Many Have It Wrong – Samples Do Contain Personal Data: The Data Protection Regulation as a Superior Framework to Protect Donor Interests in Biobanking and Genomic Research

Hallinan, Dara; Hert, Paul De

doi:10.1007/978-3-319-33525-4_6

Cited by 28 publications

(6 citation statements)

References 12 publications

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“…The GDPR arguably applies across the genomic research process whenever personal data are processedincluding to the collection, storage and use of research subjects' biological samples, genomic data and other associated data (Hallinan 2018, pp. 263-295;Hallinan and De Hert 2016). 3 Prior to considering the legal details of the GDPR's stance on broad consent, however, it is worth considering the importance of this stance for the legitimacy and utility of broad consent.…”

Section: Broad Consent: a Brief Overviewmentioning

confidence: 99%

Broad consent under the GDPR: an optimistic perspective on a bright future

Hallinan

2020

Life Sci Soc Policy

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Broad consentthe act of gaining one consent for multiple potential future research projectssits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research community. Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR anddespite the understandable concern flowing from recent jurisprudenceoffers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: the principled, the legal technical, and the practical.

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Section: Broad Consent: a Brief Overviewmentioning

confidence: 99%

Broad consent under the GDPR: an optimistic perspective on a bright future

Hallinan

2020

Life Sci Soc Policy

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“…Some point out that is since the ultimate intention of the Regulation is to protect personal data, a broad interpretation should be applied, which could allow for the inclusion of all sources, including biological samples that contain genetic data ( Shabani and Borry, 2018 ). Others argue that due to the concept of data used by the GDPR, it is impossible to identify biological material with data ( Hallinan and De Hert, 2016 ). Code development can be of pivotal importance for such countries as Ireland, where the previous health research laws were more liberal than the GDPR ( Kirwan et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

2021

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Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.

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“…One approach is since the ultimate intention of the Regulation is to protect personal data, a broad interpretation should be applied, which could allow for the inclusion of all sources, including biological samples that contain genetic data. However, given the definition provided for genetic data in the Regulation which explicitly states "data" (not samples), it will be hard to maintain such a broad interpretation [17].…”

Section: Recognition Of Genetic Data Within the Special Categories Ofmentioning

confidence: 99%

Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation

Shabani

Borry

2017

Eur J Hum Genet

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Genetic data contain sensitive health and non-health-related information about the individuals and their family members. Therefore, adopting adequate privacy safeguards is paramount when processing genetic data for research or clinical purposes. One of the major legal instruments for personal data protection in the EU is the new General Data Protection Regulation (GDPR), which has entered into force in May 2016 and repealed the Directive 95/46/EC, with an ultimate goal of enhancing effectiveness and harmonization of personal data protection in the EU. This paper explores the major provisions of the new Regulation with regard to processing genetic data, and assesses the influence of such provisions on reinforcing the legal safeguards when sharing genetic data for research purposes. The new Regulation attempts to elucidate the scope of personal data, by recognizing pseudonymized data as personal (identifiable) data, and including genetic data in the catalog of special categories of data (sensitive data). Moreover, a set of new rules is laid out in the Regulation for processing personal data under the scientific research exemption. For instance, further use of genetic data for scientific research purposes, without obtaining additional consent will be allowed, if the specific conditions is met. The new Regulation has already fueled concerns among various stakeholders, owing to the challenges that may emerge when implementing the Regulation across the countries. Notably, the provided definition for pseudonymized data has been criticized because it leaves too much room for interpretations, and it might undermine the harmonization of the data protection across the countries.

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Many Have It Wrong – Samples Do Contain Personal Data: The Data Protection Regulation as a Superior Framework to Protect Donor Interests in Biobanking and Genomic Research

Cited by 28 publications

References 12 publications

Broad consent under the GDPR: an optimistic perspective on a bright future

Broad consent under the GDPR: an optimistic perspective on a bright future

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40

Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation

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