Details
| Original language | English |
|---|---|
| Pages (from-to) | 2729-2739 |
| Number of pages | 11 |
| Journal | Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences |
| Volume | 367 |
| Issue number | 1898 |
| Publication status | Published - 13 Jul 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.
Keywords
- Central data protection agency, Data protection, De facto anonymization, Genetic data, Genetic research projects, Pseudonymization
ASJC Scopus subject areas
- Mathematics(all)
- General Mathematics
- Engineering(all)
- General Engineering
- Physics and Astronomy(all)
- General Physics and Astronomy
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In: Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences, Vol. 367, No. 1898, 13.07.2009, p. 2729-2739.
Research output: Contribution to journal › Article › Research › peer review
}
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 -