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Informed Consent

Consent to participate in a research study should be understood as a process rather than an event. Researchers should plan for and articulate the steps by which consent is initially obtained and the steps by which it is reviewed throughout the study. In order for participants to give meaningful consent, they should be able to understand the intent of the research, be clear about what they are being asked to do and if any risks are involved, and know how their information will be used.

Consent may be documented in many ways. Verbal or implied consent, with appropriate researcher documentation, may be as legitimate as written consent, and in some contexts may even be more appropriate. The primary focus of ethical concern should be on the quality of the consent. Consent should always be in language that is understandable and not legalistic or too scientific, and the consent process should make room for questions, as appropriate to the research context.

In the majority of cases, where a written-and-signed approach to consent is used, the information letter and consent form are best presented as one document. The information letter should begin with an invitation to potential participants and should explain why they have been asked to participate. The body should provide a brief plain-language description of the proposed research project including a description of the project and the nature of participation. An explanation of key ethics issues, such privacy and confidentiality, risks and benefits, and compensation, if any, should follow. The information letter should be written as if it was being sent from the researcher to the participant (i.e. in second person). It should include names of the researchers and their affiliations.

The consent portion of the form should include a brief summary of what will happen from the participant’s perspective. It should note that the study has been explained to the participant, and the participant has had a chance to have his or her questions answered. The basic elements of consent, bulleted below, are typically relevant regardless of process – whether written in hard copy, via e-mail, on the web, or presented verbally in person or over the phone. However, not all items are appropriate for all protocols, and some additional items may be requested by an REB on a case by case basis.

General points

Introductory information

Conditions for participating

Risks and Benefits

Access to information, confidentiality, and publication of results

 

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