Legal Challenges and Strategies in the Regulation of Research Biobanking

Rynning, Elisabeth

doi:10.1007/978-0-387-93872-1_19

Cited by 5 publications

(2 citation statements)

References 23 publications

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“…59,60 For example, some authors have explored the ethical obligations of genomic biobanks as public goods. 61–64 Indeed, in some countries, biobanks are created by statute or structured as a nonprofit foundation or charitable organization. 65 In the United States, biobanks created by NIH or another public entity (e.g., NIH’s dbGaP, or NCI’s caHUB) or funded publicly (e.g., the NIH-funded eMERGE Network) will bear public responsibilities accordingly.…”

Section: Part II Core Questionsmentioning

confidence: 99%

Managing incidental findings and research results in genomic research involving biobanks and archived data sets

Wolf

Crock

Ness

et al. 2012

Genetics in Medicine

404

374

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Biobanks and archived datasets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings (IFs) and individual research results (IRRs) of potential health, reproductive, or personal importance to individual contributors (using “biobank” here to refer to both collections of samples and collections of data). This paper reports recommendations from a 2-year, NIH-funded project. The authors analyze responsibilities to manage return of IFs and IRRs in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). They suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When re-identification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities: to (1) clarify the criteria for evaluating findings and roster of returnable findings, (2) analyze a particular finding in relation to this, (3) re-identify the individual contributor, and (4) recontact the contributor to offer the finding. The authors suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and that are clinically actionable should generally be offered to consenting contributors. The paper specifies 10 concrete recommendations, addressing new biobanks and biobanks already in existence.

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Section: Part II Core Questionsmentioning

confidence: 99%

Managing incidental findings and research results in genomic research involving biobanks and archived data sets

Wolf

Crock

Ness

et al. 2012

Genetics in Medicine

404

374

View full text Add to dashboard Cite

show abstract

“…There is also ongoing work within several research communities to enact standards, for example, the Global Alliance for Genomics and Health, available at genomicsandhealth.org/node/12703 and the work within the BBMRI-ERIC, especially its ELSI common service. See further Rynning, [ 9 ] and Reichel, [ 8 ].…”

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confidence: 99%

Oversight of EU medical data transfers – an administrative law perspective on cross-border biomedical research administration

Reichel

2017

Health Technol.

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The notion of privacy has long had a central role in human rights law, not least in connection to health and medicine. International, regional and national bodies have enacted a number of binding and non-binding document for physicians and researchers to adhere to, in order to protect the autonomy, dignity and privacy of patients and research subjects. With the development of new technologies, the right to privacy has gained a new perspective; the right to protection of personal data within information and communication technologies. The right to data protection has been attributed an increasing importance within EU law. Accordingly, the use of health data in medical research in general and in biobank-related medical research in particular, has made data protection law highly relevant. In medical research involving biobanks, transferring human biological samples and/or individual health data is taking place on a daily basis. These transfers involve several oversight bodies, institutional review boards (IRBs), research ethics committees, or even data protection authorities. This article investigates the role of these national oversight bodies in the transfer of health data in cross-border research, from an EU law point of view. A special focus is laid on transfer of health data for research purposes from the EU to the US, in the light of the recently enacted EU-US Privacy Shield. The main question posed is how American oversight bodies for medical research can be expected to handle the increasingly strict EU requirements for the processing of health data in medical research review.

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A Unified European Approach on Tissue Research and Biobanking? A Comparison

Beier

Lenk

2011

The International Library of Ethics, Law and Technology

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Legal Challenges and Strategies in the Regulation of Research Biobanking

Cited by 5 publications

References 23 publications

Managing incidental findings and research results in genomic research involving biobanks and archived data sets

Managing incidental findings and research results in genomic research involving biobanks and archived data sets

Oversight of EU medical data transfers – an administrative law perspective on cross-border biomedical research administration

A Unified European Approach on Tissue Research and Biobanking? A Comparison

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