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Big Data research using electronic health records (EHR) and social media (SM)available through the internet are an effective and constantly improving means togenerate quick and valuable knowledge about the functioning of human beings andsociety. They aid to answer important research questions related to health, well-being,functioning and behaviour of various populations and institutions. This type of readilyavailable data is valuable for many disciplines including medicine, psychology, andsociology. It holds the potential to have a direct impact on quality and cost-efficiency ofhealth care as validated by real time use of Big Data in smarter healthcare and citiesprojects.As research regulations have been originally conceived for clinical trials, researcherscarrying out studies that use EHR and SM face considerable uncertainty. Recently, thepublic has reacted strongly to the perception that research involving data andbiological samples (generating genetic data) is underregulated and therefore data abuseis becoming a high risk. Big Data research has opened previously unprecedentedpossibilities of data research and has increasingly highlighted public fears of abuse:predictive analysis of EHR is being developed for so-called smarter hospitals to helpidentify in real time patients at high risk for health deterrioration. Models based onalgorithms are developed to predict and address healthcare and resource allocation insmarter hospitals. In medicine and psychology, routine data from EHR offer thepotential to use data from millions of people to answer important research questions atmuch lower cost than clinical trials. Combination of information from SM, consumerdata (e.g. data from the Migros Cumulus card) and EHR data could enable in findingobjectivable results that were previously only available through more costly subjectivetools such as patient or consumer questionnaires.This type of very promising Big Data research raises new technical and regulatoryconcerns due to its specific characteristics: the vast amount (variety, volume) of usefuldata generated at an unprecedented speed (velocity) encompassing not only medicalinformation but also sociodemographic and financial data. It thus presents challengeson veracity at various levels of data flow, ranging from the extraction of information todata sharing and methods of data management and analysis. Among the mostpressing ethical and regulatory concerns are issues of consent, privacy, confidentialityand conflicts of interest. Countries are struggeling individually and often differentlywith the regulatory void, and the varying domestic approaches lead to concerningbarriers for international research. In Switzerland, it is at present not always clearwhich type of Big Data research is considered human subject research and mustreceive approval from cantonal research ethics committees (CRECs). Furthermore,CRECs lack capacities to treat all research from such grey zones, especially if they aredone outside of medical faculties. Some researchers have sought to address thisshortcoming by enacting their own department or faculty commissions to approveresearch. These commissions, in contrast to the CRECs, do not have a legal status and their competence and scope remain undefined.The past has shown that if research remains largely unregulated there is a risk ofpublic “backfire”. Citizens’ fear of abuse and of research taking place “behind theirbacks” can create the feeling that regulations must be particularly strict. There areseveral recent historical examples to this effect. The present project fills the existingresearch gap of how to deal ethically with dsata while at the same time avoidingunnecessary barriers to otherwise beneficial Big Data research. Guidance for ethicscommittees worldwide, and also locally in Switzerland, is urgently needed. Theobjectives and methods of this project are the following:i.Review existing national and international ethical as well as legal guidance related toBig Data research involving EHR and SM using classical comparative analysismethods.ii.Understand the attitudes and local needs of researchers and barriers they fear: tothis aim we will carry out qualitative interviews with (a) researchers and (b) with thosewhose data are used.iii.Use the results from the preceding parts (i. & ii.) and perform thourough ethicalanalysis, after review of the relevant ethico-legal literature, to influence the local andinternational regulatory and ethical debate and to propose and further a sensitive andefficient research ethics framework.