TY - JOUR

T1 - Donor's support tool

T2 - Enabling informed secondary use of patient's biomaterial and personal data

AU - Kondylakis, Haridimos

AU - Koumakis, Lefteris

AU - Hänold, Stephanie

AU - Nwankwo, Iheanyi

AU - Forgó, Nikolaus

AU - Marias, Kostas

AU - Tsiknakis, Manolis

AU - Graf, Norbert

N1 - Funding information: We would like to thank Maria Hatzimina, Eirini Genitsaridi, Holger Stenzhorn and Elias Neri who were involved in the development of the tools presented in this paper. This work has been supported by the EU projects p-Medicine (FP7-270089) and iManageCancer (H2020-643529) and has been partially funded by the European Commission .

PY - 2017/1

Y1 - 2017/1

N2 - Purpose Biomedical research is being catalyzed by the vast amount of data rapidly collected through the application of information technologies (IT). Despite IT advances, the methods for involving patients and citizens in biomedical research remain static, paper-based and organized around national boundaries and anachronistic legal frameworks. The purpose of this paper is to study the current practices for obtaining consent for biobanking and the legal requirements for reusing the available biomaterial and data in EU and finally to present a novel tool to this direction enabling the secondary use of data and biomaterial. Method We review existing European legislation for secondary use of patient's biomaterial and data for research, identify types and scopes of consent, formal requirements for consent, and consider their implications for implementing electronic consent tools. To this direction, we proceed further to develop a modular tool, named Donor's Support Tool (DST), designed to connect researchers with participants, and to promote engagement, informed participation and individual decision making. Results To identify the advantages of our solution we compare our tool with six other relevant approaches. The results show that our tool scores higher than the other tools in functionality, security and intelligence whereas it is the only one free and open-source. In addition, the potential of our solution is shown by a proof of concept deployment in an existing clinical setting, where it was really appreciated, as streamlining the relevant workflow.

AB - Purpose Biomedical research is being catalyzed by the vast amount of data rapidly collected through the application of information technologies (IT). Despite IT advances, the methods for involving patients and citizens in biomedical research remain static, paper-based and organized around national boundaries and anachronistic legal frameworks. The purpose of this paper is to study the current practices for obtaining consent for biobanking and the legal requirements for reusing the available biomaterial and data in EU and finally to present a novel tool to this direction enabling the secondary use of data and biomaterial. Method We review existing European legislation for secondary use of patient's biomaterial and data for research, identify types and scopes of consent, formal requirements for consent, and consider their implications for implementing electronic consent tools. To this direction, we proceed further to develop a modular tool, named Donor's Support Tool (DST), designed to connect researchers with participants, and to promote engagement, informed participation and individual decision making. Results To identify the advantages of our solution we compare our tool with six other relevant approaches. The results show that our tool scores higher than the other tools in functionality, security and intelligence whereas it is the only one free and open-source. In addition, the potential of our solution is shown by a proof of concept deployment in an existing clinical setting, where it was really appreciated, as streamlining the relevant workflow.

KW - Biobank

KW - Dynamic consent

KW - Electronic consent

KW - Secondary use of biomaterial and personal data

UR - http://www.scopus.com/inward/record.url?scp=84994910713&partnerID=8YFLogxK

U2 - 10.1016/j.ijmedinf.2016.10.019

DO - 10.1016/j.ijmedinf.2016.10.019

M3 - Article

C2 - 27919386

AN - SCOPUS:84994910713

VL - 97

SP - 282

EP - 292

JO - International Journal of Medical Informatics

JF - International Journal of Medical Informatics

SN - 1386-5056

ER -