Value of substitute consent and autonomy of research participants in Regulation (EU) No 536/2014

Abstract

Introduction and Objective For years the concept of informed consent has been gaining strength as an expression of patient and research participant’s autonomy. The interpreted Regulations allows for obtaining a substitute consent from that person’s legally designated representative which, de facto, is the decision of an authorized entity to include the participant in the study presuming that he/she would agree. The inability to consent in a specific situation and allowing for substitute consent from a different entity (a legally designated representative) is permission to participate in the proposed form of clinical trial. Through the introduced solution, the autonomy of the participant who, for various reasons, cannot consent to participate in clinical trials has been limited. The aim of the study was to analyze the concept of substitute consent in a research setting. Brief description of the state of knowledge The legal obligation to obtain consent originates from the early 20th century. This concept has evolved over the years and broadened in scope to increase the significance of patient autonomy. The analyzed Regulation indicates that the concept of informed consent has been redefined in the clinical research setting to incorporate those who lack the possibility to self-decide. The directive introduces the concept of substitute consent, which is an innovative solution that can affect current research protocols. Conclusions Traditional requirements for informed consent have been omitted (in this redefined Act), which is an innovative legislative solution that can facilitate research

Keywords

• law
• clinical trials
• informed consent
• research participants