Scope and quality assurance of research ethics committees in Finland compared to Canada, England and USA
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,031 | 0,136 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,005 | 0,005 |
| Études des sciences et des technologies | 0,003 | 0,002 |
| Communication savante | 0,006 | 0,002 |
| Science ouverte | 0,001 | 0,005 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».