Empty ethics: the problem with informed consent
Open accessAbstract
Abstract Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle‐led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials.
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When patients are facing dire situations, one cannot assume that an elicited choice will be actively and freely made based on careful consideration and adequate understanding of the information.
“Particularly when patients are facing dire situations, we cannot simply assume that an elicited choice will be actively and freely made based on careful consideration and adequate understanding of the information (27).”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [27]
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“…place on consent forms and participant information sheets, has led some way to establishing how research ethics is de fi ned (Whelan, 2018), that is, with consent often being viewed (sometimes incorrectly) as a proxy for ethics best practice, or in some cases, as an ethics panacea (Corrigan, 2003).”
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Cox, S., & McDonald, M. (2013) · Social Science & Medicine · doi:10.1016/j.socscimed.2013.09.015 · Cited by 39 · see citing works
Fisher, J. (2007) · Qualitative inquiry : QI · doi:10.1177/1077800407304460 · Cited by 46 · see citing works
“Holding autonomy and informed consent as the model for ethical practice, federal regulation places decision making about study participation within a vacuum, stripping it of all social contexts (Corrigan, 2003; Fisher, 2006b).”
BackgroundWhat's in a name? Subjects, volunteers, participants and activists in clinical research
Corrigan, O. P., & Tutton, R. (2006) · Clinical Ethics · doi:10.1258/147775006777254524 · Cited by 46 · see citing works
Self-citationHoeyer, K., & Lynöe, N. (2006) · Medicine, Health care and Philosophy · doi:10.1007/s11019-005-5067-1 · Cited by 46
Ethical Considerations for Responsible Data Curation
Andrews, J., Zhao, D., Thong, W. E., Modas, A., Papakyriakopoulos, O., & Xiang, A. (2023) · Neural Information Processing Systems · doi:10.52202/075280-2415 · Cited by 45
“Datasets collected with consent reduce the risk of being fractured, however, data subjects may later revoke their consent over, e.g., privacy concerns they may not have been aware of at the time of providing consent or language nuances [65, 379].”
BackgroundSurgical Consultation as Social Process: Implications for Shared Decision Making
Clapp, J., Arriaga, A. F., Murthy, S., Raper, S., Schwartz, J., Barg, F., & Fleisher, L. (2017) · Annals of Surgery · doi:10.1097/sla.0000000000002610 · Cited by 45 · see citing works
Sjöberg, F., Schönning, E., & Salzmann-Erikson, M. (2015) · Journal of Clinical Nursing · doi:10.1111/jocn.12844 · Cited by 45 · see citing works
The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study
Ferretti, A., Ienca, M., Velarde, M. R., Hurst, S., & Vayena, E. (2021) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/15562646211053538 · Cited by 47 · see citing works
“Some authors flag the risk of viewing these tools as ethics panacea (Babb, 2020; Corrigan, 2003).”
BackgroundHaimes, E., & Williams, R. (2007) · British Journal of Sociology · doi:10.1111/j.1468-4446.2007.00160.x · Cited by 44
‘I'm not Really Read up on Genetics’: Biobanks and the Social Context of Informed Consent
Barr, M. D. (2006) · doi:10.1017/s1745855206060029 · Cited by 43
“…as a direct result of the Holocaust and thus cannot serve as the primary standard of ethical conduct in a genetic era that deemphasizes individual rights in favour of community and solidarity (Chadwick and Berg, 2001; Corrigan, 2003; DeVries and Subedi, 1998; Hoffmaster, 2001; Rhodes, 2005).”
BackgroundSemel, B. (2021) · Science Technology & Human Values · doi:10.1177/01622439211026371 · Cited by 78 · see citing works
“In the consequentialist framework of malpractice law, consent forms should convey all possible risks and harms associated with the study that subjects agree to incur (see Corrigan 2003; Felt et al. 2009; Hoeyer 2009; Benjamin 2016).”
BackgroundInvestigación social cualitativa y dilemas éticos: de la ética vacía a la ética situada.
Miguélez, B. A., & Unibertsitatea, E. H. (2016) · Empiria Revista de metodología de ciencias sociales · doi:10.5944/empiria.34.2016.16524 · Cited by 41 · see citing works
‘Ethics was here’: Studying the language-games of ethics in the case of UK Biobank
Hoeyer, K., & Tutton, R. (2005) · doi:10.1080/09581590500523533 · Cited by 41
“Some have noted that the ethics encountered in these various biomedical contexts is an ‘empty ethics’ (Corrigan, 2003 ) or a ‘catwalk ethics’ (Lundin, 2002 ) because, by academic standards, it involves little if any in-depth analysis.”
