Navigating ELSI for FAIR multiomics data management within STEPUPIORS international rectal cancer project

EDITORS Dr.IvanaMorić Dr.ValentinaĐorđević Title Publisher Editors Technical editor ISBN Copyright 5th Belgrade Bioinformatics Conference BOOK OF ABSTRACTS Institute of Molecular Genetics and Genetic Engineering, University of Belgrade Vojvode Stepe 444a, Belgrade, Serbia https://www.imgge.bg.ac.rs/ dr.IvanaMorić dr.ValentinaĐorđevic dr.DušanRadojević 978-86-82679-16-5 © 2024 Institute of Molecular Genetics and Genetic Engineering, University of Belgrade belbi.bg.ac.rs | [email protected] BelBi2024 Committees International Advisory Board Alessandro Treves, International School for Advanced Studies, Trieste, Italy Elena Fimmel Mannheim University of Applied Sciences, Mannheim, Germany Guanglan Zhang, Boston University, Boston, USA Konstantin Severinov, Waksman Institute for Microbiology, Rutgers University, New Jersey, USA Lou Chitkushev, Metropolitan College, Boston University, Boston, USA Oxana Galzitskaya, Institute of Protein Research, Russian Academy of Sciences, Moscow, Russia International Program Committee Alexandre de Brevern, INSERM, Université Paris Cité, Université de la Réunion, Paris, France BiljanaStanković, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Serbia BranislavaGemović, VINCA Institute of Nuclear Sciences, University of Belgrade, Serbia Branko Dragovich, Mathematical Institute, Serbian Academy of Sciences and Arts, Belgrade, Serbia DraganMatić, Faculty of Sciences, Department of Mathematics and Informatics, University of Banja Luka, Bosnia and Herzegovina Paul Sorba, Laboratory of Theoretical Physics and CNRS, Annecy, France Predrag Radivojac, Khoury College of Computer Sciences, Northeastern University, Boston, USA VladimirBrusić, Li Dak Sum Chair Professor of Computer Science, University of Nottingham, Ningbo, China Vladimir Uversky, Department of Molecular Medicine, University of South Florida, Tampa, USA Yuriy Orlov, I.M. Sechenov First Moscow State Medical University, Moscow, Russia ZoranOgnjanović, Mathematical Institute, Serbian Academy of Sciences and Arts, Belgrade, Serbia Fotis Psomopoulos, Centre for Research and Technology Hellas, Thessaloniki, Greece Hong-Yu OU, Shanghai Jiao Tong University, The Microbial Bioinformatics Group, State Key Laboratory of Microbial Metabolism, Shanghai, China IvanaMorić, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Serbia IvanaStrahinić, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Serbia MarkoÐordević, Faculty of Biology, University of Belgrade, Serbia NatašaPržulj, Catalan Institution for Research and Advanced Studies (ICREA), Spain; Barcelona Supercomputing Center, Spain; University College London, UK NenadMitić, Faculty of Mathematics, University of Belgrade, Serbia Peter Tompa, VIB Structural Biology Research Center, Brussels Saša Malkov, Faculty of Mathematics, University of Belgrade, Serbia Sergei Kozyrev, Department of Mathematical Physics, Steklov Mathematical Institute RAS, Moscow, Russia ValentinaĐorđević, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Serbia Vladimir Babenko, Institute of Cytology and Genetics, Novosibirsk, Russia Branko Dragovich, Mathematical Institute, Serbian Academy of Sciences and Arts, Belgrade BranislavaGemović, VINCA Institute of Nuclear Sciences, University of Belgrade Tanja Vukov, Institute for Biological Research “Siniša Stanković”,UniversityofBelgrade,Belgrade DušanRadojević, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade IvanaMorić, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade Nikola Kotur, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade ValentinaĐorđević, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade Local Organizing Committee AnđelaRodić, Faculty of Biology, University of Belgrade MarkoĐorđević, Faculty of Biology, University of Belgrade GordanaPavlović-Lazetić, Faculty of Mathematics, University of Belgrade JovanaKovačević, Faculty of Mathematics, University of Belgrade NenadMitić, Faculty of Mathematics, University of Belgrade Saša Malkov, Faculty of Mathematics, University of Belgrade ŽeljkoD.Popović, Faculty of Sciences, University of Novi Sad ORGANIZER MAIN CO-ORGANIZERS CO-ORGANIZERS Institute of Molecular Genetics and Genetic Engineering, University of Belgrade Faculty of Biology, University of