(Wet medisch-wetenschappelijk onderzoek met mensen), Stb. 1998, 161
Entry into force:
de artikelen 1 tot en met 13, 19 tot en met 23, 27 tot en met 31 en 33 tot en met 37: met ingang van 1 december 1999 (Besluit van 13 november 1999, houdende inwerkingtreding van de Wet medisch-wetenschappelijk onderzoek met mensen, Stb. 1999, 486);Entry into force:
de artikelen 14 en 15: met ingang van 1 april 1999 (Besluit van 23 maart 1999, houdende gedeeltelijke inwerkingtreding van de Wet medisch-wetenschappelijk onderzoek met mensen, Stb. 1999, 145).
Introduction
The Medical Research Involving Human Subjects Act was adopted by the Lower House in 1997 and by the Upper House 1998. One of the principal aims of this Act is to provide protection to subjects who take part in medical research. Over the past 20 years in the Netherlands, a thorough practice has been established of medical research involving human subjects and reviewing such research in terms of medical ethics. The Act lays down the general requirements for this practice.
New is the establishment of a central committee for medical research involving human subjects. The central committee’s tasks include recognising medical ethics review committees and collecting and keeping the protocols on medical research involving human subjects. The central committee itself reviews the protocols on medical research in a number of cases.
The Medical Research Involving Human Subjects Act came into force on December 1, 1999.
In 1998, new rules also came into force in the Netherlands in line with the European directive for ‘good clinical practice’. This directive is intended to establish a common standard to protect the rights, safety and well being of human subjects in medical research carried out for the development of drugs.
The directive is also intended to guarantee the quality and reliability of the drug research. The provisions of the Medical Research Involving Human Subjects Act are in line with the European requirements, as far as possible.
Chapter 1 of this brochure explains what the Act regulates and the parties for which the Act is intended.
Chapter 2 describes how the Act operates in practice. Amongst other things, there is a description of the new method of review and its consequences, especially for medical ethics review committees and researchers.
The central committee and its role vis-à-vis the medical ethics review committees are discussed separately in chapter 3.
Chapter 4 states how two decrees based on the Act are dealt with. This includes, amongst other things, the compulsory insurance.
Chapter 5 describes the interim procedure for approving scientific research that involves the use of gametocytes and embryos.
For the text of the Act, please click here.
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Latest update: 1 November 2006. |
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