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Longer Consent Forms for Clinical Trials Compromise Patient Understanding: So Why Are They Lengthening?
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Consent forms are written at too high a grade level.
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125)”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [4]
Many participants, including biobank participants, do not understand the information disclosed to them.
“and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [4]
Consent forms are too long.
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125)”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [4]
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Research works printed but not linked: 3
- 10.1016/S0140-6736(01)06805-2 · DOI · Paper page
- 10.1200/jco.2005.23.16_suppl.564 · DOI
- 10.1093/jnci/93.2.139 · DOI
Cited by
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Dynamic consent: a patient interface for twenty-first century research networks
Kaye, J., Whitley, E. A., Lund, D., Morrison, M., Teare, H., & Melham, K. (2015) · European Journal of Human Genetics · doi:10.1038/ejhg.2014.71 · Cited by 780
Lessons from HeLa Cells: The Ethics and Policy of Biospecimens
Beskow, L. M. (2016) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-083115-022536 · Cited by 146
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundHow well informed is the informed consent for cancer clinical trials?
Malik, L., Kuo, J., Yip, D., & Mejia, A. (2014) · Clinical Trials · doi:10.1177/1740774514548734 · Cited by 18
Metadata
- Authors
- Beardsley, E., Jefford, M., & Mileshkin, L.
- Affiliations
- Peter MacCallum Cancer Centre (AU)
- Venue
- Journal of Clinical Oncology
- Published
- 2007-03-20
- Volume
- 25
- Issue
- 9
- Pages
- e13-e14
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2154002582
- Cited by
- 162
- References
- 0
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 9 · 2023: 8 · 2022: 4 · 2021: 13 · 2020: 4 · 2019: 12 · 2018: 16 · 2017: 11 · 2016: 4 · 2015: 8 · 2014: 12 · 2013: 9 · 2012: 8
- FWCI
- 7.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- 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 forms, patient understanding, clinical trial participation, informed consent
- MeSH terms
- Australia, Clinical Trials as Topic, Communication Barriers, Educational Status, Humans, Informed Consent, Health Knowledge, Attitudes, Practice, Language, Patient Education as Topic, Patient Satisfaction, Guidelines as Topic, Guideline Adherence, Disclosure, Comprehension, Consent Forms, Research Subjects
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