Is the current regulation for non-therapeutic research with incompetent persons an ethically acceptable regulation to expand the medical-scientific knowledge about diseases and medical treatment of... Show moreIs the current regulation for non-therapeutic research with incompetent persons an ethically acceptable regulation to expand the medical-scientific knowledge about diseases and medical treatment of minors and adult incompetent persons? To answer this question at first the historical line of ethics on medical-research with human subjects is followed from the Nuremburg Code until the Dutch regulation in the 21st century in part I.To what extent can the role of treating physician be combined in a morally responsible way with the role of researcher if those roles do not coincide? For example, in non-therapeutic research? There is a crucial difference between the researcher-subject relationship and physician-patient relationship. Informed consent is a necessary, but not sufficient, condition to protect patient subjects (part II).In the first version of the Dutch legislation in 1998, non-therapeutic research with incompetent persons was subject to strict conditions: group relatedness, negligible risks and minimal burden. Many medical researchers found these criteria too restrictive and called for the law to be extended. In 2016 the criteria for risks and burden were extended to ‘minimal compared to the standard treatment’(part III).This regulation is not an optimal regulation. The assumption that those who are already used to something can endure more, is questionable (part IV). Show less
