Informed consent

© The process of informed consent means telling the participant enough about the study so that they can make an informed decision about whether or not they want to take part. Generally, a participant information sheet is used to provide the necessary information. Once a participant has agreed to take part, they will be asked to sign a consent form. This is discussed further in Chapter 12. Because informed consent is a standard process for participants, often important routine information about the process is included. This is modulated based on the study protocol, but may follow a format similar to the following:

Participants will personally sign and date the informed consent form, cosigned by a member of the research team, before any study-specific procedures are performed. Written and verbal versions of the participant information and informed consent will be presented to the participants detailing the exact nature of the study and what it will involve for the participant. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. A copy of the signed informed consent will be given to the participant. The original signed form will be retained at the study site. The participant will have the opportunity to question a member of the research team to decide whether or not to participate in the study

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