Transcript Medicel Biobank

Medicel Biobank
Thomas M Attard MD FAAP FACG
Consultant Pediatrician Kansas City Childrens Mercy
Hospital, MO,
Mater Dei Hospital, B’Kara, Malta
Associate Professor University of Malta
Definition: Biobank / biological
resource center (BRC)
• long-term storage of biological samples for
research or clinical purposes
• In the broader context, a biobank includes a
complete organization with biological samples,
linked data, personnel, policies, and procedures
for handling specimens and performing other
services, such as the management of the database
and the planning of scientific studies
Dillner J (ed.), Methods in Biobanking,
Methods in Molecular Biology 2011
Population
Patient
Personal
TISSUE
DATA
Demographic
Clinical
Organization –
Storage
Retrieval
Analysis
Biobank
research product
Central or Regional / National
Tissue Banking
• Central tissue repository:
– upfront investment and logistic organization
(Ethical Board Review, Transfer of biologic
specimens → individual country specific)
– Overall more cost effective: single storage facility,
limited number of responsible personnel, uniform
SOP in tissue handling and storage
– Faster turnaround for studies, pilot studies more
feasible
Central or Regional / National
Tissue Banking
• National / Institutional Tissue Banking
– Model favored by BBMRI (Biobanking and
Biomolecular Resources Research Infrastructure)
– Variable institutional/investigator resources →
different timeline / likelihood of setup
– More expensive as every center has to replicate
every aspect of tissue handling and storage
– Impact on study design, cost, timeline
– Risk of fractionation → biobank as consortium of
independent biobanks
Anonymous
Outline Clinical
Demographic Form
Potential Biobank
Study Subject
CONSENT
PROCEDURE
N
Clinical Data Entry
Form
Y
Sampling /
Sample
processing
CODED
Identifier
SAMPLE
REPOSITORY
INDIVIDUAL
INVESTIGATOR
DATABASE
CENTRAL
BIOBANK –
Linked
DATABASE
Committee Approved
Research Proposals
LOCAL
NATIONAL
CENTRAL / REGIONAL
• PATIENT
RECRUITMENT
• CONSENT
• CODING
• SAMPLE INITIAL
PROCESSING
• DATAFORM
• IID
• SAMPLE
STORAGE
• Consent repository
• SAMPLE TRANSFER
PROCEDURES
• Central Database
• Biobank/Database
Utilization Committee
• Support Staff
LOCAL
NATIONAL
CENTRAL
• PATIENT
RECRUITMENT
• CONSENT
• CODING
• SAMPLE
INITIAL
PROCESSING
• DATAFORM
• IID
• Consent
repository
• SAMPLE
TRANSFER
PROCEDURES
• Central Database
• SAMPLE STORAGE
• Biobank/Database
Utilization Committee
• Support Staff
MEDICEL MULTINATIONAL BIOBANK –
Roles and Responsibilities
Individual investigator
responsibilities
Regional / Principal Investigator
Responsibilities
• Define affiliated staff
• Age / cultural appropriate
consent documents
• Standardized consent
procedure
• Signed consent document
storage
• Patient coding
• Standardized data entry
• Sampling and initial processing
• Define coordinating team
• Coded Database
Maintenance
• Sample Storage Facilities
• BIOBANK UTILIZATION
COMMITTEE
• Administrative Support
• National Node Data/Sample
Quality Review
• Funding
Consent Documents
• Required Components of Informed
Consent process include:
– full disclosure of the nature of the research and the
participant's involvement
– adequate comprehension on the part of the potential
participant
– the participant's voluntary choice to participate.
Informed Consent
A common consent can be formulated that includes the
minimum required consent parameters
Subjects (donors) have to know
• the purpose of the research
• the methods used, and the likely risks, immediate and
projected.
• the sources of funding
• possible conflicts of interest
• the intended benefits of the research
• any other relevant aspects of the study
• their right to withdraw consent.
