Manuel M Morente
Spanish National Cancer Research Centre – CNIO Spanish National Biobank Network
IV ESBB Annual Meeting
Leipzig, October, 2014
Where biobankers comes from?
Why a master in biobanking?
We need to prepare a
new generation of
biobankers
with
specific and normalised
training, and full time
dedication.
Why a master in biobanking?
•
Standardization
and
harmonization
could be built
over an appropriate training.
•
A
national biobanks network
is the best environment for
this training.
•
Normalised training
promotes and stabilizes
Why a master in biobanking?
The Spanish National Biobank
Network
promote a University
Master Title in collaboration
with
Catholic University of
Valencia
and
Valencia Institute
of Research in Public Health
Objectives
•
A multidisciplinary understanding of the major activities related to
the collection of biological samples for biomedical research.
•
A complete and updated training on the methodological aspects of
the general processes of biobanks knowledge.
•
An updated ethical knowledge related to the collection and use of
samples for biomedical research, promoting critical aptitudes.
•
Skills development in the management of biobanks and
decision-making.
•
Acquire basic knowledge of good scientific practice.
•
Meeting point with the relevant professionals
.
Methodology
•
Classroom activities
:
•
Lectures.
•
Special lectures
(Invited international speakers)
•
Journal Clubs.
•
Practical activities.
•
E-learning activities
:
•
Selected publications.
•
Exercises.
•
Practical learning in biobanks
.
•
Personalised tutorials
.
•
Thesis
David Guillem-Tatay
Venue
Universidad Católica de Valencia.
Medicine School
Calendar
Monday
Tuesday
Wednesday Thursday
Friday
Saturday
Sunday
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31
10 months
Thursday:
15:30-21:30
Friday:
8h-21:30
Saturday:
8h-14:00
Classroom activities
Programme
TRENDS ON BIOMEDICAL RESEARCH
BIOETHICS
LEGAL ASPECTS
TECHNICAL PROCEDURES
MANAGEMENT AND QUALITY ASSURANCE
ORGANIZATIVE STRATEGIES
MASTER FINAL PERSONAL WORK (THESIS)
•
6 ECT
•
9 ECT
•
9 ECT
•
9 ECT
•
9 ECT
•
6 ECT
•
12 ECT
Programme
MODULE 1: BIOMEDICAL RESEARCH. NEWS AND TRENDS ( 6 ECTS/24 hours )
Introduction to master
Opening lecture: “Use of human samples: A new paradigm in biomedical research” Introduction to methodology ( E-learning platform, journals clubs, etc.)
News & trends in cancer Genomics and genetics News & trends in Infectious diseases
News & trends in new therapies generations News & trends in hospital research
News & trends in new markers for cancer News & trends in molecular epidemiology News & trends in rare diseases
News & trends in neurodegenerative diseases News & trends in stem cell based research News & trends in Bioinformatics
Programme
MODULE 2: BIOETHICS APPLIED TO HUMAN SAMPLES USE IN RESEARCH (9 ECTS / 36h)
Science and Ethics dialogue.
¿What’s bioethics? Philosophical basis.
Life and human dignity: Identity and self-development. Short History of Bioethics.
Concept and valorisation of the body in the main current cosmo-visions. Current trends in Bioethics: lay ethics concept
Main principles in Bioethics
Autonomy and Informed Consent
Ethics and Genetics: person, family and society
Use of samples in research: A new paradigm in Ethics? Controversies about IC for biobanking.
Ethic Committees for research: History, current state and perspectives. Embryo-derivates in biomedical research. Ethical Problems
Privacy Guaranties: Codification and irreversible de-identification. IT use in biomedical research. Ethical problems
Autonomy and Informed Consent in paediatric patients and donors
Journal Club: Informed consent in bioethics. Study of Nuremberg Code, Belmont Report and Helsinki declaration
Journal Club: Samples ownership: an introduction to a controversial topic. Study of Moore, Catalona and Sunderland cases. Journal Club: Specific ethical issues in research with minorities: Study of Havasupai case
Programme
MODULE 3: LEGAL FRAMEWORK FOR BIOMEDICAL RESEARCH USING HUMAN
SAMPLES. 9 ECTS / 36 h
Special lecture: Genome and Law
An overview to international directives and documents regarding biomedical research Key legal principles in Spain for biomedical research
Spanish Biomedical research Law (14/2007): Informed Consent and donor rights Spanish Biomedical research Law (14/2007): Biobanks and collections
International exchange and shipping of biological samples
Legal limits on biomedical research and consequences of their violation. Specific analysis of liability for damages and insurance.
