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Article 17 Verdrag tot bescherming van de rechten van de mens en de waardigheid van het menselijk wezen met betrekking tot de toepassing van de biologie en de geneeskunde: Verdrag inzake de rechten van de mens en de biogeneeskunde

SCIENTIFIC RESEARCH

1 Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met:

(i) the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled;

(ii) the results of the research have the potential to produce real and direct benefit to his or her health;

(iii) research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

(iv) the necessary authorisation provided for under Article 6 has been given specifically and in writing, and

(v) the person concerned does not object.

2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, subparagraphs i, iii, iv and v above, and to the following additional conditions:

(i) the research has the aim of contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition,

(ii) the research entails only minimal risk and minimal burden for the individual concerned.

Regeling
Verdrag tot bescherming van de rechten van de mens en de waardigheid van het menselijk wezen met betrekking tot de toepassing van de biologie en de geneeskunde: Verdrag inzake de rechten van de mens en de biogeneeskunde
Soort
Verdrag
Geldend vanaf
04-04-1997
BWB-id
BWBV0005627
Versie
1997-04-04_0

In de hele regeling · Officiële tekst op wetten.overheid.nl