Participant Information Sheet for Interview


Study Title: RAPP: Responses to Alcohol and Pregnancy Policy
Researchers:  Fiona Woollard, Rachel Arkell, Rebecca Brione
University email: f.woollard@soton.ac.uk
ERGO number: 70549						

You are being invited to take part in the above research study. To help you decide whether you would like to take part or not, it is important that you understand why the research is being done and what it will involve. Please read the information below carefully and ask questions if anything is not clear or you would like more information before you decide to take part in this research.  You may like to discuss it with others but it is up to you to decide whether or not to take part. If you are happy to participate you will be asked to sign a consent form.

What is the research about?
Our names are Fiona Woollard, Rachel Arkell and Rebecca Brione.  Fiona is a Professor in Professor of Philosophy at the University of Southampton in the United Kingdom. Rachel is a Research and Projects Officer at the Centre for Reproductive Research and Communication at BPAS. Rebecca is a Research Assistant on our project, RAPP (Responses to Alcohol and Pregnancy Policy). The RAPP project is a collaboration between the University of Southampton and the Centre for Reproductive Research & Communication at BPAS, funded by the Public Policy|Southampton New Things Fund. We are trying to understand the impact of the introduction of mandatory alcohol screening from the perspective of midwives based in the U.K.

We are inviting you to participate in a study for the RAPP Project.  We want to hear the views of fully qualified midwives currently working as midwives in the U.K. including information about: current practice about alcohol and pregnancy; mandatory alcohol screening as part of routine antenatal care; future plans to transfer alcohol information to a childÕs health record; how this has impacted their relationships with patients; how this has impacted their view of their own role.

Why have I been asked to participate?
You have been asked to take part because you are a fully qualified midwife, currently working as a midwife in the U.K. 

We are aiming to recruit up to 6 participants for the follow up interviews. 

What will happen to me if I take part?
If you take part in this research, you will be invited to an individual interview about antenatal alcohol screening. The session should between 30 minutes and one hour.

The interview will be held on the University of Southampton Microsoft Teams. You will receive a link to join the interview.  You do not need to have a Microsoft Account to take part. A member of the research team will run the interview.  When you arrive, they will welcome you to the interview and ask whether you have any questions. After any questions are answered, they will ask you to confirm that you have signed the consent form and are happy to go ahead.

The interview will be audio and video recorded using the Microsoft Teams recording software. 

If connection issues or any other issues mean that we are unable to continue the interview on Teams, the interview will be moved to the telephone.  We will ask you to provide a telephone number in advance that the interview can use to call you if the connection to the Teams call is lost.  The telephone interview will be recorded on a separate recording device.


Are there any benefits in my taking part?
If you decide to take part in this study, your participation will contribute to knowledge in this area of research. 

We know that as a midwife you are very busy. To thank you for your time, participants that attend either the focus group or the follow up interview will be offered a £50 Love2Shop Highstreet gift voucher (https://highstreetvouchers.com).  You will receive this voucher if you attend the focus group or interview, even if you decide to withdraw during the focus group or interview.  Participants who have already received a £50 voucher for attending the focus group will not receive an additional voucher for attending the follow up interview.  

Are there any risks involved?
If you have been negatively affected by issues related to alcohol use in pregnancy or changes to your role and relationships with patients, some of the information we ask for may be distressing. However, we do not expect most participants to find the topics distressing.  You may take a break or stop the interview at any time if you feel uncomfortable or contact the following resources for support:

https://www.makebirthbetter.org/trauma-support-for-professionals

https://www.makebirthbetter.rog/help-for-professionals 

https://www.rcm.org.uk/caring-for-you-hub-home/health-and-wellbeing-support/

What data will be collected?
Before the interview begins, we will collect the following data: email correspondence with you arranging your participation in the interview; your contact details to arrange your participation in the interview, including a telephone number that we can call you on if the Team connection fails; your consent form.  

