Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands
Graduate studies at Western
Journal of Academic Ethics 7 (1-2):33-43 (2009)
|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|
|Categories||categorize this paper)|
|Through your library||Configure|
Similar books and articles
Akira Akabayashi, Brian T. Slingsby, Noriko Nagao, Ichiro Kai & Hajime Sato (2007). An Eight-Year Follow-Up National Study of Medical School and General Hospital Ethics Committees in Japan. BMC Medical Ethics 8 (1):1-8.
Ezekiel J. Emanuel (ed.) (2008). The Oxford Textbook of Clinical Research Ethics. Oxford University Press.
Dennis John Mazur (2007). Evaluating the Science and Ethics of Research on Humans: A Guide for Irb Members. Johns Hopkins University Press.
Nancy E. Kass & Jeremy Sugarman (1996). Are Research Subjects Adequately Protected? A Review and Discussion of Studies Conducted by the Advisory Committee on Human Radiation Experiments. Kennedy Institute of Ethics Journal 6 (3).
David Shaw (2011). The Ethics Committee as Ghost Author. Journal of Medical Ethics 37 (12):706-706.
David Hunter, Tis but a Scratch: The Human Tissue Act and the Use of Tissue for Research, Issues for Research Ethics Committees.
Sonja Grover (2004). What's Human Rights Got to Do with It? On the Proposed Changes to SSHRC Ethics Research Policy. Journal of Academic Ethics 2 (3):249-262.
Adil E. Shamoo (2009). Responsible Conduct of Research. Oxford University Press.
Paul M. McNeill (1993). The Ethics and Politics of Human Experimentation. Cambridge University Press.
Added to index2009-08-17
Total downloads19 ( #71,556 of 755,778 )
Recent downloads (6 months)1 ( #63,433 of 755,778 )
How can I increase my downloads?