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.
- Informed consent
- research ethics
- HIV infection and aids
- substance abusers/users of controlled substances
- policy guidelines/inst. review boards/review cttes
Statistics from Altmetric.com
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the HPTN, NIAID, or NIMH.
Study design: Cross-sectional survey embedded within a clinical trial.
Funding National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) Other Funders: NIH. JS, AC, SR, BD, DD, TYL, DC, BJ, AA, LW, YS, FL, BR and DM had full access to all of the data and have support from the HIV Prevention Trials Network (HPTN) under award numbers U01 AI068619 and U01 AI 069482 for the submitted work. The study funders were not involved in the study design, analysis, or writing of this manuscript.
Competing interests None.
Ethics approval This study was conducted with the approval of the Chiang Mai University Research Institute for Health Sciences (RIHES), Thailand; Ministry of Public Health Ethical Review Committee for Research in Human Subjects (MOPH), Nonthaburi, Thailand; Guangxi Center for Disease Prevention and Control Institutional Review Board (IRB), China; Xinxiang Uighur Autonomous Region Bureau of Health Disease Control and Treatment IRB, China; The Chinese National Center for AIDS/STD Control and Prevention IRB; and Johns Hopkins Medicine IRB #2, US.
Provenance and peer review Not commissioned; externally peer reviewed.