Legal aspects of biobanking as key issues for personalized medicine & translational exploitation

Research output: Contribution to journalJournal articlepeer-review

Standard

Legal aspects of biobanking as key issues for personalized medicine & translational exploitation. / Minssen, Timo; Schovsbo, Jens Hemmingsen.

In: Personalized Medicine, Vol. 11, No. 5, 2014, p. 497-508.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Minssen, T & Schovsbo, JH 2014, 'Legal aspects of biobanking as key issues for personalized medicine & translational exploitation', Personalized Medicine, vol. 11, no. 5, pp. 497-508. https://doi.org/10.2217/PME.14.29

APA

Minssen, T., & Schovsbo, J. H. (2014). Legal aspects of biobanking as key issues for personalized medicine & translational exploitation. Personalized Medicine, 11(5), 497-508. https://doi.org/10.2217/PME.14.29

Vancouver

Minssen T, Schovsbo JH. Legal aspects of biobanking as key issues for personalized medicine & translational exploitation. Personalized Medicine. 2014;11(5):497-508. https://doi.org/10.2217/PME.14.29

Author

Minssen, Timo ; Schovsbo, Jens Hemmingsen. / Legal aspects of biobanking as key issues for personalized medicine & translational exploitation. In: Personalized Medicine. 2014 ; Vol. 11, No. 5. pp. 497-508.

Bibtex

@article{beb9de5de9b64ea9b1ad69b53f5d21e2,
title = "Legal aspects of biobanking as key issues for personalized medicine & translational exploitation",
abstract = "This perspective article, which has is cuyrrently undergoing peer review by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry. To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM. We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).",
keywords = "Faculty of Law, biobanks, law & ethics, intellectual property, informed consent, personalized medicine, open innovation, translational medicine",
author = "Timo Minssen and Schovsbo, {Jens Hemmingsen}",
year = "2014",
doi = "10.2217/PME.14.29",
language = "English",
volume = "11",
pages = "497--508",
journal = "Personalized Medicine",
issn = "1741-0541",
publisher = "Future Medicine Ltd.",
number = "5",

}

RIS

TY - JOUR

T1 - Legal aspects of biobanking as key issues for personalized medicine & translational exploitation

AU - Minssen, Timo

AU - Schovsbo, Jens Hemmingsen

PY - 2014

Y1 - 2014

N2 - This perspective article, which has is cuyrrently undergoing peer review by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry. To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM. We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).

AB - This perspective article, which has is cuyrrently undergoing peer review by the medical journal “Personalized Medicine”, deals with the legal aspects of biobanking and points towards the concerns, interest, and choices that should be considered when establishing and operating a biobank. It focuses on public biobanks in a university setting and the specific challenges posed by PM with a special focus on publicly funded biobanks, commercialization issues and the involvement of industry. To this end we start out by briefly discussing differing definitions of the term biobank and highlighting the particular significance of biobanks for the development of PM and translational innovation. The next part describes the inherently complex, dynamic and heterogeneous environment in which legal challenges to biobanking and the regulation of biomedicine must be considered. Based on our finding we then sketch out more specific legal problems that might occur throughout the various chronological stages of biobanking regarding consent obligations and intellectual property rights (IPR). After this we use an on-going interdisciplinary research project based at the University of Copenhagen (UCPH) to illustrate how the legal and ethical challenges might be dealt with analytically and in a practical way that reflects the concerns and interest of stakeholders in biobanking and results in a transparent, legally and ethically robust system. In our closing remarks we make recommendations on how to improve the legal framework for biobanking and in particular for the challenges posed by PM. We conclude that any decisions as to the design of the regulatory environment should follow a process that takes account of the values, hopes and concerns of all stakeholders involved. In particular, we stress the importance of a careful planning of consent obligations combining traditional legal methods with an adequate institutional set up. In order to enhance the translational exploitation of biobanks, we further emphasize the pressing need to carefully consider a great variety of strategies and policy choices relating to intellectual property rights (IPRs).

KW - Faculty of Law

KW - biobanks, law & ethics, intellectual property, informed consent, personalized medicine, open innovation, translational medicine

U2 - 10.2217/PME.14.29

DO - 10.2217/PME.14.29

M3 - Journal article

VL - 11

SP - 497

EP - 508

JO - Personalized Medicine

JF - Personalized Medicine

SN - 1741-0541

IS - 5

ER -

ID: 96279689