Human Research Ethics Forms and Templates

REB 1 and REB 2

• Informed Consent Template and Guidelines (updated 10/2022)
• Sample consent form
• Information Letter Template - Survey - Implied Consent [version française] (updated 07/2021)
• Addendum to Consent
• Guidelines for Course-based Research Involving Human Participants and Students as Researchers (updated 09/2022)
• Guidelines for Oral Consent
• Non-Clinical Guidelines for New and Resumption of In-Person Research (new 09/2021)

REB 3: HREB - Health Panel

• Informed Consent Template - Health Studies (updated 01/2023)
• Information Letter Template - Survey - Implied Consent (updated 07/2021)
• Assent Form (Younger and Older Child Versions)
• Addendum to Consent
• Chart Review Guidelines and Instructions
• Guidelines for Oral Consent
• Non-Clinical Guidelines for New and Resumption of In-Person Research (new 09/2021)
• Guidance: Common Rule requirements for Consent Forms

REB 4: HREB - Biomedical Panel

• Main Informed Consent Template for Participants (updated 05/2022)
• Optional Specimen Consent (Genetic, Biobanking) (updated 03/2022)
• Addendum to Consent
• Main Informed Consent Template for Parental Consent (updated 05/2022)
• Assent Form (Younger and Older Child Versions)
• Deferred Consent
• Regained Capacity Consent
• Withdrawal Policy and Template
• Guidelines for Oral Consent
• Consent to release contact information to researcher
• Consent for family/friend to provide contact information to researcher
• Pregnancy Data Collection Consent (new 02/2021)
• Guidance: Amendment Do's and Don'ts
• Guidance: Common Rule requirements for Consent Forms
• REB 4 Application Guidance

---

Guidance

• Guidance: Use of Email to Communicate with Study Participants
• Guidance: Recruitment Guidelines (updated 06/2022)
  
• Electronic Consent Guidelines (new 01/2021)
• Guidance: Third Party Vendors (new 06/2022)

Department Approval Forms (FoMD)

• Department of Medicine Internal Review Process (updated 06/2021)
• Department of Medicine Internal Approval Request Form (updated 06/2021)
• Department of Pediatrics Requirements

Other

• Human Ethics Application Form - a reflection of a blank Human Ethics Application Form
• Protocol Templates and other (from QMCR)
• Confidentiality Agreement - Sample
• Health Canada REB Attestation Form
• Policy on FDA Form 1572
• Note-to-file: Letterhead in ARISE (Jan2021)
• Local Serious Adverse Event Form (updated 16Jun2021)
• Non-Local SAE SOP
• Protocol Deviation/Violation Form

---