Ethical Considerations
All proposed information gathering in all phases has been approved by the Ioannina General Hospital Ethics Committee.
Data protection
We will ensure that there are robust, standardised mechanisms in place, for secure, confidential handling and protection of all forms of data arising from this programme.
Our main concerns about potential problems that may arise from this programme include: i) detection of severe psychological distress in some users and the appropriate management of such distress to ensure individuals obtain appropriate help and support; ii) anxiety in some patients with long term conditions who may feel questions about psychosocial issues are not relevant to the management of their condition (our previous experience suggests that this is a very infrequent problem provided clear explanations about the nature of the research are provided).
We will set up clear protocols for the management of patients who require urgent access to Mental Health Services. Although distressing for individuals at the time, this is an example where without the research project, patients in severe distress who may be at risk of suicide may not be detected by usual services. We will carefully monitor any potential dis-benefits of the research programme, and ensure that individuals who experience adverse events as a result of participation in the programme receive advice and support, and access to help.
