1. Participant Information Leaflet

Research Site(s):
Trinity College Dublin, Dublin 2, Ireland

Principal Investigator(s):
Ms Isabela Girleanu, PhD Candidate, School of Nursing and Midwifery, Trinity College Dublin. Tel: 087 335 1883 | Email: girleani@tcd.ie. Isabela is supported by the School of Nursing and Midwifery, Trintiy College Dublin, PhD Scholarship.

Co-Investigators:
Dr. Vanessa Boland, Assistant Professor, School of Nursing and Midwifery, Trinity College Dublin.

Prof. Anne-Marie Brady, Professor of Nursing and Chronic Illness, School of Nursing and Midwifery, Trinity College Dublin.

Data Protection Officer (Research Data):
Data Protection Officer, Secretary’s Office, Trinity College Dublin, Dublin 2. Email: dataprotection@tcd.ie.

Invitation to Participate
You have been invited to take part in this research study because you are 18 years or older, were diagnosed with either lymphoma, leukaemia or myeloma cancer and are currently receiving or have previously received CAR-T therapy.

This study aims to explore the experiences and understand the needs and quality of life of patients receiving chimeric antigen receptor T-cell (CAR-T) therapy for a lymphoma, leukaemia or myeloma diagnosis. It is anticipated that the results of this study will help inform the development of healthcare and support services that are important for patients receiving CAR-T therapy.

Before you decide whether to take part, please take the time to read all sections of this information leaflet carefully. If you wish, you may discuss it with your family, friends or GP. Feel free to ask any questions you may have. Don’t feel rushed and don’t feel under pressure to make a quick decision.

You should understand the risks and benefits of participating in this study so you can make a decision that is right for you. This process is known as ‘Informed Consent'. You don’t have to take part in this study. It is entirely voluntary and up to you.

You can change your mind about taking part in the study any time you like. You don’t have to give us a reason for opting out. If you wish to discuss this further, please contact Ms Isabela Girleanu, PhD candidate, at Email: girleani@tcd.ie or Phone: 087 335 1883.
The Study

Why have I been invited to take part?
You have been invited to take part because you are 18 years or older, were diagnosed with either lymphoma, leukaemia or myeloma cancer and are currently receiving or have previously received CAR-T therapy.

Why is this study being done?
We are carrying out this study to explore the experiences and understand the needs and quality of life of patients receiving CAR-T therapy for a lymphoma, leukaemia or myeloma cancer diagnosis. The results of this study will help inform the development of healthcare and support services about the needs of patients receiving CAR-T therapy and use this information to develop healthcare services that support patient’s needs.

What does taking part involve?
If you agree to take part in this study, you will be asked to complete a consent form. You will then be invited to take part in an interview lasting approximately 45 minutes to 90 minutes. We will use the information and insights you share during this interview to inform the development of our research. If, during the course of the research, we feel that further information or clarification would be helpful, you may be invited to take part in a follow-up interview. Any follow-up interview would be discussed with you in advance, and you would be free to decide whether you wish to take part. The interview/s will take place at a time and location that suit you (face-to-face, online or by telephone). With your permission, the interview/s will be audio-recorded to facilitate analysis. You will be asked about your personal experience of receiving CAR-T therapy. Your answers will be confidential. The interview will be transcribed, and you will have the chance to review the transcript.

What are the possible benefits of taking part?
Taking part in this study may not provide a direct benefit to you. However, we hope that the information we gather from you and other participants will deepen understanding of the lived experiences, needs and quality of life of patients receiving CAR-T therapy. These findings may contribute to new knowledge that can help guide the development of services better tailored to support people with lymphoma, leukaemia or myeloma individuals undergoing CAR-T therapy.

Are there any possible disadvantages or risks from taking part?
Your well-being is our top priority. Because this study involves discussing the experience of cancer and its treatment, you may feel distressed or upset at times. If the interview brings up strong emotions, the interviewer will pause or stop the session immediately as your comfort and safety comes first.

What will happen to the results of the study?
The research is being conducted as part of an academic qualification [Ms Isabela Girleanu is a student on the Doctor of Philosophy programme with Trinity College Dublin, under the supervision of Dr Vanessa Boland and Professor Anne-Marie Brady]. This study is not being conducted for commercial purposes. The results of the study will be reported in medical/scientific journals and disclosed at medical/scientific conferences. No information which reveals your identity will be disclosed. Some quotations from the interview may be used in reports. However, no information which reveals your identity will be disclosed.
Data Protection

What information about me (personal data) will be used for this study?
Your information will be kept private and strictly confidential. We will use your name, email address/postal address or phone number only to contact you about the research study and to arrange the interview process. Once the study is complete, we will delete your contact details. With your permission, the interviews will be audio-recorded. These recordings will be destroyed once the transcription has been checked for accuracy and the analysis is complete.

Only the research lead [Ms Isabela Girleanu, TCD] will have access to the information you provide. We will take careful steps to protect your confidentiality. Your data will be securely encrypted and separate from any details that could identify you. When the analysis is completed, all identifying information will be permanently destroyed by the Principal Investigator. The findings of the study will be reported in international publications and/or conferences. No information that could reveal your identity will be disclosed.

