Potential risks and benefits

Many arts interventions may not have specific risks, and it is not necessary to over-analyse any risks that might occur. For example, when leading a singing group, there is always a chance that somebody may trip over a chair or a cable when they are in the room. However, this risk would exist even if they were not part of a research study. It is important to identify any such risks in a risk assessment (see Chapter 8), but the more important risks for this protocol are the study-specific ones. For example, if a study involves providing confidential medical data, it may be necessary to explain how it will be stored so participants are not concerned about private information being made public. There may also be other disadvantages to involvement, for example providing a blood sample may be painful or the study may involve repeat trips to a clinic, which could involve people’s time and perhaps money for travel. If any aspect of the research could cause distress, such as the posing of sensitive questions, this needs to be clearly outlined too. If there is any chance that the study could find clinically relevant data, such as a study involving heart rate monitoring showing that a participant has a heart murmur, the plans for how the participant or their healthcare professional are to be notified should be outlined. If there are no obvious risks, then this should be stated, identifying whether aspects of a study are non-invasive and pain-free.

Benefits should also be stated to demonstrate why participants may want to take part. Benefits could include participation in free arts workshops or participants being provided with some of their study data, such as copies of their own brain scans. In line with potential hypotheses in the study, benefits could also be experienced through participation in the intervention. Another benefit could be that taking part in a study might lead to improved experience for future patients at a clinic. Although not directly relevant to the participant, they may feel encouraged to know that their participation could have a positive effect longer term.

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