What’s New?

September 16, 2020 – Release of The New Consent Template

Announcing the release of the new OCREB Main Consent Template with a companion Consent Author Instructions document. The teleconference on October 4th will provide an overview.

New templates can be accessed at https://ocreb.ca/about-ocreb/guidelines-templates-and-sops/

June 23, 2020 – Collection of Infection Status and Outcome – COVID-Related Notices

OCREB Memo – COVID-19 [22-June-2020]

May 2020 – OCREB Annual Report 2019-20
The Ontario Cancer Research Ethics Board (OCREB) is pleased to present its Annual Report for 2019-2020.

OCREB Annual Report 2019-20

April 16, 2020: CCTG COVID-Related Notices
OCREB is aware that CCTG has provided study sites with COVID-19 related documents that involve changes to a number of CCTG studies. Following recent discussions with CCTG and internal discussions, OCREB recommends the following plan to manage the submission and review of these changes. Please disseminate this information to your study teams, as applicable. Please contact OCREB if you have any questions.

Provincial Applicant (PA) updated submission and implementation information:

For CCTG studies which have submitted the amendment and have received approval, a revised approval will be provided for these studies with the updated consent addendum implementation information;
For CCTG studies which have been submitted but not yet approved, the approval will include the updated consent addendum implementation information;
For new CCTG amendment submissions, CCTG will be providing an updated FAQ document on the CCTG website regarding the submissions- an updated letter to investigators will not be provided.

Changes in implementing the consent addendum:

A signature is not required for the consent addendum – this includes not requiring a signature within 30 days or at the time of the next study visit;
Participants may be informed orally of the information– as described in the addendum – by phone and their oral consent must be documented;
Participants who are unable to be contacted by phone may be provided with the addendum (without the signature page), by other means, as required – e.g., email or mail – and ongoing consent will be documented when provided;
For all affected CCTG studies, the Provincial Applicant for each study must submit the amendment (PAM), as provided by CCTG, which would include the supplementary Protocol appendix, the consent Addendum, the COVID Notification Memo, any Study specific Memos, and the Participant Letter related to Shipping of Protocol Therapy, as applicable. The Consent Addendum will be accepted as provided by CCTG – i.e., use of the OCREB consent update template is not required under the circumstances. Please remember to add the STUDY SPECIFIC information to the template provided by CCTG and please also include the French versions of the Addendum and Participant Letter with the submission.
Participating centres may implement the changes, as indicated in the CCTG communication, on an urgent basis, prior to OCREB review and approval, including the verbal notification of participants. Under the circumstances, OCREB does NOT require submission of an oral script. Ensure that the notification process is well documented in the health records and study files and that consent is maintained.
Given that OCREB has been apprised of the CCTG guidelines, there is no urgency to submit the PAM, recognizing the current work load constraints.
Unless there are non-COVID related changes included in the amendment, these amendments should meet the criteria for Delegated review.

April 1, 2020: CCTG COVID-Related Notices
OCREB is aware that CCTG has provided study sites with COVID-19 related documents that involve changes to a number of CCTG studies. Following internal discussions, OCREB recommends the following plan to manage the submission and review of these changes. Please disseminate this information to your study teams, as applicable. Please contact OCREB if you have any questions.

For all affected CCTG studies, the Provincial Applicant for each study must submit the amendment (PAM), as provided by CCTG, which would include the supplementary Protocol appendix, the consent Addendum, the COVID Notification Memo, any Study specific Memos, and the Participant Letter related to Shipping of Protocol Therapy, as applicable. The Consent Addendum will be accepted as provided by CCTG – i.e., use of the OCREB consent update template is not required under the circumstances. Please remember to add the STUDY SPECIFIC information to the template provided by CCTG and please also include the French versions of the Addendum and Participant Letter with the submission.
Participating centres may implement the changes, as indicated in the CCTG communication, on an urgent basis, prior to OCREB review and approval, including the verbal notification of participants. Under the circumstances, OCREB does NOT require submission of an oral script. Ensure that the notification process is well documented in the health records and study files.
Given that OCREB has been apprised of the CCTG guidelines, there is no urgency to submit the PAM, recognizing the current work load constraints.
Unless there are non-COVID related changes included in the amendment, these amendments should meet the criteria for Delegated review.

March 27, 2020: Updated Memo
OCREB Memo – COVID-19 (27-Mar-2020)

CANCELLED: April 3, 2020 Teleconference
April 3, 2020 teleconference has been cancelled.

