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Informed Consent Guidelines

This webpage is an online version of the printed Informed Consent Guidelines (36 KB) Word Doc, and the titles, headings, and numbering reflect those of the printed document.

Informed Consent Procedures

As it is described in the Tri-Council Policy Statement, informed consent involves three elements: Information, Consent to Participate, and Consent for the Use of Data. The requirements of each of these elements is first outlined, followed by a description of alternative procedures that would satisfy these requirements.

Requirements

Information: Potential participants must be given information about what involvement in a study would require (e.g., time required, topics to be discussed, tasks to be performed, data collection procedures), and a description of any potential risks and benefits associated with participation. Potential participants must also be informed about the intended use of their contributed data (e.g., techniques for storing the data, projected uses such as publication or public presentation). Procedures designed to protect the participant and their identity should also be described. A record of the specific information that has been given to participants must be kept to define the procedures and data usage that has been consented to.

Consent for participation: The participant must explicitly indicate that they are willing to do what the researcher has described. For example, for a qualitative study, they would indicate that they are willing to be interviewed on a particular topic for a specific amount of time. Or, for an experimental study, they would indicate that they are willing to perform a particular memory task while their speed and accuracy was measured. This consent must be explicitly requested. A variety of behavioural indicators, including cultural rituals, can be used to indicate consent to participate, provided that such behaviours are understood in this way by both the participant and researcher. This consent allows the researcher to proceed with the study procedures, including data collection.

Consent for use of information/data: The participant must also agree to the use of their data as outlined in the information given to them. The requested data use can range from general (e.g., to investigate memory processes) to specific (e.g., to describe a specific event in history from a particular perspective), depending on the type of information collected. For example, participants in an experimental study may agree to have their data included only in group means, or a participant in a qualitative interview study may agree to have their exact words quoted. Further uses of the data should be constrained by this consent, and additional uses should require additional permission from the participants. (In the latter case, a copy of the form asking for additional permission should be sent to the REB office to be included with the researcher's project file.) For example, if a participant agreed only to have their data used in group means, the researcher would need to receive additional consent to report a case study of that participants' performance. If a researcher intends to use the collected data for a wide variety of purposes, not all of which are known at the time of data collection, consent for a wide use of data would be requested (e.g., data will be analyzed to examine various questions related to this thesis and will then be archived in the U of R library for the use of other researchers). As the consent for data usage is intended to constrain the use of collected information, the details of this consent must be recorded in a form that is available for as long as the data is to be maintained.

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Alternative Procedures

Consent form: All three elements of informed consent can be addressed using a signed consent form (see checklist below). Such a form typically includes information about the requirements of participation, risks and benefits, and the intended use of the data. In this case, the signature of the participant indicates consent for both participation and data usage. However, consent forms are not the only way to meet these requirements. As stated in the U of R Policy, "Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented."

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Separate Procedures: One option is to provide a separate procedure for each of the three elements. For example, a printed information sheet, or script which is orally presented, could provide a record of the information given to participants. The options for indicating consent to participate are wide ranging, as long as both researcher and participant understand the designated behaviour in the same way. For example, continued interaction with the researcher could indicate consent to participate (i.e., the existence of data = evidence of consent to participate). A familiar example of such a procedure is the sample survey, for which the act of returning a completed questionnaire is the indicator of consent. Similarly, in telephone sampling, a participant may provide verbal consent, which is recorded by the researcher, but not hanging up the telephone is also an indicator of consent. Behaviours used to indicate consent for data usage are more constrained in that a long-term record of this consent is necessary, as described above. For example, consent for data use could be indicated by a signature, tape- or video-recorded verbal consent, or the signature of a witness (not the researcher) that they observed an explicit conversation about data use between the participant and researcher and that consent was given for a specific use of the data.

One advantage of using separate procedures is that the timing of these consent procedures can be modified to suit the specific types of research. Consent to participate must be given before any participation begins. However, consent for the use of data could appropriately occur at several points in a study, including after the data has been collected. Obtaining consent for data usage after data have been generated is particularly appropriate for qualitative, narrative, and ethnographic studies, as it is only after interviews have been completed that participants are fully informed about what their permission for use would mean. Similarly, for action research studies in which the procedural requirements of a study evolve, consent for continued participation should be sought whenever the requirements for participants change from the initial agreement.

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Multiple Levels of Consent: For some projects, multiple levels of consent must be obtained, such as when consent is needed from communities or institutions as well as from individuals. This would be particularly so when the goal of a study is to collect or document knowledge related to cultural or community history or practices in cultures that consider such knowledge to belong to the community rather than to individuals. In this case, the data do not 'belong' to the individual participant but rather to the larger community or culture. Thus, the individual cannot properly provide consent, especially for the use of such data. In these cases, both types of consent (i.e., for participation and for data usage) should be obtained from both the community and the individual participants, with the timing of such consent to be determined by the specifics of the study. The procedures to obtain community consent should make use of established cultural practices. The goal in these cases is to maximize both the information provided to all and the respect and dignity afforded to the intended participants (which would include the culture or community in these cases).

Waiving Consent Procedures: The REB may waive one or all of the elements of informed consent under some specific circumstances. Specifically, "The REB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent [...], or waive the requirement to obtain informed consent, provided that the REB finds and documents that: (i) the research involves no more than minimum risk to subjects, (ii) the waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects, (iii) the research could not practicably be carried out without the waiver or alteration, (iv) whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation, (v) the waivered or altered consent does not involve a therapeutic intervention."

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Summary

Informed consent procedures involve three elements (information, consent to participate, and consent for data use), which can either be dealt with in a single procedure (i.e., consent forms) or managed separately, depending on the needs of a particular research project. While all three elements must be addressed in some fashion, researchers are encouraged to exercise creativity in satisfying the needs of informed consent in a manner that is maximally respectful of their intended participant population.

Useful References

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