Varying ethics rules in clinical research and routine patient care – research ethics committee chairpersons’ views in Finland

Abstract

BackgroundTo present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012.MethodsNotes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons’ opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded.ResultsBased on REC chairpersons’ interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons’ assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons’ own personal view agreed with their REC.ConclusionsThe distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices.

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

“…In Finland, RECs were regulated by a detailed medical research law and in case of drug trials, as in England, by a detailed EU law (directive). Detailed legislation can lead to conflicts between laws and ethics [ 2 ]: an important ethical question concerns the amount of discretion left to researchers. A check-box mentality may make them feel that they have lost responsibility for their own work.…”

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

“…This was the case in England, but not in Finland; the data did not allow conclusions to be drawn about Canada or the USA with its highly varied health care system. In the USA, a topical issue was the integration of clinical trials and care [ 2 ]. The general understanding of what constitutes research and what requires informed consent seemed to be changing.…”

“…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.…”

“…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.…”

Research Ethics and Justice: The Case of Finland

“…At the national institute, research ethics is a topic of investigation among others. Good examples are Elina Hemminki's studies, with collaborators, on Finnish attitudes toward biomedical research in general 116 and biobank research in particular, 117 ethics committee chairpersons' views on changing rules, 118 and similarities and differences in research governance in Finland, England, Canada, and the United States. 119 Justice enters these investigations by the choice of themes, which often have to do with the proper distribution of benefits, burdens, rights, and duties within healthcare delivery and biomedical research.…”