Informed Consent
1. What language level is appropriate for an informed consent form (ICF)?
*Updated August 2022
Use language that is as non-technical as possible, and understandable to the participant, without compromising the content. An eight-grade reading level is recommended (N2 SOP006).
The Flesch-Kincaid Grade Level score, available in Microsoft Word, may be used to assess the readability of an ICF.
2. Who can approach or make initial contact with potential research participants during recruitment?
Initial contact with patients about recruitment for a research study should be made by a member of the patient’s circle of care (e.g. the patient’s physician, health professional, medical secretary, etc.). Specifically, the member of the patient’s circle of care can ask them if they would like to hear more about a research study from a member of the research team. If the patient agrees, the study team member will be permitted to speak to them about possible participation in the research study.
In certain scenarios, the REB may consider alternate acceptable methods of initial contact for patient recruitment if adequate justification is provided in the REB application:
- For minimal risk research studies, the REB may consider permitting physicians to delegate authority to research staff to contact all of their patients who are potentially eligible patients under their care.
- For greater than minimal risk research studies, the REB may consider permitting the research staff to obtain permission from the physician prior to contacting each potential participant on a per-patient basis.
In both of the above cases, research staff must ensure patients are aware that they are speaking to them on behalf of their physician and this delegation of authority must be documented in the study files. See N2 SOP 009 Addendum for more information.
3. 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. Consideration must be given to possible coercion by virtue of pre-existing relationships (i.e., physician-patient, professor-student). When feasible, to minimize any possible coercion, another member of the study staff should obtain consent.
Note: The person obtaining informed consent does not have to be the same person, or only person, that conducts the informed consent discussion.
4. Do I need to obtain consent for a survey research study?
In cases of online or paper based survey research when minimal risk or harm is anticipated and identification of the individual is not necessary for the study design, the research ethics board (REB) typically accepts the use of implied consent.
Implied consent is accomplished by providing the potential participant with the necessary information at the beginning of the survey to “inform” them of the research project. The information section should include an abbreviated version of all of the relevant material normally included in a consent form, but no signature line for the participant is needed. In the information section, the participant is instructed that participation in the survey is voluntary.
The implied consent process may state something like: “If you return/submit this survey, it will be understood that you have consented to participate.”
