Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes

Journal of Empirical Research on Human Research Ethics : JERHRE
Elina HemminkiElena Regushevskaya

Abstract

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 sen...Continue Reading

References

Nov 9, 2002·BMJ : British Medical Journal·Malcolm Boyce, UNKNOWN London multicentre research ethics committee 1997-2000
Jan 25, 2005·Health Services Research·Jennifer L Gold, Carolyn S Dewa
Oct 6, 2005·Health Research Policy and Systems·Elina Hemminki
Jan 20, 2007·International Journal of Technology Assessment in Health Care·Sarah J L EdwardsTeresa Swift
Apr 5, 2011·Journal of Empirical Research on Human Research Ethics : JERHRE·Lura Abbott, Christine Grady
Jun 18, 2011·Journal of Empirical Research on Human Research Ethics : JERHRE·Ivor A Pritchard
Aug 31, 2011·The American Psychologist·Mark D RogersonJeffrey Younggren
Apr 3, 2012·Revista Española De Cardiología·M Concepción Martín-ArribasJavier Arias-Díaz
May 16, 2012·Annals of Internal Medicine·Laura A PetersenSupicha Sookanan Chitwood
May 18, 2013·Health Research Policy and Systems·Elina HemminkiElena Regushevskaya

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