biobank certification big benefits, small effort · handling, collection and processing 8....
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Biobank Certification
Big Benefits, Small Effort
2015 National CAREB Conference and AGM
Presenters
Dr. Peter Watson BCCA Chief Physician, VIC-BCCA
Director, Tumour Tissue Repository
BCCA Professor and Staff Pathologist
Director, UBC Office of Biobank Education and Research
Sheila O’Donoghue Project Manager, Education and Certification
UBC Office of Biobank Education and Research
Biobank Leader, Tumour Tissue Repository, BC Cancer Agency
Workshop Objectives 2015
• Define banking and learn about current challenges in
biobanking.
• Participate in an exercise to appreciate the challenges
that REBs have in ensuring biobanks are operating
according to REB policies and international best
practices.
• Provide an overview of a national biobank certification
program for biobanks to address quality and accessibility
and its value for REBs and other stakeholders.
Who are we?
www.ctrnet.ca
www.ober.pathology.ubc.ca
Origins
• established fall 2004
• six founding programs
• funded by ICR-CIHR
Focus
• enhance access for research
• promote national standards
• provide education and training
www.ctrnet.ca
www.ctrnet.ca
Available Materials Standard Operating Procedures Advanced Tissue
Management
www.ober.pathology.ubc.ca
Origins
• Established 2011
• Partnership between
BC Cancer Agency and
UBC Pathology
Focus
• Support biobanking and
research in BC
Biobank =
• collection of biospecimens linked to annotating data
• physical and operational hub of the activity of biobanking
What is a biobank?
participants
approaches
focus
Biobank =
Goals of a research biobank
Collection Distribution to Researchers
Tumour Tissue Repository
Quality
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#1 #2 #3 #4 #5 #6 #7 #8 #9
Exc Mod
Value Impact
Framework Issues
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Quality
• Lack of standardization
Capacity
• Failure to meet demand
Sustainability
• Inefficiency
References
Hughes SE, et al Biopreservation and Biobanking. 8: 89-97. 2010
Barnes RO, et al . Cancer Epidemiology Biomarkers and Prevention, 17: 23344-50, 2008
Watson PH et al. J Transl Med. Nov 12;7:95. 2009
Biobank ‘A’ Biobank ‘B’
<30mins
<30mins
Consequences for research
Loss of public confidence
• Patients unwilling to participate in research
• Loss of valuable research samples
Lack of research progress
• Failure to replicate data
• Wasted effort and funds
• Accreditation Canada
▫ Qmentum Accreditation program for health care quality
• Canadian Standards Association ISO 9001
▫ Norms for quality management systems and quality
improvement
• Research Ethics Boards
▫ Expanded consideration of biobanks in TCPS
• Research funders
▫ CIHR?
• ISBER: Established Best Practices and a biobank self-assessment tool
• BBMRI Registry and web-catalogue
• HTA (UK Human Tissue Authority) Licensing
International considerations:
Background planning/surveys 2009-2011:
National considerations:
Group Activity REB Challenges and Issues
• Lack of knowledge of biobanking and clinical research
processes
• Consent issues
• No SOPs
• Documentation issues
• Facility Issues
• Inventory Issues
Review of Case and key Issues
What would you recommend as the REB plan
of action for Jane’s biobank?
Group Activity - Discussion
Solution - Certification for Biobanks
• Assurance that biobank leaders/staff have been exposed
to biobank education
• Enables conformity to best practices
• Promotion and adoption of standardized protocols
developed by the biobank community
• Registry of biobanks
• Minimizes risk to Institution
In Jan 2011 CTRNet held a national workshop on
the question of Biobank certification
Public
Biobankers
Researchers
Institutions
REBs
Funders
National consensus
Workshop conclusion
• Endorsement of CTRNet to develop a
certification type program
Agreement that the program should be
• Appropriate for all entities that conduct biobanking
• Scaled to the type/design of biobank
• Founded on self evaluation and encouragement to
learn and to adopt key principles
Development
Defining the Key elements of the program
• To promote common standards across biobanks
• To provide educational resources for biobanks to adopt of these standards
• To foster public confidence that biobanks strive to meet best practice standards
Solutions
Patient Engagement Strategy
Biobank Certification Program
How does it work?
www.ctrnet.ca
Certification Program
• Designed to be scalable and applicable to all entities
conducting biobanking
• Targeted to address • biospecimen quality (standards) and
• governance (risk)
• Launched spring 2013: >70 biobanks enrolled to date
What is unique about our program?
Expertise
•“Grass roots” approach
What is unique about our program?
Focus • Appropriate for all
kinds of biobanks
What is unique about our program?
Education • Modified with input from Canadian and
International biobanking experts
What is unique about our program?
Support • Biobank Resource Centre (BRC) products and services
available to support biobanks going through certification
Certification Process
Certification Process
Education
• Specifically focused on rationale behind standards
• Endorsed by an International biobanking organization (International
Society for Biological and Environmental Repositories)
Education
• Nine individual education modules focused on different biobanking
topics
Education
• Nine individual education modules focused on different biobanking
topics
1. Basics of Biobanking
Introductory overview, key issues in establishing, maintaining and
accessing a biobank
2. Governance
External and internal governance mechanisms for biobanks
3. Ethics
Biobank responsibilities to government, research ethics boards to
protect participants
Education
• Nine individual education modules focused on different biobanking
topics
4. Facility Design and Safety
Design of facilities to ensure safekeeping of biospecimens and data
5. Quality Management and Process Improvement
Review of different quality programs for biobanks
6. Informed Consent
Principles underlying informed consent and design and execution of the
consent process
Education
Education
• Nine individual education modules focused on different biobanking
topics
7. Biospecimen Collection and Processing
Overview of types of biospecimens and procedures in biospecimen
handling, collection and processing
8. Biospecimen Storage and Retrieval
Storage equipment, tracking and inventory systems for biospecimen
retrieval
9. Data Systems and Record Management
Annotation of biospecimens, examples of data and basic requirements for
data storage and management
Education – International Content
Education – International Content
Certification Update 72 biobanks
Biobank certification program:
What is the value for a
Research biobank?