March 23, 2020: Clarification to March 18 Memo
As a result of queries, OCREB issued a clarification of the March 18 memo. Refer to the March 23 memo below for details.

OCREB Memo – COVID-19 (23-Mar-2020)

March 18, 2020: Updated OCREB Memo – COVID 19 (Coronavirus)
Please see the updated memo below, with changes to the reporting of suspensions in study enrolment to OCREB.

OCREB Memo – COVID-19 (18-Mar-2020)

Relevant Related Materials:

March 17, 2020: OCREB Memo – COVID 19 (Coronavirus) – see attached memo
OCREB has policies and processes in place to continue with its reviews and ethics oversight during the current coronavirus (COVID-19) outbreak. Please see the attached memo for details. We understand that the situation is changing rapidly and we will continue to provide updates as the situation changes.

OCREB Memo – COVID-19 (17-Mar-2020)

Updated OCREB SOPs -Effective January 1, 2020
In September 2018, OCREB adopted version 2 of the collaboratively developed N2/CAREB REB SOPs. Although the SOPs are scheduled to be reviewed every two years, the 2018 review was delayed to ensure that the updates to the SOPs were in compliance with the revised TCPS2, released in August 2019, and with the revised Common Rule, published in January 2019. No major changes to the SOPs were required, and the third version of the N2/CAREB REB SOPs was released in December 2019. Special thanks to Alison van Nie as Chair of the REB SOP Committee. The updated SOPs have been adopted by OCREB, with minor corresponding revisions to the OCREB addenda. The SOPs are published online at OCREB Guidelines, Templates and SOPs and are effective January 1, 2020. Although the version dates of all CAREB/N2 SOPs are updated at the time of a new release, only those SOPs and corresponding OCREB addenda highlighted in the Table of Contents were revised. For details of the changes, refer to the revision history in each SOP and OCREB addendum.

Breaking 100 in 2019! Highest number of new studies EVER!
For the first time in OCREB’s 16-year history, we broke 100. The 105 new studies submitted to OCREB in 2019 surpass the previous record of 96 submissions in 2017. While that number of studies might seem somewhat low compared to the volume of new studies received by large single-centre REBs, as a central review board, OCREB also receives applications for each new study from multiple participating centres. So far in 2019, OCREB has received close to 300 new centre applications, and the year is not over yet. In addition, the studies submitted to OCREB are high-risk interventional trials, making the combined volume and complexity of the trials challenging to compare. OCREB currently is overseeing 492 approved studies associated with 1,510 active centre-studies and counting.

November 2019 – Career Opportunity -OCREB Executive Director
After 14 fulfilling years, Janet Manzo is stepping down as Executive Director of the Ontario Cancer Research Ethics Board (OCREB) in 2020. The Ontario Institute for Cancer Research is seeking her replacement.

To view the posting, go to https://www.recruitingsite.com/csbsites/oicr/careers.asp

September 2019 – TCPS2 Update
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018) – has been updated to this new version, inclusive of the following companion documents:

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)

Companion Documents:

June 2019 – OCREB Annual Report 2018-19
The Ontario Cancer Research Ethics Board (OCREB) is please to present its Annual Report for 2018-2019.

Download OCREB’s Annual report from 2018-19 [PDF]

September 24, 2018 – OCREB Adopts N2/CAREB SOPs
The Network of Networks (N2) and the Canadian Association of Research Ethics Boards (CAREB) collaboratively developed a set of Canadian REB SOPs, in compliance with applicable regulations and guidelines and with extensive reference to the OCREB SOPs and other documents. OCREB has adopted the N2/CAREB REB SOPs to facilitate a single standard for REBs in Canada. Addenda have been developed to incorporate OCREB’s central REB model, and the SOPs must be used in tandem with any corresponding addendum. The N2/CAREB SOPs and addenda are authorized for use by OCREB effective September 24, 2018. There are no substantive changes to the SOP content from the previous set of OCREB SOPs.

September 2018 – OCREB Annual Report
The Ontario Cancer Research Ethics Board (OCREB) is pleased to present its Annual Report for 2017-2018. The report summarizes the accomplishments of OCREB during an exceptionally busy and challenging year.

Download OCREB’s Annual report from 2017-18 [PDF]

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.vannie@oicr.on.ca

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 streamline@ctontario.ca 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.