Actors involved in the regulation of clinical research: Comparison of Finland to England, Canada, and the USA

Abstract

Background: The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011. Methods: Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones. Results: Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics. Conclusions: This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.