Informed Consent Guidelines
If you are conducting any research involving human participants, you must normally give them, and have them sign, an informed consent statement. Detailed information about the research may be provided as part of the informed consent statement or in an additional information letter.
An informed consent statement/information letter has two purposes:
- To enable potential research participants to make an informed choice as to their whether they wish to participate in a study; and
- To document their decision to participate.
Evidence of informed consent by the participant or authorized third party should often be obtained in writing and in some instances is mandatory (e.g., Health Canada regulations under the Food and Drugs Act). However, there are instances in which written consent is culturally unacceptable, or where there are good reasons for not needing to or not being able to record informed consent in writing. When consent is not documented in a signed consent form, researchers may use a range of consent procedures, including oral consent, field notes and other strategies, for documenting the consent process. For example:
- oral consent documented in some form of recording (e.g., field notes, consent log, audio recording)
- building a consent form into your online survey and utilizing checkboxes to document consent (e.g., Qualtrics)
Guidelines for Completing the Informed Consent Statement
The Research Ethics Board provides a downloadable informed consent statement template. We strongly suggest you use the wording provided in the template and add additional information as it applies to your study. Guidelines for the additional information are provided here.
The informed consent statement should be written in second person ("You are invited..."). Use of first person ("I") can be interpreted as suggestive and coercive. If the informed consent statement or information letter is to be in a foreign language, submit the foreign language version and an English translation when seeking Research Ethics Board (REB) review.
Depending on the research method used in the project, each participant must be given a copy of the informed consent statement (and information letter if applicable) to read prior to participation in the study, in paper or electronic format.
Use the heading, "Wilfrid Laurier University Informed Consent Statement" or "Wilfrid Laurier University Information Letter" (or indicate the name of the institution in the first paragraph of the informed consent statement/information letter).
- List the title of the project and state the researcher's/researchers' affiliation to Laurier or to another institution as the case may be. Be sure to list the names and affiliations of all the project’s researchers in the informed consent statement/information letter.
- In the case of a student’s project, it is customary to include the name, affiliation, and office telephone number/email address of all faculty advisors or supervisors. Use the faculty member's title (i.e. "Professor," "Associate Professor," etc.) or add "PhD" to the end of the researcher’s name rather than using “Dr” as this may not be appropriate in some cases, particularly in the case of clinical research as it may lead some participants to conclude incorrectly that the researcher is a medical doctor.
- In describing a researcher’s academic qualifications please list only those degrees or qualifications that have been fully completed and awarded. Researchers may indicate that they are presently enrolled in a specific academic program (e.g., I am a doctoral student in the sociology department at Laurier).
- If the project is being done for a client or sponsor, include the name of that client or sponsor in the informed consent statement/information letter.
- Invite the participants to participate and state the purpose of the research project.
- Describe the procedures – i.e. what participants will be asked to do. If a survey, questionnaire, focus group, or interview is used, mention briefly the topics that will be covered during the procedure.
- Since some people relate confidentiality and anonymity to the total number of participants, the approximate number of participants involved in the study should be indicated.
- Provide a brief and general description of the participants (e.g., five to 10 educational policy analysts from Ontario will be interviewed; approximately 200 undergraduate students 17-25 years of age). For some projects, it may be appropriate to tell participants why and how they were selected.
- Indicate the expected duration of participation. This includes the time required for each aspect of participation and, in projects where participation extends through time, the participant’s total time commitment.
- If you plan to record the participants through video or audio, request permission to do so in writing and indicate how you will be using this material, who will have access to the material, who will view/hear the material, what will happen to the multimedia material and transcripts at the end of the study, and what will happen to the material if the participant withdraws. All possible uses of the digital recordings/tapes/films/photos (current and future) must be described. Indicate how recordings will be transcribed and who has access to the transcripts. Inform the participants if the transcriber is someone other than the researcher and indicate that the transcriber will keep all information on the recordings confidential. If the researcher keeps the recordings beyond the end of the study and/or they are archived, then the researchers must notify participants that the recordings/photos will not be used for any additional purposes without their additional permission.
- If deception or concealment is used, include a statement explaining that the research cannot be fully described at this time, but that an explanation will be provided at the conclusion of participation. Provide a copy of the debriefing statement/script for REB review.
- Any costs to the participants (e.g., paying for transportation to or parking at the research site) that may result from participation in the research need to be mentioned in the informed consent statement/information letter.
- Outline any reasonably foreseeable risks and/or discomforts to participants that could result from participating in the research.
- Describe the safeguards to be used to minimize those risks and/or discomforts.
- In some situations, a statement should be included in the informed consent statement/information letter that the particular treatment or procedure may involve currently unforeseeable risks to the participant.
Describe any benefits to the participant or to others and/or the extent of contribution to the body of literature/knowledge.
