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

Hallinan, Dara

doi:10.1186/s40504-019-0096-3

Cited by 42 publications

(28 citation statements)

References 17 publications

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“…Perhaps the most important social impact we have discovered was that majority of the participants were quite positive (>90% positive response) about donating their genomic as well as clinical information, and understood how their genome could be used as a resource for healthcare research. The response was consistent with the survey results by the Korea Centers for Disease Control and Prevention (KCDC) ( Kim et al, 2020 ) and comparable to the results of the 100,000 Genome Project 11 and Qatar Genome Program (QGP) ( Qoronfleh et al, 2020 ). Certainly, it is important to note that our participants’ response was intrinsically biased by the free benefits they received.…”

Section: Discussionsupporting

confidence: 81%

“…Certainly, it is important to note that our participants’ response was intrinsically biased by the free benefits they received. However, WGP’s survey was only on the participants, while QGP ( Qoronfleh et al, 2020 ) surveyed the general Qatari population with which 71% responded positively toward the genome project. Therefore, the overwhelmingly positive response in our study may be biased but not unprecedented.…”

Section: Discussionmentioning

confidence: 99%

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Welfare Genome Project: A Participatory Korean Personal Genome Project With Free Health Check-Up and Genetic Report Followed by Counseling

Jeon

Blažytė

et al. 2021

Front. Genet.

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The Welfare Genome Project (WGP) provided 1,000 healthy Korean volunteers with detailed genetic and health reports to test the social perception of integrating personal genetic and healthcare data at a large-scale. WGP was launched in 2016 in the Ulsan Metropolitan City as the first large-scale genome project with public participation in Korea. The project produced a set of genetic materials, genotype information, clinical data, and lifestyle survey answers from participants aged 20–96. As compensation, the participants received a free general health check-up on 110 clinical traits, accompanied by a genetic report of their genotypes followed by genetic counseling. In a follow-up survey, 91.0% of the participants indicated that their genetic reports motivated them to improve their health. Overall, WGP expanded not only the general awareness of genomics, DNA sequencing technologies, bioinformatics, and bioethics regulations among all the parties involved, but also the general public’s understanding of how genome projects can indirectly benefit their health and lifestyle management. WGP established a data construction framework for not only scientific research but also the welfare of participants. In the future, the WGP framework can help lay the groundwork for a new personalized healthcare system that is seamlessly integrated with existing public medical infrastructure.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

Welfare Genome Project: A Participatory Korean Personal Genome Project With Free Health Check-Up and Genetic Report Followed by Counseling

Jeon

Blažytė

et al. 2021

Front. Genet.

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“…The GDPR applies to the processing of personal data across a large range of contexts, including those used in biomedical research and pertaining to vast areas of translational and clinical research activities, although it was probably not drafted with all the latter purposes in mind. As such, it has instigated multiple discussions among researchers and, in several cases, has raised major concerns, particularly, but not exclusively, in the genomics community (reviewed in study by Townend, 3 Phillips, 4 and Hallinan 5 ).…”

mentioning

confidence: 99%

Data Sharing Under the General Data Protection Regulation

et al. 2021

Self Cite

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The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.

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“…This will restrict the availability of this legal base further. This may for example mean that it may not be considered a suitable base for forms of blue skies research where the direct benefit in terms of public interest may not be immediately clear (Hallinan 2020 ). 51 The same is likely to be true for research that has a primarily commercial motivation.…”

Section: Potential Legal Bases For Research With Sensitive Datamentioning

confidence: 99%

Research under the GDPR – a level playing field for public and private sector research?

Quinn

2021

Life Sci Soc Policy

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Scientific research is indispensable inter alia in order to treat harmful diseases, address societal challenges and foster economic innovation. Such research is not the domain of a single type of organization but can be conducted by a range of different entities in both the public and private sectors. Given that the use of personal data may be indispensable for many forms of research, the data protection framework will play an important role in determining not only what types of research may occur but also which types of actors may carry it out. This article looks at the role the EU’s General Data Regulation plays in determining which types of actors can conduct research with personal data. In doing so it focuses on the various legal bases that are available and attempts to discern whether the GDPR can be said to favour research in either the public or private domains. As this article explains, the picture is nuanced, with either type of research actor enjoying advantages and disadvantages in specific contexts.

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

Cited by 42 publications

References 17 publications

Welfare Genome Project: A Participatory Korean Personal Genome Project With Free Health Check-Up and Genetic Report Followed by Counseling

Welfare Genome Project: A Participatory Korean Personal Genome Project With Free Health Check-Up and Genetic Report Followed by Counseling

Data Sharing Under the General Data Protection Regulation

Research under the GDPR – a level playing field for public and private sector research?

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