Table 4 Features related to quality of research ethics committee (REC) work, Finland compared to England, Canada (Ontario), and the USA, around 2010
Finland | England | Canada | USA | |
|---|---|---|---|---|
REC control body oversight | – | Strong | – | Distant |
Formal quality assurance | No | Control body | Accreditation planned | Control body, voluntary accreditation |
Inspection of RECs | No | Control body, rarely by drug authority | Rarely by drug authority | Control body and drug authority |
REC dismissal | Not in practice | Yes by central REC | Not in practice | In theory by central REC |
Researchers’ choice of REC | No | Yes | No | Varieda |
REC decision | Statement | Approval | Approval | Approval |
Appeal possibilities | Limited | Yes, clear system | Yes | In theory |
Independence from research site | Semi-independent | Yes | No | Varied |
Accountable to | Hospital districtb | Control body | Hospital boardc | Institution/None |
Transparency | Low | High | Low, recognized | Low |
Obligatory education of members | No | Yes | No | No |
Variability of decisions | Not discussed | Action taken | Identified problem | Identified problem |
Dealing with exceptions | ||||
Informed consent exemptions in trials | Not | Yes | Yes | Yes |
Emergency drug trials | Not possible | Possible | Possible | Possible |
Handling of quality assurance research | Ambiguity | Problem identified | Varied, problem identified | Varied, problem identified |