
Jeste DV, Lacro JP, Palmer BW, Rockwell E, Harris MJ, Caligiuri M (1999b) Incidence of tardive dyskinesia in early stages of low-dose treatment with typical neuroleptics in older patients. Am J Psychiatry 156:309–311
Karlawish JH, Lantos J (1997) Community equipoise and the architecture of clinical research. Cambridge Q Healthcare Ethics 6:385–396
Kim SYH, Caine ED, Currier GW, Leibovici A, Ryan JM (2001) Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 158:712–717
Kim SYH, Karlawish JHT, Caine ED (2002) Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr Psychiatry 10:151–165
Kramarow E, Lentzner H, Rooks R, Weeks J, Saydah S (1999) Health and aging chartbook, health, United States. National Center for Health Studies, Hyattsville, Md.
Marson DC, Earnst KS, Jamil F, Bartolucci A, Harrell LE (2000) Consistency of physicians' legal standard and personal judgments of competency in patients with Alzheimer's disease. J Am Geriatr Soc 48:911–918
Michels R (1999) Are research ethics bad for our mental health? N Engl J Med 340:1427–1430
National Bioethics Advisory Commission (1998) Research involving persons with mental disorders that may affect decision-making capacity. Report of the Recommendations of the National Bioethics Advisory Commission. National Bioethics Advisory Commission, Rockville, Md.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) The Belmont Report: ethical principles and guidelines for the protection of human subjects of research
Palmer BW, Heaton SC, Jeste DV (1999) Older patients with schizophrenia: challenges in the coming decades. Psychiatr Serv 50:1178–1183
Palmer BW, Nayak GV, Dunn LB, Appelbaum PS, Jeste DV (2002) Treatment-related decision-making capacity in middle-aged and older patients with psychosis: a preliminary study using the MacCAT-T and HCAT. Am J Geriatr Psychiatry 10:207–211
Reynolds CF (2002) Advancing research in decision-making capacity: An opportunity for leadership—and an obligation of geriatric psychiatry. Am J Geriatr Psychiatry 10:117–119
Roberts LW (2000) Evidence-based ethics and informed consent in mental illness research. Arch Gen Psychiatry 57:540–542
Roberts LW, Roberts B (1999) Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness. Biol Psychiatry 46:1025–1038
Roberts LW, Warner TD, Brody JL (2000) Perspectives of patients with schizophrenia and psychiatrists regarding ethically important aspects of research participation. Am J Psychiatry 157:67–74
Rothman DJ (1987) Ethics and human experimentation: Henry Beecher revisited. N Engl J Med 317:1195–1199
Saks ER, Behnke SH (1999) Competency to decide on treatment and research: MacArthur and beyond. J Contemp Legal Issues 10:103–129
Saks ER, Dunn LB, Marshall BJ, Nayak GV, Golshan S, Jeste DV (2002) The California Scale of Appreciation: a new instrument to measure the appreciation component of capacity to consent to research. Am J Geriatr Psychiatry 10:166–174
Steffens DC, Rama Krishan KR (1998) Psychotherapeutic agents in older adults. Clin Geriatr Med 14:17–31
Sugarman J, McCrory DC, Hubal RC (1998) Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc 46:517–524
Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J (1998) Informed consent: assessment of comprehension. Am J Psychiatry 155:1508–1511
Acknowledgements
This work was supported, in part, by NIMH grants MH49671, MH43693, MH59101, by the National Alliance for Research on Schizophrenia and Depression, and by the Department of Veterans Affairs.
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Jeste, D.V., Dunn, L.B., Palmer, B.W. et al. A collaborative model for research on decisional capacity and informed consent in older patients with schizophrenia: Bioethics unit of a geriatric psychiatry intervention research center. Psychopharmacology 171, 68–74 (2003). https://doi.org/10.1007/s00213-003-1507-x
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DOI: https://doi.org/10.1007/s00213-003-1507-x