Introduction

• You are being invited to take part in a research study. Before you decide whether to take part you need to understand why we are doing this research and what is involved.
• Please take time to read this leaflet. The purpose of this document is to explain to you what this study is about and what your participation would involve. This study is called ‘Women’s experiences and perceptions of pregnancy and/or birth complications. The project is supervised by supervisors from University College Cork, Cork University Hospital, and INFANT Research Centre.

The option to take part is at the bottom of the form, Thank you.

What is this study about?

•  We want to understand how pregnancy and/or birth complications affect mental health. We also want to know what supports women in Ireland, like you need.

Why is this study being done?

•  To guide the development of better support for women who experience complications during pregnancy and birth. 

What will happen if you take part in this study?

• If you choose to take part, you will take part in an interview with me (Elizabeth). At the beginning of the interview, I will ask you some questions about yourself. We will then speak about your experiences for about 40 -60 minutes online or in person.
• The interview will be audio recorded using a voice recorder. The interview will be transcribed and then deleted. The transcribed interview will not contain names or any identifying information about you.
• As part of the study, we ask for your email address and/or contact number. This will only be used to contact you for the interview and will only be available to the research team.
• All your personal information will be kept safe in a password-protected laptop/ UCC secure cloud-based storage repository for the study and will only be accessible to the project team.

Why have you been asked to take part in this study?

• You can provide unique insights into the experience of being a woman living in Ireland aged 18 years and older who has experienced pregnancy and/or birth complications between 12 months and 5 years ago.

Do you have to take part in this study?

• Taking part in the study is voluntary, you do not have to participate. If you decide to take part, you can choose not to answer specific questions.

How will your data be used and privacy protected?

• The primary data for this study is in the format of audio recordings and the transcripts of the recordings. The recordings will be deleted once transcribed.
• The transcripts will not contain any identifying information and will be stored safely on Elizabeth’s authenticated UCC OneDrive account for the duration of the study.
• All identifying features will be removed and replaced with a unique code, assigned to you when you join the study.
• You can withdraw your consent from the study up until two weeks after the interview. At this point, your interview transcripts will be unidentifiable and the data can no longer be removed from the study.
• After the interview, your identity will remain private at all times.

What are the benefits and risks of participating in this study?

• By participating in this study you are contributing to important research on pregnancy and birth complications. We hope that the results from this study will help to improve the quality of service received by women who experience pregnancy and birth complications.
• As we will talk about your personal experiences in the interview, some people may find talking about these difficult. There may be private topics that are discussed during the interview. You have the option not to answer questions or to stop the interview process at any point. If you experience distress during or after the interview, steps will immediately be taken to make sure you get any necessary support.

What will happen to the results of this study?

• The results of this study will be published in academic journals and presented at scientific meetings. You will never be identified individually during these presentations or any reports or publications.

What will happen to the information from this study?

• University College Cork (UCC) is the study’s Sponsor and will act as the data controller for this study. Any personal data which you provide to the University will be treated with the highest standards of security and confidentiality, by Irish and European Data Protection legislation. Any personal data you provide to us during the study will be processed fairly and lawfully.
• Signing the Informed Consent Form means that your data will be used for the purposes outlined in this Participant Information Leaflet (PIL).
• The study investigators and the members of the study team will use your data within the scope defined above.
• If the clinical site staff, study researcher, or study team wishes to use your data for a purpose other than the purpose specified, the researcher must contact you again to give you more information and ask your permission to use your data for the new purpose. The General Data Protection Regulation (GDPR) allows us to process your data because you have provided your consent and because the research is of substantial public interest (Articles 6(1) (e) and 9(2) (j) of the GDPR). 

For how long will this data be kept?

• We will keep identifiable information about you from this study for 10 years after the study has concluded, as per the UCC Code of Research Conduct document.
• If you have any complaints in connection with our processing of your data, you can contact DPO, UCC's Information Compliance Section: Office of Corporate & Legal Affairs, University College Cork, Western Road @ gdpr@ucc.ie
• You also have the right to complain to the Data Protection Commission if you are unhappy with our processing of your data. Details of how to complain can be found on the Data Protection Commission’s website (www.dataprotection.ie), or by telephoning 1890 252 231.

Who has reviewed this study?

• All research in Ireland is carefully reviewed by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, well-being, and dignity. This study has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC).

What will happen if I do not wish to carry on in this study?

• You are free to withdraw at any time, for any reason without giving a reason. This will not affect the high level of care you will expect for yourself. If you decide to withdraw from the study, you have the right to request that your data be deleted up to the time of transcription, or two weeks after the data was collected.

Where can I get more information?

• If you have any further questions regarding this study, please contact the Ms Elizabeth Bodunde- ebodunde@ucc.ie  or Dr. Karen Matvienko-Sikar karen.msikar@ucc.ie  or call Tel: 0874070012.

Interested in this study?

If you would like to talk to us about your experiences, please fill out the form and we will contact you.