Obtaining free and informed consent is a cornerstone of ethical research involving human participants. Consent ensures that individuals understand the nature, purpose, and potential risks of the study, and that their participation is voluntary. At Queen’s University, all research involving human participants must adhere to the principles outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and institutional Research Ethics Board (REB) policies.
Researchers are encouraged to use the approved templates and guidance materials provided by the Queen’s Research Ethics Boards. These documents outline required components and standardized language to support the preparation of clear, compliant consent materials.
Guidelines
Researchers should review the informed consent guidelines when developing, revising, or submitting research protocols involving human participants. These guidelines explain when consent is required, outline key components of the consent process, and describe situations where alternative or modified consent procedures may be appropriate, including:
- Remote and E-consent
- Alterations to Standard Consenting Procedures
- Waiver of Consent
- Assent
- Broad Consent
Review all Informed Consent Guidelines.
Form Templates
Following review of the guidelines, researchers are encouraged to use the following form templates to ensure their materials are clear, complete, and compliant with institutional and regulatory requirements. Informed consent forms (ICF) apply to General Ethics Research Board (GREB), Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB), or both, as per table below.
Access the form templates folder
| Template Name | Description / Use |
|---|---|
| [GREB] ICF for Research Participation | Use for studies reviewed by GREB (social sciences, humanities and behavioural research) where participants give explicit consent. Common activities include interviews, focus groups, surveys, observations and workshops. |
| [HSREB] ICF Non-regulated Low Risk | Use for health research reviewed by HSREB that is low risk and does not test a drug, medical device, natural health product or other product regulated by Health Canada. Examples include interviews, surveys, chart reviews and simple sample collection. |
| [HSREB] ICF Regulated Higher Risk | Use for health research reviewed by HSREB that involves a Health Canada regulated product (such as a drug, medical device or natural health product) or carries more than minimal risk, including clinical trials. It includes the additional sections these studies require, such as risks and side effects, alternatives, and what happens if a participant is injured. Should be used with the ICF components checklist. |
| [HSREB/GREB] ICF Implied | Use for minimal risk studies, usually a simple one-time survey, where completing and submitting the survey counts as consent. No signature is needed, but participants still receive all the study information so they can make an informed choice. For HSREB or GREB studies. |
| [HSREB/GREB] Assent Form | Use when some participants cannot consent on their own, such as children or adults who lack capacity to decide. It explains the study in simple, age-appropriate language so they can agree to take part. It is used together with consent from a parent, guardian or substitute decision-maker. For HSREB or GREB studies. |
| [HSREB/GREB] ICF Database Biobank Registries | Use when participants' data or biological samples will be stored in a database, biobank or registry for current or future research. It explains what is kept, how it is protected, who can access it, how long it is stored and how participants can withdraw. For HSREB or GREB studies. |
| ICF Components Checklist | Use this checklist to confirm your consent form includes everything required by the Queen's REBs, the affiliated hospitals, TCPS2 and any other regulations that apply to your study. It has four sections. The first covers items every consent form needs. The others cover extra items for clinical trials, US funded or regulated studies, and studies that involve biological samples or testing. Mark any section that doesn't apply as "Not Applicable". The person completing the checklist must sign and date it and keep it with the study records. For HSREB or GREB studies. |
| ICF Memos | You don't have to use the Queen's consent form templates. Each template has a memo that lists what every consent form must include, whether you use the template or write your own. Some wording must be copied exactly as written, and some topics can be covered in your own words. If you write your own form, check it against the memo before you submit. Please also refer to the ICF Components Checklist: use the checklist to confirm your consent form includes all the necessary elements. |