What is "informed consent"?
"Informed consent" is an ongoing process, which starts well before any consent forms are signed and continues until the participant’s participation is completed. It involves meeting with a potential participant, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation, providing an opportunity for the individual to ask questions and receive answers, and allowing individuals to decide whether to participate. If consent is to be informed, the participants must genuinely understand and appreciate the consequences of participating in the study. The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the research process. Obtaining informed consent involves ensuring that the prospective participant appreciates the consequences of their participation; it is not just giving a prospective participant a consent form to sign [TCPS 2 Ch 3].
Are sample consent forms available for review?
A consent guideline is available on our Ethics Forms and Templates page.
Who can obtain informed consent from research participants?
A member of the study staff must obtain consent. This may be the principal investigator or designate. The principal investigator for the study must consider whether there might be the possibility of coercion by virtue of pre-existing relationships (i.e., teacher-student), and demonstrate to the ORE/SFU REB how this would be minimized. An acceptable approach and when feasible, is to ensure that another member of the study staff obtains consent if the principal investigator has a pre-existing relationship with the prospective participant
Note: The person obtaining informed consent does not have to be the same person, or only person, that conducts the informed consent discussion.
If I am changing the study, when do I need to tell my participants about the changes?
Changes to a study must be reviewed and approved by the ORE/SFU REB before they are implemented. Consent documents may also need to be revised to reflect changes to a study. Participants already enrolled and actively participating in the study should be informed of the change if it might relate to the participants’ willingness to continue their participation in the study.
Do I have to use copies of the approved consent documents (e.g., consent forms, assent forms, recruitment ads) to recruit/enroll participants?
Yes. The ORE/SFU REB prior to their use in the research study must approve all consent documents
For my study I will be collecting data by electronic questionnaires and surveys. Do I need to get written consent?
- Prepare an information page about what you are doing, why and what the survey/questionnaire will cover. The information page must include the following:
a. Make it clear in the information page that the survey/questionnaire is voluntary and that the respondent can access the survey without being committed to submitting it
b. Describe the purpose of the survey/questionnaire
c. Indicate whether or not personal identifiers will be extracted or collected; and how participant privacy will be protected
d. Describe any risks to participation
- The information page must include a consent statement. Consent statements should be linked directly to the questionnaire so that you have proof that the participant would have received the information page prior to beginning the survey instrument.
- The consent statement can either be shown at the top of the questionnaire or as a separately linked form. The separate consent statement should show two links at the bottom of the statement and prior to the survey instrument. One link (continue), will take the participant directly to the instrument should they wish to continue and one link (exit) will allow the participant to leave the survey if, after having read the consent, should decide not to participate. Whether the consent statement is at the top of the instrument itself or as a separate document, this choice must be clearly shown after the consent information. Each electronic consent must include the following sentence, “By filling out this survey/questionnaire, you are consenting to participate.” Provided your electronic documents are acceptable, this will normally be construed as “implied consent” by completion and submission.
Can I obtain verbal consent rather than written consent?
Depending on the nature of the study, the ORE/SFU REB may approve verbal consent as long as a clear explanation for the use of verbal consent is included in the study details. In addition, the study details should include information regarding how consent will be recorded (e.g. logbook with name, date, time and location where consent took place).