Information for Participants
You are being invited to take part in a research study to be carried out by Dr Shona Lee at the Royal College of Surgeons in Ireland (RCSI). The study’s short title is ‘TeenPath Covid’, and will be referred to by this title throughout this information sheet.
Before you decide whether or not you wish to take part, you should read the information provided below carefully and discuss it with your parent(s) or legal guardian(s). Take time to ask questions – don’t feel rushed and don’t feel under pressure to make a quick decision.
You should clearly understand the risks and benefits of taking part in this study so that 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. If you decide not to take part it won’t affect you or anyone else. 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. If you do opt out, whatever information we have about you will be destroyed and nothing further will happen.
Why is this study being done?
TeenPath Covid is a research study being carried out to find out how young people in Ireland have experienced the COVID-19 pandemic, and what impacts it may have had on their health and well-being. We particularly would like to understand how some young people in socially and economically disadvantaged circumstances may have experienced the pandemic differently from others, what has helped them during this period, and how they can be better supported. An important aspect of the project is that it will directly involve young people and key organisations to help inform decisions about how young people are supported at this time.
We are inviting people aged 16-25 to participate in our study by taking part in a one-to-one interview about their experiences of the pandemic, and its impact on their social connections and health.
Who is organising and funding this study?
This study is being funded by an EU Marie Skłodowska-Curie Actions post-doctoral Individual Fellowship, held by Dr Shona Lee who is the Principal Investigator conducting the research. The study is funded for 24 months (July 2021 – July 2023) and is being carried out at the Department of Public Health and Epidemiology at the Royal College of Surgeons in Ireland under the supervision of Dr Debbi Stanistreet.
Why am I being asked to take part?
You are being asked to take part in this study because you are aged 16-25, living in Ireland. We welcome anyone in this age group to take part in an interview and share their views with us.
How will the study be carried out?
We are looking for participants across Ireland, including urban and rural locations to complete our online survey and to take part in an online interview. You can choose to do either or both. More details about the survey and interview are outlined in the section ‘What will happen to me if I agree to take part?’ below.
What will happen to me if I agree to take part?
Informed Consent
If you agree to take part in this study, you will be asked to sign a sheet called an ‘Informed Consent Form’. You must read and indicate that you agree with each of the statements in the form before signing it. The form will ask if you have been given information about the study (this document), if you have been given an opportunity to ask any questions you might have, and whether you understand the potential risks and benefits of the study. If you feel you have not had this information or you have not understood it fully, do not sign the form. You can speak to the principle researcher (Shona Lee) who will be able to answer any questions you have. We encourage you to take enough time (at least 3 days) to discuss this information with you parents or legal guardians, and think about whether you want to join the study.
Once you have read and understood all the study information, if you decide you would like to take part then you can sign the consent form. If you are under the age of 18, your parent or legal guardian must also sign a consent form to give us permission for you to join. Once you have signed the consent form you will be enrolled in the TeenPath Covid study. You can leave the study at any time without any cost or consequence. You do not have to give us a reason for leaving, but please do inform us if this is your decision, as it will allow us to find another participant to take your place in the study. If you choose to leave, we will withdraw you from the study and delete all records of your participation and any information we have collected about you.
Online Survey
We are inviting people aged 16-25 to participate in our study by completing an online questionnaire about their mental health and wellbeing.
Once you have read this information you can sign the online consent form at the beginning of the survey. If you are under the age of 18, your parent or legal guardian must also sign the form. This is because we also legally require their permission for you to participate in the research while you are under the age of 18.
You will then be directed to a questionnaire to complete in your own time. The questionnaire should take no longer than 10-20 minutes to complete. Once you submit your survey form your responses will be recorded in our database.
If you choose to withdraw from the study, please contact us using the details below and we will delete all records of your participation and any information we have collected about you.
The survey will ask you questions about your experiences of the COVID-19 pandemic, your current mental and social wellbeing.
