Psychological Health Study Safety Protocol
Patients, parents and controls will be informed both in writing (on the information sheet and consent form) and verbally (in the initial interview) of steps that they can take if they feel distressed at any stage throughout the research project, including contacting the researchers, contacting their medical team or their own GP.
All participants must provide contact details of their GP or another health professional with whom the research team can contact if we are sufficiently concerned about the participant. This will be explained in the information sheets. We will not contact GPs or other health professionals as standard protocol.
During The Study
It is possible that during the interview, a patient, parent or matched control participant may reveal suicidal or self-harm risk of themselves or a study participant. The study psychologist will discuss the concerns directly with the participant and assess them for suicidal and self-harm risk, and remind them of the steps that they can take if they are distressed. The study psychologist will also contact the medical professional looking after them or the on call consultant (after hours) if needed.
The questionnaires will assess symptoms of depression, anxiety and stress, as well as aspects of cancer and fertility-related quality of life. Any significant distress reported on these measures will trigger protocols involving contacting the participant to discuss their emotional state and a meeting between Dr Anazodo and the other researchers to discuss a management plan. The health professional looking after the patient will receive verbal communication about any incident.
As this study also includes adolescents aged less than 18 years, the research team takes seriously it’s duty of care to report abuse to a minor should this be revealed during the course of the study. If any participant under 18 years of age reveals at any stage that they are currently experiencing any form of abuse or neglect in the home, they will be telephoned privately to discuss this. This will trigger protocols whereby Dr Anazodo will discuss the problem with the participant. The research team will follow mandatory reporting guidelines at all times.
Members of the research team meet weekly to discuss the progress of the overall study. Dr Anazodo will continue to monitor the overall progress of the research study and will take overall responsibility for this study. All adverse events will be promptyl reported to the HREC.