SIMCA Participant information and consent form

For national and regional stakeholders

 
If you have been involved in discussions and/or decisions about the implementation of Midwifery Continuity of Carer (MCoC), we would like to hear from you. These activities relating to the MCoC may have been a central part of your professional role or just one element of your work. 
We would like to talk with a wide range of national and regional stakeholders to achieve multiple perspectives on how MCoC implementation decisions have been made and operationalised in different places. 

Read the complete information for participants

Factors influencing the implementation of the Midwifery Continuity of Carer (MCoC) model of care in England: national and regional stakeholder interviews.

Chief Investigator: Professor Aled Jones, Professor of Patient Safety and Healthcare Quality, University of Plymouth
Sponsor: University of Plymouth, reference AM1001431
You are being invited to take part in a research project. Before you decide whether or not to take part, it is important for you to understand why the research is being undertaken and what it will involve. Please take time to read the following information carefully and discuss it with others, if you wish, and ask us if there is anything that is not clear.
1. What is the purpose of this research project?
The purpose of this project is to explore the factors influencing the implementation of Midwifery Continuity of Carer model of care in England, and to examine differences in how MCoC implementation has been operationalised, sustained and experienced in different services across England. 
2. Why have I been invited to take part?
You have been invited to take part because you have been involved in discussions and/or decisions about the implementation of MCoC. It may have been a central part of your professional role or just one element of your work; we want to talk with a wide range of national and regional stakeholders to achieve multiple perspectives on how MCoC implementation decisions have been made and operationalised in different places.
3. Do I have to take part?
No, your participation in this research project is entirely voluntary. It is up to you to decide whether or not to take part and there will be no negative outcomes should you decline. You are free to withdraw your consent to participate in the research project at any time, without giving a reason, even after giving oral and/or written consent. If you withdraw from the study before 30 September 2024 you can request your interview data to be destroyed. However, it will not be possible to destroy data after this date, due to data analysis and report writing.
4. What will taking part involve?
If you decide to take part you will be asked to participate in an interview with a researcher from University of Plymouth or Cardiff University. This may take place via video e.g. Microsoft Teams, Zoom or telephone. The researcher will contact you to arrange a convenient time for the interview which will take up to an hour. Prior to the interview you will be asked to complete a consent form. During the interview you will be asked about your knowledge and experiences in relation to MCoC. The researcher will ask for your agreement to record the interview for subsequent transcription and analysis.
5. What are the possible benefits of taking part?
This study addresses an important issue around the delivery and continuity of midwifery care. Exploring how MCoC has been operationalised is crucial to creating a better understanding of midwifery services and how services change is implemented and managed. So although there will be no direct advantages or benefits to you from taking part, your contribution will help us understand and influence future implementation of MCoC and other similarly complex initiatives.
6. What are the possible risks of taking part?
Participating in the research is not anticipated to cause you any disadvantages or discomfort. If you feel uncomfortable with any of the questions asked you can refuse to answer and we can move on. If for any reason you experience further distress, the interview will be delayed, postponed and/or rearranged if need be.
7. Will my taking part in this research project be kept confidential?
All information collected from (or about) you during the research project will be kept confidential and any personal information you provide will be managed in accordance with data protection legislation.
8. What will happen to my personal data?
We will collect personal data including your name, telephone number and email address. You will be allocated a participant ID number which will be used to anonymise your information, including the organisations/location where you work. The University of Plymouth, working in association with Cardiff University, is the Data Controller and is committed to respecting and protecting your personal data in accordance with your expectations and Data Protection legislation. Please review our information on Information governance and GDPR if you would like to know more about:
  • your rights
  • the legal basis under which the University of Plymouth processes your personal data for research
  • University of Plymouth Data Protection Policy
  • how to contact the University of Plymouth Data Protection Officer
  • how to contact the Information Commissioner’s Office.
An external transcription company will transcribe the audio recorded interview. A confidentiality agreement will be in place between the University of Plymouth and the external company. Any identifiable information from the transcript will be removed and once reviewed, the original recording will be deleted.
Study data stored at University of Plymouth will be kept separate from personal information (names and addresses) and only members of the research team will have access to this identifiable data. However, in some instances, official people from regulatory authorities may need to access data for checking the quality of the research. All members of the research team and regulatory bodies are trained in data protection issues and bound by the terms of the Data Protection Act 2018. Once the study is complete and it is no longer necessary to keep identifiable information or contact details, we will destroy our records of this personal information. Other information will be kept securely for a minimum time of 5 years in line with University policies.
9. What happens to the data at the end of the research project?
The audio-recorded interview data, in the form of digital sound files, will be destroyed at the end of the project. Fully anonymised transcripts may be shared with others who are also exploring research into MCoC. Any personal data are removed during transcription and re- checked by researchers before sharing.
10. What will happen to the results of the research project?
The results of the project will directly inform ongoing policy discussions regarding MCoC implementation in England. It will also contribute to a better understanding of implementation of complex interventions within maternity settings in England. Additionally, in the medium to longer term, the study will inform decisions regarding MCoC in devolved UK nations and internationally. It is our intention to publish the results of this research project thein academic journals and present findings at conferences. Quotes from the interview may be used, but neither you nor anyone you talk about will be identified. Your name will not be included in any reports or presentations. Participants will not be identified in any report, publication or presentation. Results will also be provided to participants on request.
11. What if there is a problem?
If have any concerns or complaints about the study, please speak to the person conducting the interview in the first instance or contact the Study Manager, who will do their best to resolve the problem. If you would prefer to speak with someone independent to the study, then please contact The Centre for Trials Research at Cardiff University at ctr@cardiff.ac.uk
12. Who is organising and funding this research project?
The research is organised by Professor Aled Jones, University of Plymouth and Dr Sue Channon at the Centre of Trials Research in Cardiff University. It has been funded by the National Institute of Health Research (NIHR) Health and Social Care Delivery Research Programme (HSDR)
13. Who has reviewed this research project?
This research project has been reviewed and given a favourable opinion by the University of Plymouth’s Research Ethics Committee.
14. Further information and contact details
Should you have any questions or concerns relating to this research project, or wish to withdraw from the study please contact Professor Jones at the Rolle Building (4th floor), University of Plymouth or by email at aled.jones@plymouth.ac.uk
Concerns about the ethical conduct of this study should be forwarded to the Research Administrator, Faculty of Health Research Ethics and Integrity Committee, University of Plymouth, Level 2 Marine Building, Drake Circus, Plymouth, PL4 8AA. FOHEthics@plymouth.ac.uk
Thank you for considering taking part in this research project.