Doctoral Programme of Clinical Research 10.2.2015 Biobanks Hanna Tuhkanen Biobank of Eastern Finland Research Coordinator
Hospital biobanks Samples & data - Routine patients - Research cohorts Biobank - Multi-purpose consent - Quality system - Efficiency - Protection of privacy - Networking Research - Efficiency - Publications - Ideas Society - Awareness of research - Transparency - Data protection Individual - Diagnostics - Personalised medicine
Personalised Medicine SAMPLE & DATA COLLECTION DATA STORAGE & CATEGORISATION Collection Clinical care Transfer PATIENTS Patient interface BIOBANK Personalised care plan PERSONALISED HEALTHCARE Personalised Preventive Care Transfer of information Research Development Data mining RESEARCH Modified from Kaye, Norsk Epidemiologi 2012;21
An example: longitudinally collected specimens and health information of a prostate cancer patient UEF/Viestintä 11.2.2015 4
Finnish Benefits for biobanks High quality public health care Electronic Health Records of hospitals National registries Individual social security number People support medical research Eastern Finland Population is highly homogenous due to geographic barriers and low migration
Quality system High quality, homogenous samples Current good practices (cgp), International Organization for Standardization (ISO), Best Practices (OECD, IARC/WHO, ) Includes: Written procedures for sample management and data protection Traceability: documented life cycle from sampling to end of research project A strong information technology (IT) structure, a robust tracking system linked to a database, and standard operating procedures (SOPs)
What kind of samples will be available in biobanks? Blood samples (whole blood, plasma, serum and cell fractions) Tissue samples DNA and RNA isolated from tissues and tissue lysates Secretion samples (e.g. urine, faeces, saliva, sputum, pleural fluid, ascitic fluid) Cytological samples (e.g. fine needle aspiration samples, brushing and irrigation samples) Cells cultivated from tissues
Data transfer into biobank Electronic Health Records Biobank Lab data Medical records Imaging Storage of clinical data Sample & Coding data registry Harmonization Code registry Coding Consent 20.11.2014
Data harmonization Inside biobank Nationally Data in different information systems Aim: Uniform mainline data in biobanks Information systems swap data between biobanks National services available Management of consents in Omakanta Electronic access and availability services for researchers International integration Field Entered value Harmonized value Grade 3 3 Grade High grade 3 Grade Grade 3 3 Grade III 3
Biobank act: Equal access to biobank material Biobanks are shared research resources Biobank can restrict delivery of its samples and data only if The intended use is against the biobank s field of activities Safeguarding ongoing primary research Safeguarding IPR Preservation of limited precious collections for very significant purposes Safeguarding privacy Reasons related to research ethics
How can samples be obtained from the biobank in the future? Samples can be used in medical research according to research field of the biobank Sufficient professional skills and scientific competent Research plan and other documents Preparations together with the biobank A research permit from the local Scientific Board The scientific level and interest of the research and the adequacy of the samples for the applied study Favourable statement from the ethics committee
Material transfer agreement Assignment is always performed based on a written contract to a research institution or company representing the researcher Samples and data are delivered in a coded format All procedures must protect the privacy of the sample donors Returning the sample analyses data to the biobank!
Finnish biobanks * * * * *licence
Biobanking and Biomolecular Resources Research Infrastructure Facilitate use and access to biological samples of human origin and associated data Building a national IT infrastructure for biobanks
Amounth of samples in biobanks
Biobank of Eastern Finland Owners: PSSHP, UEF, ESSHP, ISSHP, PKSSK Administrative Board Scientific Board Biobank director Research Manager Research Coordinator Quality Coordinator System Designer (IT) Laboratory Staff Research Staff
Research area All the specialities of the hospital districts Support research of cardiovascular and metabolic diseases, musculoskeletal disorders, neurological diseases, cancer and mental health in particular Population over 500 000 in Eastern Finland
Sample storage Liquid nitrogen freezers, samples in vapour Chart MVE Heco 2D barcoded sample storage tubes, readers and capping/decapping system Sample management system SamWise
Plans for 2015 Statement from National Committee on Medical Research Ethics (TUKIJA) Licence from National Supervisory Authority for Welfare and Health (Valvira) Planning quality system Planning information system Collaboration: biobank network BBMRI.fi Survey: needs of researches
Lab of the Biobank The aim is to start operations during 2015 through pilot projects at KUH Consents & new samples Transfer of old diagnostic tissue blocks
Biobank materials Example: paraffin embedded tissues from KUH Age, gender 2010-31.8.2013 31 651 cases Organ class, organ subtype Diagnosis, sample type
Donors Example: paraffin embedded tumor tissues from KUH KUH, pathology, 2010-31.8.2013
Digital pathology co-operation with other biobanks