Value to Researchers
Addresses future impact of research by aligning with national
biobanking standards and so tackles the ‘garbage in, garbage, out’
dilemma that has been recognized as a serious problem by leading
biomedical journals including Nature and Science.
Ensures that research data generated on biospecimens today will
meet tomorrow’s increased standards for publication in high impact
journals.
Harmonizes biospecimen quality to enable compilation of super
cohorts and participation in international collaborations.
Supports a ‘home grown’ solution that fits the Canadian research
system.
Biobank certification program:
What is the value to a REB?
Value to REBs
Provides an additional degree of oversight for the governance
structure of biobanks. The need to strengthen the biobank
governance structure has become necessary due to the increased
risks to biobank participants’ privacy created by evolution of
molecular assays and increasingly enriched data collection.
Streamlines REB review of biobank applications by creating a
separate system where technical aspects of biobanking are
assessed (e.g., data security, biospecimen
collection/processing/storage).
Adds assurance that the biobank is aware of national standards and
that biobank personnel have been exposed to a comprehensive
biobank education program.
Creates a registry of those biobanks that have completed the
registration phase.
Biobank certification program:
What is the next step for all
stakeholders?
Call to Action
• Key stakeholders with a direct role in Canadian biomedical research
with a human biobanking component (research
leaders/institutions/funders/REBs) are being asked to endorse
the widespread adoption of ‘biobank certification’
the following process to facilitate this adoption
• Registration – Make registration in this program a mandatory
requirement for all biobanks through the inclusion of a registration
requirement as part of REB review and approval
• Certification – Make certification in this program a graded
requirement for all key stakeholders (e.g. an REB decision at time of
review of a project with a large biobank component and a funder
decision at the time of release of funding)
Biobank certification program:
Suggestions for the process of rolling
out the program
• The UBC Ethics Application now includes an additional
section related to Biobanks and Registries to aid REBs in
determining the operational design of biobanks
Solution for REBs and Biobanks:
Communication with:
• Research leaders (VP Research and senior researchers)
• Medicine and Science Leaders (Dean of Medicine, Dept heads)
• Ethics Leaders – Director of Research Services, REB chairs and
manager
• Funders – local foundations, provincial and national funding
organizations
Resource available:
• Templates of letters and PP presentations
• Biobank Certification Video
Biobank certification program:
Where can biobanks go for support?
A Web-based Biobank Resource Centre
www.biobanking.org
The Biobank Resource Centre
• Membership Options
• Biobank Registry
• Education
• Templates
• Biobank Inventory Database
• Services and Tools
• Workshops
Membership Options
Introductory rates:
A. Individual Membership - $25
B. Biobank Membership - $50
C. Institutional Membership - $250
Any organization with many biobanks under their jurisdiction e.g.
University of British Columbia
Institution will assign a coordinator (institutional coordinator) to
monitor all biobanks under their institutional membership
Institutional Coordinator
Biobank Team Leader
Team Members - Status
Biobank Registry
Biobank Profile
Templates
• Common biobanking templates
• Created by biobanking experts
▫ Privacy and Security
▫ Governance
▫ Access and Release
▫ Quality Management
▫ Staff Training and Education
▫ Biospecimen Collection and Processing
▫ Biospecimen Storage
▫ Storage Equipment
▫ Facility Design
Biobank Inventory Database
ATiM (Advanced Tissue Management)
• Developed by CTRNet in conjunction with Canadian
biobanks
• Key Features:
▫ Clinical Annotation
▫ Inventory Management
▫ Query and Reports
▫ Data Browser
Advanced Tissue Management System (ATiM)
Tools
Biospecimen Data Reporting Tool
• To address lack of standardized reporting of biospecimen related
data required to validate studies
• Easy to use web-tool to enter data
• Used by biobanks to generate a report to give to researchers with
release of biospecimens
Cheah and Dee et al, BIO, Dec 2012
Cheah and Dee et al, BIO, Dec 2012
Biospecimen Data Reporting Tool
Biobank User Fee Calculator
• To help answer: How much should a biobank charge a
researcher for a biospecimen and associated data?
• Used by biobanks to input capital and operating costs
• Derives consistent and ethically based biobank user fees
Biobank User Fee Calculator
Biobank User Fee Calculator
Services
• Patient Engagement Strategy
• Workshops
• Biobank Design and Consultation
Patient Engagement
Permission to Contact Platform
• Overcomes the consent
bottleneck of patient referral
• Asks all eligible patients for
their permission to be
contacted about future
research as part of routine
clinical practice
Consent Process
Permission to Contact (PTC)
• Created to increase patient engagement and
enrollment in research
• Meets ethical and privacy requirements
• Benefits REBs by allowing easier approval of studies
utilizing the Platform for participant recruitment
Workshops
For biobankers, pathology residents, technicians:
• How to biobank i.e. collect, process and store a
human tissue sample, governance, consent
• How to identify appropriate specimens and the
transfer of samples
• Show the participant experience (recruitment, the
consent process, privacy issues)
Consulting Services
Type of Service
Setting up a new biobank
Ethics and regulatory preparation
Budget proposals and business planning
Biospecimen related advice
Facilities design and management
REB Access to the BRC
• REB members have free access
• Go to www.biobanking.org
Funder and Enablers