You are being invited to take part in a research study. 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. Please ask if you would like more information. Take time to decide whether or not you wish to take part. Thank you for taking the time to read this.
About the research
Who will conduct the research?
The research is being conducted by a team of researchers from the University of Manchester. The research is being led by Professor Kieran Walshe (Chief Investigator), Alliance Manchester Business School, University of Manchester, M15 6PB. The researchers for this project are Dr Jane Ferguson and [RA yet to be appointed].
What is the purpose of the research?
The numbers of doctors working in temporary positions (known as locums) in the NHS has doubled in recent years, and there are concerns about the quality and safety of locum practice and the way NHS organisations use locum doctors. Very little research has been done about locum doctors, so we don’t really know whether or why there are differences in the quality and safety of care between locum and permanent doctors. It is clear that a better understanding of the quality and safety of locum doctors working in the NHS is needed, and could help to find ways to improve the working arrangements for locum doctors and the quality and safety of patient care that they provide.
Our research will find out where locum doctors work in the NHS in England, what kinds of work they do, and how the use of locum doctors is organised. NHS organisations need the flexibility and staffing capacity provided by using locum doctors, and our research will help them to understand how best to use locums, and how to ensure that locum doctors can provide safe, high quality care.
Why have I been chosen?
You have been asked to take part because the trust of GP practice you attend is involved in the research or because you have experience and expertise relevant to understanding locum working.
Will the outcomes of the research be published?
The findings of this study will be disseminated through presentations at seminars, conferences and workshops, web pages, as well as through peer-reviewed journal articles and promoted via various communications routes. If you request, you will be advised where to access publications and sent details of relevant seminars and conferences.
Who has reviewed the research project?
The project has been reviewed by NHS REC (08/12/2020) and has been given HRA approval.
Who is funding the research project?
This project is funded by the National Institute of Health Research.
What would my involvement be?
What would I be asked to do if I took part?
You are being asked to take part in a focus group. The focus group will involve about five to seven patients and/or carers discussing their views of locum doctors and experiences of locum doctor working. We will carry out the focus group on hospital or Clinical Commissioning Group premises and it will last for approximately one hour. If social distancing guidance is in place, we may conduct the focus group on Zoom. The focus group will be conducted by two researchers from the University of Manchester one of whom is a patient and public involvement representative. If you agree to take part, your prior written permission will be sought to audio-record the focus group. You will also be asked to complete a form to collect some basic demographic information about you, such as your age, gender and ethnicity so we can monitor how diverse our focus groups are. It is important for you to know that if you are concerned about any questions we ask, you can skip those questions. You may also leave the discussion and withdraw from the study at any time without giving reason.
Will I be compensated for taking part?
Yes, you will be paid £25 to reimburse you for your travel and involvement in a focus group.
What happens if I do not want to take part or if I change my mind?
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 consent form. If you do take part you are still free to withdraw at any time without giving a reason and without detriment to yourself. Your data will be removed and destroyed. This does not affect your data protection rights.
Audio-recording is essential for participation in this study. However participants should be comfortable with the recording process at all times and you are free to stop recording at any time. We recognise that it might feel very uncomfortable to stop a focus group part way through if you are feeling uncomfortable. If this happens, you can speak to a researcher afterwards and withdraw from the study if you no longer wish to take part. While we would be unable to remove your data from the recording, we will not quote you when the study is reported.
If you become distressed or uncomfortable during the focus group, the researcher will stop the discussion and you can take a break. The researcher will offer you support in a separate quiet area. If you feel able to continue, the researcher will carry on the discussion and offer you continued support. If you are unable to carry on, you will be offered support by the researcher who will check with you if you need support from someone else too. With your permission, we will follow up with a courtesy call the next day.
What information will you collect about me?
With your permission we will collect information that could identify you, called “personal identifiable information”. Specifically we will ask you to fill in a form to collect information about your:
· Contact details (to arrange participation in the focus group)
· Gender
· Ethnicity
· Age
This is so we can monitor how diverse out sample is and get a sense of who has taken part. We will collect your contact details to arrange the focus group. Subject to your written consent, all focus groups will be audio-recorded (voice only) and transcribed verbatim. Upon your request, transcripts can be sent back to you for comments and feedback.
Only members of the immediate research team and staff of the transcription company will have access to the data.
Under what legal basis are you collecting this information?
We are collecting and storing this personal identifiable information in accordance with data protection law which protect your rights. These state that we must have a legal basis (specific reason) for collecting your data. For this study, the specific reason is that it is “a public interest task” and “a process necessary for research purposes”.
