Guidance and REB Templates

OVERVIEW

The OHSN-REB reviews each participant Informed Consent Form (ICF) to ensure that the information that is being presented to participants is clear and accurate.

All consent forms must be submitted with your initial REB application.

Please ensure information in the ICF is consistent with the research protocol and the REB application form. The OHSN-REB specifically reviews these documents for consistency.

All ICFs must be approved by the OHSN-REB before being given to potential research participants.

Once signed, the original Informed Consent Form must be kept securely with the study essential documents. A copy of the signed document must be provided to the study participant.

REVISIONS

Any changes required to an approved document, must be submitted as an amendment and approved by the OHSN-REB before use.

Research participants may be required to sign the revised Informed Consent Form. If the research participant has completed his/her participation in the study, the investigator must inform him/her about any new information which may affect them, e.g., safety information. However, if there is no possible impact to them (e.g. visit schedule change or drug dosing change for those still on therapy, etc.) there is no need to re-contact for re-consent.

OHSN-REB Templates
Please follow the instruction page at the beginning of each template and ensure the instruction page is removed prior to submission to the OHSN-REB.	Template Language	Version Date
Informed Consent Form (ICF) Checklist
All ICF templates have been designed to meet current regulatory and ethical standards.	English only	December 7, 2017
The ICF checklist identifies the regulations, guidelines and policies that require the language in the ICF templates. The checklist is meant to be used as a guide to ensure all applicable elements are present in the consent form.
Main Clinical Trial/Study Informed Consent Form
To be used for studies that are above minimal risk.
Main Clinical Trial/Study Informed Consent Form Template	English / French	February 10, 2022
Summary of revisions to the main clinical trial/study consent template	English only	February 10, 2022
Minimal Risk Informed Consent Form
To be used for minimal risk studies only.
Minimal risk Informed Consent Form Template	English / French	February 10, 2022
Summary of revisions to the minimal risk consent template	English only	February 10, 2022
Optional Informed Consent Form
To be used as a supplement to the main study consent form when there is an optional component for the study (e.g.: optional biomarker research, optional genetic research, optional bio-banking, etc.).
Optional Informed Consent Form Template	English / French	February 10, 2022
Summary of revisions to the optional informed consent template	English only	February 10, 2022
Pregnant Partner Release of Information Informed Consent Form
Not required at the time of initial ethics submission. To be created when the pregnancy event occurs, and only if the ethics application and main participant ICF indicated that the investigator planned to collect information from the partner should she become pregnant. The pregnant partner ICF must be submitted with a Main Reportable Event Form and Pregnant Partner Event section form; see the 'Forms' tab of the OHSN-REB website. Note: If a sponsor requires the pregnant partner consent form to be submitted at the time of initial ethics submission, it may be uploaded into the application for review and approval.
Pregnant Partner Release of Information Informed Consent Form Template	English / French	April 14, 2021
Summary of revisions to the pregnant partner informed consent template	English only	April 14, 2021
Update Informed Consent Form
To be used for participant re-consent purposes only.
Update Informed Consent Form Template	English / French	December 7, 2017
Guidance for Providing New Information to Study Participants	English only	December 7, 2017
Main Informed Consent Form for Oncology Studies
To be used for oncology studies that are submitted for local OHSN-REB ethics approval.
Main Informed Consent form for local oncology studies Template	English / French	April 14, 2021
Summary of revisions to the main consent for local oncology studies template	English only	April 14, 2021
Verbal Consent (minimal risk studies only)
To be used for minimal risk studies only, when the participant will verbally agree to participate in the research (written signature will not be collected).
Guidance on Verbal Consent Process	English only	Coming soon
Verbal Consent Script	English / French	December 3, 2020
Information Sheet	English / French	July 15, 2021
Implied Consent (minimal risk studies only)
To be used for minimal risk studies only. Implied consent occurs through the actions or conduct of the participant rather than direct communication through words. For example, when the participant will indicate that they knowingly agree to participate in the research by completing a research activity, most commonly a one-time survey/questionnaire (written or verbal consent will not be obtained).
Guidance on Implied Consent Process	English only	Coming soon
Implied Consent Form	English / French	December 3, 2020
Virtual/Remote Recruitment and Consent
Participants may be recruited and/or consented remotely when in-person recruitment and/or consent is not feasible, provided the remote methods adhere to ethical principles and privacy protections.
Virtual Guidelines for Studies Requiring Written Consent	English only	July 15, 2021
Request for Use of Alternative Virtual Platforms at TOH	English only	July 25, 2024
Request for Use of Third-Party Technologies at TOH and UOHI	English only	February 10, 2022
Secure Methods of Document Transfer:
EPIC/MyChart	English only	May 2021
Instructions for Use of Microsoft 365 SharePoint and OneDrive	English only	November 25, 2020
Instructions for Use of Mail	English only	July 15, 2021
Instructions for Use of Fax	English only	July 15, 2021
Instructions for Use of Photograph to Document Written Consent	English only	Coming soon
Instructions for Use of MS Teams Chat to Send and Receive Documents	English only	July 15, 2021
Note: For guidance on use of email with patients, please see the 'Email Process and Templates' section below.
Electronic Signature Platforms approved for Use: NOT Health Canada or FDA Compliant:
Guidance for Use of DocuSign	English only	Coming soon
Guidance for Use of UOHI REDCap (for Heart Institute studies that are conducting in-person consent on an iPad only)	English only	Coming soon
Health Canada or FDA Compliant:
Guidance for Use of TOH Methods Centre Electronic Data Capture System (EDCS)	English only	Coming soon
Audio and/or Video Recording:
Guidelines for Use of Audio and/or Video Recording of Participants	English only	July 15, 2021
Instructions for Audio and Video Recording in Microsoft Teams	English only	July 15, 2021
Instructions for Transcription in Microsoft Teams	English only	July 15, 2021
Email Process and Templates
Process for contacting patient participants via email:
OHSN-REB Guidance for Use of Email in Clinical Research	English only	October 20, 2023
Use of Patient Email in Clinical Research � Researcher FAQs	English only	October 20, 2023
Guidance for Obtaining Participant Consent Using the "Research Participant Consent to Communicate by Email" Form	English only	October 20, 2023
Consent Form: Research Participant Consent to Communicate by Email	English / French	November 20, 2020
Email Templates:
Email Template - Staff Recruitment Email	English only	September 15, 2023
Email Template - Patient Recruitment Email	English only	October 5, 2023
Email Template - Reminder Recruitment Email	English / French	December 3, 2020
Email Template - Appointment Reminder	English / French	December 3, 2020
Email Template - Survey/Questionnaire Reminder	English / French	December 3, 2020
Email Template - Sending ICF to Potential Participant	English / French	July 15, 2021
Onsite In-Person Impartial Witness Consenting Process During the COVID-19 Pandemic
To be utilized onsite during an in-person consenting process when there is a potential risk of COVID-19 therefore a signature from the participant is not able to be obtained. For example, potential participant in isolation for COVID-19 and not able to share pen/paper.
Guidance for In-Person Consenting Process with the use of an Impartial Witness	English only	Coming soon
In-person Consenting with Impartial Witness Process Checklist	English only	October 15, 2020
Impartial Witness Addendum to Consent Signature Page	English / French	October 15, 2020
Other:
Recruitment Poster	English / French	December 13, 2023
Recruitment In-class Script	English / French	December 7, 2017
Recruitment Letter	English / French	July 15, 2021
Debriefing Form	English / French	December 7, 2017
Wallet Card	English / French	December 7, 2017
Guidance Research with Minors	English only	December 7, 2017