Hospital care, experimentation/clinical trial and Belgian laws

Transcription

1 Hospital care, experimentation/clinical trial and Belgian laws Information Security workshop, Brussels, December 5 th 2013 Christine Bigot [email protected] Etienne Stanus [email protected] Institut Jules Bordet Instituut Université Libre de Bruxelles

2 2 Experiments on the human person Belgian legal framework : 1. Background : Good clinical Practices / GCP Guidelines Harmonization 1996 European Clinical Trials Directive 2001/20/EC creating a framework for ICH-GCP Guidelines European Clinical Trials Directive 2005/28/EC GCP, 2. LEH (7 May 2004) (+ 3 Royal Decrees) : transposing the European Clinical Trials Directive 2001/20/EC in the Belgian law LEH has a broader scope than European Clinical Trial Directive

3 3 LEH S scope -LEH LEH LEH +.. Scientific research Exp. Hum. Pers. - MED MED - Interv Interv

4 Prospective versus retrospective 4 research In a simple way, retrospective studies look back. Prospective studies look forward. But the differences go beyond that! Retrospective Case-control studies Prospective studies Randomized controlled trials, Source: ve-vs-prospective-studies

5 5 Experiment Definition : LEH (Art. 2, 11 ) : An trial, study or research performed on a human person, in view of the development of biological or medical knowledge Scientific research with human biological material already separated from the body ; with embryos in vitro ; with corpses ; research on existing data (retrospective non-interventional trials) is not covered by LEH

6 6 The actors Subjects : An individual who participates in an experiment irrespective of whether he belongs to the experimental group or the control group (Art. 2,20 LEH) ; Investigators : A medical doctor or any other person exercising a profession referred to in the Royal Decree No. 78 of November 10, 1967 concerning the exercise of healthcare professions and who is qualified to conduct an experiment ( ) (Art. 2, 17 LEH) ; Sponsor :An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of clinical trials ; CRA : Organization/person responsible for the management of designated clinical trials including Monitoring the assigned clinical trial, following company SOPs and in accordance with GCP ( Inspection (official review) )

7 7 ICH GCP / LEH : Prot. Private life/pers.data LEH (Art 5.) : An experiment may be undertaken or pursued only if the following conditions are met: ( ) 4 the foreseeable risks and inconveniences, in particular those of a physical, psychological, social and economic nature, have been weighed against the anticipated benefit for the individual subject and other persons, including respect for the physical and mental integrity and the right to respect for private life and the protection of personal data ( )

8 8 Protection of personal data within Belgian framework 1. Penal Code (Art. 458) 2. Belgian Privacy law (8 th December 1992) Before the experimentation starts : Protocol(s) information ICF CPVP declaration + authorization CE / Data coding - Trusted Third Party? During the conduct of the experimentation : Right to consult but restrictions applies right of rectification of erroneous information right to withdraw

9 9 Additional duties for research associates After the conduct of the experimentation - Publications Only coded data- multimedia! Data retention period Data protection eference_en_matiere_de_securite_applicables_a_tout_traitement_de_donnees_a_caractere_ personnel.pdf Try to use Anonymized data (which fall out of the scope of the Data privacy law) Coded data (Id/code and code/data kept separately!)

10 EURECA Project : Pseudonymization versus anonymization Credit: Cyril Krykwinski, IT Dept. Institut Bordet 10

11 11 How are the data privacy aspects handled within Bordet? Everybody has a personal ID Every user including Clinical Research monitors and auditors have to sign a confidentiality agreement before accessing data!!! Dedicated procedure for auditors!!! All Oribase (Bordet home made EHR) access are logged and tracked including read access! Monitors and auditors access to Oribase is strictly restricted to patients recruited in the study(-ies) they monitor/audit Pseudonymisation build within Oribase EHR

12 12 Oribase EHR: patient browsing page for scientific research Credit: Philippe Hennebert, Head of IT dept.institut Bordet

13 13 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

14 14 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

15 15 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

16 16 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

17 17 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

18 18 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

19 19 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet

20 20 Trialerium: Clinical studies management program (&+) Credit: Jerome Lhaut, IT Dept Institut Bordet