THE MALTA BIOBANK & THE MALTESE GENOME PROJECT BIOBANKS What is a biobank? “ a collection of biological material (blood, DNA, cells, tissues e.g. muscle) and associated data and information stored in an organised system” (OECD) Examples of biobanks: Malta BioBank WHY DO WE NEED BIOBANKS 4Ps: play an invaluable role in healthcare provide resources required to carry out research and development promote gene discovery research in many complex diseases improve personalisation of care THE MALTA BIOBANK Malta’s first national archive of blood and DNA samples THE BIOBANKING FACILITY BIOBANK NETWORKS BBMRI-MT THE MALTESE GENOME PROJECT A new project to further expand the Malta BioBank and search for genes responsible for causing diseases in the Maltese population A new collection of 4200 biological samples and associated health information (1% of the population) Different ages & gender Families THE NEW COLLECTION 4200 samples (different ages & gender) 1 newborn sample + family (30-40members) ~100 families Informed Consent Form Questionnaire Clinical exam Collection of samples (blood & urine) Clinical tests Genetic tests PROCEDURE Give consent to take part by signing an informed consent form Answer some health and lifestyle questions (questionnaire) with the help of a trained interviewer Undertake a clinical check up by a medical or nursing graduate: anthropometric measurements, blood pressure monitoring, electrocardiogram (ECG) Sample collection: blood (<10ml), urine (30ml) Clinical tests: Complete Blood Count (CBC), Blood profile, Lipid profile (blood cholesterol), biochemical analysis of urine, genetic mutation analysis Time: approx. 1hour SAMPLES AND DATA Samples and data stored separately Samples – stored for 10 years Partially anonymised by coding for research Data custodian: Prof Alex Felice – link to code In his absence, delegate Joanna Vella Identifiable collection: 1) should consent be required for additional tests 2) if consent was given to disclose results to family doctor or back to participant 3) to destroy samples if withdraw from study 4) to avoid listing the same individual under different codes RISKS? Blood: can cause some bruising/bleeding/discomfort at the injection site when drawing blood Genetic analysis – may identify genes that cause diseases. This may have implications for health/life insurance/jobs Insurance companies will only be able to access medical records if consent is given by the participant Genetic data will not be placed in the participant’s medical records to protect the privacy of the participant RESULTS & INFORMATION Results will be sent to the family doctor if consent was given to do so A participant group or association will be setup Meetings will be held to update participants about the progress of the research Malta BioBank website: www.um.edu.mt/biobank Malta BioBank: 23403048 Mon-Fri 9-5 OUTCOMES Understand diseases specific to the Maltese population Discover new therapies Improve prevention Better diagnosis Cure disease