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Models and Challenges of Research Governance Systems

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

Abstract

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.

Keywords

Governance Drug Regulatory Authority National Research Ethics Committees Accountability Transparency 

References

  1. Hirtle, M., T. Lemmens, and D. Sprumont. 2000. A comparative analysis of research ethics review mechanisms and the ICH good clinical practice guideline. European Journal of Health Law 7: 265–292.Google Scholar
  2. McDonald, M., D. Pullman, N.P. Anderson, and H. Sampson. 2011. Research ethics in 2020: Strengths, weaknesses, opportunities, and threats. Health Law Review 19 (3): 36–55.Google Scholar
  3. Ndebele, P. 2017. A review of national ethical review systems in selected African countries: What lessons can we learn for strengthening national health research oversight? Presented at: Enhancing ethics of clinical trials. Khartoum University, Sudan.Google Scholar
  4. Nwabueze, R.N. 2016. Legal and ethical regulation of biomedical research in developing countries. New York: Routledge/Taylor & Francis Group.Google Scholar
  5. Slamet, L. S. 2008. Communications between regulators (NRA) and ethics committees on clinical trials. In: The 13th international conference for drug regulatory authority, Bern, Switzerland.Google Scholar
  6. Sweeney, F. 2010. Introduction to ICH-GCP: Role of regulatory agencies and ethics committees. Inspection approach. European Medicines Agency. Presented at the: International Workshop on ethical and GCP aspects of the acceptance of clinical trials submitted in Marketing Authorisation Applications to EMA; London.Google Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.University of MarylandBaltimoreUSA

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