ArticlePLoS biology2012
Inclusion of residual tissue in biobanks: opt-in or opt-out?
Article in PLoS biology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed.
- Patient views on research use of clinical data without consent: Legal, but also acceptable?European journal of human genetics : EJHG · 2019Trial
- Trial
- A thick opt-out for genomic newborn screening, retention, and reuse of genomic data.European journal of human genetics : EJHG · 2026Article
- From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework.PloS one · 2024Article
- Creation and use of organoids in biomedical research and healthcare: the bioethical and metabioethical issues.Cell adhesion & migration · 2021Article
- Presumed Consent With Opt-Out: An Ethical Consent Approach to Automatically Refer Patients With Cancer to Tobacco Treatment Services.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Article
- Ethical Issues in Research and Development of Epigenome-wide Technologies.Epigenetics insights · 2020Article
- Paying Tribute to Henrietta Lacks at Tuskegee University and at The Virginia Henrietta Lacks Commission, Richmond, Virginia.Journal of health care for the poor and underserved · 2019Article
- Determinants of the willingness to participate in biobanking among Malaysian stakeholders in the Klang Valley.BMC medical research methodology · 2018Article
- Pediatric oncology as a Learning Health System: Ethical implications for best available treatment protocols.Learning health systems · 2018Article
- Brain tumor biobanking in the precision medicine era: building a high-quality resource for translational research in neuro-oncology.Neuro-oncology practice · 2017Review
- Paediatric biobanking: Dutch experts reflecting on appropriate legal standards for practice.European journal of pediatrics · 2017Review
- Ethical considerations in the translation of regenerative biofabrication technologies into clinic and society.Biofabrication · 2016Review
- Lessons from HeLa Cells: The Ethics and Policy of Biospecimens.Annual review of genomics and human genetics · 2016Review
- Organoid biobanking: identifying the ethics: Organoids revive old and raise new ethical challenges for basic research and therapeutic use.EMBO reports · 2016Article
- When Children Become Adults: Should Biobanks Re-Contact?PLoS medicine · 2016Review
- Whole-genome sequencing in outbreak analysis.Clinical microbiology reviews · 2015Review
- The MICHR Genomic DNA BioLibrary: An Empirical Study of the Ethics of Biorepository Development.Journal of empirical research on human research ethics : JERHRE · 2015Article
- Clarifying assent in pediatric research.European journal of human genetics : EJHG · 2014Article
- An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank.BMC medical ethics · 2013Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.