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

Abstract

BackgroundThe 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.MethodsSeveral 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.ResultsCommon 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.ConclusionsThis 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.

Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

“…The methods used herein have been described in detail in previous papers [ 4 , 15 , 16 ], and briefly summarized below. Several approaches and data sources were used.…”

“…Review by research ethics committees (RECs), also called research ethics boards or institutional review boards, has become the key in clinical research regulation [ 1 - 4 ]. In the European Union (EU), the 2001 Clinical Trial Directive, which required the establishment of ethics committees to review drug trials, was an important stimulus for the appearance of such bodies.…”

“…In the European Union (EU), the 2001 Clinical Trial Directive, which required the establishment of ethics committees to review drug trials, was an important stimulus for the appearance of such bodies. As part of a larger study on clinical research regulation, the work of RECs in Finland was compared to three other countries: England, Canada, and the United States of America (USA) [ 4 ]. This paper aims to compare common features and variation in the work of RECs in the late 2000s, concentrating on the main REC system.…”

“…This paper aims to compare common features and variation in the work of RECs in the late 2000s, concentrating on the main REC system. The comparison of REC structures and the study context have been previously published [ 4 ], and are only briefly summarized below.…”

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands

“…Comparisons between different countries' approaches to exempting from ethics reviews of low-risk human health/medical researchthat is, research that generally falls on the minimal burden, intrusion or inconvenience end of the research risk spectrummay shed light into each country's individual practices as well as identify possible solutions to problems [18][19][20]. Better understanding of the examples of exemptions of human health/medical research from ethics review in different jurisdictions may also help guide modification of review processes and help reduce waste of researchers' and ethics committees' time and resources when assessing low risk research.…”