THE ROLE OF ETHICS IN CLINICAL TRIAL CONTRACTING: A FRAMEWORK FOR INDUSTRY STANDARDS

Abstract

Clinical trials involve contractual agreements between multiple parties that govern the day-to-day interactions during the study. Ethical contracting is crucial to ensuring effective and mutually agreed-upon contractual agreements that protect the interests of all parties involved. The article proposes two ethical cross-check methods, the Virtuous Business Model and the Four-Way Test, to evaluate unknown factors such as patient safety and force majeure occurrences. The manuscript discusses the most important contractual components, including confidentiality, legal terms, and study-specific agreements. The document illustrates how evaluation of force majeure legal terms and patient safety risks is critical for ethical contracting. The article concludes that an ethical review of clinical trial contracts offers increased assurance to all parties involved, ensuring that all expectations are well-understood and unexpected risks and expenses are avoided