Advertisement

Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands

  • Marcel J H Kenter
Article

Abstract

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals.

Keywords

Medical research Clinical trial Accreditation Ethics Review Trial registry the Netherlands 

Notes

Acknowledgements

Thanks to M. Al, J. Dute, and K. Wilson for their critical reading of this manuscript and helpful suggestions.

References

  1. Brown, J. M. (2009). The impact of clinical trials legislation on clinical pharmacology: problems and solutions. Br J Clin Pharm, 67, 487–493.CrossRefGoogle Scholar
  2. Gunsalus, C. H., Bruner, E. M., Bruburles, N. C., Dash, L., Finkin, M., Goldberg, J. P., et al. (2006). Mission creep in the IRB world. Science, 312, 1441.CrossRefGoogle Scholar
  3. Keim, B. (2007). Tied up in red tape, European trials shut down. Nat Med, 13, 110.Google Scholar
  4. Kenter, M. J. H., & Cohen, A. F. (2006). Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet, 368, 1387–1291.CrossRefGoogle Scholar
  5. Kenter, M. J. H. (2008). Legislation and Review of Medical Research with Minors in the Netherlands. Eur J Health Law, 15, 145–151.CrossRefGoogle Scholar
  6. Ritter, J. M. (2009). Research governance: the Dutch defence. Br J Clin Pharm, 67, 485–486.CrossRefGoogle Scholar
  7. Saunders, J. (2002). Research ethics committees—time for change? Clin Med, 2, 534–538.Google Scholar
  8. Savulescu, J. (2002). Two deaths and two lessons: it is time to review the structure and function of research committees? J Med Ethics, 28, 1–2.CrossRefGoogle Scholar
  9. Steinbrook, R. (2005). Gag clauses in clinical-trial agreements. N Eng J Med, 352, 2202–2010.CrossRefGoogle Scholar
  10. Stewart, P. M., Stears, A., Tomlinson, J. W., & Brown, M. J. (2008). Regulation—the real threat to clinical research. BMJ, 337, 1085–1087.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2009

Authors and Affiliations

  1. 1.Central Committee on Research Involving Human Subjects (CCMO)The HagueThe Netherlands

Personalised recommendations