Alpha 2.0
Login Register
» Articles » PMID: 31903508

Broad Consent Under the GDPR: an Optimistic Perspective on a Bright Future

Overview
Journal Life Sci Soc Policy
Publisher Biomed Central
Specialty Medical Ethics
Date 2020 Jan 7
PMID 31903508
Citations 20
Authors
Dara Hallinan
Affiliations
Soon will be listed here.
Abstract

Broad consent - the act of gaining one consent for multiple potential future research projects - sits 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 and - despite the understandable concern flowing from recent jurisprudence - offers 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.

Citing Articles

Data altruism and the "consent" question: a study into the "consent" models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data.

Christofidou M, Arvanitis T, Kalra D, Lea N, Shabani M, Coorevits P Front Med (Lausanne). 2025; 11:1489925.

PMID: 40070923 PMC: 11894576. DOI: 10.3389/fmed.2024.1489925.

Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study.

Hans F, Kleinekort J, Boerries M, Nieters A, Kindle G, Rautenberg M JMIR Med Inform. 2024; 12():e65646.

PMID: 39626089 PMC: 11688594. DOI: 10.2196/65646.

Dynamic governance: A new era for consent for stem cell research.

Isasi R, Bentzen H, Fabbri M, Fuhr A, Glover J, Mah N Stem Cell Reports. 2024; 19(9):1233-1241.

PMID: 39151430 PMC: 11411296. DOI: 10.1016/j.stemcr.2024.07.006.

Nonfungible Tokens as a Blockchain Solution to Ethical Challenges for the Secondary Use of Biospecimens: Viewpoint.

Gross M, Hood A, Miller Jr R JMIR Bioinform Biotechnol. 2024; 2(1):e29905.

PMID: 38943235 PMC: 11168237. DOI: 10.2196/29905.

Ethical and social reflections on the proposed European Health Data Space.

Staunton C, Shabani M, Mascalzoni D, Mezinska S, Slokenberga S Eur J Hum Genet. 2024; 32(5):498-505.

PMID: 38355959 PMC: 11061131. DOI: 10.1038/s41431-024-01543-9.

References
1.
Visscher P, Brown M, McCarthy M, Yang J . Five years of GWAS discovery. Am J Hum Genet. 2012; 90(1):7-24. PMC: 3257326. DOI: 10.1016/j.ajhg.2011.11.029. View
2.
Visscher P, Wray N, Zhang Q, Sklar P, McCarthy M, Brown M . 10 Years of GWAS Discovery: Biology, Function, and Translation. Am J Hum Genet. 2017; 101(1):5-22. PMC: 5501872. DOI: 10.1016/j.ajhg.2017.06.005. View
3.
Rumbold J, Pierscionek B . The Effect of the General Data Protection Regulation on Medical Research. J Med Internet Res. 2017; 19(2):e47. PMC: 5346164. DOI: 10.2196/jmir.7108. View
4.
Hallinan D, Friedewald M . Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?. Life Sci Soc Policy. 2015; 11:1. PMC: 4480798. DOI: 10.1186/s40504-014-0020-9. View
5.
Strech D, Bein S, Brumhard M, Eisenmenger W, Glinicke C, Herbst T . A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process. Eur J Med Genet. 2016; 59(6-7):295-309. DOI: 10.1016/j.ejmg.2016.04.002. View