Résumés
Abstract
The Health Research Ethics Authority (HREA) Act was established to ensure that research ethics review of all human health research in the province of Newfoundland and Labrador is conducted by a local, in-province, Research Ethics Board (REB). The HREA Act arose as a result of complaints by patients and family members enrolled in a clinical genetics research study being conducted by a team of researchers from outside the province who failed to provide appropriate clinical follow-up. This review provides a record of the steps taken to draft the legislation and prepare for proclamation and includes information on the key stakeholders involved in the process. The review also provides a brief commentary on the HREA, and the newly formed Health Research Ethics Board, in the years following proclamation and how the HREA aligns with national interests for harmonizing research ethics review across multiple REBs. At the outset, the process was envisioned as simply moving to a provincially legislated research ethics board; however, the actual task involved establishing a new entity to oversee research ethics review and expanding or enhancing the office required to manage this research ethics review oversight. The task for the working committees involved in establishing the legislation was more complex than envisioned by the partner organizations, the government of Newfoundland and Labrador, Memorial University of Newfoundland and the Eastern Health Authority, and the workload and time to establish and proclaim the legislation was more involved than anticipated.
Keywords:
- integrity,
- accountability,
- provincial legislation,
- Research Ethics Board,
- Health Research Ethics Authority
Résumé
La Loi Health Research Ethics Authority (HREA) a été créée pour garantir que l’évaluation éthique de toutes les recherches sur la santé humaine dans la province de Terre-Neuve-et-Labrador est effectuée par un comité d’éthique de la recherche (CER) local, dans la province. La Loi HREA a été adoptée à la suite de plaintes déposées par des patients et des membres de leur famille participant à une étude de recherche clinique en génétique menée par une équipe de chercheurs de l’extérieur de la province qui n’ont pas assuré un suivi clinique approprié. Cet examen fournit un compte rendu des étapes de la rédaction de la loi et de la préparation de sa promulgation et comprend des informations sur les principaux intervenants impliqués dans le processus. Elle fournit également un bref commentaire sur la HREA et le nouveau Comité d’éthique de la recherche en santé, dans les années qui ont suivi la proclamation, et sur la façon dont la HREA s’aligne sur les intérêts nationaux d’harmonisation de l’évaluation éthique de la recherche dans plusieurs CER. Au départ, le processus a été envisagé comme un simple passage à un comité d’éthique de la recherche légiféré par la province ; cependant, la tâche réelle a consisté à établir une nouvelle entité pour superviser l’évaluation éthique de la recherche et à élargir ou améliorer le bureau nécessaire pour gérer cette supervision de l’évaluation éthique de la recherche. La tâche des comités de travail chargés d’établir la législation s’est avérée plus complexe que ne l’avaient envisagé les organisations partenaires, le gouvernement de Terre-Neuve-et-Labrador, l’Université Memorial de Terre-Neuve et l’Eastern Health Authority, et la charge de travail et le temps nécessaires pour établir et proclamer la législation ont été plus importants que prévu.
Mots-clés :
- intégrité,
- responsabilité,
- législation provinciale,
- Comité d’éthique de la recherche,
- Autorité d’éthique de la recherche en santé
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Parties annexes
Remerciements / Acknowledgements
Les auteurs souhaitent reconnaître et remercier le travail des membres du CRSP, de l’équipe de transition et du GCP. En particulier, les auteurs souhaitent reconnaître et remercier le Dr Lawrence Felt, professeur au département de sociologie de l’Université Memorial de Terre-Neuve, qui a travaillé sur les premières versions de ce manuscrit et qui est décédé en avril 2016. Les auteurs souhaitent également reconnaître et remercier le Dr. Verna Skanes pour sa disponibilité et ses observations sur le travail du PHREB, de l’équipe de transition et du PAG.
The authors wish to acknowledge and thank the work of the members of the PHREB, Transition Team and PAG. In particular, the authors wish to acknowledge and thank Dr. Lawrence Felt, Professor, Department Sociology, Memorial University of Newfoundland, who worked on the early drafts of this manuscript and passed away in April 2016. The authors would also like to acknowledge and thank Dr. Verna Skanes for being available and providing insight on the work of the PHREB, Transition Team and PAG.
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