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.. 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.

Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine by the Council of Europe: Convention on Human Rights and Biomedicine (ETS No. 164, 1997). https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164

On research involving minors:

Code of Federal Regulations. Protection Of Human Subjects, last revised October 24, 2024. (45 C.F.R. § 46.100 2024). https://www.ecfr.gov/on/2024-10-24/title-45/part-46

Research regarding a risk minimisation model:

Maio, G. (2002). Ethik der Forschung am Menschen. Zur Begründung der Moral in ihrer historischen Bedingtheit (Medizin und Philosophie 6). frommann-holzboog. https://www.frommann-holzboog.de/reihen/59/590000620?lang=de