This presentation talks about the biobanking of biospecimen and the various underlying considerations.

1. BIOBANKING

2. OVERVIEW
• About a biobank
• Specimens in a biobank
• Best practices in a biobank
• Identification and organization of samples
• BBMRI
• Ethical considerations
• Biomedical research and biobanks
• Conclusion

3. WHAT IS A BIOBANK?
• Defined by many authors, institutions,
societies and organizations in many different
ways.
• Organized collections and storage of human
biological samples and associated data of
great significance for research and
personalized medicine.
-BBMRI-European Commission (EC) in 2015

4. REQUIREMENTS OF A BIOBANK
The data associated with stored biospecimens
have increased in complexity in the followiung
aspects such as:-
• Date of collection
• Diagnosis
• Participant or Patient Phenotype
• Genomic & Proteomic information

5. NEED FOR A BIOBANK
• Represented countries face challenges re. unique
population, diversity of cultures and evolving resources.
• Way ahead includes studying our unique population.
• A biobank represents a single, organized, common
resource that can be utilized to perform multiple
hypothesis-driven studies, interface with industry and
monitor the evolution of curative dose in our societies.

6. BIOBANK POPULATION GROUPS
• Two large groups of Biobanks:
– Whole population
– Subset of population
• Whole population
– Collection of samples from a large number of the general population
– Not disease specific
– Useful for epidemiological studies as well as prospective studies
• Subset of population
– Collections from a subset of the population with specific conditions
– Includes family collections
– Useful to identify the causes (both genetic and environmental) of the
condition

7. COMPONENTS OF BIOBANK
• Biological human sample (Biospecimen);
• Attached or connected information;
• The legal issues like consent and
patient/individual data safety and protection.

8. TYPES OF BIOBANKS
• Population wide biobanks
• Virtual biobanks
• Tissue biobanks
• Disease oriented biobanks
Watson & Barnes emphasized the importance of
properly classifying biobanks.

9. SCOPE OF BIOBANKING

10. IMPACT OF BIOBANKING
• Clinical Practise: Better screening diagnosis
and treatment match.
• Health Economy: Better public health and
improved outcomes.
• Drug Development: Newer or better
medicines matched to patients.
• Ethical Credibility: Increased credibility and
support for R&D.

11. SCHEMATIC REPRESENTATION OF
BIOBANKING

13. BIOSPECIMEN
• Blood,
• Plasma,
• Serum,
• RBC,
• White cells,
• DNA,
• RNA
• Protein,
• Cell lines,
• Urine,
• Cerebrospinal fluid,
• Synovial fluid,
• Amniotic fluid buffy coat,
• Bone marrow stem cells
and
• Tissues(freshly frozen or
FFPE).

14. BIOSPECIMENS IN A HUMAN BIOBANK
• Freshly obtained
• Frozen
• Fixed
• Formalin-fixed paraffin-embedded (FFPE)
• Alcohol-fixed
• Other fixatives

15. FIXED TISSUE SAMPLES
• Tissue is usually derived from pathologically
altered tissue and is usually fixed.
• Similar to the pathalogical biobanks present in
many hospitals.
• Advent of new molecular biology techniques and
the ability to isolate single cells from the fixed
tissue, both abnormal and normal DNA as well as
RNA information is available.
• Information about the protein structure is limited
severely and hence not possible to reproduce
cells from the fixed tissues.

16. DNA/RNA BANKS
• The genetic material is usually obtained
from White blood cells or from other
donor tissue.
• Stored as either DEEP FROZEN (DNA or
RNA) or as DRY SAMPLES (DNA) for a
relatively long period of time.

17. BODY FLUIDS
• Storage of body fluids (plasma, serum, CSF,
urine) usually at very low freezing
temperatures (< -80oC).
• Useful to identify Fluid composition at a point
in time.

18. CELL CULTURE BANKS
• Consists of donor samples which are
transformed into permanent cell cultures.
• Stored in very low freezing temperatures in
liquid nitrogen cans which whereby creates an
inexhaustible source of DNA of almost
unlimited durability.
• Used to study Gene Function, Expression and
Cellular functions.

