This document discusses biobanks, which are organized collections of human biological samples and associated data for research purposes. A biobank is a type of biorepository that specifically stores human samples. Biobanks have evolved from small university collections to larger population-based and virtual biobanks. They classify samples by disease, population, or tissue type. Biobanks benefit research into personalized medicine but also raise ethical issues regarding informed consent, privacy, and ownership that require oversight. Biobanking is an important part of modern biomedical research.

1. Biobanking
Presented by: Sanjay Singh

2. What is aBiobank?
• 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

3. Biobank vs Biorepository
• Biorepository is a biological
materials repository that collects,
processes, stores, and distributes
biospecimens to support future
scientific investigation.
• Biorepositories can contain or
manage specimens from animals,
including humans, and many
other living organisms.
A biobank is a type of
biorepository that stores
human biological samples for
use in research.

4. History of biobanking
 Started with small, predominantly university-based
repositories that were developed for the research needs of
specific projects
 Gradually evolved institutional and government supported
repositories, commercial (for profit) biorepositories,
population based biobanks and most recently to virtual
biobanks
 Data associated with stored biospecimens have increased in
complexity

5. Classification schemes of Biobanks
 Disease-oriented biobanks usually have a hospital affiliation collect
samples
•Representing a variety of diseases
•Search for biomarkers affiliated with disease
 Population-based biobanks need no particular hospital affiliation
because they take samples from large numbers of all kinds of people
•Look for biomarkers for disease susceptibility in a general population
 Virtual biobanks : Developed to assist investigators locate
biospecimens for testing and data mining from multiple biobanks in
dispersed locations.
•They can be accessed using specialized software or web portals designed to
connect biobanks and investigators throughout the world

6. Types ofBiobanks
• Human biobank classification is based on:
1. Tissue type(tumor tissue, cells, blood, DNA or RNA )
2. Purpose/intended use (research, forensics, transplantation, source
for therapeutics, e.g., umbilical blood, stem cell biobanks for
individual or community use, ordiagnostics)
3. Ownership (academic and research institutions, hospitals,
biotechnology and pharmaceutical companies or governmentrun)

7. Types of Biobanks
 Tissue bank – (i) Surgical tissues,
Transplant tissues
 Cancer / Tumor bank
 Cord blood / Stem cell bank
 Blood bank – Dried Blood Spots
 Body fluids – (i) Synovial, (ii) Urine,
(iii)Sputum, (iv) Buccal scrapings,
(v) Sperm
 DNA / RNA bank
 Cornea bank

8. Examples of biobanks

9.  Biobank consists of three groups of distinct information.
1. Biological human sample(Biospecimen)
2. Attached or connected information
3. The legal issues like consent and patient/individual data
safety and protection
Biobanking
• Blood, plasma, serum, RBC, white cells, DNA, RNA, protein, cell
lines, fluid, urine, cerebrospinal fluid, synovial fluid, amniotic fluid
buffy coat, bone marrow stem cells and tissues(freshly frozen or
FFPE).
 Biospecimen

11. Biobanking Work Processes

12. Specimen Accessioning, Processing and Storage
Workflow

13. Specimen Withdrawal/Request Workflow

14. Who are thedonors?
• Patient at the hospital or avolunteer.
• Sometimes, biobank collections are driven by researchers needs or
population based research.
• Samples and information are labelled with unique identifiers.
• Samples are divided into separatealiquots.
• Samples are stored in a way appropriatefor the sample material and the
intended research purpose.
• Blood, plasma, serum, and DNA are stored in -80°C freezers.
• Tissues and cell lines are preserved in liquid nitrogen freezers at -196°C.
Storage of samples

15. Utilities of a biobank
•Therapeuticwork-
•Bone allografts used in spinal fusion surgery
•Tendon allografts for knee ligament
replacement
•Heart valves for treatment of congenital
heart defect in children
•Viable and non-viable skin dressing for burn
patients
•Hematopoetic stem cells and marrow used to
replace bone marrow.
•Sperms in fertility preservation.
• RESEARCHWORK
• Diseasebased research
• Populationbased
epidemiological research

16. Benefits ofBiobanking?

17. Biobanking in personalizedmedicine

19. Biobanks Ethical and safety Issues
 For tissue banking, freely given informed patient consent is
mandatory.
 “The Privacy Rule,” set new standards and regulations to protect patients from
inappropriate disclosures of their “protected health information.
 One way of ensuring the individual’s right to privacy and upholding the principle of
confidentiality is to delink the person from his/her biological material
 QA and QC checks necessary right from planning, implementation, up
to documentation and analysis
 Secondary or extended uses of stored samples
 Ethical issues relating to re-consent
The ICMR guidelines make no mention of re-consent as a requirement, saying only that
“for secondary use of samples, the original consent shall not be transgressed”.
 Final decision with ethics committee

20.  Findings of participants and informing participants
Debatable matter
While some hold that no feedback should be given at all, others are of the view that
feedback should be given under specific conditions, such as if the test result has clinical
relevance and if there is a known therapy/intervention which is effective.
The UK Biobank, for example, states clearly in its framework that “participants will
receive no feedback at all, since the findings will all be in an aggregate form, with no
release of individual data .
The ICMR guidelines do not make any mention of providing results to participants.
 Ownership of samples and results
• Multiple stakeholders in a biobank – the donors, investigators, funding agencies,
institution housing the biosamples and ethics review committee
• The institution of the biobank should hold “custodianship” for the use of the resource,
and that the custodian of the samples should fulfil numerous responsibilities
• Include strict adherence to ethics and regulations, commitment to ensuring the stated
scientific outcomes and translating the scientific outcomes into broader health benefits
Biobanks Ethical and safety Issues

21. Biobanks in India
Brain Biobank
NIMHANS, Bangalore
ACTREC, Mumbai
Cancer Biobank

22. Organ Retrieval Banking
Organization (ORBO),
AIIMS, New Delhi
Mycobacterial Repository,
JALMA, Agra
National Repository for
Cell Lines / Hybridomas,
NCCS, Pune
Repositories in India

23. • Biobanks are complex systems of systematically programmed storage of human
material and associated data.
• In the past 20 years the science of biobanks has became an integral part of
personalized medicine.
• A great number of biobanks have been established all over the world to support the
dramatic development in diseases prevention, prediction, diagnosis and treatment.
• There are multiple stakeholders in biobanking research. The current regulations in
biobanking research reflect the “subordinate” role of the individual providing the
sample
• There is a greater need to understand public perceptions and the readiness of the people to
participate in biobanking research. it is necessary to commit to a deeper, wider engagement
with the community to ensure equity, transparency and trust.
Conclusion