Ignacio Mastroleo

The term “innovation” or “innovative care” has recently gained attention in the context of the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities insufficiently validated for its regular use in healthcare that fall into this category, such as stem cell treatments, genome sequencing for diagnostic purposes, or novel reproductive technologies. Latin American countries are among the places where new and non-validated medical activities take place, notably due to a lack of clear regulations and the poor support of authorities of existent legal and ethical guidelines, which is driven by “hidden battles” on the moral status of certain interventions. The increasing importance of innovative care underlines the importance of developing a general framework for these practices. Therefore, the present chapter scrutinizes this nascent field of inquiry in Latin America and offers a conceptual framework for innovation as well as its ethical justification. As we will argue, an important use of the term “innovation” or “innovative care” is best interpreted as “new non-validated practice” and not as a research activity. Then, we will defend that responsible innovation understood as responsible new non-validated practice is ethically permissible and poses an acceptable medical option if done in exceptional circumstances—where no reasonable alternatives can be provided to an individual patient—and following special ethical principles. Finally, we focus on the peculiarities and specific difficulties the concept of new non-validated practice poses to the Latin American context. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America.

La investigación clínica, entendida como la búsqueda de soluciones para los problemas que acechan a la salud es, por su objetivo, una de las actividades de mayor trascendencia para el ser humano. Esta obra colectiva, como su propio título indica, explora no solo lo mucho que de positivo (las luces) tiene la investigación clínica, cómo se realiza, qué problemas encuentra y qué soluciones se plantean, sino también algunos aspectos negativos (las sombras) que la comunidad científica ha sido, hasta la fecha, incapaz de impedir que se produzcan.