In-depth Interview
The interview will be conducted by the lead researcher (Shona Lee) and will be arranged with you at a time and in a place where you will be comfortable to speak privately. However, you can choose to have an adult present (a parent, or a member of youth service staff, or another researcher) during the interview if you prefer.
The interview can take place at a date and time of your choosing, either in person, or online using a free video conferencing platform such as Microsoft Teams or Zoom. The interview should take no longer than 1 hour, but if you need to leave at any time please let us know and we will end the interview and can arrange to finish it another time. You can let us know before or during the interview that you would like to avoid certain topics and can refuse to answer any questions without giving us a reason. If you feel uncomfortable or upset at any point during the interview, please let the researcher know and they will pause or end the interview.
The interview will cover topics such as: your experiences of the COVID-19 pandemic; your health and health behaviours during and since the pandemic began; your personal social connections and how these have been impacted by the pandemic; what has helped you cope throughout this period, and what could help support you now and in future.
Video/and or Audio recordings?
An audio voice recording of the in-depth interview will be made so that an accurate transcript (electronic word document) of our conversation can be created that we can read and analyse. No personal information that can identify you will be attached to this file and will be saved electronically in a secure place. The recording will also be deleted from our records once we have received the transcript. If you do not wish your voice to be recorded, please let the researcher know, and hand-written notes can be taken instead.
The file will be transferred securely to a third-party transcriber who will type the conversation into text. The transcriber will have signed a contract that strictly sets out the conditions of confidentiality, and forbid them from keeping or sharing the audio file after the transcript has been produced and returned to us. Once we have the final transcript, the audio file of your interview will be deleted from our records.
What are the benefits?
There are no direct individual benefits in taking part in this research. By taking part you can help researchers and policy decision-makers understand young people’s experiences during the pandemic and find ways to address particular challenges they face. Others may benefit from recommendations made based on the study’s findings, and your involvement throughout the project will improve its value and relevance to science and society.
What are the risks?
There is low risk to you taking part in this research. However, no study is completely without risks, and we try to minimise these wherever possible. This may include experiencing psychological or emotional distress when discussing sensitive and upsetting topics during an interview, particularly where these could trigger any traumatic experiences you may have had.
We will make a topic guide of the interview available to you in advance, so that you can see some of the subjects we will cover. If you feel you would not like to discuss certain subjects in the topic guide, please let us know in advance. You do not need to give us any reason why, and we will make a note to avoid this topic in your interview. During the interview, you may also refuse to answer any question you do not wish to without giving an explanation. You will not be expected or pressured to talk about anything you do not want to.
There are some aspects of the study that involve giving us some personal information about yourself when you join the study, for example your age and gender, and your telephone number or email address so we can contact you to arrange interviews, invite you to activities or events, or inform you of any important changes to the study. This personal information will be deleted from our records at the soonest possible opportunity once we no longer need to contact you (e.g. after we have finished sharing our results). Please see the section below on ‘Data Protection’ to learn more about how we store, manage, and protect all of your data during and after the study.
What if something goes wrong when I’m taking part in this study?
If something happens to you during the study that affects your ability to continue taking part, please let us know. Again, you do not need to explain your reasons or go into detail about why you would like to leave, your decision will be completely respected. If you have concerns about the conduct of the study or you wish to make a complaint at any time, you can do this by contacting the Royal College of Surgeons Ethics Committee at recadmin@rcsi.ie or by phone on +353 1 402 2205.
If you become uncomfortable or upset during the interview, let the researcher know and they will pause or end the interview. You can then decide whether to resume the interview at another time, or to decline to be interviewed. We can direct you to support resources and services such as counselling if you require them as a result of your taking part in the study.
We will keep everything you share with us as part of the study private and confidential. However, if something gives us cause for concern that either you or any other vulnerable person or child are in danger, then legally we must contact the relevant authorities and break confidentiality (report what you have told us). If you raise any concerns with us or tell us something that make us worried that you are at risk we are also obliged under the Criminal Justice Act 2012 to report to the Gardaí any information relating to offences against children and vulnerable persons, including sexual offence against anyone under the age of 18. These are the only situations where we will break confidentiality and reveal any personal details about you to anyone outside of the project.