19. BEST PRACTICES OF BIOBANKS
• Goal of a biobank is to collect, store and
disseminate specimens and related data.
• Management team should ensure they follow
“Best Practices”.
• Publications discussing Best Practices:-
1. International Society of Biological &
Environmental Repositories (ISBER)
2. National Cancer Institute (NCI)

21. IDENTIFICATION OF SPECIMENS
• Anonymous- the sample was collected without the
identity of the donor.
• Anonymized – the sample was collected with the
known identity, but the identification was removed
• Coded (Linked) – the sample is given a unique
identifier that cannot be easily deciphered
• Identified – the sample has a common identifier
(name, hospital number)

22. CURRENT TREND OF IDENTIFYING
SPECIMENS
 Any human biospecimen that can be identified by
any one person, anywhere, is an identifiable
sample
 If a sample is coded, and any investigator keeps a
key to the code, the sample is identifiable.
 Exception (Office of Human Research Protections):
If the recipient (i.e., the researcher) of the human
biospecimen signs an agreement that there is no
intent to identify the sample, the sample may be
considered unidentifiable.

23. ORGANIZATION OF SAMPLES AND DATA
• Samples need to be organised in a way that
they can be easily identified and withdrawn
from bank
• Use of well designed storage area
• Organisation of data
– Standardised design
– Electronic database
– Control on data accessibility

24. TISSUE DATA
Population
Patient
Organization –
Storage
Retrieval Analysis
Biobank
research product
Demographic
Personal
Clinical

25. Requirements for a Successful Biobank
Infrastructure - Blood
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
Serum
-80 oC
• Protein/Amino Acid • Easily obtained
• Can remain viable for
decades
• Relatively large quantity
of serum for analysis
• Large storage space
• Large expense in adequate
sample tubes, freezers,
ancillary equipment and
energy costs (especially in
tropical and subtropical areas
- require adequate
environmental cooling)

26. Requirements for a Successful Biobank
Infrastructure - Living Tissues
Stored as: Use Pro Con
Liquid Nitrogen
Storage
-196oC
Viable cells that
can be grown.
• Can remain viable
for decades
• Practically
unlimited supply of
tissues
• More difficult to
obtain tissues
• Requires fast
processing
• Large expense in
adequate sample tubes,
liquid nitrogen or
freezers, and ancillary
equipment

27. REQUIREMENTS FOR A SUCCESSFUL
BIOBANK
• Information Technology
– Adequate database containing the fullest data possible
– Adequate security measures in place to safeguard data
protection
– Easy protocols to share data between researchers
– Adequate measures to identify ownership as well as
recognition
• Laboratory facilities
– Medium level – sample preparation
– High Level – for advanced analysis

28. CONFIDENTIALITY & PRIVACY
• Confidentiality- the principle in medical ethics that the
information a patient reveals to a health care provider is
private and has limits on how and when it can be disclosed
to a third party
• Privacy - culturally specific concept defining the extent,
timing, and circumstances of sharing oneself
• Physical
• Behavioral
• Medical

31. BBMRI - Biobanking & Biomolecular
Resources Research Infrastructure
• Funded by EC through ERIC (European Research
Infrastructure Consortium) legal entity.
• 53-member consortium with over 280 associated
organisations (largely biobanks) from over 30
countries - largest research infrastructure project in
Europe.
• will form interface between specimens and data and
top-level biological and medical research.
– achieved through a distributed research infrastructure
with operational units in all participating Member States.

32. ETHICAL CONSIDERATIONS
Informed consent of the donor
• a universally acceptable principle.
• implies that the person has the “capacity to give
consent.”
• “capacity to give consent”
– to understand the purposes, nature, significance and
implications of the measure calling for consent,
– believe that information;
– to weigh the pros and cons and
– to exercise the right of self-determination in the light of
the understanding arrived at.

33. ETHICAL CONSIDERATIONS (contd..)
Data Protection
• Ability to trace back the identity the donor can be an
issue where the samples are not anonymized
• 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
– Anonymous - samples were donated in a completely anonymous form
→ no personal identifier data

34. ETHICAL CONSIDERATIONS (contd..)
Secondary Use of Stored Tissues
• ability to use the tissues for a research not anticipated for when
the tissues were originally harvested.
• Ideally all research on archival material should have had prior
consent for that study, in actual fact in most cases not available
and not feasible to obtain .
• The decision based on
– the traceability or otherwise of the person,
– the possible anticipated use as compared to the original use,
– the risk implications of the research on the individual and
– the type of consent at the time of collection.
• A common thread is that there is a need for an approval from an
independent committee.

35. BIOMEDICAL RESEARCH & BIOBANKS
• Increase knowledge
• Understand biological processes
• Improve public health
• New diagnostic tests
• New prognostic tests
• New or improved therapy

36. CONCLUSION
• Biobanks are useful to as a research tool
• Reduce the time and expense of research
• Should be set up in a collaborative way were
infrastructure is shared
• Requires robust legal and ethical regulations
• Idea of regional hubs should be encouraged

37. THANK YOU!