ArticleJournal of medical ethics2011
Are there adverse consequences of quizzing during informed consent for HIV research?
Article in Journal of medical ethics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00270257 (A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence.Journal of the International AIDS Society · 2018Pooled it
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
- "Like a dialogue": Teach-back in the emergency department.Patient education and counseling · 2016Article
- Ethical issues in HIV prevention research with people who inject drugs.Clinical trials (London, England) · 2014Article
- Article
- Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).Clinical and translational science · 2013Article
- Experience in international clinical research: the HIV Prevention Trials Network.Clinical investigation · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
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, China¼255, Xinjiang, China¼229, Chiang Mai, Thailand¼41). 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 (6e10 yrs vs 0e5 yrs: OR¼0.27, p¼0.03; more than 11 yrs vs 0e5 yrs: OR¼0.18, p¼0.03). There were also site differences (Heng County vs Xinjiang) in feeling anxious (OR¼0.07; p¼<0.01), not minding (OR¼0.26; p¼0.03), being bored (OR¼0.25; p¼0.01) and not finding the questions easy (OR¼0.10; p¼<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.
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