During the interview, we will ask you questions about (A) mandatory alcohol screening as part of Ôroutine antenatal careÕ; (B) the transferral of alcohol information from maternity records to childrenÕs health records; (C) the potential impact these measures could have on relationships between midwives and patients; and (D) the potential impact these measures could have on the professional identity of midwives.

The interview will be audio and video recorded using the Microsoft Teams recording software. A transcript of the interview will be generated using Microsoft TeamsÕ automatic transcription.  Fiona Woollard will produce a corrected transcript checking the automatic transcription against the recording.  Any identifying details will be removed from the corrected transcript.  

If connection issues or any other issues mean that we are unable to continue the interview on Teams, the interview will be moved to the telephone.  The telephone interview will be recorded on a separate password-protected recording device.  Fiona Woollard will produce a transcript from recording. Any identifying details will be removed from the corrected transcript.  

 
Will my participation be confidential?
Your participation and the information we collect about you during the course of the research will be kept strictly confidential. 

Members of the research team and responsible members of the University of Southampton may be given access to data about you for monitoring purposes and/or to carry out an audit of the study to ensure that the research is complying with applicable regulations. Individuals from regulatory authorities (people who check that we are carrying out the study correctly) may require access to your data. All of these people have a duty to keep your information, as a research participant, strictly confidential.

Any emails will be stored in a password protected University of Southampton email account and deleted when the study is finished.  

Your contact details will be stored in a password protected University of Southampton OneDrive storage. Members of the research team from outside the University of Southampton may be given access to this information in order to make arrangements for the interviews.  Your contact details will be deleted when the study is finished.

Your consent form will be stored securely on the University of Southampton OneDrive storage.  Members of the research team from outside the University of Southampton will not be given access to the consent form.   

The audio/video recording and automatically generated transcript will be initially stored on the University of Southampton Microsoft Teams system before being downloaded to the password protected University of Southampton OneDrive storage.  They will be deleted once the corrected transcript has been produced. Members of the research team outside the University of Southampton will not be given access to the audio/video recording or automatically generated transcript.

If connection issues or any other issues mean that we are unable to continue the interview on Teams, the interview will be moved to the telephone.  The telephone interview will be recorded on a separate recording device.  The device will be passport protected.  The recording will be downloaded from the device and stored on the password protected University of Southampton OneDrive storage. Fiona Woollard will produce a transcript from the recording. Any identifying details will be removed from the corrected transcript.  

The corrected transcript, with identifying details removed, will be stored securely on the University of Southampton OneDrive storage.  Members of the research team from outside the University of Southampton will be given access to the corrected transcript with identifying details removed.  You will also be given the opportunity to see the corrected transcript with identifying details removed.

After the study, the corrected transcript (with any identifying information removed) will be archived in the University of Southampton data repository so it can be used for future research and learning.

Do I have to take part?
No, it is entirely up to you to decide whether or not to take part. If you decide you want to take part, you will need to sign a consent form to show you have agreed to take part. 

What happens if I change my mind?
You have the right to change your mind and withdraw at any time until the end of the study without giving a reason and without your participant rights being affected.  If you wish to withdraw before the interview has started, please inform the researchers by emailing f.woollard@soton.ac.uk. If you wish to withdraw during the interview, you can tell the researcher running the interview verbally or by using the chat function, then simply press the leave button.  

If you withdraw from the study, after preliminary results have been analysed/ published, we will keep the information about you that we have already obtained only when required to support the already analysed/ published material.

What will happen to the results of the research?
Your personal details will remain strictly confidential. Research findings made available in any reports or publications will not include information that can directly identify you.

The information collected will be analysed and published in policy briefs, reports and academic papers. It may also be used in conference presentations or work aimed at a popular audience. 

After the study, the corrected transcript (with any identifying information removed) will be archived in the University of Southampton data repository so it can be used for future research and learning.

Please email f.woollard@soton.ac.uk if you would like to see the corrected transcript (with any identifying information removed) or would like us to share any outcomes arising from the study with you.


