April 3, 2018 – OCREB no longer requires the submission of Health Canada authorizations or the Clinical Trial registration number
After careful consideration by its Policies and Procedures Committee, and in consultation with affiliated oncology institutions, OCREB has discontinued the requirement to submit Health Canada (HC) documentation (i.e., NOL, ITA) and Clinical Trial (CT) Registration information to OCREB.
Historically, the REB often acted as the institutional gate-keeper for many institutional, non-ethics requirements, and some institutions still rely on the REB to fulfil this role. However, HC authorizations and CT Registration, while important, are independent of the ethical decision-making of the REB. Serving as institutional gate-keeper is not consistent with the responsibilities of a central, external REB and in fact, might provide the site with a false sense of security. There are numerous requirements that must be met prior to the initiation of research at a site, of which HC authorizations and CT registration prior to the first participant’s enrolment, are only two. In the event that HC requests changes and REB approval already has been issued, it is the sponsor’s responsibility to ensure that an amendment is submitted to the REB to address the HC-mandated changes. Regardless, the study cannot commence until the sponsor and the site have received the HC authorization for the REB-approved protocol, thus the risk of initiating a study without having the appropriate requirements in place is low.
April 3, 2018 – REMINDER. OCREB Controlled Honour System Model for Centre Consents
We would like to take this opportunity to remind everyone of OCREB’s long-standing practice with respect to the review of centre consent forms. Similar to other central REBs – most notably the US National Cancer Institute Central IRB (NCI CIRB) – for over eight years, OCREB has had a controlled honour system for the implementation of consent forms at participating centres. OCREB’s policy is to approve the provincial consent forms, which subsequently are adopted by all participating centres, ensuring that participants in Ontario receive the same information. Centres are authorized to applyonly pre-approved administrative changes to the consent forms (see Guidance for pre-approved administrative changes [May 5, 2017], as well as any centre-specific changes that have been pre-approved formally by OCREB.
The changes may include proposed institutional requirements provided to CTO (DIER), which, along with their supporting rationale, must be reviewed by the Policies & Procedures Committee and approved by OCREB prior to their inclusion in the centre-specific consent forms. OCREB works with the institution to resolve any discrepancies between the existing OCREB pre-approved changes and any requirements in the DIER.
The OCREB pre-approval process means that the submission of centre specific consent forms to OCREB is not required. Currently centre initial applications in CTO Stream require centres to upload their centre-specific consent forms; however, as per its policy, OCREB does not review the centre consent forms. Instead, OCREB conducts periodic quality assurance monitoring of signed consent forms to ensure compliance with the OCREB requirements.
March 14, 2018 – Annotated Application Forms Posted
The CTO Stream annotated application forms have been posted to the OCREB website in the “How to Apply” section on the Investigators & Research Teams page of the OCREB website. The annotations include explanatory information or clarification of questions in the application forms that have been brought to OCREB’s attention by applicants. This information is intended to assist the applicant with the completion of the form and reduce the potential for re-submissions. If you have any questions or would like to request clarification of additional questions on the applications, please submit your request to Alison.email@example.com
October 13, 2017 – Transition to CTO Stream Complete
The transition is complete and CTO Stream must be used for all submissions to OCREB. However, all OCREB policies, procedures and templates remain in effect.
July 4, 2017 – OCREB Annual Report Issued
An online copy of the 2016-17 OCREB Annual Report can be accessed at OCREB Annual Reports
March 2017 – Phase 1 of the transition to CTO Stream Commenced
As of the March 21, 2017 all new studies must be submitted in CTO Stream. However, it is business as usual for the submission of post-approval applications on studies already in O2. Thus, there will be two systems in use until the studies in O2 are imported into CTO Stream in phase 2 of the transition. Email firstname.lastname@example.org to inquire about CTO Stream training for OCREB users.
February 23, 2017 – OICR Enters into Participation Agreement with Clinical Trials Ontario
The Ontario Institute for Cancer Research (OICR) entered into a Participation Agreement with Clinical Trials Ontario (CTO). CTO provides the infrastructure to allow for a single ethics review of all multi-centre clinical trials in Ontario. OCREB will be moving from its current online system (O2) to CTO Stream, a secure, web-based system developed and administered by CTO.