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Cited by 48Ethics in Clinical ResearchEthics and bioethics in healthcareBiomedical Ethics and Regulation

Inclusion of Residual Tissue in Biobanks: Opt-In or Opt-Out?

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Giesbertz, Noor A. A., Bredenoord, Annelien L., van Delden, Johannes J. M.·2012·PLoS Biology
DOI 10.1371/journal.pbio.1001373PMC PMC3415320
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Abstract

Residual samples are an important source of tissue for biobanks. They refer to leftover tissue that is obtained in the course of clinical care. Residual samples can be included through an opt-in method--that is, a person explicitly expresses consent to include residual tissue--or an opt-out method--that is, the tissue is stored unless a person explicitly refuses. At the moment there is a renewed interest in the appropriate method for the inclusion of residual samples in biobanks. The expansion of biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure. In this article we revisit the arguments in favor and against opt-in and opt-out methods for residual tissue research. We conclude firstly that an opt-out method is only justifiable when certain conditions are met: (1) awareness has to be raised, (2) sufficient information has to be provided, and (3) a genuine possibility to object has to be offered. An opt-out procedure that fulfills these conditions can be called a "thick" opt-out method. As a consequence, the dichotomy between opt-in and opt-out is less stark than usually suggested, as both methods require a certain amount of effort. Secondly, we conclude that because of the diversity of tissue and research, not every situation can be treated alike. There are at least four situations that require opt-in procedures: (1) research with higher risks or increased burdens, (2) the use of controversial or high-impact techniques, (3) research on sensitive tissue types, and (4) research involving vulnerable patients. We suggest that further interdisciplinary debate should answer the question when to opt-in or when to opt-out.

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  • Active opt-out procedures for the research use of residual clinical specimens arguably afford the same benefits as traditional opt-out but at a lower cost.

    “In contrast to traditional opt-out, in which a brief mention of research use may be buried in a consent-to-treat form, actively notifying patients that their biospecimens may be used for research and alerting them to their right to opt out arguably affords the same benefits elucidated in Table 4, but at a lower “cost.””

    From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [44]

    The “Lower Financial Costs” section says a thin opt-out procedure is less expensive, while adding adequate information and a genuine opportunity to object requires more effort and money. The “Concluding Remarks” also say a thin procedure is insufficient, rather than affording the same protections as an actively communicated, thick opt-out procedure. The paper compares opt-out costs with opt-in costs; it does not support a lower cost for active opt-out than for traditional thin opt-out. Page numbers are unavailable in our copy. (LLM, conf=0.88)

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Research works printed but not linked: 3

  1. [22]Laurie G (2008) Consent for Biobanking. Lack of dissent when opting in doesn't necessarily support “opt out”. BMJ 337: a337. 18617495
  2. [36]Savulescu J (2002) No consent should be needed for using leftover body material for scientific purposes. BMJ 325: 648– 651. 12269316
  3. [71]Levine RJ (2003) Consent issues in human research. In: Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C, editors. Ethical and regulatory aspects of clinical research: readings and commentary. John Hopkins University Press. 197–201.

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Authors
Giesbertz, N. A. A., Bredenoord, A. L., & van Delden, J. J. M.
Affiliations
University Medical Center Utrecht (NL)
Corresponding author
Giesbertz, Noor A. A.
ORCID
Venue
PLoS Biology
Publisher
Public Library of Science (PLoS)
Published
2012-08-07
Volume
10
Issue
8
Pages
e1001373
ISSN
  • 1544-9173 (ISSN-L)
  • 1545-7885
DOI
10.1371/journal.pbio.1001373
PMC
PMC3415320
OpenAlex
W2077408969
Cited by
48
References
77
Citations by year
2026: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2021: 6 · 2020: 2 · 2019: 2 · 2018: 5 · 2017: 4 · 2016: 8 · 2015: 3 · 2014: 4 · 2013: 7
FWCI
4.33
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS Biology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
ZonMw
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
residual tissue, biobanks, opt-in consent, presumed consent, informed consent, vulnerable patients
MeSH terms
Attitude, Choice Behavior, Humans, Informed Consent, Tissue Banks, Tissue Donors, Personal Autonomy, Moral Obligations, Biomedical Research

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