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

Hemminki Health Research Policy and Systems Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA Elina Hemminki 0 1 0 Department of Public Health, University of Helsinki , Helsinki , Finland 1 National Institute for Health and Welfare , P.O. Box 3000271 Helsinki , Finland 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. Comparative study; Drug control; Governance; Research regulation - Background The regulation of clinical research is governed by two opposing sets of interests. While demand for evidencebased medicine and the interests of health care and industry favor research facilitation, the regulators, patient protection, and autonomy are putting the case for greater regulation. Concern has been raised about the relevance and quantity of clinical research and it is even claimed that regulation hinders research activity [1-4]. Due to the high volume of drug trials, strong commercial interests, tighter control traditionally, and problems related to the European Union (EU) Clinical Trials Directive, a special focus has been placed on drug research. The aim of this paper is to compare clinical research regulation in Finland to that of three other countries, in order to illustrate common features and variations around the period 20102011, while focusing on the various actors involved in research regulation. Research ethics committees (RECs) will be discussed in more detail in another paper (Hemminki, unpublished manuscript 2015); only their general structures are presented here. In all countries compared, particularly England, changes have occurred since 2011, but in order to preserve a common timeframe these changes are referred to only briefly. Regulation concerns both research ethics (content) and practical issues (research governance); in this article, the term research regulation is used to cover both. The focus is on clinical research, defined as medical research conducted on and with patients. Regulation of medical research using animals, body parts (samples), or information alone, including the regulation of registers, records, and bio-banks is not covered; privacy and data protection issues are not independently considered. Previous studies have investigated research regulation in Finland [1,2,5], highlighting various elements in need of improvement. To better understand the regulation system and to get ideas for improvements, comparisons were made with three other countries. The comparison countries were chosen based on the assumption that they have a great interest in research regulation, as well as for reasons of convenience (contacts through which data collection could be organized). Finland is an EU country with largely publicly funded health care, conducting much clinical research for its size. England (UK) is an EU country with a national health care system, a great deal of clinical research and ongoing discussion of research regulation. Canada has publicly funded health care. To some extent, research regulation varies by province and our results are mainly based on Ontario, Canadas largest province. The USA, a leader in medical research, has a major international impact on the field. Methods Several approaches and data sources were used. The key method applied consisted of semi-structured and unstructured interviews of experts. In addition, use was made of previous reports, documents, presentations in meetings, observations and, in the case of Finland, previous knowledge. Empirical data was collected: in Finland in 20092011, in Canada in late 2010, in England in early 2011, and in the USA in late 2011. Some data was completed up to spring 2014 using web pages and publications and, later, interviews. The data collection conducted in Finland has been reported in more detail in previous publications [1,2,5]. A total of 26 experts involved in Finlands research and health services were purposefully selected to cover the expertise of clinical research policy makers and regulators. All of the experts approached, or their substitutes, agreed to be interviewed (15 face-to-face and 11 via telephone) by two researchers with a medical background; 22 chairpersons from 25 official medical RECs were interviewed by two other researchers, a dentist and a lawyer. In the comparison countries, the persons interviewed were chosen based on previous knowledge of important institutes in this context, suggestions made by the interviewees, geographical proximity, and availability during the data collection visits. All persons contacted agreed to participate if the timing was possible. Interviews were performed by a researcher with a medical background. In England (London, Oxford), 21 persons were interviewed in spring 2011; in addition, various informal discussions were held with experts. Feedback interviews were conducted with four interviewees in late 2013. An important source of data was the report and background documents on health research regulation [6]. In Canada (Toronto), 13 persons were interviewed in the fall (...truncated)