Individual Site Responsibilities:
Consent
• Consent (adult / parent / guardian) and Assent (minor)
forms
• Must address all required components
• A copy of the proposed consent (and translation) needs
to be made available to Coordinating site
• Institutional Investigational/Scientific Review Board
acceptance documentation to be made available
Coordinating Center Responsibilities:
Consent
• Develop and disseminate outline of consent/assent
document with minimum content requirements (individual
sites may choose more extensive content)
• Review proposed consent/assent forms for adherence to
consent principles
• Document informed consent obtained for every subject in
biobank
• Periodically review consent procedure and content
adequacy
MEDICEL Biobank: Data Protection
• Ability to trace back the identity the donor can be an issue
where the samples are not anonymized
• This is important both with respect to patient protection as
well as prospective Ethical Review approval
• various methods by which the data can be coded:
– Direct identification
– Coded - identifiable data is physically separated from the personal data but the
procurer of the sample has access to the code
– Encrypted - third party persons transform the code into a number of characters,
thus identificable by third party
– Anonymized - connection between the code and the identifiable data is
completely lost
MEDICEL Biobank – Tissue Types and
Storage
Storage
Use
Pro
Con
Dry Sample on Filter
paper
Room Temperature
• DNA analysis
• Protein/Amino Acid
• Relatively small storage
space
• Easily obtained
• Can remain viable for
decades
• Sensitive to humidity
especially fungal attack
• Requires adequate drying
at sampling time
• Amount of tissue limited
Whole Blood
-20 oC
• DNA analysis
• Limited use for
protein/amino acid
• Easily obtained
• Can remain viable for
decades
• Relatively large
quantity of DNA
• Relatively large storage
space
• Moderate expense in
adequate sample tubes,
freezers, ancillary equipment
and energy costs
• Choice of Tissue type depends on funding (mainly
processing/transport and storage), accessibility to
sampling process and overall goals/scope of
Biobank
Medicel Biobank Tissue Sample
Responsibilities (Central Model)
Individual investigator
responsibilities
• Define staff roles and
responsibilities
• Assign unique identifier linked to
data entry form
• Sampling SOP in line with
common biobank guidelines
• Initial processing
• Sample storage / sample transfer
Regional / Principal Investigator
Responsibilities
• Define staff roles and
responsibilities
• Sample storage / backup
storage (power failure etc.)
• Continuous storage quality
control
• Temperature monitoring
procedures
MEDICEL Biobank – Data Entry –
Clinical Data
• Medicel Prospective Study already has very
comprehensive data entry sheet
• Encrypted identifier to link to Tissue samples
• Survey / expert opinion prior to project on
further data / data format
Specimen Shipment
• Ultimately, International Shipment of Biological
Samples (tissue) is almost inevitable
– Initial sample transport for Biobanking
– Study related specimen transport
– (alternatively biobank-study related procedures involving
tissue to take place at every center)
• The cost / complexity of (air) transport varies with
the tissue in question (DNA – post / whole blood courier)
• Requiring strict adherence to the relevant rules and
regulations.
Sexton KC (ISBER) Cell Preserv Technol (2008)
(IATA) http://www.iatabooks.com.
Air transport
• Technical Instructions for the Safe Transport of Dangerous
Goods by Air
– ICAO
http://www.icao.int/safety/DangerousGoods/Pages/technicalinstructions.aspx
• Dangerous Goods Regulations
– IATA
• Minimum Category B
• Assign to UN 3373 -
Sending dangerous goods by
courier
• Must meet classification, packaging and labelling
requirements
• Give full description of goods to courier in advance
• Some couriers will not carry dangerous goods or
impose additional requirements
• It is illegal to conceal dangerous goods in any
packaging not showing appropriate labels
Packaging
• All use triple layer system
• For some must use UN type-approved
packaging
• Quantity limits on packages (and some
primarys) for air transport
• Procedure and type specified in applicable
Packing Instruction
Standard Procedures Manual – before
initial setup to include:
• Common consent component requirements
• SP for tissue sampling – type of sample, method,
containers, cold chain, tissue handling, initial storage,
safety procedures,
• SP for transfer / long term storage (regional model)
• SP for laboratory investigation (comparable /
identical Tgase assay) / uniform histology reporting
(Marsh Classification)
Questions for the Group
• Central or Regional/Institutional Tissue Repisotory
• Membership of biobank oversight committee
• Who is the target population? – all celiacs / symptomatic /
screening (high risk or general population)
• → may be problematic if certain centers have
asymptomatic affecteds screening programs, variability
in societal/medical community awareness
• Coded data at national/local – encrypted data for studies etc.
Questions for the Group
• ‘open consent’ for future studies? Consent limited to
academic +/- industry sponsored / not defined
• More extensive (/less extensive) data collection form?
• Cost / viability analysis ↔ Funding
Standard procedure for blood
collection
• (new, sterile 3 ml or larger syringe and 18 – 22 gauge
needle to collect 12 mls of blood from each subject
being tested)
• IMMEDIATELY TRANSFER the blood to a lavender
(purple) top tube (EDTA anti-coagulant), 5 ml size or
larger.
• INVERT THE TUBE several times to prevent clotting.
(DNA cannot be extracted from clotted blood.)