Protected: Patient Information Leaflet (RoI)

Version: 2, Date: May 2025

Table of Contents:

• Study title
• Principal investigator’s name
• Co-investigator’s name
• Data Controller
• Invitation to participate
• Voluntary participation
• Why is this study being done?
• Who is organising and funding this study?
• Why am I being asked to take part?
• How will the study be carried out?
• What will happen to me if I agree to take part?
• What are the benefits?
• What are the risks? / What if something goes wrong?
• Will it cost me anything to take part?
• Is the study confidential?
• Data Protection
• Where can I get further information?

Study title: Psychological wellbeing of people living with Inherited retinal degenerations (IRDs)

Principal investigator’s name: Dr Nabin Paudel

Principal investigator’s title: Head of Research and Programmes
Telephone number: +353 85 867 7328
Email: nabin.paudel@retina-international.org

Co-investigator’s name: Dr Ellen Moran

Co-investigator’s title: Scientific Programme Manager
Email: ellen.moran@retina-international.org

Data Controller

Data Controller: Retina International
Data Controller Contact Details: info@retina-international.org
Data Protection Officer: Ms Avril Daly
Data Protection Officer Contact Details: info@retina-international.org

You are being invited to take part in a research study to be carried out on an online survey by Retina International

Before you decide whether or not you wish to take part, you should read the information provided below carefully and, if you wish, discuss it with your family, friends or GP (doctor). Take time to ask questions – don’t feel rushed and don’t feel under pressure to make a quick decision.

You don’t have to take part in this study.

You can change your mind about taking part in the study any time you like. Even if the study has started, you can still opt out. You don’t have to give us a reason.

Why is this study being done?

Retina International is conducting a survey to better understand the mental health impacts of inherited retinal degenerations. This is a part of a larger research programme examining the psychological and social well-being of people living with retinal degenerative diseases.

The specific aims of this study are:

• To explore psychological/mental health burden of people living with IRDs
• To explore the rate of suicidal thoughts in patients with IRDs
• To assess the relationship between self-reported visual status, demographic and socio-economic factors and psychological status in patients with IRDs.

Information collected through this survey (IRD) will inform knowledge and understanding of the mental health needs of the people living with inherited retinal degenerations and the factors influencing mental wellbeing. The questions you answer today could lead to tomorrow’s treatment.

Who is organising and funding this study?

Retina International, a global patient led membership organisation is organising this study. The work of Retina International is funded by member organisations and industry partners.

Why am I being asked to take part?

You are being asked to take part as you are a person at least eighteen years old living with an Inherited retinal degeneration (IRD) or are a person with family member or friend living with an Inherited retinal degeneration (IRD)

How will the study be carried out?

This study will be carried out by an online questionnaire.

What will happen to me if I agree to take part?

As part of this study, you are invited to complete an online survey. This survey will collect personal information about you including demographic information (such as your age and gender) and details about your work and education. It will also collect personal information about your condition and the impact your condition has on your wellbeing.

What are the benefits?

The survey will assist us to better understand the mental health impacts of inherited retinal degenerations. This is a part of a larger research programme examining the psychological and social well-being of people living with retinal degenerative diseases. Sharing your experiences could also improve how to identify and treat mental health issues for more people living with the same condition as yours.

The data will also be used to inform policy actions that reflect the need of people living with IRDs.

What are the risks? / What if something goes wrong when I’m taking part in this study?

There are no anticipated risks in taking part. If you experience any unsettled feelings while completing this survey there are several support options available

• Contact SAMARITANS who provide confidential support in Ireland or the UK for free from any phone on 116 123.
• Contact Emotional Supports at Vision Ireland
  Telephone 1800 911 250
  https://vi.ie/emotional-supports/
• Insight Counselling Services at Fighting Blindness Ireland
  Telephone +353 1 674 6496
  Insight Counselling Service

If you have any concerns about your IRD care and management, please contact your general practitioner/preferred health provider. Our research team are also available to discuss any concerns that you may have, or feelings of distress from the questions – you can contact us via email (info@retina-international.org) if needed.

Will it cost me anything to take part?

There are no costs to taking part in the survey.

Is the study confidential?

Yes. Your contribution to the survey will be collected and data will be stored in a secured location for a period of five years.

All data will be anonymized, and you will not be identifiable within any publications/reports/presentations made as a result of this study.

Data Protection

This survey will collect personal information about you including demographic information (for example your age, gender, socioeconomic status, educational attainment). It will also collect personal information about your condition and experiences of vision-related anxiety, depression and suicidal thoughts.

Your personal information collected as part of this survey will be kept strictly confidential. Your identity will not be revealed, and your confidentiality will be protected in any reviews and reports of this study which may be published.

Your participation in this survey is voluntary; and you can withdraw at any time if you change your mind. If you decide to withdraw your consent by exiting the survey mid-way through, your responses will not be recorded.

You also have the right to:

• ask that we delete the personal information that you provide, or restrict the way in which we use your personal information.
• withdraw consent to our processing of your personal information; and
• obtain and/or move your personal information

You can do so by emailing: info@retina-international.org

Where can I get further information?

If you have any further questions about the study or if you want to opt out of the study, you can rest assured it won’t affect the quality of treatment you get in the future.

If you need any further information now or at any time in the future, please contact:

Dr Nabin Paudel – Nabin.paudel@retina-international.org
Dr Ellen Moran – ellen.moran@retina-international.org