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Biobanking 17072018 sanjay singh

Biobanking

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Biobanking 17072018 sanjay singh

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  1. Biobanking Presented by: Sanjay Singh

  2. What is aBiobank? • Defined by many authors, institutions, societies andorganizations in many differentways. • Organized collections and storage of human biological samples and associated data of great significance for research and personalizedmedicine. • ---BBMRI-European Commission (EC) in2015

  3. Biobank vsBiorepository • 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, includinghumans, and many other living organisms. A biobank is atypeof biorepository that stores human biological samples for use inresearch.

  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 basedon: • Tissue type(tumor tissue, cells, blood, DNA or RNA ) • Purpose/intended use (research, forensics, transplantation,source for therapeutics, e.g., umbilical blood, stem cell biobanks for individual or community use, ordiagnostics) • Ownership (academic and research institutions, hospitals, biotechnology and pharmaceutical companies or governmentrun)

  7. Types ofBiobanks • Tissue bank – (i) Surgicaltissues,Transplanttissues • Cancer / Tumorbank • Cord blood / Stem cellbank • Blood bank – Dried BloodSpots • Body fluids – (i) Synovial, (ii)Urine, (iii)Sputum, (iv) Buccal scrapings, (v) Sperm • DNA / RNAbank • Corneabank

  8. Examples of biobanks

  9. Biobanking • Biobank consists of three groups of distinctinformation. • Biological humansample(Biospecimen) • Attached or connectedinformation • The legal issues like consent and patient/individual data safety andprotection • Biospecimen • Blood, plasma, serum, RBC, white cells, DNA, RNA, protein,celllines, fluid, urine, cerebrospinal fluid, synovial fluid, amniotic fluid buffy coat, bone marrow stem cells and tissues(freshly frozen or FFPE).

  10. Biobanking Work Processes

  11. Specimen Accessioning, Processing and StorageWorkflow

  12. Specimen Withdrawal/Request Workflow

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

  14. Utilities of abiobank • Therapeuticwork- • Bone allografts used in spinal fusionsurgery • Tendon allografts for kneeligament replacement • Heart valves for treatment ofcongenital • heart defect inchildren • Viable and non-viable skin dressing forburn patients • Hematopoetic stem cells and marrow usedto • replace bonemarrow. • Sperms in fertilitypreservation. • RESEARCHWORK • Diseasebasedresearch • Populationbasedepidemiological research

  15. Benefits ofBiobanking?

  16. Biobanking in personalizedmedicine

  17. Biobanks Ethical and safety Issues • For tissue banking, freely given informed patient consentis 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 andanalysis • 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

  18. Biobanks Ethical and safety Issues • 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

  19. Biobanks inIndia Brain Biobank NIMHANS,Bangalore CancerBiobank ACTREC,Mumbai

  20. Repositories inIndia Organ Retrieval Banking Organization (ORBO), AIIMS, NewDelhi National Repository for Cell Lines / Hybridomas, NCCS,Pune Mycobacterial Repository, JALMA,Agra

  21. Conclusion • Biobanks are complex systems of systematically programmed storage of human material and associateddata. • 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 overthe world to support the dramatic development in diseases prevention, prediction, diagnosis andtreatment. • 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.

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