News

New SOPs for Canadian REBs

  • October 3, 2014
  • News

The CAREB and N2 organizations are pleased to announce the release of the first set of collaboratively developed, standardized, Canadian REB SOPs via open access. 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.

The goal of the development of the CAREB/N2 REB SOPs was to create one set of well- written SOPs. The SOP development process was a rigorous one involving representatives from across the country and from both participating organizations.

CAREB and N2 established a working group comprised of experienced research ethics board professionals. This group consulted original sets of REB SOPS to develop the set of documents, and final drafts of the SOPs were sent to a qualified reviewer to be audited for compliance with all applicable regulations and guidance. The recommendations of the reviewer were incorporated into the final version.

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 alison.vannie@oicr.on.ca

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. Significant changes will be addressed ASAP and a revised document will be posted if required.

Access to the REB SOP documents and associated information can be obtained from the following website: https://oicronca.box.com/s/95k7ydj574579ajvbe06

Please Note: once funding is secured a French language version of the documents will be available.

With thanks to all those who provided support and guidance to the project, especially to the members of the subcommittee, and with special thanks to:

  • N2 for providing continuing administrative support and public access to the documents,
  • CAREB for providing resources for the initial editing of the draft documents, and
  • Clinical Trials Ontario (CTO) for its funding for the two day face to face subcommittee meeting and for providing the resources to complete the expert regulatory compliance review of the documents and assistance with the publication of the documents