Innovation as new non-validated practice: the case of Latin America

Terms such as innovation or innovative care have recently gained importance in relation to offering new options for desperate patients with serious conditions and without reasonable alternatives. However, innovation has multiple meanings. Therefore, this presentation aims, first, to distinguish one specific meaning from traditional research ethics and, second, to propose “new non-validated practice” as a better designation for future use in a framework of responsible use of innovative care. To identify this meaning, we start with the traditional research ethics’ distinction between research, validated practice, and innovation. Then, we propose a refined definition of innovation as new non-validated practice, that is, the use of new, scientifically sound interventions with an insufficient level of validation for regular healthcare, that aim to benefit individual patients. We then analyze the three core elements of our definition and present a classification for interventions used in practice, namely, novelty, validation, and the intention to benefit patients. Finally, we show the practical potential of our proposal by discussing epistemic and ethical concerns of new non-validated practice, special types of research that target patients’ unmet health needs and serious conditions, as well as the implications on new regulatory standards.