Medicel Biobank Thomas M Attard MD FAAP FACG Consultant Pediatrician Kansas City Childrens Mercy...
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Transcript of Medicel Biobank Thomas M Attard MD FAAP FACG Consultant Pediatrician Kansas City Childrens Mercy...
Medicel Biobank
Thomas M Attard MD FAAP FACG Consultant Pediatrician Kansas City Childrens Mercy Hospital, MO, Mater Dei Hospital, B’Kara, MaltaAssociate 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
TISSUE DATA
Population
Patient
Organization – Storage
Retrieval Analysis Biobank research product
Demographic
Personal
Clinical
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
• 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
Central or Regional / National Tissue Banking
Potential Biobank Study Subject
INDIVIDUAL INVESTIGATOR
DATABASE
CENTRAL BIOBANK –
Linked DATABASE
SAMPLE REPOSITORY
Sampling / Sample
processing
Y
N
Anonymous Outline Clinical
Demographic Form
Clinical Data Entry Form
CODED Identifier
CONSENT PROCEDURE
Committee Approved Research Proposals
• 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 / REGIONAL
• PATIENT RECRUITMENT• CONSENT• CODING• SAMPLE
INITIAL PROCESSING• DATAFORM
• IID • Consent
repository• SAMPLE
TRANSFER PROCEDURES
• Central Database• SAMPLE STORAGE• Biobank/Database
Utilization Committee• Support Staff
LOCAL NATIONAL
CENTRAL
MEDICEL MULTINATIONAL BIOBANK – Roles and Responsibilities
Individual 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
Regional / Principal Investigator Responsibilities
• 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.
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.
Informed 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
• Choice of Tissue type depends on funding (mainly processing/transport and storage), accessibility to sampling process and overall goals/scope of Biobank
Storage Use Pro ConDry 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
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
– ICAOhttp://www.icao.int/safety/DangerousGoods/Pages/technical-
instructions.aspx
• Dangerous Goods Regulations– IATA
• Minimum Category B
• Assign to UN 3373 -
Sending dangerous goods bycourier
• 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.)