Clinical research in Finland in 2002 and 2007: quantity and type

Journal of Empirical Research on Human Research Ethics

Virtanen

Regushevskaya

2015

Self Cite

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects.

Section: Methodsmentioning

confidence: 90%

Decisions by Finnish Medical Research Ethics Committees

Journal of Empirical Research on Human Research Ethics

Virtanen

Regushevskaya

2015

Self Cite

“…Certain features of research regulation in individual countries could serve as a model for other countries: the streamlining of the ethics committee system in England, the content advice provided on the handling of ethical issues in Canada, and the separation of drug trials to be used in licensing and other drug research in the USA are examples. Finland could learn a great deal from the other countries and an article has been written on improving the local control system [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

“…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 Finland’s research and health services were purposefully selected to cover the expertise of clinical research policy makers and regulators.…”

Section: Methodsmentioning

confidence: 99%

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

2015

Health Res Policy Sys

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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.

“…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.…”

Section: Methodsmentioning

confidence: 99%

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

2016

Health Res Policy Sys

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BackgroundThe aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries – England, Canada, the United States of America (USA) – in the late 2000s.MethodsSeveral approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized.ResultsIn Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland.ConclusionsThe work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-016-0078-3) contains supplementary material, which is available to authorized users.