Research Volunteer

Abstract

This chapter provides an analysis of the legal position of those individuals who voluntarily participate in clinical trials. A growing number of investigations, studies and clinical trials, ever more diverse in their scope and nature, at both a national and an international level, have quantitatively and qualitatively increased the complexity of the relationships between the different agents (personal and/or institutional) involved in scientific studies. At the outset it must be stressed that there is an unavoidable need to have the participation of patients and healthy volunteers, given that there are no scientifically viable alternatives to such participation in the research field. Therefore, legislation must balance the legal rights of those involved and, in all cases, protect and uphold the fundamental rights of volunteers who freely participate in such scientific investigations. Contemporary European Union legislation covering scientific research in particular is still wanting, although Regulation 536/2014 represents an important advance in the standardization of the specific regulations governing clinical trials. The principles and rights contained in this Regulation lay down a minimum standard for the protection of participants, and incorporate additional measures in relation to vulnerable groups.