First-in-Human Research

First research in humans involves a wide variety of studies where the common factor is to test a new intervention, that is, never before tested in humans. In addition, it is a topic of interest for research ethics since failures in research projects have been reported that caused serious harm and even the death of some healthy participants. But this is only the worrying reason because also this type of research proposes to achieve a great advance in knowledge by trying to transfer the preclinical findings to the clinic. If a balance is struck between the need to develop new therapeutics and adequate protection for participants, society will benefit without unfairly burdening any of its members. In order to properly analyze this topic, three fundamental questions about first human research will be attempted: What is it, how is it justified? And how is it regulated?