Data protection in grid-based multicentric clinical trials: Killjoy or confidence-building measure?

Publikation: Beitrag in FachzeitschriftArtikelForschungPeer-Review

Autoren

  • Marian Arning
  • Nikolaus Forgó
  • Tina Cornelius-Krügel

Organisationseinheiten

Forschungs-netzwerk anzeigen

Details

OriginalspracheEnglisch
Seiten (von - bis)2729-2739
Seitenumfang11
FachzeitschriftPhilosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences
Jahrgang367
Ausgabenummer1898
PublikationsstatusVeröffentlicht - 13 Juli 2009

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.

ASJC Scopus Sachgebiete

Zitieren

Data protection in grid-based multicentric clinical trials: Killjoy or confidence-building measure? / Arning, Marian; Forgó, Nikolaus; Cornelius-Krügel, Tina.
in: Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences, Jahrgang 367, Nr. 1898, 13.07.2009, S. 2729-2739.

Publikation: Beitrag in FachzeitschriftArtikelForschungPeer-Review

Download
@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",

}

Download

TY - JOUR

T1 - Data protection in grid-based multicentric clinical trials

T2 - Killjoy or confidence-building measure?

AU - Arning, Marian

AU - Forgó, Nikolaus

AU - Cornelius-Krügel, Tina

PY - 2009/7/13

Y1 - 2009/7/13

N2 - 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.

AB - 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.

KW - Central data protection agency

KW - Data protection

KW - De facto anonymization

KW - Genetic data

KW - Genetic research projects

KW - Pseudonymization

UR - http://www.scopus.com/inward/record.url?scp=67650287089&partnerID=8YFLogxK

U2 - 10.1098/rsta.2009.0060

DO - 10.1098/rsta.2009.0060

M3 - Article

C2 - 19487208

AN - SCOPUS:67650287089

VL - 367

SP - 2729

EP - 2739

JO - Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences

JF - Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences

SN - 1364-503X

IS - 1898

ER -