Will it cost me anything to take part?
It will not cost you anything to take part in this study. Any expenses in taking part in this study will be arranged at the cost of the project. At the end of the study (once we have completed all of our interviews) you will receive a pre-paid ‘one4all’ gift voucher to the value of €20 as a token of appreciation for your time.
Is the study confidential?
Records
The information you provide us will be strictly confidential, except for purposes of child protection, where in the event that you raise concerns about your safety or wellbeing we would need to notify the relevant authorities.
The only data processors (people who can access or handle your personal data) are the project leader (Shona Lee) and a third-party transcription service. Only the researcher (Dr Shona Lee) will know what you have shared in in the interview. Information that we will keep that could potentially identify you will be your name, age, or location (town or city name). Each person taking part in the study will be given a unique identifier code (e.g. ‘TP_UB_17’) that will be used to refer to them and any data relating to them throughout the study. This made up name is called a ‘pseudonym’ that we use to link all of your information without revealing your identity. You can learn more about how we protect your personal information in the section below on ‘Data Protection’.
Your personal details – such as your name, address, telephone number or email address – will remain completely confidential (private) and will not be shared with anyone outside of the TeenPath Covid study (except with regard to the national Child First and Criminal Justice Act obligations outlined above). Reports or papers written about the study will not include any information that would identify you.
Your research data will be kept on a secure online server in a password protected folder. Only the lead researcher will have access to this folder. Data will be processed (read, organised, analysed and stored) on an encrypted, password protected laptop that will be kept secure at all times. Processed data will be saved onto the server and not kept on any one device, including portable devices such as USB keys or tablets.
We will keep your information for 10 years after the end of the study, in line with data retention recommendations of the RCSI Research Data Management Policy. However, as time passes and your situation changes (e.g. leaving school, moving home, applying for jobs, going to college etc.) we understand that some things that were not important or anonymous now may become significant and you might change your mind about what the information we have stored. We will review periodically (every year) the information we hold on participants and erase anything no longer necessary. You can request to have your data updated or removed at any time. All of the information we have about you will be destroyed after 10 years.
Results
You will receive the results of the study through a number of dissemination (results sharing) activities. This includes the end of project policy workshop where we will share and discuss some of the study’s early findings, but also academic papers (research articles published in scientific journals), press releases and blog entries shared online and through social media. The findings will also be presented at academic conferences and meetings. No information capable of identifying you in any way will appear in these publications or presentations. We will notify you of any materials resulting from the research as they become publically available using the contact details you provide us when you join the study.
Data Protection
1. We will be using your personal information in our research to help us study the impacts of the COVID-19 pandemic on the health and well-being of young people in Ireland. We need to know some personal information about you, such as your gender and age to understand the profile of our participants individually and as a group and help us interpret our results.
2. The use of participant data associated with this project is covered by the EU General Data Protection Regulation (Regulation (EU) 2016/679) (GDPR). The lawful basis for processing pseudonymised personal data is that processing is necessary for the purposes of the legitimate interests pursued by the controller (Dr Shona Lee) (Article 6(1)(f)), and for archiving purposes in the public interest, scientific or historical research purposes (Article 9(2)(j)).
3. The recipients of the data (who will have access to your information) are limited to the named Principal Investigator (lead researcher) on the project, Shona Lee. While your data is pseudonymised, no other person except the lead researcher (Shona Lee) will have access to your personal information that could identify you. Only once this data associated with you is fully anonymised (cannot be linked to you personally in any way), it will be accessible to other named researchers on the TeenPath Covid project team so that it can be analysed thoroughly.
4. The TeenPath Covid study is participating in the Open Research Data Pilot (ORDP), which aims to improve and maximise access to and re-use of research data generated by Horizon 2020 projects. The ORDP applies primarily to the data needed to validate the results presented in scientific publications. All anonymised data will be stored in an open-access data repository for Open Access publication, and will be deleted after a 10 year period.
