Abstract
The conduct of clinical research is characterized by several features, with a strong emphasis on expertise, professionalism, experience, adherence to legislative standards and ethical requirements, safety of subjects, data quality, and validity collected during clinical research, as well as regular monitoring of clinical studies. When faced with epistemic uncertainty related to the outcome of therapy using investigational medicinal products, whose efficacy and safety are still in the testing, monitoring, and evaluation phase, researchers bear a much greater responsibility for patient safety than during the application of approved therapeutic interventions.
Decision-making in such situations is challenging and requires consistent guidance from qualified ethical deliberation based on ethical theories and principles. Additionally, human qualities like empathy and compassion may also play a role in the decision-making process