Guidelines, Templates and SOPs
Despite the change in the online submission system, all OCREB requirements as found in its policies, procedures and consent form templates remain in effect. This includes the pre-approval of all centre-specific consent forms without the requirement for OCREB review. For any questions related to OCREB’s policies, procedures, please contact the OCREB Research Ethics Officer.
Guidelines
- Guidance for pre-approved administrative changes [April 1, 2024] **NEW
- Guidelines for Protocol Deviation Reporting [September 25, 2018]
- Guidelines for Managing Conflict of Interest [April 4, 2014]
- Guidelines_for_Providing New Information [March 23, 2018]
- OCREB Withdrawal Template – Sample Guidance for Documenting Participant Withdrawal
- Memo Pre-Screening Consent Criteria
- Memo DIL and Protocol Clarification Letters
Templates
Paediatric Studies
Please note that there now are 2 sets of paediatric consent templates, one for COG studies and one for non-COG studies
NEW! Non-COG Templates
- OCREB – Paediatric Adult Consent Template [25-Feb-2022] – updated version of the ICF template with minor wording changes
- OCREB – Paediatric Consent Template [25-Feb-2022] – updated version of the ICF template with minor wording changes
- OCREB – Paediatric Consent Update Form Template [20-April-2021]
- OCREB – Assent Template [20-May-2020]
- OCREB Instruction Guide for ICF Authors [06-July-2022]
COG Templates
- COG – OCREB Main/ Optional Consent Template [February 07, 2024] **NEW**
- COG – OCREB Paediatric Consent Update Form Template [June 25, 2018]
- COG – OCREB Assent Form Main Study [August 17, 2015]
- COG Short Forms – FOR COG USE ONLY
All Other Studies
Mandatory templates for new studies or new consent forms submitted AFTER December 1, 2020 (note: main ICF and author instructions are together in a zipped folder):
- OCREB Main Consent Template and Author Instructions updated version of the ICF template with minor wording changes
- OCREB Consent Update Form Template [April 20, 2021]
- OCREB Pre-Screening Consent Form Template [January 16, 2024] **NEW**
- OCREB Treatment Beyond Disease Progression Signature Page Template [September 05, 2019]
- OCREB Wallet Card Template [Feb 19, 2015]
- OCREB Wallet Card Template French Version [Feb 19, 2015]
Previously used consent templates for ongoing (currently approved) studies submitted prior to Dec. 1, 2020 may be requested from OCREB staff, if needed.
Standard Operating Procedures (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. There are no substantive changes to the SOP content from the previous set of OCREB SOPs.
The N2/CAREB SOPs and addenda below are authorized for use by OCREB effective September 24, 2018.
- OCREB Terms of Reference [2019]
- OCREB Overview [November 2018]
- Table of Contents and Authorization for Use
- Glossary of Terms
- References 2019
100 GENERAL ADMINISTRATION
- 101 Authority and Purpose
- 102 Research Requiring REB Review
- 103 Training and Education
- 104 Management of REB Office Personnel
- 105A Conflicts of Interest REB Members and REB Office Personnel
- 105B Conflicts of Interest Researcher
- 105C Conflicts of Interest Organization
- 106 Signatory Authority
- 107 Use and Disclosure of Personal Information
- 108 Standard Operating Procedures Maintenance
200 REB ORGANIZATION
300 FUNCTIONS & OPERATIONS
- 301 REB Submission Requirements and Administrative Review
- 302 REB Meeting Administration
- 303 Document Management
400 REVIEW OF RESEARCH
- 401 Delegated Review
- 402 REB Review Decisions
- 403 Initial Review Criteria for REB ApprovalSOP 403 Initial Review Criteria for REB Approval
- 404 Ongoing REB Review Activities
- 405 Continuing Review
- 406 Research Completion
- 407 Suspension or temination of REB Approval
