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Contents : AKH Biobank Collaboration Contract Version: 1.2 Fecit: Helmuth Haslacher Georg Endler Claudia Marsik Erstellt am: 17.01.2008 BIOBANK BIOBANK AKH BIOBANK COLABORATION CONTRACT A BACKGROUND DATA Study Title: Summary: Management of the AKH Biobank Georg Endler Helmuth Haslacher Thomas Kampitsch Oswald Wagner Klinisches Institut f r Med. & Chem. Labordiagnostik MEDIZINISCHE UNIVERSIT T WIEN W hringer G rtel 18-20 A-1090 Wien Tel.: ** 43-1-40400 5356 FAX: ** 43-1-40400 5389 e-mail: Oswald.wagner@meduniwien.ac.at Internet: www.kimcl.at Clinical investigator ...................................................................... ...................................................................... Date Signature Date Signature Both parties have read and approved the following agreement and consent to publication of the above stated summary of the study at the AKH-Biobank Homepage 1/5 BIOBANK BIOBANK AKH Biobank Collaboration Contract Version: 1.2 Fecit: Helmuth Haslacher Georg Endler Claudia Marsik Erstellt am: 17.01.2008 B TECHNICAL DATA Project number assigned to the study: Expected Number of patient samples per Year: Expected duration of the study: Samples and Aliquots to be stored: aliquots Serum ( 400 l) aliquots whole blood ( 700 l) Other materials: aliquots Citrate Plasma ( 200 l) aliquots Urine ( 400 l) Checklist Study has been approved by the Ethics Committee: Informed consent will be stored in patient s records: Who will be responsible for patient s informed consent Who will be responsible for drawing patient s samples Sample transportation clarified: Who will obtain clinical data Database for clinical Data established: Access control to clinical data established : How will Clinical Data and laboratory data be merged Social security number MAC 2/5 YES YES NO NO YES NO YES YES NO NO other codes please specify: AKH Biobank Collaboration Contract Version: 1.2 Fecit: Helmuth Haslacher Georg Endler Claudia Marsik Erstellt am: 17.01.2008 BIOBANK BIOBANK C TERMS AND CONDITIONS 1 AKH BIOBANK PURPOSE The AKH Biobank is a scientific project founded for the public good. Its purpose is to provide an opportunity to research into cures for the most common diseases as there are f. e. cancer diabetes Alzheimer Parkinson cardiovascular or immune mediated diseases. In this context it acts as a facility that transfers allocates and stores human probes (normally blood serum blood plasma DNA RNA and urine) for further studies which can be conducted by the AKH Biobank itself or the clinical partners within the particular projects. 2 CORE PRINCIPLES AND ACCESS POLICY As part of the academic research infrastructure of the Medical University of Vienna the AKH Biobank is dedicated to provide free access to partners in and outside its institution. On the other hand due to limited resources of biological material access has to be restricted to projects which will most likely yield benefits for patient treatment and risk prediction. In general both the Clinical partner and the AKH Biobank will consensually decide upon access to anonymised clinical data and material on the principles of good scientific practice and ethical standards of the Medical University of Vienna. Among others the following points will have influence on the decision whether the AKH Biobank could be used for research: 1. 2. 3. 4. Compliance with ethical standards Balance of expected benefits and predicted costs of the study Agreement on Intellectual Property Viability and financing of the study 3 PRINCIPLES OF ACCESS 3.1 General In General each kind of information which could be used for identifying patients will not be given to third party accessing institutions. Moreover the AKH Biobank garuantees that its data will not be shared for the purpose of forensic investigations. To ensure this the AKH Biobank logistic team anonymizes each patient s probes at the time of processing which is standardized by a standard operating procedure (SOP). Released data will have also been checked for its security by privacy protection tests. The AKH Biobank will determine this processes in consultion with the AKH Ethics committee (EC). 3.2 General In order to take additional samples or request other information we reserve the possibility to recontact patients participating in any study. These contact will be made by the leader of the particular study (clinical partner) in which this patient participated. The AKH Biobank will in close cooperation with the AKH EC be responsible for seeing that the number of recontacts does not overburden participating patients. 3/5 AKH Biobank Collaboration Contract Version: 1.2 Fecit: Helmuth Haslacher Georg Endler Claudia Marsik Erstellt am: 17.01.2008 BIOBANK BIOBANK 3.2 Access on patient s samples and clinical data Patient s samples are proprietary to the particular clinical partner who leads the study in what connection the samples are taken

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