From “Codice di Atlantide”

a PARTICIPATORY approach Interaction, transparency, public information,

co-production of knowledge, networking, scientific citizenship, gathering to extend active involvement

to an increasing number of patients and professionals, to train together in view of good practice of biobanking …

interactive informed consent… biomedical research with human beings.

A participatory experience where all actors at stake meet in a peer laboratory to weave, for some days out of the box,

a network of shared knowledge and best practices that can make a difference and orient research by and on the needs of the person.

UNIAMO F.I.M.R. onlus, proactive in biobanking UNIAMO F.I.M.R. onlus (non-profit) is the Italian Federation including the

organizations of patients affected by rare diseases and it is always committed in the safeguard of the patients’ rights and in the improvement of the quality of life of RD patients and their families.

The Federation, founded in 1999 upon the initiative of a small group of Associations, in ten years of activity has come to over 100 Patients’ Associations representing more than 600 different rare diseases. It is member of EURORDIS European Organization of Rare Disease.

UNIAMO F.I.M.R. onlus is a reference and representative voice for rare diseases bringing the opinions of the patients and their families in the decision-making processes relevant to the national and regional measures adopted in Public Health.

It is signatory of a memorandum of intent with Farmindustria, agreed in the year 2000, for the development of a culture on orphan drugs and rare diseases through joint initiatives.

At the forefront of biobanking UNIAMO F.I.M.R. onlus is part of the Advisory Board of Telethon Network of Genetic Biobanks; in 2012 it formalised a framework agreement with Telethon Foundation to be the basis of each agreement between one of the Biobanks of the Network and a specific Patients’ Association. After some literacy activities on biobanking with patients, in

collaboration with Telethon Foundation, UNIAMO F.I.M.R. onlus has changed gears.

Taking into great account some Associations’ experiences UNIAMO F.I.M.R. onlus has promoted a space of

interaction to make concrete and proactive Associations’ role in biobanking.

Introduction 2014 is a very special year for biobanking: the European infrastructure BBMRI-ERIC is operative, the Council of Europe renews the “Recommendation on research on biological materials of human origin” and RD-Connect Project works for best practices. Each initiative considers crucial citizens’ active involvement and public information, which changes the perception of citizenship concerning conservation and scientific use of human biological materials.

It should be a participatory agreement among citizens, patients, and researchers, mediated by health professionals, that represents also a responsibility agreement among all the actors at stake: from patients to researchers, all are mutually necessary for an innovative model of scientific research that biobanking as well as advanced research require.

UNIAMO F.I.M.R. onlus has identified this deep need across its interaction with Rare Diseases Associations, Research Institutes, Biobanks networks and, during a pilot initiative ATTIVAMENTE INSIEME PER LA RICERCA, performed at ARC-NET Biobank, in Verona, and at Institute of Genetics and Biophysics, in Naples, Rare Diseases Associations expressed to be active part in biobanking.

As a result, UNIAMO F.I.M.R. onlus in partnership with Welfare Ministry and the principal research institutions has been working to promote participation as standard of biobanking good practice, to build an novel participatory pact, thanks to DETERMINAZIONE RARA. Attivamente insieme nella ricerca di frontiera e nella sperimentazione clinica, a training advanced national programme.

Conclusion

DETERMINAZIONE RARA as shared empowerment experience among UNIAMO F.I.M.R. onlus, Associations and research and biobanking Institution,s has tried as possible

a space for dialogue where all the actors were included and considered ”necessary interlocutors" because carriers of knowledge, experiences, values, needs, interests at stake within knowledge and decision-making processes that make possible scientific knowledge itself:

the space of bioethics as a laboratory of empowerment.

The training journey was patterned by the conditions of the possibility of an ethical & participatory research:

-  participatory construction of a shared language, -  transparency and traceability of the processes data accessibility,

-  inclusive governance in the processes of evaluation and monitoring of research.

è! biobanking as context study for rethinking the governance of scientific research,

èè the laboratory of bioethics as a space for detection and regeneration of good practice, a space for policy in which each association is called upon to make a contribution,

èè rethinking the role of ethical expertise and institutional profiles, in order to replace the current model of gatekeeping, with a broader approach that transforms the analysis of the ethical implications of biomedicine in a more open discussion.

