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Article

French

ID: <

10670/1.ym617p

>

Where these data come from
Human protection beyond regulation in biomedical research

Abstract

`titreb Protecting Human Beings Over and Beyond the Regulations Governing Bio-Medical Research. `/titreb `alinea/b Biomedical research is governed by an extremely strict set of regulations laid down by a number of laws, each of which underline the necessity for full and clear consent on the part of the participating individual involved. Successive texts have been voted by Parliament to ensure the safety of these individuals. Yet over and above the legal context surrounding biomedical research, sometimes cruelly lacking in clarity and flexibility in the light of the advancing scope of research in the field of human medicine, a number of other stakeholders also play key roles. These range from project leaders, whose goal may be purely scientific but not necessarily devoid of financial interest, to investigators responsible for enrolling and informing participants and following their progress throughout the trial period, to the Committee for the Protection of Individuals, whose task has become increasingly heavy over recent years, putting greater pressure on its members from both the scientific community and interest groups, all of whom are volunteers and who make decisions which engage their personal liability. We will also look at the participants themselves, whether they be volunteers or sufferers of a given condition or disease, people often motivated by a personal quest for treatment or cure through medical innovation, or meagre financial profit as provided for and restricted by the law, or by their desire as citizens to contribute to the general good.

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