The consent process is fully discussed in Chapter 3 of the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (TCPS 2). This includes a discussion of the information generally required for informed consent. The following are some sample consent forms that you may use to guide the development of the consent forms that are most appropriate to your research study.
Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not be including in the informed consent forms that you develop and provide to participants in your research.
For additional Guidelines & Templates, visit the webpage.
| Informed Consent Form Guideline/Policy | Document |
|---|---|
| Remote and Econsent | Guidelines on Remote and Econsent (PDF 160 KB) |
| Alterations to Standard Consenting Procedures | Guidelines on Alterations to Standard Consenting Procedures (PDF 131 KB) |
| Waiver of Consent | Guidelines on Waiver of Consent (PDF 124 KB) |
Informed Consent Forms (ICF) Templates
This ICF template is to be used for prospective research studies involving human participants submitted to HSREB that are regulated by Health Canada or the U.S Food and Drug Administration (FDA). Prospective research evaluates the effects of one or more health-related interventions on health outcomes. Investigations include, but are not restricted to, drug administration, surgical procedures, radiologic procedures, devices, genetic therapies, cells and other biological products, radiopharmaceuticals, natural health products (NHPs), preventive care, manual therapies, psychotherapies, as well as prospectively collecting data/biological specimens, or interventions and physical interventions, interviews, surveys, questionnaires, focus groups/sharing circles, biological sample collection, etc.
This ICF template is to be used for prospective research studies involving human participants submitted to HSREB that are NOT regulated by Health Canada or the U.S Food and Drug Administration (FDA). Prospective research evaluates the effects of one or more health-related interventions on health outcomes. Investigations include, but are not restricted to, surgical procedures, preventive care, manual therapies, psychotherapies, as well as prospectively collecting data/biological specimens, or interventions and physical interventions, interviews, surveys, questionnaires, focus groups/sharing circles, biological sample collection, etc.
This ICF template is to be used for prospective research studies involving human participants submitted to HSREB that are NOT regulated by Health Canada or the U.S Food and Drug Administration (FDA). Prospective research evaluates the effects of one or more health-related interventions on health outcomes. Investigations include interviews, surveys, questionnaires, focus groups/sharing circles, etc.
This ICF template is to be used for prospective research studies involving human participants submitted to GREB or HSREB when using implied consent as the model of consent for survey research. Implied consent may be appropriate for minimal risk studies, where participants indicate that they knowingly agree to participate in the study by completing a research activity (e.g., by completing a survey/questionnaire). It does not require a signed consent form (i.e., express/explicit consent), but it does require provision of information to research participants so they can make an informed choice. It is most used in research that involves the completion of a simple, one-time survey/questionnaire, where the act of completion and return of the survey/ questionnaire implies their consent to participate.
This ICF template is to be used for prospective research studies involving human participants submitted to GREB. Prospective research evaluates the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems. They include psychological phenomena such as emotions, biases, and motivations. Psychological therapy and counselling studies fall under behavioural research. Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved. Common methods include, but are not limited to, interviews, focus groups, surveys, questionnaires, behavioural therapy workshops, experimental coaching, and observations.
Access ICF for Observational Prospective Research with Human Participants - GREB (WORD 112 KB).
This ICF Components Checklist is designed for researchers or study team members who opt not to use the standard ICF template. By referring to this checklist, they can ensure that all required components of the ICF are included.
This tool has been developed to verify informed consent forms against the requirements of the Queen’s Ethics Boards, affiliated hospitals, TCPS2 (2022), and, where applicable, Good Clinical Practice guidelines (for interventional trials) and US regulations (for US-funded and/or regulated studies).
For detailed guidance on ICF components and recommended language, please consult the REB-provided ICF templates and the Guidance and Examples section of this document.
Note: To avoid unnecessary delays and prolonged review times, it is strongly recommended to use the REB-provided ICF templates. For trials reviewed through the CTO mechanism or OCREB as the board of record, their respective templates must be used.
Informed Consent could also be conducted verbally. Ensure documentation of verbal consent by using the verbal consent log template. This can be used for studies submitted to either HSREB or GREB.
Access Verbal Consent Documentation Log Template (WORD 84 KB).