Strengths and weaknesses of the European concept of informed consent: Theoretical issues and practical examples

Author

Forgo, Nikolaus ; Goralczyk, Magdalena ; von Rex, C.G.

Author_Institution

Inst. for Legal Inf., LUH Hannover, Hannover, Germany

fYear

2012

fDate

11-13 Nov. 2012

Firstpage

638

Lastpage

643

Abstract

A general overview of the legal requirements for consent in health in European Union is presented and a comparison between three different usage of consent is being offered: consent for care; consent for clinical trial participation and consent for data processing. On a second stage a practical example of the strengths and weaknesses of the European concept of informed consent, the research project Linked2Safety is presented. Particular attention is being paid to the involved patients in the project, the different types of consent and the phases of the project as well as the data within the project.

Keywords

data handling; government policies; health care; international collaboration; legislation; medical administrative data processing; European Union; European concept of informed consent; clinical trial participation; data processing; legal requirements; research project Linked2Safety; Clinical trials; Context; Contracts; Data processing; Europe; Law; European Union framework; Infromed consent; clinical tirals; patients; sensitive data;

fLanguage

English

Publisher

ieee

Conference_Titel

Bioinformatics & Bioengineering (BIBE), 2012 IEEE 12th International Conference on

Conference_Location

Larnaca

Print_ISBN

978-1-4673-4357-2

Type

conf

DOI

10.1109/BIBE.2012.6399776

Filename

6399776