The CAREB and N2 organizations are pleased to announce the release of the French language version of the Canadian REB SOPs.
The French language SOP documents have been translated from the English language documents that were previously released. (October 2014)
The translation project has been generously supported with funding provided by Clinical Trials Ontario (CTO), and with administrative support provided by N2.
The REB SOPs are specific to ethics boards that review health sciences research and are compliant with applicable Canadian and US regulatory, and ethics guidance criteria. The implementation of the REB SOPs will facilitate the distribution, adoption and maintenance of a single standard for REBs in Canada.
Within the health sciences research environment, regulatory authorities require that ethics boards that review health sciences research utilize standard operating procedures (SOPs) to ensure that the ethics board is constituted appropriately and conducts its processes in a way that protects the rights and safety of study participants, and that meets all applicable regulatory and guidance criteria while ensuring ongoing compliance with all requirements.
Please note that changes to the formal set of REB SOPs may result in the SOPs no longer being compliant and it is for this reason that the SOPs appear as print only, PDF documents.
Documents that assist the organization to ‘bridge’ information in the SOPs with specific/local procedures (tools, checklists, sample forms, local guidance documents, contact information) are not part of the official SOPs but can be created or adapted as needed, to meet the needs of the organization.
Comments, questions and other feedback is encouraged and should be directed to the REB SOP Subcommittee Chair by contacting:
Alison van Nie at firstname.lastname@example.org
The REB SOP Subcommittee has a formal process in place to manage comments, questions and/or concerns. Comments will be logged and then reviewed and a decision will be made to determine whether a change [to a document] is required. Comments related to semantics and/or to personal preferences regarding wording may not necessitate a change. All proposed revisions to the documents will be reviewed to determine their applicability.
If you notice an error or an omission in a document, please inform the Chair/Alison. Significant changes will be addressed ASAP and a revised document will be posted if required.
With thanks to all those who provided support and guidance for the project.
Alison van Nie
N2/CAREB REB SOP Committee Chair