Minimal Risk

The concept of minimal risk is especially influential in the US debate, not least because it is enshrined in the so-called Code of Federal Regulations containing rules governing research on human subjects. On research involving minors cf. in particular Subpart D., § 46.401-46.409. The concept of minimal risk also has a crucial status in Art.17 II of the Convention on Human Rights and Biomedicine of the Council of Europe (cf. Module 13). In the German debate Maio inter alia puts forward a risk minimization model in order to justify research conducted on minors for the benefit of others, cf. Maio 2002.

Code of Federal Regulations. Title 45 "Public Welfare". Subtitle A - Department of Health and Human Services. Part 46 "Protection Of Human Subjects". Revised June 23, 2005. Online Version

Maio, Giovanni (2002): Ethik der Forschung am Menschen. Zur Begründung der Moral in ihrer historischen Bedingtheit. Stuttgart-Bad Cannstatt: frommann-holzboog (Medizin und Philosophie 6).

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