Active choice but not too active: Public perspectives on biobank consent models
Open accessAbstract
Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result.
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In the Simon et al. study, broad consent was the most commonly preferred scope (54% of focus group participants and 41% of survey participants), study-specific consent was preferred by 21% and 29%, and categorical consent by 21% and 25%.
“In terms of scope, broad consent was the most commonly preferred (54% of focus group participants and 41% of survey participants), for reasons such as greater ease and flexibility for research (and thus a boost to research output) and recognized uncertainties regarding future research. Study-specific consent was preferred by 21% and 29% of focus group and survey participants, respectively, and”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [128]
The Results (Survey results, page unavailable) give the claimed survey preferences: 41% broad, 29% study-specific, and 25% categorical. The Results (Focus group results, page unavailable) say broad consent received the strongest support and describe participants’ reasons, including research flexibility and uncertainty about future studies. Our copy does not give the claimed separate focus-group percentages of 54%, 21%, and 21%; the Discussion reports only that 42% preferred categorical or study-specific consent combined. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn support of proposed regulatory changes, the NPRM cited four articles reporting public opinions about biospecimen research, but these publications do not necessarily suggest consensus.
“In support of proposed regulatory changes, the NPRM cited four articles reporting public opinions about biospecimen research (77, 128, 140, 144). But as summarized below, these publications do not necessarily suggest consensus.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [128]
In the Simon et al. study, if study-specific and categorical consent preferences are combined as a general control/choice model, it could be seen as preferred (by 42% of focus group and 54% of survey participants) over broad consent.
“The authors noted that, theoretically, the proportions that preferred study-specific and categorical consent could be combined on the grounds that both models promote control and choice over future use. If so, a general control/choice model could be seen as preferred (by 42% and 54% of focus group and survey participants, respectively) over broad consent.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [128]
In the Simon et al. study, a majority (63% of focus group participants and 67% of survey participants) preferred an opt-in approach to initial consent, while opt-out was preferred by 25% and 18%, respectively, and "no consent" was preferred by 5% of survey respondents.
“A majority (63% of focus group participants and 67% of survey participants) preferred an opt-in approach to initial consent. Common reasons included that opt-in provided the opportunity to make a more positive, active, and informed choice and would receive greater public acceptance as fitting with traditional notions of consent. Opt-out was preferred by 25% and 18% of focus group and survey”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [128]
In the Simon et al. telephone survey, an opt-out approach to initial consent was the preferred choice for only 18%, but it was supported by 78%.
“An opt-out approach to initial consent was the preferred choice for only 18%, but it was supported by 78%.”
From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [128]
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- Authors
- Simon, C. M., L’Heureux, J., Murray, J. C., Winokur, P., Weiner, G., Newbury, E., Shinkunas, L., & Zimmerman, B.
- Affiliations
- University of Iowa (US)
- Corresponding author
- Simon, Christian M.
- Venue
- Genetics in Medicine
- Publisher
- Elsevier BV
- Published
- 2011-09
- Volume
- 13
- Issue
- 9
- Pages
- 821-831
- ISSN
- 1098-3600 (ISSN-L)
- PMC
- PMC3658114
- OpenAlex
- W2115300617
- Cited by
- 168
- References
- 34
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 7 · 2023: 5 · 2022: 6 · 2021: 26 · 2020: 8 · 2019: 9 · 2018: 11 · 2017: 15 · 2016: 6 · 2015: 17 · 2014: 11 · 2013: 17 · 2012: 19
- FWCI
- 16.04
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Genetics in Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Institute of Clinical and Translational Sciences
- University of Northern Iowa
- National Institutes of Health (UL1TR000442)
- Roy J. and Lucille A. Carver College of Medicine, University of Iowa
- National Center for Advancing Translational Sciences
- 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
- biobanks, informed consent, consent models, public attitudes, opt-in consent, presumed consent, broad consent, research utilization, informed choice, public trust
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Informed Consent, Male, Middle Aged, Public Opinion, United States, Mental Competency, Focus Groups, Biological Specimen Banks
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