Interventions to Improve Research Participants' Understanding in Informed Consent for Research: A Systematic Review
Abstract
Context Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. Objective To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. Data sources and study selection A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. Data extraction Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results w…
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Interventions to improve informed consent processes and participant understanding have met with minimal success.
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [39]
Across four systematic reviews, the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [39]
The available evidence on interventions to improve informed consent is notably limited, with studies often suffering from lack of power, nonrandomized designs, poor generalizability, questionable methods for measuring comprehension outcomes, and/or too narrow a focus on a single aspect of the consent process.
“However, all four reviews found the available evidence notably limited, with the studies often suffering from lack of power, nonrandomized designs, poor generalizability, questionable methods for measuring comprehension outcomes, and/or too narrow a focus on a single aspect of the consent process.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [39]
No citation lists for this paper
No citation lists for this paper yet — checked again daily.
References 48 · Cited by 1,067
- Authors
- Flory, J., & Emanuel, E.
- Affiliations
- National Institutes of Health (US)
- ORCID
- Flory, James
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2004-10-06
- Volume
- 292
- Issue
- 13
- Pages
- 1593
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2002325729
- Cited by
- 1,067
- References
- 48
- Citations by year
- 2026: 31 · 2025: 27 · 2024: 34 · 2023: 25 · 2022: 51 · 2021: 87 · 2020: 49 · 2019: 49 · 2018: 51 · 2017: 49 · 2016: 57 · 2015: 67 · 2014: 73 · 2013: 64 · 2012: 62
- FWCI
- 36.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Keywords
- informed consent, multimedia intervention, test feedback, participant satisfaction, educational attainment, clinical research ethics
- MeSH terms
- Communication, Humans, Informed Consent, Multimedia, Disclosure, Comprehension, Biomedical Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
