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Decision of 5 March 1999 laying down rules for the central assessment of medical scientific research with human beings (Decision central assessment of medical scientific research with humans)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of Our Minister for Health, Welfare and Sport of 7 December 1998, DWZJ-U-981341, made on behalf of our Minister of Justice;
Having regard to Article 2, second paragraph (b), (4) of the Law on Medical Scientific Research with People ;
The Council of State heard (opinion delivered on 21 January 1999, no. W13.98.0574);
Having regard to the further report of our Minister for Health, Welfare and Sport of 26 February 1999, DWJZ-U-99188, also on behalf of our Minister of Justice;
Have found good and understand:
As scientific research whose research protocol must have obtained a positive judgment from the central commission referred to in Article 14 of the Law Medical Scientific Research with People shall be designated:
a. Scientific research involving deliberate changes in human body cells in the genetic material or the functioning of the genetic material is specifically affected;
a. Scientific examination in which the living constituents of an animal or of a foetus or embryo of an animal or any human element in which they are purposefully exposed shall be placed in or on the body of a Human;
c. scientific research using means at which Article 2 or Article 3 of the Opium Law apply, in pharmaceutical form, to persons who are addicted to such agents, in the context of treatment of addiction to those resources;
d. Scientific research with sex cells;
(e) scientific research aimed at the development of a vaccine;
f. Scientific research focused on the development of cell therapy, using live cells;
g. scientific research with a medicinal product containing genetically modified organisms as intended Article 1.1 of the Genetically Modified Environmental Management Decision 2013 contains.
This Decision shall enter into force on a date to be determined by Royal Decree.
This decision is cited as: Decision central assessment of medical scientific research with human beings.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 5 March 1999
Beatrix
The Minister for Health, Welfare and Sport,
E. Borst-Eilers
The Minister of Justice,
A.H. Korthals
Published the 13th April 1999The Minister of Justice,
A.H. Korthals
