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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 or information letter has two purposes:
- To enable potential research participants to make an informed choice as to whether they wish to participate in a study.
- To document their decision to participate.
The words and language used to describe these factors must be understandable to potential participants. In order to make an informed choice, potential participants must:
- understand the study,
- how they are involved in the study, and
- what sort of risks it poses to them.
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.
Exceptions to Written Consent
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)
Template
The Research Ethics Board (REB) provides a downloadable informed consent statement template that you can use. We strongly suggest you use the wording provided in the template and consult the guidelines below to complete the template.
Use one of the following heading options:
- Wilfrid Laurier University Informed Consent Statement
- Wilfrid Laurier University Information Letter
Indicate the name of the institution in the first paragraph of the informed consent statement/information letter.
Title of Project
- List the title of the project.
- State the researcher's/researcher's affiliation to Laurier (or to another institution as the case may be).
- List the names and affiliations of all the project's researchers in the informed consent statement/information letter.
- Enter researcher academic qualifications:
- List only degrees or qualifications that are fully completed and awarded.
- You may indicate that you are presently enrolled in a specific academic program.
- Enter the supervisor information for student projects:
- Include name, affiliation and office telephone number/email address of all faculty advisors or supervisors.
- Use faculty member's title or add "PhD" to the end of the researcher's name rather than using "Dr." In the case of clinical research, "Dr." may lead participants to conclude that the researcher is a medical doctor.
- Enter name of client or sponsor, if applicable.
This section invites the participants to participate and states the purpose of your research project.
Insert Description of Procedures
- Describe the procedures. For example, 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.
Insert Number Minutes/Hours
- Indicate the expected duration of participation.
- Include the time required for each aspect of participation.
- In projects where participation requires more than one data collection time point, indicate the participant's total time commitment.
Participant Information
- Insert number of participants: Since some people relate confidentiality and anonymity to the total number of participants, this number should be indicated.
- Insert brief description of participants (inclusion criteria):
- Provide a brief and general description of the participants. For example: Five to 10 educational policy analysts from Ontario will be interviewed. Approximately 200 undergraduate students 17 to 25 years of age.
- For some projects, it may be appropriate to tell participants why and how they were selected.
Deception, Concealment, Partial Disclosure
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. A template is available for researchers to use.
Reimbursement
Indicate any costs to the participants that may result from participation in the research. For example, paying for transportation to or parking at the research site.
Risks
In some situations, a statement should be included in the informed consent statement/information letter that the procedures may involve currently unforeseeable risks to the participants.
- Insert description of risks/discomforts: Outline any reasonably foreseeable risks and/or discomforts to participants that could result from participating in the research.
- Risks/discomforts: insert description of safeguards: Describe the safeguards to be used to minimize those risks and/or discomforts.
Benefits
- Insert benefits: Describe any benefits to the participants or to others.
- Insert body of literature/knowledge: Describe the extent of contribution to the body of literature/knowledge.
Confidentiality OR anonymity: Inform participants whether their information will be kept confidential or anonymous.
Insert methods followed to ensure confidentiality or anonymity:
- Describe the extent, if any, to which confidentiality or anonymity of records identifying the participant will be maintained.
- 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.
Audio recording, video recording or photographs:
- If you plan to record 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.
- Indicate that the transcriber will keep all the 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 additional purposes without their additional permission.
Limitations to confidentiality:
- Explain when and how confidentiality will be broken, when required by professional codes of conducts or laws. For example, requirement to report children in need of protection.
Data management plan:
- Indicate how long the information participants provide will be kept and how that information will be disposed of, if that will occur. You may keep the data indefinitely, provided TCPS 2 Article 3.13 is followed to ensure participants appropriately consent to the storage of data for future unspecified research.
- Explain what will happen to data if a participant withdraws.
- Indicate the disposition of the data if data gathered contains participant identifiers.
State the terms of any compensation for study participation.
Insert incentive type/amount:
- Indicate how and when they will receive compensation (e.g. compensation of cash, donation, toys, books, gifts, etc.).
- Indicate the value of the compensation.
- Explain if there will be any partial payment if the participant withdraws prior to the completion of the study.
Class Credits
- 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.
Draw or Lottery
Provide details of the draw:
- who is eligible
- odds of winning
- method for determining the winner(s)
- prize(s) to be won
- when and how the winner(s) will be notified
Canada Revenue Agency Requirements
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.
Contact
- 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.
- 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.
Participation
Insert process for requesting data removal/destruction: Inform participants that:
- Participation is voluntary and that they may decline to participate without penalty or withdraw from the study at anytime.
- They have the right to refuse to answer any question or participate in any activity.
Describe participation termination procedure:
- Explain what will happen to data if a participant withdraws.
- 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, etc.
Insert agency/company/client: Indicate who will receive a report upon completion of the project.
Executive summary request:
- 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.
Include a statement that says the participant:
- Has read and understands the informed consent statement.
- Acknowledges receiving a copy of the statement.
- Agrees to participate in the study.
Signature lines:
- Provide the 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 statement.
- In cases where signatures are not feasible or appropriate, consider other methods of obtaining informed consent (checkboxes, oral agreement, etc.).
Consent
- 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.
- For participants 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 aged 16 years 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.