BackgroundInfluentialManaging ethical uncertainty: implicit normativity and the sociology of ethics
Cribb, A. (2019) · Sociology of Health and Illness · doi:10.1111/1467-9566.13010 · Cited by 40
“…influence of hierarchy, power and trust whether at a micro-level, such as in actual enactments of consent (Armstrong et al. 2012, Brown et al. 2015, Corrigan 2003) or at a macro-level, such as in relation to the possibilities and challenges of genuinely emancipatory forms of patient and public…”
BackgroundBloemraad, I., & Menjívar, C. (2021) · International Migration Review · doi:10.1177/01979183211014455 · Cited by 47 · see citing works
“…(2020) argue, the individualism inherent in Western notions of informed consent may not travel to places or populations that “have conceptions of the self that extend beyond an individual making the typical wet [hand-written] signature” (see also Corrigan 2003; McLaughlin and AlfaroVelcamp 2015).”
BackgroundGillies, K., & Entwistle, V. (2012) · Journal of Medical Ethics · doi:10.1136/medethics-2011-100059 · Cited by 39 · see citing works
Population Biobanks: The Ethical Gravity of Informed Consent
Brekke, O. A., & Sirnes, T. (2006) · doi:10.1017/s1745855206004029 · Cited by 39
Living alone but eating together: Exploring lunch clubs as a dining out experience
Thomas, N., & Emond, R. (2017) · Appetite · doi:10.1016/j.appet.2017.03.003 · Cited by 43 · see citing works
“Consent was considered an ongoing process (Corrigan, 2003); as such 213 participants were reminded of the aims of the project and provided the opportunity for 214 questions and feedback throughout their involvement.”
MethodGuraya, S., London, N., & Guraya, S. (2014) · Journal of Microscopy and Ultrastructure · doi:10.1016/j.jmau.2014.03.003 · Cited by 38 · see citing works
Making prevention public: The co-production of gender and technology in HIV prevention research
Montgomery, C. M. (2012) · Social Studies of Science · doi:10.1177/0306312712457707 · Cited by 47 · see citing works
“…concepts of freedom and autonomy versus powerful autocratic medical practices fails to recognise that power is not just a phenomenon that is exercised as an external constraint, but that prevailing cultural norms, values and systems of expertise shape the field of choice’ (Corrigan, 2003: 789).”
BackgroundHoeyer, K. (2012) · Norsk Epidemiologi · doi:10.5324/nje.v21i2.1496 · Cited by 38 · see citing works
Adley, M., Alderson, H., Jackson, K., McGovern, W., Spencer, L., Addison, M. T., & O'Donnell, A. J. (2023) · International Journal of Social Research Methodology · doi:10.1080/13645579.2023.2228600 · Cited by 39 · see citing works
“…was the process of securing informed consent: a central aspect of research ethics that seeks to counteract the potential danger of participants being coerced to take part in research and to ensure that they fully understand its purpose, including how their data will be used (Corrigan, 2003).”
AI Consent Futures: A Case Study on Voice Data Collection with Clinicians
Wilcox, L. G., Brewer, R. N., & Díaz, F. (2023) · Proceedings of the ACM on Human-Computer Interaction · doi:10.1145/3610107 · Cited by 37 · see citing works
Beyond informed choice: prenatal risk assessment, decision-making and trust
Schwennesen, N., Svendsen, M., & Koch, L. (2008) · Clinical Ethics · doi:10.1258/ce.2010.010041 · Cited by 36 · see citing works
Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research
Walker, R. L., Cottingham, M., & Fisher, J. (2018) · Journal of Medicine and Philosophy · doi:10.1093/jmp/jhx033 · Cited by 35 · see citing works
“…along with the structural factors that allow researchers and pharmaceutical companies to take advantage of these social deficits, offers much richer entry points for concerns about justice (on both phase 1 and later phase clinical trials, see Corrigan, 2003; Fisher, 2007, 2009; Kingori, 2013).”
BackgroundPonder, M., Statham, H., Hallowell, N., Moon, J., Richards, M., & Raymond, F. L. (2008) · Journal of Medical Ethics · doi:10.1136/jme.2006.018564 · Cited by 35 · see citing works
Performing informed consent in transgender medicine
Shuster, S. M. (2019) · Social Science & Medicine · doi:10.1016/j.socscimed.2019.02.053 · Cited by 36 · see citing works
Co‐production with “vulnerable” groups: Balancing protection and participation
Liabo, K., Ingold, A., & Roberts, H. M. (2017) · Health Science Reports · doi:10.1002/hsr2.19 · Cited by 36 · see citing works
“Much debate on research ethics focuses on informed consent, and the extent to which people can be autonomous and fully informed when signing up to participate in research.(26,51,52,58) Our data provide an illustration of the importance of the relationship between the researcher and the researched in offering both prot…”
BackgroundBahadur, G., Morrison, M., & Machin, L. (2010) · Reproductive Biomedicine Online · doi:10.1016/j.rbmo.2010.10.001 · Cited by 34 · see citing works
“Such an approach also responds to the sociological critique that bioethical approaches and devices, such as informed consent, too often frame issues as abstract cases and in doing so fail to pay sufficient attention to the variable social contexts of decision making (Bosk, 1999; Corrigan, 2003; Hedgecoe, 2004).”
