ArticleAIDS (London, England)2011
Empirical evaluation of the need for 'on-going consent' in clinical research.
Article in AIDS (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Becoming a coresearcher in dementia care research: a mixed-methods study protocol for evaluation of theBMJ open · 2026Article
- The impact of central IRB's on informed consent readability and trial adherence in SPRINT.Contemporary clinical trials communications · 2019Article
- Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda.BMC medical ethics · 2015Review
- Research into a functional cure for HIV in neonates: the need for ethical foresight.The Lancet. Infectious diseases · 2014Article
- "I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.Perspectives in clinical research · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveSome commentators argue that informed consent for clinical research should be an on-going process, which begins, rather than ends, with participants' initial consent. Lacking, however, are empirical data on whether there is a need for 'on-going consent'.
designTwo self-administered surveys - a baseline survey at initial consent and a follow-up survey 2-3 years later - to assess whether participants remain informed over time.
methodsRespondents were adults with HIV disease from Argentina, Brazil and Thailand enrolled in a long-term clinical trial.
resultsRespondents overall were well informed at baseline. At follow-up, many reported being not informed about aspects of the study central to their on-going participation. With respect to the possibility of withdrawal, 38.5% of respondents at follow-up reported being 'not at all' informed. At follow-up, 71.1% wanted more information. Yet, 62.8% had not asked any questions during the entire study. Reasons for not asking questions included not having an opportunity (16.4%) and not knowing whom to ask (15.5%).
conclusionsThe standard consent process resulted in participants being well informed at enrollment. Yet, this process was not sufficient to keep them informed about aspects of the study central to their on-going participation. In addition, participants who wanted more information often did not ask for it. These findings provide empirical support for recommendations that clinical trials should consider including a process of 'on-going consent'.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.