*** Associations participanting ABC - Ass. Bimbi Cri Du Chat, A.C.A.R.- Ass. conto alla rovescia, Acondroplasia - Insieme per Crescere, A.I.C.I.- Ass. It. Cistite Interstiziale, AIFP - Ass. It. Febbre Periodiche, AIdel 22 - Ass. It. Delezione del Cromosoma 22,, A.I.M.A.R. - Ass. It. per le Malformazioni Anorettali, A.I.S.A.C.- Ass. per l'informazione e lo studio dell'Acondroplasia, A.I.S.M.M.E. - Ass. It. Studio Malattie Metaboliche Ereditarie, AISPHEM – Ass. It. Sindrom Phelan – Mc Dermid, AMRI – Ass. Malattie Reumatiche Infantili, Angeli Noonan - Ass. Ita. Sindrome di Noonan, L'A.P.E. onlus – Ass. PKU, A.P.M.M.C. Associazione Prevenzione Malattie Metaboliche Congenite, Ass. A.N.D.E, A.S.C.E – Ass. Sarda Coaguloptici Emorragici, Ass. It. Sindrome di Poland, ASM17 Italia, Ass. Italiana Sindromi Costello e Cardiofaciocutanea, A.T.D.L.- Ass. Talassemici Lombardi, A.S.T- Ass. Sclerosi tuberosa, CIDP – Ass. It. Pazienti Polineuropatia Cronica, F.O.P. Ass. Italia Fibrodisplasia Ossificante Progressiva, - I.A.G.S.A. – International Aicardi Gouthiers Syndrome Ass., I Colori del Vento, ILA - Ass. It. Angiodisplasia e Emangiomi Infantili, LIRH Lega It.Ricerca Huntington, MITOCON - Insieme per lo studio e la Cura delle Malattie Mitocondriali, UNITI Unione italiana Ittiosi.

*For information: sara.casati@unimib.it

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Patients Associations promoting a novel participatory agreement of biobanking

Sara Casati*, Maria Marcheselli, Renza Barbon Galluppi UNIAMO F.I.M.R. onlus

STARTING WITH ALL THE ACTORS AT STAKE

DELIBERATING ACTIONS

WIDENING PARTICIPATION

IMPLEMENTING INNOVATION

VERIFYING AND SHARING RESULTS

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Dedicated interactive platform with which all the representatives of patients involved interact, communicate, find out documents and dates, share ideas. (On the right a screenshot of the actual website ->)

Trough a pilot experience in stages where each training event will be preceded by a preparatory meeting with the associations - more involved and interested in the topics of research, -  more active in the macro territorial area that hosted

the event.

A “space of interaction” for an innovative pact of participation in research processes between patients & researchers:

NORTH – EASTERN STAGE VENETO December 2012 – January 2013: Clinical Research Center – CRC, Arc-Net Biobank working with Associations, on a research protocol with SLA patients and on a model of biobanking in place.

CENTRE- SOUTH STAGE CAMPANIA February 2013 – April 2013: Institute of Genetics and Biophysics and TIGEM researchers together with Associations exploring biobanking as the engine of basic research and models of genetic research.

To DETERMINAZIONE RARA a traning advanced national programme National and a laboratory of modelling good practice of research & biobanking, together with some of the best Research Institutions AIFA, ISS, BBMRI IT, Telethon, IRCCS Bambino Gesù. WHERE: inside the research places, WHEN: from November 2013 to June 2014, 6 stages & a great public final event, HOW: cross-disciplinary, experience-based-training, peer & interactive laboratories

Specific Laboratories dedicated to Biobanking, frontier research and scientific citizenship: new scenarios of research, participation and knowledge Facing biobanking as ü  research infrastructure/infrastructure Of knowledge ü  good practice & active involvement laboratory ü  Patients’ & associations active role

AT STAKE FOR BIOBANKING a pact of participation and

a renewed agreement among

UNIAMO F.I.M.R. onlus, all Associations involved and Telethon Network of Genetic Biobanks- TNGB.

DETERMINAZIONE RARA is project financed by Ministry of Labor and Welfare.

Thanks also to GSK and Sanofi Aventis for their endowment to DETERMINAZIONE RARA.

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