Data protection in grid-based multicentric clinical trials

Killjoy or confidence-building measure?

verfasst von: Marian Arning, Nikolaus Forgó, Tina Cornelius-Krügel
Abstract: In order to protect the privacy of participating patients in multicentric genetic research projects and to improve the working conditions for researchers in such projects a data protection framework needs to be installed. In the first place, all genetic data processed in the project has to be pseudonymized. In addition to that, contracts have to be concluded between the project and each project partner to guarantee that genetic data are used only within the project and that each partner complies with data security standards. Furthermore, a central data protection authority has to be installed in the project to control the partners' compliance with these contracts and to serve as a central contact point for participants. If these conditions are fulfilled, only (de facto) anonymous data are used in the project, so that data protection legislation is not directly applicable. Second, each participant has to sign a special consent form for ethical reasons and as a fallback solution if the pseudonymizatio n of the genetic data fails. With this safety net it is possible to protect the participants' privacy and to improve the working conditions for researchers.
Organisationseinheit(en): Institut für Rechtsinformatik (IRI)
Typ: Artikel
Journal: Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences
Band: 367
Seiten: 2729-2739
Anzahl der Seiten: 11
ISSN: 1364-503X
Publikationsdatum: 13.07.2009
Publikationsstatus: Veröffentlicht
Peer-reviewed: Ja
ASJC Scopus Sachgebiete: Allgemeine Mathematik, Allgemeiner Maschinenbau, Allgemeine Physik und Astronomie
Elektronische Version(en): https://doi.org/10.1098/rsta.2009.0060 (Zugang: Geschlossen)

BibTeX

@article{ea5d2cec93e64f81bb549ca68cbcfa6a,
title = "Data protection in grid-based multicentric clinical trials: Killjoy or confidence-building measure?",
abstract = "In order to protect the privacy of participating patients in multicentric genetic research projects and to improve the working conditions for researchers in such projects a data protection framework needs to be installed. In the first place, all genetic data processed in the project has to be pseudonymized. In addition to that, contracts have to be concluded between the project and each project partner to guarantee that genetic data are used only within the project and that each partner complies with data security standards. Furthermore, a central data protection authority has to be installed in the project to control the partners' compliance with these contracts and to serve as a central contact point for participants. If these conditions are fulfilled, only (de facto) anonymous data are used in the project, so that data protection legislation is not directly applicable. Second, each participant has to sign a special consent form for ethical reasons and as a fallback solution if the pseudonymizatio n of the genetic data fails. With this safety net it is possible to protect the participants' privacy and to improve the working conditions for researchers.",
keywords = "Central data protection agency, Data protection, De facto anonymization, Genetic data, Genetic research projects, Pseudonymization",
author = "Marian Arning and Nikolaus Forg{\'o} and Tina Cornelius-Kr{\"u}gel",
year = "2009",
month = jul,
day = "13",
doi = "10.1098/rsta.2009.0060",
language = "English",
volume = "367",
pages = "2729--2739",
journal = "Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences",
issn = "1364-503X",
publisher = "The Royal Society",
number = "1898",
}