04. How do I ensure my study’s participants can provide free and informed consent?

4.1 Written consent

As part of the consent process, you may use a pre-study consent form (CF). This should allow participants to make an informed decision about whether they want to participate in the study. In general, a good way to assess your CF is to ask yourself if the person participating in your study might be surprised by aspects of your protocol that they might not expect. If so, then your CF is likely incomplete. Even if the CF informs the person that some things will not be revealed until the end, they should still be warned about what they are about to do.

CFs are typically comprised of the following parts:

• The general purpose of the research activity.
• Required information in order to fulfil the activities (filling out questionnaires, conducting tests, etc.).
• The duration, cost, and potential gain (compensation, gift certificate, etc.).
• Potential risks and how they are controlled by the research protocol.
• The anonymous or non-anonymous nature of the data being collected.
• Whether personal data or sensitive personal data are collected, and if so, which ones.
• Where the data goes (storage and duration of storage, anonymization, etc.), its uses and access rights, deletion, or rectification.
• The individuals who will have access to personal data.
• The researchers’ contact information.

The researchers will determine whether further clarification is necessary. Examples of consent forms and a guide to writing a consent form are available for download by clicking the links below:

CUREG-2023-06-20-GuideRedactionFormulaireConsentment

CUREG-2023-06-20-InformationConsentement_adultes

CUREG-2023-06-20-InformationConsentement_parents-enfants

 

 

 

4.2 Oral consent

In the social sciences and humanities, and particularly in the context of qualitative methods using interviews and/or ethnographic observations, providing written consent can sometimes be problematic or not appropriate. These methods are based on a situated and relational approach with regards to the interaction between the researcher and participant. The expression “investigative relationship” points to a social relationship, and written consent can disrupt this relationship by introducing misunderstandings or preventing the development of mutual trust. This is particularly true when researchers and participants are in regular contact in an ethnographic field (“in situ”).

Furthermore, written consent is deemed not appropriate when participants have characteristics specifically related to literacy or the contractual dimension of the signature, or when the researcher adopts an immersive and/or participatory ethnographic approach.

In cases where written consent is problematic or irrelevant, the applicant to the CUREG must be accompanied by an information and consent protocol in lieu of the written information and consent form. There are two options:

a) mixed written + oral: participants are given a research information sheet (a written document), they are asked questions about the research and their participation, and then are asked to provide oral consent.

b) entirely oral: participants are informed orally, they are invited to ask questions about the research and their participation and are then invited to give their oral consent (e.g., individual oral information in the case of individual interviews; oral information during information sessions at the beginning of the ethnographic fieldwork in a community, etc.).

The information and consent protocol must include the desired option (a or b) and provide details about how it is to be implemented.