What are my rights in relation to the information you will collect about me?
You have a number of rights under data protection law regarding your personal information. For example you can request a copy of the information we hold about you, including audio recordings. This is known as a Subject Access Request. If you would like to know more about your different rights, please consult our Privacy Notice for Research Participants (http://documents.manchester.ac.uk/display.aspx?DocID=37095).
Will my participation in the study be confidential and my personal identifiable information be protected?
In accordance with data protection law, The University of Manchester is the Data Controller for this project. This means that we are responsible for making sure your personal information is kept secure, confidential and used only in the way you have been told it will be used. All researchers are trained with this in mind and your data will be looked after.
The study team at the University of Manchester will have access to your personal identifiable information, that is data which could identify you, but they will pseudonymised it as soon as practical. This means that your name and any other identifying information will be removed and replaced with a random ID code so that the data can no longer be attributed to a you without the use of additional information, i.e. a key code that will only be accessed by the research team and kept in a separate password protected file on encrypted computers. Your participation in the study will be kept confidential to the study team and those with access to your personal information as listed above.
The information collected from focus groups will be kept strictly confidential, and your responses will be pseudonymised. If you take part in an audio-recorded focus group it will be transcribed by a university-approved transcription company whose staff also have a duty of confidentiality. Only members of the immediate research team and staff of the transcription company will have access to the data. Audio-recordings and transcripts from focus groups will be stored on a secure university password-protected server. Consent forms will be stored in a locked cabinet on University of Manchester premises. All published and unpublished reports will disguise the identity of individuals and be reported anonymously without identifying names of individuals or organisations. Transcripts will be stored for 5 years. Audio files will be destroyed as soon as transcripts have been checked. Consent forms will be retained as essential documents for five years but contact details will be deleted as soon as they are no longer required.
If you wish to have a summary of the findings for this study researchers will retain your contact details in order to forward you this information, but will delete these immediately after. This is optional. Contact details of the Chief Investigator for the project, Professor Kieran Walshe, are provide at the end of this information sheet should you wish to contact the research team about research findings.
Please also note that individuals from The University of Manchester, NHS trusts or regulatory authorities may need to look at the data collected for this study to make sure the project is being carried out as planned. This may involve looking at identifiable data. All individuals involved in auditing and monitoring the study will have a strict duty of confidentiality to you as a research participant.
Any discussions that take place during the study are confidential. However, if you were to tell us something that could put someone at risk of harm, or reveal unsafe practice that has not been reported through the usual procedures the researcher might be professionally obliged to report the incident through the normal risk management procedures. Information that indicates harm to patients or professional misconduct will be disclosed by the research team as part of a safeguarding process, in accordance with established good research practice and with the University of Manchester’s own policy on whistleblowing and public interest disclosure. If this happens, the recording will be stopped and we will discuss with you what we intend to do.
If you have a minor complaint then you need to contact the researcher(s) in the first instance:
Professor Kieran Walshe | Principal Investigator | Room 7.034 | Alliance Manchester Business School | University of Manchester | Booth Street West | Manchester M15 6PB | +44 (0)161 275 3852 | kieran.walshe@manchester.ac.uk
Or
Dr Jane Ferguson | Room 7.045| Alliance Manchester Business School | University of Manchester | Booth Street West | Manchester M15 6PB | +44(0)7785694288 | jane.ferguson@manchester.ac.uk
If you wish to make a formal complaint or if you are not satisfied with the response you have gained from the researchers in the first instance then please contact the Research Governance and Integrity Manager, Research Office, Christie Building, University of Manchester, Oxford Road, Manchester, M13 9PL, by emailing: research.complaints@manchester.ac.uk or by telephoning 0161 275 2674.
If you wish to contact us about your data protection rights, please email dataprotection@manchester.ac.uk or write to The Information Governance Office, Christie Building, The University of Manchester, Oxford Road, M13 9PL at the University and we will guide you through the process of exercising your rights.
You also have a right to complain to the Information Commissioner’s Office about complaints relating to your personal identifiable information (https://ico.org.uk/make-a-complaint/) Tel 0303 123 1113
In the unlikely event that something does go wrong and you are harmed during the research you may have grounds for a legal action for compensation against the University of Manchester but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.
If you have any queries about the study or if you are interested in taking part then please contact the researcher(s):
Dr Jane Ferguson | Room 7.045| Alliance Manchester Business School | University of Manchester | Booth Street West | Manchester M15 6PB | +44(0)7785694288 | jane.ferguson@manchester.ac.uk
[INSERT RA DETAILS AFTER APPOINTMENT]