Note (March 2024): Some of the links below are not currently working; we are investigating and hope to have a fix shortly. In the meantime, please email researchethics@unityhealth.to to request a form that cannot be downloaded.
You can either:
| TEMPLATES | ||
| Consent form checklist | Utilize this checklist prior to submitting a consent form to the REB. | November 05, 2013 |
| Consent form template and guidelines | The consent form provided to research participants must provide all the information needed to make an informed decision about taking part in the research. This document provides a template for and detailed guidance on how to write a consent form. | May 17, 2022 |
| Consent summary template and guidelines | A Consent Summary is required for any study that receives US Federal funds. It can also be used in other studies if the researchers feel that it will be helpful to their participants. | March 01, 2021 |
| GDPR consent form template | For research studies that plan to recruit participants from the EU/UK/EEA (European Union, United Kingdom, Europe Economic Area), researchers must use the following ICF template for EU/UK/EEA participants. This template is required for processing personal information and must be signed by participants in addition to the standard ICF. | August 2023 |
| Databank and biobank governance plan template | This template can be used to outline the governance plan of a research databank or biobank | August 2023 |
| Protocol deviations log | Use this log to submit a summary of all protocol deviations to the Research Ethics Board only if required by the study sponsor (also see Guidelines for reporting protocol deviations) | June 08, 2018 |
| QUICK REFERENCE TOOLS |
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| Investigator Signature Requirements | Outlines the requirements for the investigator signature on all submissions to the Research Ethics Board (REB). | June 08, 2018 |
| Reporting serious adverse events (SAEs) / unanticipated problems (UPs) to the REB | A quick reference tool that can be used to help determine which Adverse Events (AEs) and Unanticipated Problems (UPs), both internal and external, need to be reported to the REB. | June 08, 2018 |
| Serious adverse event (SAE) / unanticipated problem (UP) reporting timelines | A quick reference on the timelines for reporting Serious Adverse Events (SAEs) and Unanticipated Problems (UPs) to the REB. | June 08, 2018 |
| GUIDELINES | ||
| Guidelines for reporting serious adverse events / unanticipated problems | This revised document provides the definition of a local and external serious adverse event and an unanticipated problem; criteria for reporting unanticipated problems and updated safety information, instructions on how to complete the appropriate form and the process and timelines for reporting unanticipated problems and safety information to the Research Ethics Board. | March 12, 2019 |
| Guidelines for reporting protocol deviations | This guidance document includes a definition of a protocol deviation, the types of protocol deviations that require reporting, instructions on how to complete the protocol deviation reporting form and the process and timelines for reporting protocol deviations to the Research Ethics Board. | June 08, 2018 |
| Supplementary consent requirements: Whole genome and whole exome sequencing | This guideline describes the minimum privacy requirements for consenting participants to whole genome sequencing and whole exome sequencing of a human/person (i.e., not a virus or part of a human genome, such as a tumor DNA). | June 2023 |
| Privacy & Security Guideline: Email Communication in Research | This document explains the required privacy & security controls that must be in place for communicating with research participants via email. | April 2019 |
| Privacy & Security Guideline: Texting in Research | This document explains the required privacy & security controls that must be in place for using text messaging in research. | April 30, 2019 |
| Privacy & Security Guideline: Survey Tools in Research | This document explains the required privacy & security controls that must be in place for research using online survey tools. | October 2020 |
| Privacy & Security Guideline: Audio Recording in Research | This document explains the required privacy & security controls that must be in place for using audio recording in research. | December 18, 2020 |
| Privacy & Security Guideline: Adding Research Data to a Clinical Record | This document explains the required privacy & security controls that must be in place if any research-related information (including but not limited to a copy of the consent form, diagnostic test results and/or notices to care providers regarding treatment undergone by the participant) will be stored in a clinical record (paper or electronic) or sent to a participant’s clinician at Unity Health | June 2019 |
| Privacy & Security Guideline: Minimum Requirements for the Governance of Research Biobanks and Databanks | This guideline describes the minimum privacy requirements for the governance of biobanks (also known as biorepositories) and databanks (also known as data repositories, registries and databases), as well as substudies. | August 2023 |
| Guidelines for signatures on consent forms | This guideline document provides examples and discussion on the types of signature recommended in consent documents. | June 05, 2002 |
| Safety & Crisis Planning Document & Guidelines For Research Staff, Managers and Principal Investigators | The aim of this document is to provide guidelines to safely manage any challenging scenarios in a responsible, respectful and confidential manner. These guidelines were developed and written by research staff working at The Upstream Lab, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Board. This document is intended to serve as an on-hand reference to research staff, in the interests of protecting study participants and research staff. | December 21, 2017 |
| Preparing Interviewers and Research Participants for a Safe Interview | The aim of this document is to provide tips on planning and implementing safety protocols increases the likelihood of having a safe and positive research interview. These guidelines were developed and written by research staff working at Survey Research Unit, Centre for Urban Health Solutions, St. Michael’s Hospital in consultation with the Research Ethics Office. | 2017 |
| Guidance document for reviewing clinical trials in diabetes | This document provides guidance for members of the Research Ethics Board who are reviewing clinical trials in diabetes. This guidance is intended to ensure a consistent approach in the Research Ethics Board review of such trials, and should be used by investigators when they are preparing their Research Ethics Board submissions. | November 04, 2010 |