BackgroundInformed consent practices of physiotherapists in the treatment of low back pain.
Fenety, A., Harman, K., Hoens, A., & Bassett, R. (2009) · Manual Therapy · doi:10.1016/j.math.2009.02.007 · Cited by 34 · see citing works
The Dao of human cloning: utopian/dystopian hype in the British press and popular films
Jensen, E. (2008) · Public Understanding of Science · doi:10.1177/0963662506065874 · Cited by 34
“…field of bioethics has quickly become institutionalized as bioethicists joined the wellentrenched non-democratic scientific decision-making mechanism of expert panels and commissions advising and constructing science policy on the basis of formally rational deliberations (e.g., see Corrigan, 2003).”
BackgroundCross-nursing, ethics, and giving breast milk in the contemporary context
Shaw, R. (2007) · doi:10.1016/j.wsif.2007.07.001 · Cited by 34
Javdani, S., Singh, S., & Sichel, C. E. (2017) · American Journal of Community Psychology · doi:10.1002/ajcp.12185 · Cited by 58 · see citing works
“Through this training, we aimed to create a collective consciousness about the invisible power inherent in seemingly commonplace research acts such as obtaining consent and collecting data (Corrigan, 2003) and challenge researcher and method neutrality (Bhattacharya, 2007).”
Snell, K., Starkbaum, J., Lauss, G., Vermeer, A., & Helén, I. (2012) · Public Health Genomics · doi:10.1159/000336541 · Cited by 33
“In discussion on bioethics and governance of bio-banks, privacy and its bioethical twin, informed consent are considered problematic or even futile by scholars [16, 35, 36] .”
BackgroundCummings, J. A., Zagrodney, J. L., & Day, T. E. (2015) · PLoS ONE · doi:10.1371/journal.pone.0125208 · Cited by 35 · see citing works
“Current models of informed consent assume the following steps: autonomous individuals are given information about a study, provided with time to assess that information, and then make a conscious decision about whether to participate [21].”
BackgroundInfluentialDove, E., Avard, D., Black, L. J., & Knoppers, B. (2013) · BMC Medical Ethics · doi:10.1186/1472-6939-14-5 · Cited by 31
“study project, location, resources) and must go beyond mere duties of disclosure to actually achieve understanding [51], the further researchers and REBs can move towards ensuring there is genuine research participation, and indeed, engagement [52-54].”
Background
- Authors
- Corrigan, O.
- Affiliations
- University of Cambridge (GB)
- Corresponding author
- Corrigan, Oonagh
- ORCID
- Corrigan, Oonagh
- Venue
- Sociology of Health & Illness
- Publisher
- Wiley
- Published
- 2003-11
- Volume
- 25
- Issue
- 7
- Pages
- 768-792
- ISSN
- 0141-9889 (ISSN-L)
- 1467-9566
- OpenAlex
- W2061123320
- Cited by
- 436
- References
- 0
- Citations by year
- 2026: 14 · 2025: 9 · 2024: 17 · 2023: 10 · 2022: 15 · 2021: 35 · 2020: 12 · 2019: 16 · 2018: 21 · 2017: 30 · 2016: 25 · 2015: 14 · 2014: 22 · 2013: 31 · 2012: 21
- FWCI
- 15.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Sociology of Health & Illness (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- National Institutes of Health
- 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 › Public Health, Environmental and Occupational Health › Medical and Health Sciences Research
- Keywords
- informed consent, clinical drug trials, patient consent, paternalism, individual choice, bioethical principles, healthy volunteers, clinical ethics
- MeSH terms
- Attitude of Health Personnel, Choice Behavior, Clinical Trials as Topic, Decision Making, Female, United Kingdom, Humans, Informed Consent, Interviews as Topic, Male, Surveys and Questionnaires, Social Perception, Drugs, Investigational, Randomized Controlled Trials as Topic, Personal Autonomy, Bioethical Issues, Ethics, Clinical, Paternalism, Principle-Based Ethics, Ethics, Research, Narration, Biomedical Research
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