Where can I get more information?
Email Fiona Woollard f.woollard@soton.ac.uk 

What happens if there is a problem?
If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions. 
You can contact the researchers by email at f.woollard@soton.ac.uk 
If you remain unhappy or have a complaint about any aspect of this study, please contact the University of Southampton Research Integrity and Governance Manager (023 8059 5058, rgoinfo@soton.ac.uk).


Data Protection Privacy Notices
The University of Southampton conducts research to the highest standards of research integrity. As a publicly-funded organisation, the University has to ensure that it is in the public interest when we use personally-identifiable information about people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use information about you in the ways needed, and for the purposes specified, to conduct and complete the research project. Under data protection law, ÔPersonal dataÕ means any information that relates to and is capable of identifying a living individual. The UniversityÕs data protection policy governing the use of personal data by the University can be found on its website (https://www.southampton.ac.uk/legalservices/what-we-do/data-protection-and-foi.page). 

This Participant Information Sheet tells you what data will be collected for this project and whether this includes any personal data. Please ask the research team if you have any questions or are unclear what data is being collected about you. 

Our privacy notice for research participants provides more information on how the University of Southampton collects and uses your personal data when you take part in one of our research projects and can be found at http://www.southampton.ac.uk/assets/sharepoint/intranet/ls/Public/Research%20and%20Integrity%20Privacy%20Notice/Privacy%20Notice%20for%20Research%20Participants.pdf 

Any personal data we collect in this study will be used only for the purposes of carrying out our research and will be handled according to the UniversityÕs policies in line with data protection law. If any personal data is used from which you can be identified directly, it will not be disclosed to anyone else without your consent unless the University of Southampton is required by law to disclose it. 

Data protection law requires us to have a valid legal reason (Ôlawful basisÕ) to process and use your Personal data. The lawful basis for processing personal information in this research study is for the performance of a task carried out in the public interest. Personal data collected for research will not be used for any other purpose.

For the purposes of data protection law, the University of Southampton is the ÔData ControllerÕ for this study, which means that we are responsible for looking after your information and using it properly. The University of Southampton will keep your consent forms Ð which contain identifiable information about you - for 10 years after the study has finished after which time any link between you and your information will be removed.

To safeguard your rights, we will use the minimum personal data necessary to achieve our research study objectives. Your data protection rights Ð such as to access, change, or transfer such information - may be limited, however, in order for the research output to be reliable and accurate. The University will not do anything with your personal data that you would not reasonably expect. 

If you have any questions about how your personal data is used, or wish to exercise any of your rights, please consult the UniversityÕs data protection webpage (https://www.southampton.ac.uk/legalservices/what-we-do/data-protection-and-foi.page) where you can make a request using our online form. If you need further assistance, please contact the UniversityÕs Data Protection Officer (data.protection@soton.ac.uk).

This project is a collaboration between researchers at the University of Southampton and the Centre for Reproductive Research and Communication at BPAS, funded by the Public Policy at Southampton New Things Fund.  The funding allowed us to hire a research assistant to conduct the focus groups and contribute to study design and analysis. Members of the research team outside the University of Southampton will be given access to (a) contact details for arranging focus groups and interviews; (b) anonymous data from the online research survey Ð once it has been downloaded and confirmed it contains no identifying data; (c) the corrected transcripts of the focus groups and interviews when all identifying data has been removed. 

The interview will take place on Microsoft Teams, a third-party platform.ÊÊ This third party may have access to your data.Ê There is also a very small possibility the interview could be listened to by unauthorised third parties (e.g., computer hackers).Ê The.
Microsoft Teams Privacy Statement is here:Êhttps://privacy.microsoft.com/en-gb/privacystatement

After the study, the corrected transcript (with any identifying information removed) will be archived in the University of Southampton data repository so it can be used for future research and learning.

Thank you.
Thank you for taking the time to read the information sheet and considering taking part in our research.















4/5/2022 Version 2		[ERGO number 70549]