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Enregistrement W227965805

Monitoring Contracts with Industry: Why Research Ethics Boards Must Be Involved

2003· article· en· W227965805 sur OpenAlex
Jennifer Gold, Michelle S. Laxer, Paula A. Rochon

Pourquoi ce travail est dans la base

Une base qui oublie comment elle a trouvé un travail ne peut pas être vérifiée. Voici les voies qui ont admis celui-ci.

venuePublié dans une revue dont le pays d'attache est le Canada.
aboutLe titre ou le résumé porte un signal canadien du lexique géographique.
no affAucune affiliation canadienne : ce travail est invisible pour une base fondée sur la seule affiliation.
Aucune affiliation canadienne. Une base fondée sur la seule affiliation (le devis habituel) n'aurait jamais vu ce travail. C'est l'un des travaux qui justifient l'inversion de la base.

Notice bibliographique

RevueHealth law review · 2003
Typearticle
Langueen
DomainePharmacology, Toxicology and Pharmaceutics
ThématiquePharmaceutical industry and healthcare
Établissements canadiensnon disponible
Organismes subventionnairesnon disponible
Mots-clésDocumentationResearch ethicsAccountingInstitutionPublic relationsBusinessPolitical scienceLawEngineering ethicsEngineering
DOInon disponible

Résumé

récupéré en direct d'OpenAlex

Introduction Industry-university collaboration is an increasingly common phenomenon in Canada. A recent study on university-industry partnerships in this country indicated that the amount of research funded by private companies jumped from 2% in 1976 to 13% in 1996. (1) Critics have raised concerns that such research may have an underlying bias in favour of its sponsors. (2) To compound the problem, institutional research ethics boards (REBs) are often not privy to contracts negotiated between the institution and the industry sponsor. (3) Such contracts may contain ethically questionable clauses, and it is therefore imperative that REBs be able to view them before deciding whether a given research protocol is deserving of ethics approval. Without access to contracts and related documentation, an REB is precluded from making an educated decision on the matter. This could result in research proceeding that is unethical in nature, putting subjects at risk. It may further result in publication restrictions and other constraints on the investigator, jeopardizing the scientific integrity of the research. REBs and the Regulation of Research in Canada There is no single regulatory regime that governs research conduct in Canada. Most research is regulated indirectly through requirements of the three major federal funding agencies (CIHR, SSHRC, and NSERC). The Tri-Council Policy Statement, which governs federally funded research, requires that all research be approved by a local REB before investigators can proceed. (4) However, not being federal public entities, pharmaceutical companies and thus industry-sponsored research are not subject to the Tri-Council guidelines. While most academic institutions have in place requirements for REB approval of all research, the lack of official and formal regulation of ethics review by the Canadian government renders the situation somewhat murky in terms of what is, and is not, acceptable. Research ethics boards are generally composed of individuals from different areas of expertise. Most include a lawyer; an ethics expert; at least one person with expertise in the research area under review; and a member of the community unaffiliated with the institution. (5) The mandate of REBs is to scrutinize research protocols and related documents (e.g., consent forms) for ethical acceptability. Protocols that are deemed unacceptable must be resubmitted with the necessary changes made. Several principles should guide REBs in making their decisions. These include the respect for persons, beneficence, and justice. (6) REB members must closely examine submitted protocols for such things as improper informed consent, deception, unnecessary exposures to risk, and any other harms that could be incurred by participating subjects. The purpose of such ethical scrutiny is primarily to protect subjects from injury or harm of the kind suffered by human research subjects in such notorious historical events as human experimentation by the Nazis, or the Tuskegee Syphilis Study. Research Contracts: A Cause for Concern? A research contract is an agreement by a host institution to conduct research on behalf of a company in exchange for the payment of all related costs. (7) The terms of the contract dictate how the research will be carried out. Research contracts are currently not standardized. There is therefore no universal contract that is acceptable to all parties. This lack of standards is problematic, since it could translate into a discrepancy in practice even between different sites in the same industry-sponsored multicentre trial. Further, unlike peer-reviewed grants from public funding agencies like CIHR, industry-sponsored research contracts are generally initiated by pharmaceutical companies and are therefore necessarily profit-motivated. Good scholarship and scientific integrity may be secondary to this goal. As well, investigators contracting with industry may stand to profit from their involvement with the company. …

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.

Prédiction distillée sur la base complète

Imitation des enseignants

Ni 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.

score de la tête « metaresearch » (Codex)0,019
score de la tête « metaresearch » (Gemma)0,001
Version: codex-gemma-dda1882f352aStatut de validation: machine_predicted_unvalidated
Catégories candidatesMéta-épidémiologie (sens strict), Études des sciences et des technologies, Intégrité de la recherche, Charge utile insuffisante (le modèle a refusé de juger)
Catégories consensuellesIntégrité de la recherche
DomaineSignal candidat: aucune · Signal consensuel: aucune
Devis d'étudeSignal candidat: Sans objet · Signal consensuel: aucune
GenreSignal candidat: Synthèse · Signal consensuel: aucune
Score de désaccord entre enseignants0,738
Score d'incertitude au seuil1,000

Scores Codex et Gemma par catégorie

CatégorieCodexGemma
Métarecherche0,0190,001
Méta-épidémiologie (sens strict)0,0000,000
Méta-épidémiologie (sens large)0,0010,000
Bibliométrie0,0000,001
Études des sciences et des technologies0,0020,001
Communication savante0,0000,000
Science ouverte0,0000,000
Intégrité de la recherche0,0020,024
Charge utile insuffisante (le modèle a refusé de juger)0,0020,000

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.

Tête enseignante Opus0,872
Tête enseignante GPT0,692
Écart entre enseignants0,179 · la distance entre les deux têtes enseignantes sur ce seul travail
Statut de validationscore_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 découle