A trial of consent procedures for future research with clinically derived biological samples
Open accessAbstract
BACKGROUND: The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are. METHODS: We offered 264 cancer patients three different consent procedures: 'one-time general consent' (asked written informed consent), 'opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures. RESULTS: In all, 99% of patients consented to research with their residual tissue. In the 'one-time consent' group 85% sent back their consent form. Patients preferred 'opt-out plus' (43%) above 'one-time consent' (34%) or 'opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice. CONCLUSIONS: The 'opt-out plus' procedure, which places fewer demands on administrative resources than 'one-time consent', can also address the information needs of patients.
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In the Vermeulen et al. study at one cancer institute in the Netherlands, 82% of the onetime consent group and 65% of the opt-out plus group felt well informed, while 73% of the control group had not seen or did not remember the information about tissue research.
“Among the respondents, 82% of those in the onetime consent group and 65% of those in the opt-out plus group felt well informed; by contrast, 73% of those in the control group had not seen or did not remember having read the information about tissue research.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [144]
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Experimental — accuracy not yet measuredIn the Vermeulen et al. study, among all respondents, 43% preferred opt-out plus, 34% preferred onetime consent, 16% preferred standard opt-out, and 8% said no information was needed.
“Among all respondents, 43% preferred opt-out plus, 34% preferred onetime consent, 16% preferred the standard opt-out procedure, and 8% said that no information at all was needed.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [144]
In the Vermeulen et al. study, respondents who were younger, female, and more highly educated and considered themselves owners of their tissue were more likely to prefer onetime consent and opt-out plus over standard opt-out, and in all subgroups opt-out plus was preferred more often than other approaches.
“Respondents who were younger, female, and more highly educated and considered themselves to be the owners of their tissue were more likely to prefer onetime consent and opt-out plus over standard opt-out. In all subgroups, opt-out plus was preferred more often than other approaches.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [144]
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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
“(144)], and their awareness could be reinforced through video spots on waiting room and patient room TVs, email and smartphone messaging, newsletters, brochures, posters, websites, and newspaper and radio stories (16).”
BackgroundInclusion of Residual Tissue in Biobanks: Opt-In or Opt-Out?
Giesbertz, N. A. A., Bredenoord, A. L., & van Delden, J. J. M. (2012) · PLoS Biology · doi:10.1371/journal.pbio.1001373 · Cited by 48 · see citing works
- Authors
- Vermeulen, E., Schmidt, M. K., Aaronson, N. K., Kuenen, M., Baas-Vrancken Peeters, M.-J., van der Poel, H., Horenblas, S., Boot, H., Verwaal, V. J., Cats, A., & van Leeuwen, F. E.
- Affiliations
- The Netherlands Cancer Institute (NL)
- Venue
- British Journal of Cancer
- Published
- 2009-09-29
- Volume
- 101
- Issue
- 9
- Pages
- 1505-1512
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- PMC
- PMC2778511
- OpenAlex
- W1999918196
- Cited by
- 39
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 4 · 2017: 1 · 2016: 5 · 2015: 1 · 2014: 2 · 2013: 7 · 2012: 9
- FWCI
- 4.71
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- www.springer.com/tdm (unspecified)
- Locations
- British Journal of Cancer (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Cancer Genomics Centre
- 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, presumed consent, residual tissue, cancer patients, patient preferences, patient information needs
- MeSH terms
- Female, Humans, Informed Consent, Male, Neoplasms, Surveys and Questionnaires, Tissue Banks, Patient Satisfaction, Biomedical Research
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