Are there adverse consequences of quizzing during informed consent for HIV research?

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

doi:10.1136/jme.2011.042358

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Are there adverse consequences of quizzing during informed consent for HIV research?

Journal article

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Are there adverse consequences of quizzing during informed consent for HIV research?

J Sugarman, A Corneli, D Donnell, T Y Liu, S Rose, D Celentano, B Jackson, A Aramrattana, L Wei, Y Shao, …

Journal of medical ethics, Vol.37(11), pp.693-697

11/2011

DOI: 10.1136/jme.2011.042358

PMCID: PMC3200567

PMID: 21653649

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https://www.ncbi.nlm.nih.gov/pmc/articles/3200567View

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Abstract

IntroductionWhile 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.MethodsEnrolment procedures included an informed consent comprehension quiz. An informed consent survey followed.Results525 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).ConclusionsQuizzing 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 Registrationclinicaltrials.gov number NCT00270257.

Details

Title: Subtitle: Are there adverse consequences of quizzing during informed consent for HIV research?
Creators: J Sugarman - Johns Hopkins University
A Corneli - FHI 360
D Donnell - Cancer Research Center
T Y Liu - Cancer Research Center
S Rose - FHI 360
D Celentano - Johns Hopkins University
B Jackson - Administration (TMED)
A Aramrattana - Chiang Mai University
L Wei - Centers for Disease Control and Prevention
Y Shao - Taiwan Centers for Disease Control
F Liping - Centers for Disease Control and Prevention
R Baoling - Centers for Disease Control and Prevention
B Dye - University of Pennsylvania
D Metzger - University of Pennsylvania
Resource Type: Journal article
Publication Details: Journal of medical ethics, Vol.37(11), pp.693-697
DOI: 10.1136/jme.2011.042358
PMID: 21653649
PMCID: PMC3200567
NLM abbreviation: J Med Ethics
ISSN: 0306-6800
eISSN: 1473-4257
Language: English
Date published: 11/2011
Academic Unit: Pathology; VPMA - Administration
Record Identifier: 9984186524302771

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