Biobank Certification Big Benefits, Small Effort · handling, collection and processing 8....

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

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

#1 #2 #3 #4 #5 #6 #7 #8 #9

Exc Mod

Value Impact

Framework Issues

Tis

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e B

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ecim

en

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er

1988 1993 1998 2003 20080

50

100

150

200

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


Focus • Appropriate for all

kinds of biobanks


Education • Modified with input from Canadian and

International biobanking experts


Support • Biobank Resource Centre (BRC) products and services

available to support biobanks going through certification

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


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


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


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

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.


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.


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)


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


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

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

Questions, comments, criticisms

Website: www.biobanking.org

E-mail: [email protected]

Biobank Certification Big Benefits, Small Effort · handling, collection and processing 8....

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