David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jonathan Jenkins Ichikawa
Jack Alan Reynolds
Learn more about PhilPapers
J. Sugarman, A. Corneli, D. Donnell, T. Y. Liu, S. Rose, D. Celentano, B. Jackson, A. Aramrattana, L. Wei, Y. Shao, F. Liping, R. Baoling, B. Dye & D. Metzger
Journal of Medical Ethics 37 (11):693-697 (2011)
Introduction While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand. Methods Enrolment procedures included an informed consent comprehension quiz. An informed consent survey followed. Results 525 participants completed the informed consent survey (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs vs 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs vs 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p=0.01) and not finding the questions easy (OR=0.10; p=<0.01). Conclusions Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent. Trial Registration clinicaltrials.gov number NCT00270257
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
Danielle Bromwich & Annette Rid (2015). Can Informed Consent to Research Be Adapted to Risk? Journal of Medical Ethics 41 (7):521-528.
Similar books and articles
Shaun D. Pattinson (2009). Consent and Informational Responsibility. Journal of Medical Ethics 35 (3):176-179.
Martin Gunderson, David J. Mayo & Frank S. Rhame (1996). Routine HIV Testing of Hospital Patients and Pregnant Women: Informed Consent in the Real World. Kennedy Institute of Ethics Journal 6 (2):161-182.
Loretta M. Kopelman (1994). Informed Consent and Anonymous Tissue Samples: The Case of Hiv Seroprevalence Studies. Journal of Medicine and Philosophy 19 (6):525-552.
Timothy F. Murphy (1994). Health Care Workers with Hiv and a Patient's Right to Know. Journal of Medicine and Philosophy 19 (6):553-569.
Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Rebecca Erwin Wells & Ted J. Kaptchuk (2012). To Tell the Truth, the Whole Truth, May Do Patients Harm: The Problem of the Nocebo Effect for Informed Consent. American Journal of Bioethics 12 (3):22-29.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
Deborah Bowman (2011). Informed Consent: A Primer for Clinical Practice. Cambridge University Press.
Matthew K. Wynia (2006). Routine Screening: Informed Consent, Stigma and the Waning of HIV Exceptionalism. American Journal of Bioethics 6 (4):5 – 8.
Augustine Frimpong-mansoh (2008). Culture and Voluntary Informed Consent in African Health Care Systems. Developing World Bioethics 8 (2):104-114.
Janet L. Brody, John P. Cluck & Alfredo S. Aragon (1997). Participants' Understanding of the Process of Psychological Research: Informed Consent. Ethics and Behavior 7 (4):285 – 298.
Christopher F. C. Jordens, Kathleen Montgomery & Rowena Forsyth (2013). Trouble in the Gap: A Bioethical and Sociological Analysis of Informed Consent for High-Risk Medical Procedures. [REVIEW] Journal of Bioethical Inquiry 10 (1):67-77.
James R. P. Ogloff & Randy K. Otto (1991). Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research. Ethics and Behavior 1 (4):239 – 252.
Added to index2011-10-19
Total downloads6 ( #541,983 of 1,940,955 )
Recent downloads (6 months)1 ( #457,798 of 1,940,955 )
How can I increase my downloads?