Making consent more informed: preliminary results from a multiple-choice test among probation-referred marijuana users entering a randomized clinical trial.
Although individuals who use illicit drugs are a potentially vulnerable population, there have been no objective evaluations of the effectiveness of standard informed consent procedures in assuring that prospective participants entering drug abuse treatment trials fully understand the nature of the research and treatments in which they have agreed to participate. Young, marijuana-dependent adults referred by the criminal justice system who were enrolling in a randomized treatment trial were asked to complete a multiple-choice quiz concerning basic elements of the trial before providing written informed consent. Participants were assigned to standard drug counseling or motivational interviewing/skills-building therapy, delivered alone or with incentives for attending sessions and submitting marijuana-free urine specimens. Only 55 percent of the 130 participants correctly answered all four questions, and 20 percent incorrectly answered a question concerning their right to refuse to participate. An unexpected finding was that quiz scores were modestly associated with marijuana use outcome measures. These preliminary findings highlight the importance of systematically evaluating the understanding of research participants, particularly those in vulnerable populations, of their rights and key aspects of the trials in which they agree to participate.
Rounsaville
Daniel B
DB
University of Maryland Baltimore County, Baltimore, MD, USA.
Hunkele
Karen
K
Easton
Caroline J
CJ
Nich
Charla
C
Carroll
Kathleen M
KM
D015928:Cognitive Behavioral Therapy; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D002189:Marijuana Abuse / Q000175:diagnosis* / Q000628:therapy; D011581:Psychological Tests / Q000592:standards; D016032:Randomized Controlled Trials as Topic; D014481:United States; D055815:Young Adult
J Consult Clin Psychol. 2006 Oct;74(5):955-66
17032099
Health Serv Res. 1995 Dec;30(5):707-26
8537228
Lancet. 2001 Nov 24;358(9295):1772-7
11734235
J Consult Clin Psychol. 1999 Apr;67(2):186-93
10224728
Am J Psychiatry. 1998 Nov;155(11):1508-11
9812110
J Stud Alcohol. 2000 Jan;61(1):55-63
10627097
J Consult Clin Psychol. 2000 Feb;68(1):134-44
10710848
Addict Behav. 2000 Mar-Apr;25(2):217-28
10795946
J Med Ethics. 2003 Feb;29(1):4-7
12569185
Am J Addict. 2003 Jul-Sep;12(4):314-23
14504024
Compr Psychiatry. 2004 Jan-Feb;45(1):1-9
14671730
Arch Gen Psychiatry. 2004 Mar;61(3):264-72
14993114
IRB. 2003 Nov-Dec;25(6):1-7
15035248
Clin Pharmacol Ther. 1980 Apr;27(4):435-40
6987027
Hosp Community Psychiatry. 1992 Feb;43(2):132-6
1572608
J Subst Abuse Treat. 1992;9(3):199-213
1334156
J Stud Alcohol Suppl. 1994 Dec;12:112-8
7722987
J Drug Issues. 2004 Fall;34(4):991-1005
17073036