Capacity of persons with mental retardation to consent to participate in randomized clinical trials

American Journal of Psychiatry

Volumn 163, Issue 10, 2006, Pages 1813-1820

  Fisher, Celia B ^a   Cea, Christine D ^b   Davidson, Philip W ^b   Fried, Adam L ^b  

^a FORDHAM UNIVERSITY   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADAPTIVE BEHAVIOR; ADULT; AGED; AGGRESSION; ANAMNESIS; ARTICLE; ATTENTION DISTURBANCE; CLINICAL TRIAL; COGNITIVE DEFECT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECISION MAKING; DISEASE SEVERITY; ETHICS; FEMALE; HUMAN; INFORMED CONSENT; INTELLIGENCE; LANGUAGE DISABILITY; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; MEMORY DISORDER; MENTAL CAPACITY; MENTAL DEFICIENCY; MULTIVARIATE ANALYSIS; PATIENT RIGHT; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; PSYCHOSOCIAL CARE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; UNIVARIATE ANALYSIS;

EID: 33749465805     PISSN: 0002953X     EISSN: None     Source Type: Journal    
DOI: 10.1176/ajp.2006.163.10.1813     Document Type: Article

References (18)

1. Lewis MH, Aman MG, Gadow KD, Schroeder SR, Thompson T: Psychopharmacology, in Manual of Diagnosis and Professional Practice in Mental Retardation. Edited by Jacobson JW, Mulick JA. Washington, DC, American Psychological Corporation, 1996, pp 323-340
2. Davidson PW, Cain NN, Sloane-Reeves JE, Van Speybroech A, Segel J, Gutkin J, Quijano LE, Kraner BM, Porter B, Shoham I, Goldstein E: Characteristics of community-based individuals with mental retardation and aggressive behavioral disorders. Am J Ment Retard 1994; 98:704-716
3. Cea CD, Fisher CB: Health care decision-making by adults with mental retardation. Ment Retard 2003; 41:78-87
4. Morris DC, Niederbuhl JM, Mahr JM: Determining the capability of individuals with mental retardation to give informed consent. Am J Ment Retard 1993; 98:263-272
5. Arscott K, Dagnan D, Kroese BS: Consent to psychological research by people with an intellectual disability. Journal of Applied Research in Intellectual Disabilities 1998; 11:77-83
6. Appelbaum PS, Grisso T, Frank E, O'Donnell S, Kupfer DJ: Competence of depressed patients for consent to research. Am J Psychiatry 1999; 156:1380-1384
7. Moser DJ, Schultz SK, Arndt S, Benjamin ML, Fleming FW, Brems CS, Paulsen JS, Appelbaum PS, Andreasen NC: Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry 2002; 159:1201-1207
8. Kim SYH, Caine ED, Currier GW, Leibovici A, Ryan JM: Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 2001; 158:712-717
9. Kim SYH, Cox C, Caine ED: Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. Am J Psychiatry 2002; 159:797-802
10. Grisso TH, Appelbaum PS: Assessing Patients' Capacities to Consent to Treatment: A Guide for Healthcare Professionals. New York, Oxford University Press, 1998
11. Kaufman AS, Kaufman NL: K-Bit: Kaufman Brief Intelligence Test. Circle Pines, N Mex, American Guidance Service, 1990
12. Sparrow SS, Balla DA, Cicchetti DV: Vineland Adaptive Behavior Scales, Survey Form Manual. Circle Pines, N Mex, American Guidance Service, 1984
13. Grisso TH, Appelbaum PS: MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Sarasota, Fla, Professional Resource Press, 2001
14. Fisher CB: A goodness-of-fit ethic for informed consent to research involving persons with mental retardation and developmental disabilities. Ment Retard Dev Disabil Res Rev 2003; 9:27-31
15. Roberts LW, Warner TD, Brody JL, Roberts B, Lauriello J, Lyketsos C: Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions. Am J Psychiatry 2002; 159:573-584
16. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W: False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987; 17:20-24
17. Fisher CB: Relational ethics and research with vulnerable populations. Reports on Research Involving Persons With Mental Disorders That May Affect Decision-Making Capacity, vol II: Commissioned Papers by the National Bioethics Advisory Commission, Papers. Rockville, Md, 1999:29-49
18. Delano SJ: Research involving adults with decisional impairment, in Institutional Review Boards: Management and Function. Edited by Amdur RJ, Bankert EA. Sudbury, Mass, Jones & Bartlett, 2002, pp 389-893