UNIAMO FIMR onlus

!
Patients Associations promoting a novel participatory agreement of
biobanking
Sara Casati*, Maria Marcheselli, Renza Barbon Galluppi
UNIAMO F.I.M.R. onlus
Introduction
UNIAMO F.I.M.R. onlus, proactive in biobanking
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 a innovative model of scientific research that biobanking
as well as advanced research required.
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 part active 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 number 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 thought joint
initiatives.
At the forefront of biobanking UNIAMO F.I.M.R. onlus is part of the Advisory Board of
Telethon Network of Genetic biobank;
in 2012 it has formalised a framework agreement with Telethon to be the basis of
As a result, UNIAMO F.I.M.R. onlus in partnership with Welfare Minister and the
each agreement between one of the Biobanks of the Network and a specific Patients’
principal research institutions has been working to promote participation as standard
Association.
of biobanking good practice, to build an novel participatory pact, thanks to
After some literacy activities on biobanking with patients, in
DETERMINAZIONE RARA. Attivamente insieme nella ricerca di frontiera e nella
collaboration with Telethon, UNIAMO F.I.M.R. onlus has
sperimentazione clinica, a training advanced national programme.
changed gears.
taking
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’
From “Codice di Atlantide”
STARTING WITH ALL THE
role in biobanking.
ACTORS AT STAKE
DELIBERATING ACTIONS
WIDENING PARTICIPATION
IMPLEMENTING INNOVATION
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.
VERIFYING AND SHARING
RESULTS
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’ & associtians 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.
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 the 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.
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 ->)
.
Conclusion
DETERMINAZIONE RARA as shared empowerment experience among UNIAMO F.I.M.R.
onlus, Associations and research and biobanking Institutions have 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 in the
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 processesdata accessibility,
-  inclusive governance in the processes of evaluation and monitoring of research.
èè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,
è! biobanking as context study for rethinking the governance of scientific research,
èè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 onlus, A.I.C.I.- Ass. It. Cistite Interstiziale, AIFP-Ass. It. Febbre Peridoidche, 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 Polland, ASM17 Italia onlus, 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 onlus- Insieme per lo studio e la Cura delle Malattie Mitocondriali, Rete Malattie Rare, UNITI
Unione italiana Ittiosi.
*For information: [email protected]