The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects

Pharmacotherapy

Volumn 16, Issue 5 I, 1996, Pages 872-878

  Miller, Cheryl K ^a,e   O'Donnell, Dannielle C ^b,c   Searight, H Russell ^a   Barbarash, Rick A ^d  

^a SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^c TEXAS A M COLLEGE OF MEDICINE   (United States)

^d Orthopedic Center of St Louis   (United States)

^e Deaconess Family Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; COMPREHENSION; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; RATING SCALE; RELIABILITY; SCORING SYSTEM; SELF EVALUATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

ADOLESCENT; ADULT; AGED; CLINICAL TRIALS; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PATIENT EDUCATION; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS;

EID: 0029745021     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. Beecher H. Ethics and clinical research. N Engl J Med 1966;274:1354-60.
2. World Medical Association. Declaration of Helsinki. Br Med J 1963;2:1623-7.
3. Department of Health and Human Services. Federal Register 56 (June 18, 1991);45CFR:46.101-46.124.
4. Hamilton MP. Role of the ethicist in the conduct of clinical trials in the United States. Controlled Clin Trials 1981;1:411-20.
5. Taub HL. Comprehension of informed consent for research: issues and directions for future study. IRB 1986;Nov-Dec:7-10.
6. Bergler JH, Pennington AC, Metcalfe M, Freis ED. Informed consent: how much does the patient understand? Clin Pharmacol Ther 1980;27:435-40.
7. Morgan LW, Schwartz IR. Informed consent in senile cataract extraction Arch Ophthalmol 1986;104:42-5.
8. Taub HA, Baker MT. The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res 1983;9:135-8.
9. Taub HA, Baker MT. A reevaluation of informed consent in the elderly: a method for improving comprehension through direct testing. Clin Res 1984;32:17-21.
10. Ogloff JR, Otto RK. Are research participants truly informed? Readability of informed consent forms used in research. Ethics Behav 1991;3:239-52.
11. Taub HL, Sturr JF. Evaluating informed consent for research: a methodological study with older adults. Educ Gerontol 1990;16:273-81.
12. Miller CK, Searight HR, Grable D, Schwartz R, Barbarash RA. Comprehension and recall of the informational content of the informed consent document: an evaluation of 168 patients in a controlled clinical trial. J Clin Res Drug Dev 1994;8:237-48.
13. Anastasi A. Psychological testing, 5th ed. New York: Macmillan, 1982.
14. Wechsler D. WAIS-R manual. New York: Psychological Corporation, 1981.
15. Jastak S, Wilkinson GS. Wide range achievement test-revised. Wilmington, DE: Jastak Assessment Systems, 1984.
16. Flesch R. A new readability yardstick. J Appl Psychol 1948;32:221-33.
17. Appelbaum PS, Lidz CW, Meisel A. Informed consent: legal theory and clinical practice. New York: Oxford University Press, 1987.
18. Janofsky JS, McCarthy RJ, Fulstein MF. The Hopkins competency assessment test: a brief method for evaluating patients' capacity to give informal consent. Hosp Commun Psychiatry 1992;43:132-6.
19. Searight HR, Miller CK. Perceptions of informed consent and the research process by participants in a clinical drug study: results of a qualitative study. J Am Board Fam Pract 1996;9:14-22.