Fixing Research Subjects Protection in the United States: Moving Beyond Consent
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Informed consent cannot bear the weight it is being asked to shoulder.
“First and foremost, informed consent cannot bear the weight it is being asked to shoulder (16, 81).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [81]
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Research works printed but not linked: 9
- Henderson GE. Is informed consent broken? Am J Med Sci. 2011;342(4):267-272.
- Emanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects. N Engl J Med. 2011;365(12): 1145-1150.
- Abbott L, Grady C. A systematic review of the empirical liter- ature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6(1):3-19.
- Yarborough MA. Increasing enrollment in drug trials: the need for greater transparency about the social value of research in recruitment efforts. Mayo Clin Proc. 2013;88(5):442-445.
- Chludzinski A, Irani C, Mascha EJ, Kurz A, Devereaux PJ, Sessler DI. Protocol understanding and anxiety in perioperative clinical trial patients approached for consent on the day of sur- gery. Mayo Clin Proc. 2013;88(5):446-454.
- Stark L. Behind Closed Doors: IRBs and the Making of Ethical Research. Chicago, IL: The University of Chicago Press; 2012.
- Griffin JM, Struve JK, Collins D, Liu A, Nelson DB, Bloomfield HE. Long term clinical trials: how much information do participants retain from the informed consent process? Contemp Clin Trials. 2006;27(5):441-448.
- Fisher JA. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Hoboken, NJ: Rutgers University Press; 2009.
- Petryna A. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. Princeton, NJ: Princeton University Press; 2009.
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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 · see citing works
“First and foremost, informed consent cannot bear the weight it is being asked to shoulder (16, 81).”
BackgroundHave We Asked Too Much of Consent?
Koenig, B. A. (2014) · Hastings Center Report · doi:10.1002/hast.329 · Cited by 87 · see citing works
Self-citation
- Authors
- Koenig, B. A.
- Affiliations
- University of California, San Francisco (US)
- Corresponding author
- Koenig, Barbara A.
- ORCID
- Koenig, Barbara A.
- Venue
- Mayo Clinic Proceedings
- Publisher
- Elsevier BV
- Published
- 2013-05
- Volume
- 88
- Issue
- 5
- Pages
- 428-430
- ISSN
- 0025-6196 (ISSN-L)
- OpenAlex
- W2048203984
- Cited by
- 7
- References
- 0
- Citations by year
- 2022: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2016: 1 · 2014: 1
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Mayo Clinic Proceedings (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 › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- research participant protection, informed consent, research ethics committees, clinical trials, research participants, informed consent forms, research ethics oversight, United States
- MeSH terms
- Anxiety, Clinical Trials as Topic, Female, Humans, Informed Consent, Male, Social Values, Patient Selection, Biomedical Research, Preoperative Period
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