Innovation as new non-validated practice: definition, justification, principles, and context in Latin America

MASTROLEO, IGNACIO; HOLZER, FELICITAS

Controversies in Latin American Bioethics

Springer

Lugar: Berlin; Año: 2019; p. 145 - 176

This chapter introduces the concept "new non-validated practice" that originally stems from an interpretation of the term ?innovation?, commonly referred to in the literature of research ethics. "Innovations" interpreted as "new non-validated practices" in the clinical context have gained increasing importance as individualized therapeutic approaches. In the current literature, one of the most paradigmatic cases of a new, but insufficiently validated medical intervention has been the application of stem cell treatments in umbilical cord blood transplants outside sound clinical trials in the 1990s. These treatments have paved the way for some valuable clinical procedures, nowadays validated and established in clinical routine. However, recent incidences of an insufficiently regulated and, most probably, unethical use of stem cell treatments point to the substantive risks associated with new and unproven interventions.