Spanish Regional Normatives. National Biobank Registry
Spanish personal data protection Law: general aspects and those applied to biobanks Problems about including clinical archives in biobanks
Legislation in biological waste treatment. Occupational health legislation.
Intellectual property: Patents
Programme
MODULE 4: OPERATIVE PROCEDURES IN BIOBANKING. 9 ECTS / 36h
Types of biobanks. Basic processes Solid samples acquisition and handling.
Basic procedures for serum-banks and other blood derivates Basic procedures for cord blood cells banks
Basic procedures for DNA banks Basic procedures for brain banks. Samples storage
The role of the pathologist in hospital biobanks Sample access policies.
Norm ISO/IEC 27001: Secure management of information Health data management and peculiarities. The clinical record Commercial IT platforms for biobank management
Data security, confidentiality and transmission
Health data standardization (CIE, SNOMED, TNM, etc.).
Data bases: how to create and manage data bases in research projects How to inscribe a data base in the personal Data Protection Agency Practical activity: CIE codification
Programme
MODULE 5: BIOBANK MANAGEMENT AND QUALITY ASSURANCE (9 ECTS / 36 h)
Biobank management… The honest broker model Social and economic impact of biomedical research Hospital based biobanks: Organizative peculiarities How to promote and create a hospital-based biobank. Markers of success in biobanking
Minimal and optimum equipment and staffing
Concept of quality assurance: certification, accreditation, normalization bodies Processes control and management
Continuous improvement and contingency plans ISO normative: ISO 9001:2008.
Quality management assurance in biobanking. Quality assurance for serum banks
Quality assurance for DNA and cell cultures.
Quality assurance for FFPE and frozen solid samples Biohazard in biobanking: Physical and chemical factors Biohazard in biobanking: biological factors
Programme
MODULE 6: ORGANIZATIVE STRATEGIES IN BIOBANKING (9 ECTS / 36 h)
Management Skills. Leadership, motivation, decision making, teamwork and conflict resolution Sustainability and cost recovery
Biobank participation in clinical trials
Biobank participation in research projects: Is the costumer always right? Networking: lights and shadows
Biobank network models 1: CIBERER (Spanish rare diseases Network)
Biobank network models 2: CIBERESP (Spanish respiratory diseases network) Biobank network models 3: Basque Country biobank network
Biobank network models 4: Valencia biobank network
Biobank network models 5: Spanish National Biobank Network - ISCIII International integration: P3G
International integration: BBMRI - ERIC International integration: ISBER and EBBS
International integration: Other collectives in Europe and America Practical activity: Orientations about Master Final Work
Practical activity: Calculate the costs of your biobank Final special lecture
Programme
MASTER FINAL WORK (Thesis) 12 ECTS
• The master's thesis must show that the student is able to work in a scholarly manner and is acquainted with the principal works published on the subject of the thesis.
• It should be an original contribution.
• Experimental projects are welcome.
• Subject is proposed by the student but should be approved by Master’s directors
• Students have a thesis supervisor
• Is defended in public
TITLES AND MASTER CONCLUDING CEREMONY
•
Continuous assessment. Final Note:
•
40%... on-line examinations
•
30%... Thesis
•
20%... on-line activities
I Edition (2011-2012)
25 students
II Edition (2012-2013)
15 students
Quality evaluation
Permanent evaluation by the students
High satisfaction results
III edition (2015)
•
Bridge between Spanish
and Latin-America biobank
communities.
•
In collaboration with the
Latin-America & Caribbean
Alliance of Tumour Banks.
•
100% on-line methodology
•
UCV e-learning IT platform.
The team
•
Directors:
•
Elisa Oltra & Manuel M Morente
•
Coordinators:
•
José Antonio López-Guerrero
•
Jacobo Martínez-Santamaría
•
Jerónimo Forteza
Germán Cerdá
(Dean
The future
•
Biobank training at higher level is not only a
local challenge but a global one.
•
European institutions facilitate international
master titles through Marie
Sklodowska-Curie actions under Horizon-2020
programme.
•
It could be of great value for the next
