Legal Aspects of Non-Interventional Studies Conduction

Abstract

Even though in Russia there has been a growing interest in conducting non-interventional studies (NIS) in recent years, the existence of gaps in their legal regulation leads to the fact that many medical institutions and healthcare professionals refuse to participate in this type of activities. This paper analyzes such refusals and discusses several legal aspects, such as the contracting with medical organizations and investigators, issues of personal data protection, as well as a brief comparative analysis of the requirements for non-intervention trials in the EEU countries. To overcome the organizational barriers of NIS, it is necessary to develop common criteria/concepts at both pharmaceutical companies and professional medical communities levels, with the subsequent training of healthcare professionals and organizers on various aspects of NIS. This article will be helpful for all healthcare professionals, especially physicians, researchers and decision-makers, who decide to conduct NIS at medical institutions.