spainrdr - spanish rare diseases registries research network – an initiative of the international...
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SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
Spanish Rare Diseases Registries Research Network - SpainRDR
https://spainrdr.isciii.es
WP-4. LEGAL AND ETHICAL ISSUES
María José Carroquino, MPH,Ph.D. Instituto de Investigación de Enfermedades Raras (IIER) Instituto de Salud Carlos III
Analysis of [regional] legal mandates to create/integrate
Rare Disease Registries
WP2 - Registering activity related methodsWP2. T6. Analyzing the current status of ongoing population-based
registries in Spain´s Autonomous Regions
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
WP4 - Legal and ethical issuesWP4. T17. Analysis of the legal framework of health registries and
translating this to RD registries
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
• Reviewed five existing legal mandates (Autonomous Communities):• Andalucía• Islas Canarias• Castilla la Mancha• Extremadura• Región de Murcia
• Summary of contents (legal framework, administrative issues, competences and responsibilities, structure and organization of registry, coordination with other registries, information sources, and
• data access/provision and security measures for personal data protection
• Elaborated Guideline Document for the Elaboration of a Legal Mandate to Create
Rare Disease RegistriesDraft Mandate
Analysis of [regional] legal mandates to create/integrate
Rare Disease Registries
Published(Castilla la Mancha, Valencia, Cataluña, Baleares, Cantabria)
Soon to be published (Galicia, Asturias, Castilla y Leon, Pais Vasco, Aragón)
Pending(Extremadura, Andalucia, Murcia, Navarra, Madrid, Canarias)
Current status of legal mandates to create/integrate
Rare Disease Registries
AUTONOMOUS COMMUNITY
PUBLICATION (expected) PENDING
PUBLISHED
(No modification planned/needed)
Cataluña Signed agreement for data access/transfer 10/11/2006
Madrid Publication date?
Comunidad Valenciana 4/4/2012
Galicia Publication date?
Castilla y León Draft in progress May 2013
País Vasco Draft in progress July /August 2013
Aragón March 2013
Navarra April/May 2013?
Current status of legal mandates to
create/integrate Rare Disease Registries
Current status of legal mandates to create/integrate
Rare Disease Registries
AUTONOMOUS COMMUNITY
PUBLICATION (expected) PENDING
PUBLISHED
(No modification planned/needed)
Islas Baleares 29/1/2013
Principado de Asturias March?
Navarra April/May 2013
Cantabria 18/7/2012
La Rioja NO PUBLICATION – DATABASE INCLUDED IN EPIDEMIOLOGICAL SURVEILLANCE SYSTEM
Ceuta y Melilla COMPETENCE OF STATE
AUTONOMOUS COMMUNITY
PUBLICATION(expected)
PENDINGPUBLISHED
(No modification planned/needed)
Andalucía 25/05/2010
Castilla-La Mancha 19/01/2012
Islas Canarias 18/05/2011
Región de Murcia 8/1/2010
Extremadura 25/5/2004
Current status of legal mandates to create/integrate
Rare Disease Registries
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
National Registry of rare diseases
Art. One: Creation of the National Registry of rare diseases.• The registry will be integrated into the Health Information System of the
National Health System
Article Two: Purpose of the National Register of rare diseases.Keeping a national census of patients suffering from a rare disease in order to meet the information needs of these diseases, and to develop and evaluate prevention and health planning activities, and provide information for any other activity that contributes to a better understanding scientific-technical and quality of life of these patients and their families.
•Draft proposal sent to Ministry of Health•Report of predicted economic impact
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
National Registry of rare diseases
Article Three. Intended uses.1.Research on rare diseases2.Development epidemiological knowledge of these diseases, providing proven
validity information on the incidence and prevalence of the same, favoring the analysis of factors associated with the study of its
determinants, development, welfare activity, prevention and treatment3.Development of indicators that enable the comparison of data between the
different regions and with other countries.4.Standardization of the information in accordance with internationally
approved standards.5.Support for the following research activities:
a)Collection, processing, integration and analysis of information.b)Conducting periodic reports and publications.
•Draft proposal sent to Ministry of Health
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
Article Four. Body responsible for the National Register of rare diseases.Research Institute for Rare Diseases, Institute of Health Carlos III,
Article Five: Collection and processing of data.1. The collection and processing of data is carried out through the Rare Disease Registry File and Sample Bank, created by
SCO/1730/2005 Order of May 31.2. The health departments of the autonomous communities, through their own record systems will
carry out the following activities:a) Collect data of patients diagnosed cases of rare diseases that are seen in the areas of
responsibility and report them to the National Register of rare diseases, b) Assist in the validation and verification aspects of information.c) Have a system for information retrieval for health-care, teaching and research purposesd) Tracking active cases.e) Provide the information that is required by the National Registry of rare diseases and facilitate
the activities required to perform the registry in order to function properlyCompliance with the above activities will fall on the heads of rare disease registries or, where
appropriate, on those responsible for patients may request that their personal data and health and / or data associated with biological samples to the administrative body responsible for the National Register, information systems in regional health.
3. ……………….
National Registry of rare diseases
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC
Article Six: Coordination with other records
1. The National Register of rare diseases will be included, within the communications network of the National Health System, …..
2. Autonomic Rare Disease Registries will be integrated in the National Register of rare diseases.
3. The National Register of rare diseases will coordinate with similar registries outside of Spain especially those included in the International Consortium agreement Rare Diseases Research
Draft proposal sent to Ministry
Thank you very much!
SpainRDR - Spanish Rare Diseases Registries Research Network – https://spainrdr.isciii.es An initiative of the International Rare Diseases Research Consortium-IRDiRC