- Inform participants of the extent to which the information that they provide will be kept confidential and/or anonymous. Describe the extent, if any, to which confidentiality and/or anonymity of records identifying the participant will be maintained. Describe how confidentiality and anonymity will be maintained.
- Explain when and how confidentiality will be broken (i.e., when required by professional codes of conduct or laws e.g. requirement to report children in need of protection).
- Provide a statement about the ways in which the research results will be published or distributed (e.g. only aggregate results will be published or distributed).
- If participants might be identifiable in reports because individual responses will be described, a statement to this effect must be included in the informed consent statement/information letter.
- The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant needs to be described in the informed consent statement/information letter. Explain what will happen to data if a participant withdraws. If data are gathered that contain participant identifiers, the disposition of the data must be stated.
- Indicate to participants in the informed consent statement/information letter how long the information that they provide will be kept and how that information will be disposed of, if that will occur. You may keep the data indefinitely.
- State the terms of any compensation for study participation. If participants will receive compensation for participating, indicate how and when they will receive that compensation (e.g., compensation of cash, donation, toys, books, gifts). Indicate the value of the compensation where appropriate.
- Explain if there will be any partial payment if the participant withdraws prior to completion of the study.
- If class credit will be given, indicate the amount of credit to be earned by participating and the conditions for earning credit toward the final grade. Mention any alternative ways to earn the same amount of credit.
- If participants are compensated through a draw or lottery, provide the details of the draw in the informed consent statement/information letter: who is eligible, the odds of winning, the method for determining the winner(s), the prize(s) to be won, when and how the winner(s) will be notified.
- Inform participants of Canada Revenue Agency requirements to report compensation for income tax purposes:
- Money (e.g., cash, cheque, or direct deposit) must be reported.
- Near-cash (e.g., gift certificates) must be reported.
- Tangible items do not need to be reported provided the value is nominal (e.g., t-shirts, food item).
- Gift certificates or other tangible items given as a prize for a draw where all parties have equal opportunity to win the prize do not need to be reported.
- Include an invitation for participants to ask any questions about the study, its procedures, or their rights as participants; include a means to contact the researcher (usually a telephone number and/or email address). Only provide institutional contact information and do not provide home addresses or personal phone numbers or emails.
- Indicate that the project has been reviewed and approved by the Research Ethics Board and include REB Chair contact information.
- Inform participants that participation is voluntary and that they may decline to participate without penalty or withdraw from the study at any time without penalty.
- Tell participants that they have the right to refuse to answer any question or participate in any activity.
- Tell participants what will happen to their data if they withdraw from the study. Explain what will happen to data if a participant withdraws. If data are gathered that contain participant identifiers, the disposition of the data must be stated.
- Outline any anticipated circumstances under which the investigator may terminate the participant's participation without regard to the participant's consent.
- Provide a statement about the ways in which the research results will be written up or presented (for example, a thesis, course project report, book, journal article, conference presentation, class presentation).
- If the project is being conducted on behalf of an agency, company, or client, indicate who will receive a report upon completion of the project.
- Tell participants how and when they will be informed of the results of the research. This could be replaced by a question asking the participants whether they would like a written summary of the results at the conclusion of the study.
- Laurier’s REB does not allow the use of negative option or passive consent, where participants are required to contact the principal investigator (PI) to indicate that they do not wish to be a participant.
- Provide two copies of the informed consent statement, one to be retained by the participant and one to be signed by the participant and, if applicable, the participant's parent(s)/guardian(s)/legal representative(s) and returned to you. For online surveys, participants should be instructed to print or save a copy of the form.
- If your form is more than one page, there should be a line at the bottom of each page for the participant’s initials, except for the last page where the signature is obtained.
- Include a statement that says the participant has read and understands the informed consent statement, acknowledges receiving a copy of the statement, and agrees to participate in the study. Provide lines for signature of the participant and the researcher, and the date. In some cases the participant's parent(s)/guardian(s)/legal representative(s) will also sign the/an informed consent statement.
- If the proposed participants include persons under the age of 16 a separate informed consent statement or, in the case of very young children, oral assent must be obtained both from them and from their parent(s) or guardian(s), and, if applicable, from a school authority, agency director, etc. Normally, persons age 16 and over may give free and informed consent on their own behalf.
- For younger children, prepare a script for REB review of what will be said to them to verbally recruit their participation, using age-appropriate language. Despite the informed consent of parent(s)/guardian(s), children must be able to refuse to participate in research or to withdraw their participation at any time.
- In research involving participants who are not competent to give free and informed consent on their own behalf, free and informed consent must be sought from their authorized representative(s). In such situations where third-party consent has been obtained, but participants understand the nature and consequence of the research, their assent must be obtained; a potential participant's dissent will preclude his or her participation.