Interpretation of the standards concerning "Risk" and "Stress"

Empirical surveys attest that standards, such as "minimal risk" or "minimal stress" are interpreted in varying ways by both, physicians and ethics commissions. This room for interpretation is made possible by the existing guidelines and laws. Because of this, the abstract demarcations are increasingly made concrete and linked with recommendations by clinical examples. In accordance with the German drug law, Radenbach and Wiesemann suggest to differentiate between to levels of risks and stress: "Minimal risk" and "more than minimal risk" as well as "minimal stress" and "more than minimal stress". Whether or not an intervention falls under the "risk-category" depends on medical factors, while the classification of the "stress-category" depends on the specific consequences of the intervention on the child – the discussions concern questions of possible feelings of shame or the mediation of what is required of the child through games. Hence, "stress" is defined as relational, depending on the child’s subjective perception, rather than determining general "stress-standards". This is why a low risk examination can be very stressful for the child. 

Radenbach, Katrin; Wiesemann, Claudia: Risiko und Belastung als Kriterien der Zulässigkeit von Forschung mit Kindern und Jugendlichen.In: Marckmann, Georg; Niethammer, Dietrich: Ethische Aspekte der pädiatrischen Forschung : mit der Dokumentation der 26. Jahresversammlung des Arbeitskreises Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland am 14. und 15. November 2008 (2010) 37-50

 

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