Describe the measures in place in the event of any unexpected outcomes or adverse effects to participants arising from their involvement in the project.
Does the project involve any possible distress, discomfort or harm to participants or researchers?
Identify, as far as possible, all potential risks to participants associated with the proposed activity/research.
Consider all possible causes of distress carefully, including likely reactions to the subject matter, debriefing, deception or burdens imposed and any preparatory requirements.
Provide details and say what steps are to be taken to protect the participants. Details should also be given of any potential risks to investigators.
Describe the measures in place in the event of any unexpected outcomes or adverse effects to participants arising from their involvement in the project.
An adverse effect may be defined as one which is ‘related’ and ‘unexpected’. For example, how will any problems identified by the investigator during the study be referred on-wards or dealt with ?