5. There are some risks associated with processing your data that could affect you directly or indirectly. For example, if your data is lost or accessed by unauthorised third parties (data breach) it is possible that your personal identity could be revealed and linked to you and your study data. We minimise this risk as much as possible by implementing strategies to keep your data stored as securely as possible at all times in line with our Data Management Plan, developed in line with RCSI data management policies. In the unlikely event that your data is compromised in any way, we will contact and notify you immediately.
6. You have the right to withdraw consent to your personal data being used in this research project. You will be able to do this by contacting Dr Shona Lee at shonajlee@rcsi.ie and clearly stating that you no longer wish to take part in the study and would like to withdraw your data from being used. You will receive a formal notification to confirm that you have been withdrawn from the study and your data has been destroyed.
7. You have a right to lodge a complaint with the Data Protection Commissioner if you are concerned that your data is being mismanaged and places you or anyone else at risk. You can contact RCSI’s Data Protection Officer data at dataprotection@rcsi.ie to report any concerns about the project. You can find out more at https://www.dataprotection.ie/ and navigate to the ‘take action’ panel to raise a concern with the Data Protection Commissioner.
8. You have a right to request access to your data and a copy of it, unless this request would make it impossible or make it very difficult to conduct the research. You can make this request by contacting the lead researcher Shona Lee at shonajlee@rcsi.ie and copying in RCSI’s Data Protection Officer data dataprotection@rcsi.ie. Our Data Protection Officer is responsible for monitoring compliance with relevant legislation in relation to the protection of personal data.
9. You have a right to restrict or object to processing, unless this request would make it impossible or make it very difficult to conduct the research e.g. if you don’t mind having it collected and stored, but don’t want your data analysed or shared.
10. You have a right to have any inaccurate information about you corrected or deleted, unless this request would make it impossible or make it very difficult to conduct the research. If you believe we have stored incorrect or inaccurate information about you, you can contact Shona Lee at shonajlee@rcsi.ie and request this information be corrected or removed.
11. You have a right to have your personal data deleted, unless this request would make it impossible or make it very difficult to conduct the research. For example, if you wanted us to delete your data at the end of a research project just before it is due to be published. You have the right to withdraw consent to your personal data being used in this research project. You will be able to do this by contacting Shona Lee at shonajlee@rcsi.ie and making a formal request to withdraw from the study and have your data being deleted. This will require filling out a form where you will specific which data you are requesting to see, amend, or erase.
12. You have a right to data portability, meaning you have a right to move your data in a readable format (saved onto a USB or printed off) and given from one Data Controller to another.
13. This study will involve some degree of profiling. Profiling is any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to the person, for example to analyse aspects of health or behaviour.
14. You have a right to object to automated processing including profiling if you wish.
15. We will inform you if we intend to further process your personal data and provide you with information on that other purpose.
16. We will inform you if we wish to transfer your data to a country outside of the EU or an international organisation and will advise you of the safeguards we have in place to protect your data.
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 this won’t affect you or your involvement in any future research projects you may wish to participate in. If you need any further information now or at any time in the future, please contact:
Dr Shona Lee
Department of Public Health and Epidemiology, Beaux Lane House, Dublin 2
Email: teenpath@rcsi.ie or shonajlee@rcsi.ie
Phone: 0892009693
Principal investigator’s name: Shona Lee
Principal investigator’s title: Dr
Telephone number of principal investigator: 0892009693
Consultant/co-investigator’s name: Debbi Stanistreet
Consultant/co-investigator’s title: Dr
Data Controller’s/joint Controller’s Identity: Dr Shona Lee
Data Controller’s/joint Controller’s Contact Details: shonajlee@rcsi.ie
Data Protection Officer’s Identity: Dónall King
Data Protection Officer’s Contact Details: dataprotection@rcsi.ie