Consent Forms
| UHN/CTO Integrated consent form template with guidance (link is external) | This template/guidance document aligns with the Clinical Trials Ontario consent form template. *Please note: if you are submitting to CTO Stream directly you must use the template and process outlined on CTOs Website |
| UHN/CTO Minimal risk integrated consent form template with guidance (link is external) | Minimal risk consent form template with guidance |
| UHN/CTO Integrated Optional Consent Form template with guidance (link is external) | Optional consent form template with guidance |
Template for consenting participants for follow-up upon pregnancy (note: you must be on UHN's network to access this link) | |
| Sample Addendum to Consent Form | REB-created document to aid in the creation of an addendum to an existing study specific consent form. |
Guidelines
Guidelines, definitions, sub-study information, exceptions, and procedures regarding study amendments. Version date: June 30, 2017 | |
| UHN-REB Guidance on Case Reports | Instructions for writing Case Reports. |
Guidance document provided by CAREB. | |
| UHN REB: Guidance on Providing New Information to Study Participants (link is external) | Guidelines, definitions and instructions on providing new information to participants. Version date: April 7, 2025 |
US Department of Health and Human Services: Office for Human Research Protections (OHRP) | |
US Department of Health and Human Services FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRB | |
| UHN Guidance on Pregnancy Prevention (link is external) | UHN Guidance on Pregnancy Prevention |
| Submitting an Investigator's Brochure / Product Monograph (link is external) | UHN-REB Guidance on Submitting an Investigator's Brochure / Product Monograph |
| UHN REB Guidance for Management Plan Issued by the UHN Compliance Office (link is external) | UHN-REB Guidance on how to advise the REB of a conflict of interest as per management plan issued by UHN Compliance Office |
| Ethical Considerations for Remote Consent (link is external) | Ethical Considerations for Remote Consent Version date: August 6, 2024 |
| Return of Results to Participants (link is external) | Return of Results to Participants- Version date: July 20th, 2022 |
Supporting Documents
| Attestation Policy | Memo stating the UHN REBs policy on signing the REB Attestation Form |
| Sample Protocol for Prospective Studies (link is external) | Sample Prospective Protocol for guidance. |
| Sample Protocol for Chart Reviews (link is external) | Sample Chart Review Protocol for guidance |
| Sample Protocol for Tissue Studies (link is external) | Sample TIssue Protocol for guidance |
| Pregnancy Prevention Information Sheet (link is external) | Pregnancy Prevention Information Sheet |
| Remote Monitoring Participant Notification letter (link is external) | Remote Monitoring Participant Notification letter |
| Instructions for Obtaining Remote Research Consent (link is external) | UHN guidance on the options for obtaining research consent remotely as a safety measure due to COVID-19. Version date: March 08, 2021 |