Christian Democrats Party: 'The current Dutch law does not allow experiments with incapacitated persons if is not in their interest' and 'The consideration that a principle point of view in this case a ban on nontherapeutic experiments with incapacitated subjects will hinder a part of science, does in itself not provide enough argumentation to allow these experiments', source: Minutes debate Lower House, 2 October 1992 (translation by MJHK).
Christian Democrats Party: 'The current Dutch law does not allow experiments with incapacitated persons if is not in their interest' and 'The consideration that a principle point of view in this case a ban on nontherapeutic experiments with incapacitated subjects will hinder a part of science, does in itself not provide enough argumentation to allow these experiments', source: Minutes debate Lower House, 2 October 1992 (translation by MJHK).
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Committee on Medical Experiments Involving Incapacitated Persons, Medical research involving incapacitated persons, Report regarding the regulation of medical research involving minors and incapacitated persons, The Hague, May 15
Committee on Medical Experiments Involving Incapacitated Persons, Medical research involving incapacitated persons - Report regarding the regulation of medical research involving minors and incapacitated persons, The Hague, May 15, 1995.
(1995)
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WMO Section 4, subsection 1: 'It it prohibited to conduct research involving as subjects persons of less than eighteen years of age or persons who cannot be deemed capable of giving informed consent. This prohibition shall not apply to research which may be of direct benefit to the subjects, nor shall it apply to trials which could not be conducted without the participation of persons of the same category as the subject, provided that the risk associated with participation is negligible and the burden minimal'.
WMO Section 4, subsection 1: 'It it prohibited to conduct research involving as subjects persons of less than eighteen years of age or persons who cannot be deemed capable of giving informed consent. This prohibition shall not apply to research which may be of direct benefit to the subjects, nor shall it apply to trials which could not be conducted without the participation of persons of the same category as the subject, provided that the risk associated with participation is negligible and the burden minimal'.
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'The State party should further remove minors and other persons unable to give genuine consent for any medical experiments which do not directly benefit these individuals (non-therapeutic research).' Source United Nations Human Right Committee, Consideration of reports submitted by member states parties under article 40 of the covenant, Third periodic report, The Netherlands, 25 August 2000.
'The State party should further remove minors and other persons unable to give genuine consent for any medical experiments which do not directly benefit these individuals (non-therapeutic research).' Source United Nations Human Right Committee, Consideration of reports submitted by member states parties under article 40 of the covenant, Third periodic report, The Netherlands, 25 August 2000.
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See for instance: Implementation of the International Covenant on Civil and Political Rights, Th e Netherlands
See for instance: Implementation of the International Covenant on Civil and Political Rights, fourth periodic report, Th e Netherlands, 2007.
Member of Parliament dr Peter Liese, a German paediatrician from the CDU party
Member of Parliament dr Peter Liese, a German paediatrician from the CDU party.
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Directive 2001/20/EC Article 4: 'A clinical trial on minors may be undertaken only if . . . (e) some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give consent or by other research methods; additionally, such research should either relate directly to a clinical condition form which minor concerned suffers or be of such a nature that it can only be carried out on minors'.
Directive 2001/20/EC Article 4: 'A clinical trial on minors may be undertaken only if . . . (e) some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give consent or by other research methods; additionally, such research should either relate directly to a clinical condition form which minor concerned suffers or be of such a nature that it can only be carried out on minors'.
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Directive 2001/20/EC Article 5: '. . . . . inclusion in clinical trials of incapacitated adults who have not given ( . . .) informed consent ( . . .) shall only be allowed if . . . . (i) there are grounds for expecting that administering the medicinal product to be tested will produce a benefit to the patient outweighing the risks or produce no risk at all'.
Directive 2001/20/EC Article 5: '. . . . . inclusion in clinical trials of incapacitated adults who have not given ( . . .) informed consent ( . . .) shall only be allowed if . . . . (i) there are grounds for expecting that administering the medicinal product to be tested will produce a benefit to the patient outweighing the risks or produce no risk at all'.
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Press release Peter Liese 18 December 2000: 'For adults, which are not able to give legal consent in a clinical trial (e.g., mentally handicapped people), even stricter standards were specified.'.
Press release Peter Liese 18 December 2000: 'For adults, which are not able to give legal consent in a clinical trial (e.g., mentally handicapped people), even stricter standards were specified.'.
* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.
