Ref & Version: 191211/1
Ethics ID number: 63021
Date: 23/03/2025
Participant Information Sheet
The title of the research project
Understanding the decision-making process for women with common mental disorders around prescribed psychiatric medication use during pregnancy.
Invitation to take part
You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.
Who is organising/funding the research?
My name is Jess Correia. I am a registered midwife and currently completing my postgraduate research masters at Bournemouth University. My degree is funded by the National Institute for Health Research. As part of my project, I am supported by a team of academic researchers and clinicians. The team include; Dr Steve Trenoweth, academic and registered mental health nurse and Dr Daisy Wiggins, academic and registered midwife.
What is the purpose of the project?
The aim of this project is to help understand how women and birthing people make decisions about the use of prescribed psychiatric medication in pregnancy. The term birthing people is used to describe any person who experiences childbirth regardless of their gender identity. It is not possible for clinicians to determine safety of these medications during pregnancy. This can make it challenging for women to make an informed decision. There are lots of sources of information available to women and other people may also play a role in their decision. This study seeks to understand what influences the decision women make and why. This will help give clinical recommendations to improve counselling around medication and address potential misinformation.
Why have I been invited?
You have been invited because you have struggled with mood, anxiety and/or stress during pregnancy. You may not have a diagnosis of a mental health disorder but have either accepted or declined psychiatric medication during pregnancy. Examples of diagnoses that are relevant to this study include; depression and generalised anxiety. You will have had a baby within the last 3 years and are aged 18 or over.
What would taking part involve?
Taking part in this research study will involve a 1-1 interview via Microsoft Teams or Zoom. It is anticipated that the interviews will take no longer than 1 hour. Interviews may take place face-face if this is preferred and will be arranged for a time and date mutually agreed by yourself and the researcher.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a participant agreement form. We want you to understand what participation involves, before you make a decision on whether to participate.
If you or any family member have an on-going relationship with BU or the research team, e.g. as a member of staff, as student or other service user, your decision on whether to take part (or continue to take part) will not affect this relationship in any way.
Can I change my mind about taking part?
After you decide to withdraw from the study, we will not collect any further information from or about you.
If I change my mind, what happens to my information?
After you decide to withdraw from the study, we will not collect any further information from or about you.
As regards to the information we have already collected before this point, your rights to access, change or move that information are limited. This is because we need to manage your information in specific ways for the research to be reliable and accurate. Further explanation about this is in the Personal Information section below.
Will I be reimbursed for taking part?
Participants will be offered a £25 shopping voucher as reimbursement for their time and contributions to the research project. These will be sent following completion of the 1-1 interview.
What are the advantages and possible disadvantages or risks of taking part?
Whilst there are no immediate benefits to you participating in the project, it is hoped that this work will help to understand how health professionals can better support women and birthing people making decisions around the use of prescribed medication in pregnancy.
Whilst we do not anticipate any risks to you in taking part in this study, you may find it difficult to talk about the decisions you made. Pregnancy and childbirth are important milestones in our lives and re-visiting this may lead to emotional discussions. Should you feel that you need to talk further you will be signposted to appropriate further support.
What type of information will be sought from me and why is the collection of this information relevant for achieving the research project’s objectives?
Limited demographic information will be collected to ensure anonymity. However, you will be asked about your age both current and at the time of having your pregnancy. Interview questions will explore what information you used to help make your decision, including discussions with the people in your life or past experiences that may have influenced your decision. Interviews will explore cultural, religious or societal influences that may have impacted your decision and ask you to consider whether your views of medication use in pregnancy have since changed.
Will I be recorded, and how will the recorded media be used?
The interview will be recorded. The audio and video recordings of your activities made during this research will be used only for analysis and the transcription of the recording(s) for illustration in conference presentations, publication and lectures. No other use will be made of them without your written permission, and no one outside the project will be allowed access to the original recordings.
How will my information be managed?
Bournemouth University (BU) is the organisation with overall responsibility for this study and the Data Controller of your personal information, which means that we are responsible for looking after your information and using it appropriately. Research is a task that we perform in the public interest, as part of our core function as a university.
Undertaking this research study involves collecting and/or generating information about you. We manage research data strictly in accordance with:
· Ethical requirements; and
· Current data protection laws. These control use of information about identifiable individuals, but do not apply to anonymous research data: “anonymous” means that we have either removed or not collected any pieces of data or links to other data which identify a specific person as the subject or source of a research result.
BU’s Research Participant Privacy Notice sets out more information about how we fulfil our responsibilities as a data controller and about your rights as an individual under the data protection legislation. We ask you to read this Notice so that you can fully understand the basis on which we will process your personal information.
Research data will be used only for the purposes of the study or related uses identified in the Privacy Notice or this Information Sheet. To safeguard your rights in relation to your personal information, we will use the minimum personally-identifiable information possible and control access to that data as described below.
Publication
You will not be able to be identified in any external reports or publications about the research without your specific consent. Otherwise, your information will only be included in these materials in an anonymous form, i.e. you will not be identifiable. Should you wish to have a copy of the final research findings either as the full write up, a summary and/or a short video summary this will be shared with you via the email address you provide once the project is complete.
Security and access controls
BU will hold the information we collect about you in hard copy in a secure location and on a BU password protected secure network where held electronically.
Personal information which has not been anonymised will be accessed and used only by appropriate, authorised individuals and when this is necessary for the purposes of the research or another purpose identified in the Privacy Notice. This may include giving access to BU staff or others responsible for monitoring and/or audit of the study, who need to ensure that the research is complying with applicable regulations.
Further use of your information
The information collected about you may be used to support other research projects in the future and access to it will not be restricted. You will not be able to be identified in the data without your specific consent. To enable this use, the data will be added to an appropriate research data repository such as BORDaR (BU’s Data Repository): this is a central location where data is stored, which is accessible to the public.
Keeping your information if you withdraw from the study
If you withdraw from active participation in the study we will keep information which we have already collected from or about you, if this has on-going relevance or value to the study. This may include your personal identifiable information. As explained above, your legal rights to access, change, delete or move this information are limited as we need to manage your information in specific ways in order for the research to be reliable and accurate. However if you have concerns about how this will affect you personally, you can raise these with the research team when you withdraw from the study.
You can find out more about your rights in relation to your data and how to raise queries or complaints in our Privacy Notice.
Retention of research data
Project governance documentation, including copies of signed participant agreements: we keep this documentation for a long period after completion of the research, so that we have records of how we conducted the research and who took part. The only personal information in this documentation will be your name and signature, and we will not be able to link this to any anonymised research results.
Research results:
As described above, during the course of the study we will anonymise the information we have collected about you as an individual. This means that we will not hold your personal information in identifiable form after we have completed the research activities.
You can find more specific information about retention periods for personal information in our Privacy Notice.
We keep anonymised research data indefinitely, so that it can be used for other research as described above.
Contact for further information
If you have any questions or would like further information, please contact:
Jessica Correia - Lead Researcher CorreiaJ@bournemouth.ac.uk
Dr. Steve Trenoweth - Lead Supervisor Strenoweth@bournemouth.ac.uk
Dr. Daisy Wiggins - Supervisor DWiggins@bournemouth.ac.uk
In case of complaints
Any concerns about the study should be directed to Professor Jane Murphy, Deputy Dean for Research & Professional Practice for Health and Social Sciences at Bournemouth University by email to researchgovernance@bournemouth.ac.uk.
Finally
If you decide to take part, you will be given a copy of the information sheet and a signed participant agreement form to keep.
Thank you for considering taking part in this research project. To register your interest please click the link below.