Notice bibliographique
Résumé
Scenario 1: An oncology researcher approaches the Research Ethics Board (REB) office of a Canadian institution to request guidance on an REB submission. researcher, a neurosurgeon, intends to take part in a multi-centre trial of a new agent for the treatment of the intractable and fatal condition Glioblastoma Multiforme (GBM), a brain cancer for which currently available surgical, radiographic and chemotherapeutic approaches increase mean survival rimes to only 12-14 months. experimental procedure involves implanting a device to deliver existing chemotherapeutic agents in a novel fashion; this implantation would take place during the surgical excision of the tumour in open-brain surgery, a treatment option that patients with GBM almost universally accept. researcher points to Section C.1 of the Tri-Council Policy Statement and claims that his research project needs no more than expedited review. The patients are all going to undergo brain surgery and chemotherapy anyway; clearly the risks involved in this procedure are as they are within the risks of daily living for people with GBM for whom undergoing brain surgery is normal--and that's how the Tri-Council Policy Statement defines minimal risk'. A month later, another neurosurgeon at the institution approaches the REB office with a research study for the same population: his procedure specifically targets the tumour as it reappears after initial treatment, and involves stereotactic surgery, which as a neurosurgical procedure is safer than the original surgery to excise the tumour. He points to the same Section C.I of the Tri-Council Policy Statement and argues that his research proposal should receive expedited review; after all the procedure is even safer than the craniotomy that such patients have already undergone, and the disease itself carries universal extreme morbidity and, for the patients eligible for his study, a very high likelihood of death within a matter of weeks or months. Hence, relative to the condition itself and the ordinary course of its treatment, the risks of his stereotactic surgery are well below the risks such patients face in the course of their lives. Scenario 2: A stem cell researcher approaches the REB office with a research protocol for an experimental neurosurgical intervention for the rare (and uniformly fatal) genetic condition called Batten disease. Children would undergo stereotactic brain surgery to implant neural fetal stem cells that are expected to provide the appropriate enzymatic activity to counteract the disease. researcher is puzzled as to the correct interpretation of the restrictions the Tri-Council Policy Statement places on risk in research with children. The Tri-Council Policy Statement says I can only do non-therapeutic research with children that exposes them to risk--I looked up Section C1 on risk in order to understand what this restriction in Article 2.5(c) amounts to. That section seems to suggest that what I'm doing is risk, because these patients already live with significant risk. But we've never implanted fetal neural stem cells into children s brains before--or adults, for that matter. risks are significant indeed. When I looked at the Tri-Council definition, it seems to me that perhaps we've been far too cautious about our research all along. If your REB office just consults their risks of daily living--well, these are virtually certain death within a couple of years, even with out best medical care. There are much riskier procedures that fall within that range that I can take straight to human trials without so much time-consuming pre-clinical work with animal models! (1) How should a Canadian REB office respond to each researcher? Should it offer expedited review to the experimental neurosurgical procedures of Scenario 1? Does reference to the guiding ethical principle of Minimizing Harm (Context of an Ethics Framework (C)) answer the question of the researcher in Scenario 2? …
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,005 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».