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You should consider how your research will manage informed consent, including the design and format of your participant consent forms, as you plan your research and create your research ethics application. You will have to submit the consent forms in the application;  ARISE provides a space for you to upload consent forms and other documents.

The REO provides some online guidance for consent forms, including suggested templates. Consent forms are checked for content and format during the review process. Researchers can speed and assist this process by following the guidelines below..

The guidance provided by the REO and the question prompts used in ARISE tend to assume that consent will be written, but it is just as acceptable to document consent orally. The choice of written or oral consent depends on factors including how comfortable the participants involved are with reading and signing a consent form. If your research will use oral rather than written consent, a consent script that you will go over with participants must be provided in ARISE. This script does not need to be read to participants verbatim; instead you should move through it step by step to ensure that all of the necessary information has been provided to participants and understood. Oral consent must include all of the essential points that would be provided in a written consent form (see below). ARISE also asks researchers to indicate how consent will be documented (e.g. by recording the participant’s agreement) and how participants will be given a record of the agreement to keep (e.g. by providing them with a printed copy of the consent script).  

At a minimum, researchers (or their qualified designates, such as research assistants) need to provide prospective participants with the following:

• information that the individual is being invited to participate in a research project;
• comprehensible statements of the research purpose, the identity of the researcher, the expected duration and nature of participation and a description of research procedures;
• comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation;
• an assurance that prospective participants are free not to participate, have the right to withdraw at any time during their participation without prejudice to pre-existing entitlements, and shall be given continuing and meaningful opportunities for deciding whether or not to continue to participate;
• specific details on withdrawing from the research after their participation is complete, including whether this is possible, how it can be done and how long it will be possible;
• the possibility of commercialization of research findings and the presence of any apparent or actual or potential conflict of interest on the part of researchers, their institutions or sponsors; and
• the name and contact information for a person who may be contacted in the case of concerns, complaints or consequences.

In the list above, ‘comprehensible’ means clearly expressed in a language that participants are comfortable with and in a style that is appropriate for their expected reading level. Comprehensibility depends on the participants you plan to involve; generally though, the wording used in academic settings is inappropriate. To ensure truly informed consent, the consent document should be written in as clear and jargon-free a manner as possible.