Belgrade Institute for Biological Research“SinišaStanković”, University of Belgrade Institute for Medical Research, University in Belgrade Faculty of Sciences, University of Novi Sad Faculty of Engineering, University of Kragujevac Serbian Society for Molecular Biology Serbian Society for Microbiology Centre for the Fourth Industrial Revolution in Serbia Biophysical Society of Serbia Center for the Promotion of Science Mathematical Institute of SASA, Belgrade Serbian Society for Bioinformatics and Computational Biology VinčaInstituteof Nuclear Sciences, University of Belgrade Faculty of Mathematics, University of Belgrade BioIRC - Bioengineering Research and Development Center Navigating ELSI for FAIR multiomics data management within STEPUPIORS international rectal cancer project MiljanaTanić1, Mariska Bierkens2,MarkoRadulović1,AleksandraStanojević1, MladenMarinković3,AnaKrivokuća1,RadmilaJanković1,AnaĐurić1, Sergi Castellvi-Bel4, Jerome Zoidakis5,6, Remond J. Fijneman2 andMilenaČavić1 1 Experimental Oncology Department, Institute for Oncology and Radiology of Serbia (IORS), Belgrade, Serbia 2 Department of Pathology, Netherlands Cancer Institute (NKI), Amsterdam, Netherlands 3 Department of Radiation Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia 4 Gastroenterology Department, Fundació Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), Barcelona, Spain 5 Department of Biotechnology, Biomedical Research Foundation, Academy of Athens (BRFAA), Athens, Greece. 6 Department of Biology, National and Kapodistrian University of Athens, Athens, Greece [email protected] The STEPUPIORS project entails a multi-omics approach to studying neoadjuvant chemoradiotherapy (nCRT) response in locally-advanced rectal cancer (LARC) patients through retrospective and prospective longitudinal sample and data collection. Through a multinational collaboration including four partnering institutions (IORS - Serbia, NKI - Netherlands, BRFAA - Greece, FRCB-IDIBAPS - Spain) different layers of omics data are being generated and integrated to derive biomarkers and models for prediction of patient’s response to nCRT. Consideration of Ethical, legal and societal issues (ELSI) is mandatory for projects dealing with personal and sensitive data, and collection of biological material from patients. The international nature of the project necessitates compliance with both national (Serbian) and EU laws and regulatory provisions governing data privacy and patient protection. Ethics approvals were sought with the IORS’ local Committee for retrospective use of samples and health records, and for prospective collection and biobanking of samples and associated metadata, supplying patient information sheet and 2-tiered informed consent form. Prospectively collected samples and data will be managed by a Laboratory Information Management System (LIMS) acquired within the newly established IORS Biobank. International collaboration was facilitated through signing of Consortium and Joint controller agreements specifying terms for transfer of material including data, non-disclosure of information and data processing activities. A Data Management Plan (DMP) was made considering a wide range of data types including structured information from patients’ medical records, radiology images, genomics, transcriptomics and proteomics data. DMP contained detailed descriptions of type of processing, source of data, data format and quantity. Means of maintaining confidentiality were described, which include access control, pseudonymization, separate processing of data collected for different purposes. Free access to data was achieved through deposition of raw data in appropriate repositories (Zenodo, EGA, cBioPortal) and as Supplementary data 117 Flash talks in open access publications in accordance with EU’s Open Science policy and in line with Findable, Accessible, Interoperable Research data (FAIR) principles. Here we provide the roadmap and examples for navigating the complex ELSI landscape required for FAIR biomedical and multi-omics data management in accordance with the applicable regulatory provisions relating to the protection of the personal data and to medical confidentiality. Keywords: data management, regulatory, ethics, privacy, omics Acknowledgement: Horizon Europe Project STEPUPIORS (101079217) 118 Flash talks