Who will access my personal data?
Your data will be handled in a confidential and secure manner. Only the principal researcher (Ms Isabela Girleanu, TCD) will have direct access to the information you provide. The study supervisor(s) (Dr. Vanessa Boland, TCD and Prof. Anne-Marie Brady, TCD) may review the codes research data to ensure academic quality but they will not have access to your personal identifying details. Your data will be stored securely within the EU and will not be transferred outside the EU.

How is the information kept confidential and secure?
Your privacy is important to us. We take many steps to make sure that we protect your confidentiality. The Principal Investigator (Isabela Girleanu, TCD) will encrypt your data by replacing your name with a code on all research data. They will securely keep the file which links your identity to the research separately. All research data will be held securely on TCD Microsoft SharePoint. Only the researchers mentioned will have access to this folder. The PI and co-investigators are governed by a professional code of ethics to maintain your confidentiality. The PI and co-investigators are trained in data protection law, and practice has been provided to those individuals involved in carrying out the research. A data protection impact assessment was carried out and the risk identified was (pending DPO review). Your data will be stored securely within the EU and will not be transferred outside the EU.

How long will my personal data be needed?
The research data will be retained for a period of 3 years post award of qualification. At that point, the link between you and your personal data will be securely deleted. The audio recording of the interview will be retained until it has been transcribed and the content verified, after which it will be securely deleted. The transcript and consent form will be retained for a period of 3 years post-award of qualification in line with TCD’s retention policy.

What is the lawful (legal) basis to use my personal data?
We will only use your data in the ways needed to conducting this research study following Article 6(1)(e) and Article 9(2)(j) of the General Data Protection Regulations (2018). We will also ask for your consent as a requirement of the Health Research Regulations.
What are my rights under Data Protection law?
As a participant of this research study, by law you are entitled to:
  • You have the right to request access to your personal data and to receive a copy of it free of charge, in writing and within one month (in exceptional circumstances this may be extended to two months); unless your request would make it impossible or make it very difficult to conduct the research.
  • You have the right to have any inaccurate personal data be corrected or deleted; unless your request would make it impossible or make it very difficult to conduct the research.
  • You have the right to have your personal data deleted; unless your request would make it impossible or make it very difficult to conduct the research.
  • You have the right to restrict or object the use of your personal data; unless your request would make it impossible or make it very difficult to conduct the research.
  • You have the right to manage your personal data for your own purposes across different digital platforms.
  • You have the right object to profiling or decisions to be made about your data by automated means.
By law you can exercise the above rights in relation to your personal data, unless the request would make it impossible or very difficult to conduct the research. For example, if the study is about to be published then we may not be able to delete data as it would impact on the results.

You can exercise these rights by contacting Miss Isabela Girleanu at email: girleani@tcd.ie and/or phone: 087 335 1883 or the Trinity College Data Protection Officer, Secretary’s Office, Trinity College Dublin, Dublin 2, Ireland. Email: dataprotection@tcd.ie. Website: https://www.tcd.ie/dataprotection/

Approval, Organising and Funding

Has this study been approved by a research ethics committee?
Yes, this study has been approved by the Faculty of Health Sciences Research Ethics Committee (REC), Trinity College Dublin. Approval was granted on (awaiting DPO decision). An annual report will be provided to the REC upon completion of the study.

Who is organising and funding this study?
The research is being conducted as part of an academic qualification [Ms Isabela Girleanu is a student on the Doctor of Philosophy programme with Trinity College Dublin, under the supervision of Professor Anne-Marie Brady and Dr Vanessa Boland]. This research is funded by the School of Nursing & Midwifery 3 year full-time PhD Scholarship, Trinity College Dublin. This study is not being conducted for commercial purposes.

Will I be paid for taking part?
No, we are not paying you to take part. However, you will be reimbursed for travel expenses due to your participation in this study.

Future Research
Will my personal data be used in future studies?
The data collected for the purpose of this study will not be used in future studies.
Further Information

What happens if I change my mind?
Your participation in this study is voluntary. You can change your mind and opt out even if the study has started. You do not have to give a reason for opting out. This will not affect your cancer care in any way.

If you would like to withdraw from the study, please contact Ms Isabela Girleanu at girleani@tcd.ie or on 087 335 1883, who can organise this for you.

We will discuss with if you are happy for us to continue to use information about you (personal data) which has already been collected. If you do not consent to your personal data being retained for this study, we will delete any information that could identify you.

Please note that we will not be able to remove personal data that has been shared or pooled for publication use before your request for deletion. We will not contact you again.

Who should I contact about participation or for further information/concerns?
If you would like to take part in this study, you will be asked to fill out a consent form and to provide your name and contact information before commencing the interview study. If you have any concerns or questions, you can contact: Principal Investigator: Ms Isabela Girleanu at email: girleani@tcd.ie and/or phone: 087 335 1883

If you have any questions in relation to your rights under data protection law, you can contact the Data Protection Officer, Trinity College Dublin: Data Protection Officer, Secretary’s Office, Trinity College Dublin, Dublin 2, Ireland. Email: dataprotection@tcd.ie. Website: https://www.tcd.ie/dataprotection/. Under GDPR, if you are not satisfied with how your data is being processed, you have the right to raise a concern with the Office of the Data Protection Commission, 21 Fitzwilliam Square South, Dublin 2, Ireland. Website: www.dataprotection.ie

Thank you for taking the time to read this Participant Information Leaflet and for considering participating in this study.

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