ArticleThe American journal of bioethics : AJOB2009
Must research participants understand randomization?
Article in The American journal of bioethics : AJOB, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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
6 citing papers in PubMed, 28 citations in OpenAlex.
- Disentangling informing participants from obtaining their consent.Learning health systems · 2025Article
- Article
- A Study of a Culturally and Contextually Situated Multimedia Approach to Recruit a Hard-to-Reach Spanish-Speaking Population for a Randomized Control Trial (RCT).Journal of empirical research on human research ethics : JERHRE · 2022Article
- If children understand drawing straws and flipping coins, research participants can understand randomization.The American journal of bioethics : AJOB · 2009Article
- Ethics of Adaptive Designs for Randomized Controlled Trials.Ethics & human researchArticle
- Article
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Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials.
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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.