Emmanuelle Rial-Sebbag INSERM Unité 558
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From this document you will learn the answers to the following questions:
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1 Emmanuelle Rial-Sebbag INSERM Unité 558
2 Les échantillons biologiques Eléments du corps humains ADN Les données associées Identifiantes, personnelles Non-identifiantes Voir les définitions données par ICH Topic E 15, 1st Nov (Identified, Coded, Anonymised, Anonymous)
3 Textes contraignants (ex.) European Parliament and Council Directive 95/46/ EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases is a European Union directive in the field of copyright law, made under the internal market provisions of the Treaty of Rome.
4 Textes non-contraignants (ex.) World Medical Association (WMA) Declaration on Ethical Considerations Regarding Health Databases, Washington, 2002 Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, Seoul, 2008 European Society of Human Genetics (ESHG): Data Storage and DNA Banking for Biomedical Research: Technical, Ethical and Social Issues, November 2001 Human Genome Organisation (HUGO): Statement on Human Genomic Databases, London, December 2002
5 Qualifier les données ; Procédure CNIL si données identifiantes ; CNIL + CCTIRS si données de santé Information des personnes sur le traitement, ces objectifs et leurs droits (Accès, rectification, retrait) Consentement exprès si les sources des données sont des éléments biologiques identifiants (ADN) Droit à l oubli Si des échanges sont prévus (notion clé : protection équivalente) Au sein de l Union européenne En dehors de l Union européenne
6 DB1 DB5 DB2 DB4 DB3
7 Get Data in Data definition issue Data protection issue Database Project Data storage and infrastruc ture Data ownership issue Database ownership issue Get Data out Access and commercialisation Protection of the person from whom the data are processed
8 Law has to balance between science progress and protection of individual rights Law should not be an obstacle to the development of sharing data New regulations encourage the open access to databases and the sharing of the samples
9 OBJECTIVES To address practically a series of relevant requests, for different countries, on the issue of regulatory aspects of exchanging human biological samples across borders. To allow every registered person to get information on theoretical as well practical legal aspects, for exchanges of human biological samples for research purposes. To present the legal state of the art at date
10 IDENTIFICATION OF COMPETENCIES NEEDED Lawyers, not only to search documents but also to understand the issue at stake from the researcher point of view and to implement them in the tool Strong collaboration with computer scientist To construct the questions tree To program the website To conceive the data base To design the website To organise the requests To update the database
11 IDENTIFY FREQUENT QUESTIONS POSED BY RESEARCHERS: practical aspects of import/ export addressed by researchers Documents to be produced? What kind of forms? To which authority? Consent form issue?
12 IDENTIFICATION OF THE LEGAL RELEVANT TEXTS IN THE COUNTRIES Ga2len partners Proof of concept with 2 countries (France and UK) to be extended to 2 others (Poland and Spain) Research made by jurists from the Genetic and Society Platform IDENTIFICATION OF LEGAL EXPERTS To validate the information TECHNICAL IMPLEMENTATION IN THE WEB-BASED TOOL
13 Registration or identification Selection of the countries of departure and arrival Access to an html page divided in 4 boxes Overview Theory Practice Problems
14
15
16 Technical Design of the database Construction of the tree of questions Legal Language to be implemented in the tool Access to the legal information in other countries Validate Update Incentives
17 Managing the website is a challenge Need for manager website Need for validate legal information Need for a legal network s experts: INCENTIVES Make the tool open beyond the Ga2len community, BBMRI, P3G Sustainability of the tool
18 Extend the database to the rule governing Data exchanges, transport... Each category should be divided according the kind of HBM when relevant: blood, cells, tissues, serum, DNA INPUT NEEDED TO IDENTIFY THE FUTURE DEVELOPMENTS
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