Transcript STRATEGIC PLAN FOR TECHNOLOGY IN EDUCATION

Biospecimen Collection and
Processing
Jim Potter
Malcolm Brock
“To wrest from nature the secrets which have
perplexed philosophers in all ages, to track to
their sources the causes of disease, to correlate
the vast stores of knowledge, that they are
quickly available for the prevention and cure
of disease – these are our ambitions.”
- Sir William Osler, 1906
Biobanks: Collaborating for Cures
Clinical
Research
Translational
Research
Clinical Research
Registry/Database
CRMS DB
Roles:
•Pt Identification
•Pt Recruitment
•Facilitate Clinical Trials,
Translational and Basic Research
•Support of Patient Registry and Database
Basic
Research
Tissue Repository
Repository
CaTissue DB
Roles:
•Best Practices/SOP
•Tissue Processing
•Tissue Storage
•Management of Tissues
•Distribution of Tissues
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Purpose of the Biorepository:
• To formalize the collection of all
specimens following Best Practices (BP)
and Standard Operating Procedures
(SOPs)
• The Informal collection of specimens
stored in Investigator’s freezer should be
avoided.
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
NCI / ISBER Guidelines for
Biorepository Best Practices
1. Biospecimen collection
2. Biospecimen processing and annotation
3. Biospecimen storage and distribution
4. Quality assurance and standardization
5. Bioinformatics and data management
6. Ethical concerns
7. Intellectual property and legal issues
8. Outreach, patient education and postresearch communication
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Informed Consent:
Restricted or tiered consent
•Specimen use limited to study design or
disease state
•Specimen use may be limited to tenure of
the investigator
General consent
•Maximizes scientific utility of the
repository
•Promotes valuable new science
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Biorepository:
Oversight Committee
•Provide ethical oversight of all research
involving repository specimens
•Assure the best possible biospecimen quality
 BP are followed
SOP Manual reviewed, updated and
followed
Oversight Committee
•Provide consistent documentation
•Establish guidelines for collection, processing,
storage and retrieval of specimens
•Assessment of new technologies and the
incorporation of new technologies into the
repository
•Assure the fair and impartial utilization of
specimen resources
Oversight Committee
Access decisions guided by a set of general principles
defined in the NCI Best Practices including:
•Investigator agreement covering confidentiality, use, disposition,
and security of biospecimens and associated data.
•Timely, equitable, and appropriate access to specimens
•Fair and clearly communicated access procedures
•Scientific merit with institutional research qualifications, and a
research plan appropriate to answer the study questions
•An appeals process for addressing disputes over allocation
decisions
Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006.
First-Generation Guidelines for NCI Supported Biorepositories
Oversight Committee Example:
GI-TxB Oversight Committee
Division Director
Anthony Kalloo
•Core Center PI - Mark Donowitz
•Directors - Jim Potter, Steve Brant
•One PI from each of “8 study sections”
•At least two rotating independent non-GI,
JHU investigators (Geneticist, Bioethicist)
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Funding
•Grants
•Divisional Support
•Charge Back Scheme by Biorepository Core
•Donation of Specimens to Biorepository Core
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Hardware:
•Cryofreezer (N2 vapor )
•-80˚C freezer
•-20˚C freezer
•4˚C Refrigerator
•Freezer Monitoring System
alarmed to FTE Cell phone
internet accessible
•N2 vapor transport system
•Barcoding
•Centrifuges
•Cryostat
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Tissue Bank Database Software
• CaTissue DB Software – NCI Open
Source software established through caBig
(Cancer Biomedical Informatics Grid)
• Pilot Projects:
Cassella – Sickle Cell Disease
Multi-Institutional – 3 sites
 Richard Roden – Cervical Cancer SPORE
 Jim Potter, Steve Brant - IBD
 James
caTissue Suite:
•
Core Functions / Modules
– Administration: Create and edit users,
protocols, and storage systems associated with
a biospecimen inventory.
– Biospecimen: Create and edit data
concerning participants and their
corresponding biospecimens.
– Query: Identify biospecimens and their data
based upon one or more selection criteria.
Key Functions and Benefits of
caTissue Suite
• Search
Allows biospecimen resource staff and scientists alike to
search for biospecimens based on a combination of
properties
• Biospecimen Tracking
Allows biospecimen resource staff to record events
related to biospecimen processing and quality assurance
and to annotate biospecimens with pathological, clinical,
and custom data
• Biospecimen Inventory Management
Allows biospecimen resource staff to record data about
biospecimen collection, storage, requests, and
distribution.
caTissue - Benefits
For University
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centralized application
no licensing fees (Open Source)
HIPAA compliance easy to monitor
Data Security and Integrity
For PIs:
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No need for custom databases
Easier data sharing
Improved data organization
HL7 importing of data
caTissue Pilots:
Pilot approach
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Install caTissue and provide training
Migrate pilot tissue banking data to caTissue
Integrate with JHM systems (ADT, eIRB, CRMS
Customize for non-cancer tissue banks
Extend to handle data elements not in caTissue
Bug fixes/ maintenance during pilot period
Funding in place to hire group to extend and
support caTissue
Specimen Collection:
Factors to be considered:
• Purpose of the Biorepository
• Best Practices / SOPs
• Consent
• Governance / Oversight
• Funding Support
• Hardware
• Software/Audit/Security
• Personnel (FTE)
Personnel
FTE role
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Cataloging, storing, removal and processing of
tissues
Supervision and training of FTEs directly
receiving tissues from patients to assure Best
Practices.
Best Practice: All FTEs responsible for tissue
procurement should be directed by the tissue
repository administration
Specimen Collection FTE
•Procure via Best Practices & SOP
•Specimen ID (barcode)
•Preserve specimen
•Transportation to the Tissue Bank
•Register specimen ID (barcode) in
database
•Process the specimen, if required (blood,
RNA, DNA, etc.)
•Storage
•Archive
Systematic BioSpecimen Collection
for
Personalized Cancer Medicine
at
Johns Hopkins Medical Institutes
(Robotic Biospecimen Storage Facility)
Blood specimen processing and
cryopreservation
Tumor and control tissue cryopreservation
Specimen Processing:
•Would you use a Specimen Processing Service?
•Research Phlebotomist Services and possibly
processing capability can be purchased.
References:
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Best Practices for Repositories I: collection, storage and
retrieval of human biological materials for research, ISBER.
Cell Preservation Technology; Volume3, Number1, 2005,
Update 2008.
National Cancer Institute, Best Practices for Biospecimen
Resources 2007
Case Studies of Human Tissue Repositories; Best Practices for
a Biospecimen Resource for the Genomic and Proteomic Era.
RAND Scientific Corporation, prepared for the National
Cancer Institute. http://biospecimens.cancer.gov/nbn/rand.asp
References:
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Cancer Bioinformatics Grid, caBIG:
https://cabig.nci.nih.gov/.
First Generation Guidelines for NCI Supported
Biorepositories:http://biospecimens.cancer.gov/bioreposito
ries/NCI-Supported_Biorepositories.pdf
Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006.
First-Generation Guidelines for NCI Supported
Biorepositories