“working gRoup on EthicAl, Legal issues related to bIobank and reSEarch activities”
(Realise)
Typology: Reaserch Groups
Duration: starting from 2018
Responsible for the Coordinator:, Roberto Cippitani, Valentina Colcelli
Key Staff: Joanna Osiejewicz; A.Langella R.Arnold Dunia Duic Michał Jackowski Paula Poretti Joakim Nergelius Andreia da Costa Andrade Carla Barbosa, Christoph Broacchusen Tunjica Petrasevic Stefania Stefanelli Mireille Martine Caruana Hedley Christ Joaquín Sarrión Joaquín Sarrión
Description: research and analysis on how the GDPR affects the biobank landscape.
Purpose: creation of publications and conferences
Objectives and activities
Esperts and scholars will analysis the legislation of the Member States for the processing of health data for research purposes with particular attention to research-related Biobank activities. The GDPR provides a two-level framework to allow for exceptions to these rights when it comes to scientific research: 1) directly invoking the provisions of the GDPR provided that guarantees are in place which must include “technical and organizational measures”; 2) through the law of the Member State.
So we would like to know, among other information, if in the national legal system / systems you are analyzing:
A) Does national legislation provide the legal basis for the processing of personal data for research purposes?
B) Is there a research exemption?
C) Does the Member State include genetic and biometric data?
Q) How can historical archives of health data be used / reused?
E) Are there clear governance procedures and policies on the use and reuse of personal data?
F) How long could the fabrics be kept? Is there a specific focus on DNA and RNA obtainable from tissues?
G) There are some specific laws on biobacking activity.
Results:
- Handbook that will be published in Law & Science – Book series co-edited by Rainer Arnold, Roberto Cippitani and Valentina Colcelli, Universität Regensburg, in the UMBRIABIOBANKING project coordinated by Prof. Angelo Sidoni.
- Conference : GDPR Requirements for Biobanking Activities Across Europe