Scope and quality assurance of research ethics committees in Finland compared to Canada, England and USA
Bibliographic record
Abstract
Background Review by research ethics committees (REC) is the key in regulating health research. Besides ethics, RECs have been given legal and administrative duties. REC work has been little studied, but anecdotal evidence suggests variation in work and quality. Methods Several approaches and data sources were used in Finland and three comparison countries. The key method was semi- or unstructured interviews of experts. In addition, previous reports, documents, presentations and observations, and in Finland, previous knowledge were used. Empirical data were systematically collected: in Finland in 2009-11, in Canada (Ontario) late 2010, in England early 2011, in USA late 2011; some data were completed up to early 2014 from web-pages, publications and later interviews. Results Legal basis varied, but ethics codes used were similar, even though in different types of documents. In each country a leading document could be traced, but its origin varied: government (Finland, USA), research financer (Canada) and health service provider (England). Type of research handled within the same system was broad (human research) in USA and Canada, narrow in Finland (certain type of health research) and England (research within NHS). In all countries handling of health services research was variable and rules unclear. Mechanisms for the difficulty particularly in Finland were rigid requirement for informed consent and using drug trial rules for other type of research. In all countries the key task of RECs was participant protection, but the extent of other tasks (e.g. advancement of research and availability of results, review of scientific quality, legal and technical duties, research follow-up, and contract making) varied. Selection and competence requirements of REC members and work processes varied. Quality assurance of REC work was organized in England by the central committee. In the other countries the quality depended mainly on individual REC members’ activity. In Finland quality assurance system was least developed. Conclusions Clarification and standardization of the role of RECs are needed, particularly to guarantee good judgment for research outside drug trials and other traditional clinical medicine approaches. Key messages Review by RECs regulates health research, but the work of RECs varied notably in the four countries studied; the rules used outside pure clinical research were unclear. Quality assurance of REC work was organized in England, but not in the other countries.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.031 | 0.136 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.006 | 0.002 |
| Open science | 0.001 | 0.005 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".