Participant Information Sheet (PIS)
We’d like to invite you to take part in our research study of women who have chronic/persistent pain during the peri-menopause – the years preceding and just after the menopause. To help you decide, we are providing some information on why this research is being done and what it involves for you. Please take time to read this information and discuss it with friends or family if you wish. If there is anything that is not clear, or if you would like more information, please ask us – our contact details are at the end of this document.
What is it about?
Women are more likely to develop chronic/persistent pain conditions compared to men, yet we don’t know why this happens. The peri-menopause is often associated with an increase in pain. What is it about womanhood that predisposes to pain during the peri-menopause? There has been some research into the physical factors that can contribute to this, like changes in hormone levels – but the evidence suggests that the causes might be due to a combination of factors. This study wants to understand the experiences of women like you who have chronic pain during this time, and understand how this relates to your experience of the peri-menopause and of being a woman. The aim is to increase understanding of this little-explored field and influence the development of clinical services that are modelled around women’s needs.
What does taking part involve?
This study involves three interviews, which aim at understanding women’s experiences of health across their lives, experiences of peri-menopause, experiences of pain and thoughts on how these three aspects interact.
The first interview (60-90 minutes) will involve an exercise in which you and the researcher draw a map of important health (such as illness, pain) and life events (such as starting a family) across your life.
The second interview (60-90 minutes) is about your experience of chronic pain and peri-menopause, and how these have affected your life. The aim is to understand which factors have most impact.
The final interview (60-90 minutes) is a go-along interview, in which you will guide the researcher through a daily task or activity of your choice (like cooking, or shopping), which will allow the researcher to see how you negotiate daily activities and symptoms, and to address any significant points emerged during the first two meetings.
These interviews will take place at your home (interviews one and two) and community (interview three, according to your preference) over three weeks (3-4.5 hours overall). If you are unable to meet weekly we can accommodate this to every two or three weeks at a date and time that suits you. This study is conducted in addition to your normal NHS care and will not interfere in your clinical treatment.
There will be the opportunity for some participants to engage with the researcher over a longer period, with visits once a month for four months lasting 60-120 minutes – these can take place at your home, when you visit clinic or in the community (overall 4-8 hours). This is known as participant observation and will help the researcher understand your experience of living with pain further. This is an additional opportunity and is not compulsory.
What are the possible benefits of taking part?
Participating in this study offers you an opportunity to contribute in research about pain at peri-menopause, which is a poorly understood topic. Research participants report feeling a sense of satisfaction in knowing that their participation contributes to science and to work that may be valuable to others in the future.
What are the possible disadvantages and risks of taking part?
This study is not anticipated to create any disadvantage or risks – as it is based on interviews and will not interfere with clinical treatment. However, interviews can sometimes address topics that are sensitive and may be upsetting. Should this be the case, the researcher reserves the right to pause the interview until settled, and participants have the right of withdrawing from the study at any time. Should a situation emerge that poses a risk to a participant’s safety or to third parties, the relevant details will be shared with emergency services and/or the participant’s clinical team.
Any criminal activity or health issue thought to be an immediate safety risk to you will result in the appropriate services being notified. Any criminal activity or health issue which is not an immediate risk will be escalated to the clinical team.
In regards to the current COVID-19 pandemic, the research and clinical teams will monitor the safety of conducting face-to-face interviews. Research staff will be vaccinated and respect national government and public health guidelines. In addition, researchers will wear a face mask sanitise hands regularly.
What if something goes wrong?
In the unlikely event that something does go wrong, that you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against UCL or your NHS Trust but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).
Should you have a complaint during your time in the study please contact a member of the study team (details below) or the Patient Advice and Liaison Services at your treating trust:
UCLH: telephone 0203 447 3042, email firstname.lastname@example.org.
Royal Free Hospital: 020 7472 6446 or 020 7472 6447 (Monday-Friday, 10am to 4pm) or 020 7472 6445 (24 hour answerphone), email email@example.com
Do I have to take part?
Taking part in research is completely voluntary, and your decision will not affect your clinical care in any way.
What will happen if I don’t want to carry on with the study?
Participation in research studies is voluntary. Should you decide not to participate this will not influence your clinical care. If you participate and change your mind at a later date, you have the right to withdraw from the study and the researcher will explain the process regarding the use of your data. If you decide to withdraw, you can either allow any data collected so far to be analysed as part of the study or you can ask for it to be deleted. If you would like your data to be deleted you will have up to one week after data collection to withdraw your consent for data to be used. Outside of this window, anonymised data will be retained for study purposes. Due to the analysis process decoupling specific information from individual interviews is not possible. No further data will be collected or any other research procedures carried out in relation to you if you were to decide to withdraw.
How will my information be kept confidential?
Your personal information will be kept secure in line with GDPR and NHS guidelines and will be pseudonymised. The interviews will be audio-recorded, transcribed and stored securely within the UCL Data Safe Haven, a secure data storage portal.
The researchers use a UCL approved transcription company, who are officially registered Data Controllers and are registered on the UK Government Data Protection Public Register. Researchers will upload the audio-recordings and receive the completed transcripts via the transcription company’s encrypted UK-based server. Recordings and transcripts of those recordings will be deleted from the transcription company’s servers within 60 days of completion.
After transcription, the audio-recording will be deleted, and the anonymised transcripts of the interviews will be archived securely at UCL for ten years, in accordance with UCL guidelines. No references to identifiable information will be made in research reports.
What will happen to the results of this study?
The results of the study will be shared with the research team, the funders and the participants in a first instance. They will subsequently be shared with the scientific community through research papers and conferences. In addition, our patient advisors have expressed the wish that results be disseminated with primary care providers such as GPs, so an ad hoc report will be shared through appropriate media.
Who is organising and funding this study?
This study is part of the researcher Catherine Borra’s doctoral training, which is funded by the Economic and Social research Council, and the Biological and Biotechnological Research Council. Catherine Borra has a background as a clinician working in women’s health and pain management. The Chief Investigator of the study is Prof Sahra Gibbon, UCL Anthropology.
How have patients and the public been involved in this study?
Patients have helped shape the initial study questions through interviews, and four reviewers have commented on the protocol and paperwork of this study.
Who has reviewed this study?
This study has been reviewed by a steering committee and external reviewers consisting of pain and menopause specialists, and clinical research specialists.
What to expect during the consent process
During the consent process, the researcher will ascertain that you have understood the information in this sheet and that you have had the opportunity to address questions you may have. You will be required to give written consent and you will receive a copy of your signed form.
Further information and contact details
Catherine Borra (study researcher)
Prof Sahra Gibbon (Chief Investigator)
Alexandra Potts (UCL Data Protection officer)
Data Protection Privacy Notice
The controller for this project will be University College London (UCL). The UCL Data Protection Officer provides oversight of UCL activities involving the processing of personal data, and can be contacted at firstname.lastname@example.org
This ‘local’ privacy notice sets out the information that applies to this particular study. Further information on how UCL uses participant information can be found in our ‘general’ privacy notice:
For participants in research studies, click here or follow https://www.ucl.ac.uk/legal-services/privacy/ucl-general-research-participant-privacy-notice
The information that is required to be provided to participants under data protection legislation (GDPR and DPA 2018) is provided across both the ‘local’ and ‘general’ privacy notices.
The lawful basis that will be used to process your personal data is: ‘Public task’ for personal data.
Your personal data will be processed so long as it is required for the research project. If we are able to anonymise or pseudonymise the personal data you provide we will undertake this, and will endeavour to minimise the processing of personal data wherever possible.
If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact UCL in the first instance at email@example.com