Models and Challenges of Research Governance Systems

  • Henry SilvermanEmail author
Part of the Research Ethics Forum book series (REFF, volume 5)


A governance system for health research represents the regulatory and oversight mechanisms established for the protection of research participants in a country and ensuring the data crediability and science validity of the research activity. This chapter provides an introduction to the different types of research governance systems and discuss the challenges of such systems. It will conclude with a discussion regarding the importance of enhancing communications and the understanding of roles responsibilities between National Regulatory Authorities and Research Ethics Committees to ensure the rights and welfare of research participants and the safety of approved medicines.


Governance Drug Regulatory Authority National Research Ethics Committees Accountability Transparency 


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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.University of MarylandBaltimoreUSA

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