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Regulating Big Data research: A new frontier

 

This project will analyse existing ethical and legal regulations on research using Big Data. It will also explore the practical needs of stakeholders by interviewing researchers and representatives of patients and the public.

Portrait / project description (ongoing research project)

The project has three phases. First, we will review existing national and international ethical and legal documents related to Big Data research involving electronic health records and social media using classical analytical methods. Second, we will investigate the attitudes, needs and concerns of involved stakeholders by conducting interviews with researchers and those whose data are being used. Finally, we will conduct a thorough ethical and legal analysis of the issues identified during the interviews and an independent review of the relevant ethical literature and legal documents.

Background

Research using Big Data has the potential to contribute to quality, affordable health care. But regulations governing research have not kept pace with technology. Research involving electronic health records or social media are but two prominent examples. This regulatory uncertainty could stoke public fears about privacy and confidentiality. Research issues related to informed consent and conflicts of interest thus urgently require careful ethical and legal assessment.

Aim

The absence of clear ethical guidance could lead to reduced sharing of data and hinder research in a way that affects the societal benefit of Big Data research. The primary goal of this study is thus to strive towards a sensible and efficient use of electronic health records and social media data. The project aims to reduce ethical and regulatory uncertainty by providing ethical guidance for individual researchers and research institutions concerning the collection, storage and analysis of large electronic health record data sets and other digital data.

Relevance/application

This project will contribute to the local and international regulatory and ethical debate on the use of Big Data in biomedical research. In so doing, the project will help to provide practical guidance for researchers and lead to better understanding of public fears about misuse of data. An optimal outcome would be regulatory solutions that protect the privacy, confidentiality and informed consent of those whose data are being used while maximising the societal benefits of this emerging research trend.

Original title

Ethical and legal regulation of Big Data research – towards a sensible and efficient use of electronic health records and social media data [BigResearchEthics]

Project leaders

  • Prof. Bernice Simone Elger, Institut für Bio- und Medizinethik (IBMB), Universität Basel
  • Prof. Claudia Seitz, Juristische Fakultät, Universität Basel
  • Professor Marie-Laure Papaux van Delden, Université de Genève, Faculté de droit

 

 

Further information on this content

 Contact

Prof. Bernice Simone Elger Institut für Bio- und Medizinethik (IBMB) Universität Basel Bernoullistrasse 28 4056 Basel b.elger@unibas.ch

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