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

Giesbertz, Noor A. A.; Bredenoord, Annelien L.; Delden, Johannes J. M. van

doi:10.1371/journal.pbio.1001373

Cited by 48 publications

(48 citation statements)

References 63 publications

(71 reference statements)

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“…[1][2][3][4][5] A biobank can be defined as a collection of human biological samples stored for medical-scientific research purposes, usually linked to phenotypic data in one way or another. [6][7][8] Hence, the primary goal of biobanks is to facilitate research, not to provide medical care. The inclusion of children in biobanks brings forward specific ethical issues.…”

Section: Introductionmentioning

confidence: 99%

Clarifying assent in pediatric research

2013

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Section: Introductionmentioning

confidence: 99%

Clarifying assent in pediatric research

2013

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“…Giesbertz defines residual samples as leftover tissue obtained in the course of clinical care that can be included or collected through an opt-in method (a person explicitly expresses consent to include residual tissue) or an opt-out method and the tissue is stored unless a person explicitly refuses [34] . He further notes that the "opt in" is an appropriate approach to collect residual samples.…”

Section: Discussionmentioning

confidence: 99%

“…However, the expansion of Biobanks and rapid developments in biomedical research underscore the need to evaluate the proper procedure, as each community will be different. Nonetheless, the development of Biobank has caused many legal and ethical issues to arise ranging from the need for community consultation, informed consent, legal measures enacted to protect patients and researchers, and reporting of return results [34][35][36] . Additionally, researchers need to have a better understanding of the reason for low opt-out rates.…”

Section: Discussionmentioning

confidence: 99%

Perceptions toward establishing a biobank and clinical data warehouse: Voices from the community

Spruill

Gibbs²,

Laken³

et al. 2014

Clinical Nursing Studies

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As Biobanking projects become more prevalent as an enabling resource for large -scale genetic research, it is important to assess public opinions from the community whose samples populate Biobanks. Although major studies were conducted to engage community members in advance of establishing Biobanks, few have included the attitudes/perceptions and educational needs of residents in the planning process. This qualitative pilot project was designed to engage the community in the planning process of establishing a Biobank and Clinical Data Warehouse. A thematic analysis of transcripts from seven focus groups and ten individual interviews revealed four major themes: Altruism, Acceptance, Anxiety & Fear, and Education. The voices from our community indicated a willingness to accept and participate using medical waste (biomaterials), given appropriate education is provided to patient and communities and they can exercise autonomy by signing a consent. This is a pivotal time in health care, especially in lieu of the evolving genomic era. Nurses have a tremendous responsibility and opportunity to become leaders in the era of Biobanking, and bridging the gap between discoveries from Biobanking and improving the quality of clinical care from bench to bedside.

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“…the clinical laboratory) to officially release the post-retention tissue, (2) the future stewards (e.g. the research biobank) to officially accept the tissue and (3) the REB to provide oversight for considerations around specific research consent for banking of tissue for future research and proper de-identification/coding of samples [6,16,17]. After these prerequisites are fulfilled, the post-retention DT becomes RT and there is an official transfer of stewardship from the clinical laboratory to the research biobank.…”

Section: Post-retention Dt As a Source Of Rtmentioning

confidence: 99%

The Role of Diagnostic Tissue in Research

Cheung

Torlakovic²,

Porwit

2014

Pathobiology

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There are two broad classes (or categories) of excised human tissue: diagnostic tissue (DT) and research tissue (RT). Classification of excised human tissue does not define its ultimate use and ultimate use of excised human tissue does not define its classification. While both DT and RT can be used for research, DT has specific requirements with respect to how it must be handled if and when being accessed for research. We highlight distinguishing features of DT: (1) it is a clinical record, (2) it must be identifiable to a specific individual, (3) it is stewarded by pathology departments/clinical laboratories and (4) it has a mandatory retention period. We discuss how the further sub-classification of DT into archived DT (aDT) and excess DT (eDT) impacts the nature of its role in research. We examine the concept of DT as a clinical record and emphasize the impact of mandatory retention as it applies to how DT may be accessed for research purposes. We explain the role of post-retention eDT as a source of RT as well as procedures for access to in-retention aDT for research. Clarity of such issues will facilitate responsible access to DT for research.

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

Abstract: This paper reviews the key arguments of the two predominant methods for the inclusion of human residual tissue in biobanks: opt-in and opt-out.

Cited by 48 publications

References 63 publications

Clarifying assent in pediatric research

Clarifying assent in pediatric research

Perceptions toward establishing a biobank and clinical data warehouse: Voices from the community

The Role of Diagnostic Tissue in Research

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