Participant Data Sheet (PIS)
We’d like to ask you to participate in our analysis examine of girls who’ve continual/persistent ache in the course of the peri-menopause – the years previous and simply after the menopause. That will help you resolve, we’re offering some data on why this analysis is being accomplished and what it entails for you. Please take time to learn this data and talk about it with pals or household if you want. If there may be something that isn’t clear, or if you want extra data, please ask us – our contact particulars are on the finish of this doc.
What’s it about?
Girls usually tend to develop continual/persistent ache situations in comparison with males, but we don’t know why this occurs. The peri-menopause is commonly related to a rise in ache. What’s it about womanhood that predisposes to ache in the course of the peri-menopause? There was some analysis into the bodily components that may contribute to this, like adjustments in hormone ranges – however the proof means that the causes could be because of a mixture of things. This examine needs to grasp the experiences of girls such as you who’ve continual ache throughout this time, and perceive how this pertains to your expertise of the peri-menopause and of being a girl. The purpose is to extend understanding of this little-explored subject and affect the event of scientific companies which are modelled round ladies’s wants.
What does participating contain?
This examine entails three interviews, which purpose at understanding ladies’s experiences of well being throughout their lives, experiences of peri-menopause, experiences of ache and ideas on how these three facets work together.
The primary interview (60-90 minutes) will contain an train through which you and the researcher draw a map of vital well being (comparable to sickness, ache) and life occasions (comparable to beginning a household) throughout your life.
The second interview (60-90 minutes) is about your expertise of continual ache and peri-menopause, and the way these have affected your life. The purpose is to grasp which components have most influence.
The ultimate interview (60-90 minutes) is a go-along interview, through which you’ll information the researcher via a every day job or exercise of your alternative (like cooking, or buying), which can enable the researcher to see the way you negotiate every day actions and signs, and to deal with any important factors emerged in the course of the first two conferences.
These interviews will happen at your property (interviews one and two) and neighborhood (interview three, in response to your desire) over three weeks (3-4.5 hours general). If you’re unable to fulfill weekly we are able to accommodate this to each two or three weeks at a date and time that fits you. This examine is performed along with your regular NHS care and won’t intervene in your scientific therapy.
There would be the alternative for some individuals to have interaction with the researcher over an extended interval, with visits as soon as a month for 4 months lasting 60-120 minutes – these can happen at your property, once you go to clinic or in the neighborhood (general 4-8 hours). This is named participant commentary and can assist the researcher perceive your expertise of dwelling with ache additional. That is an extra alternative and isn’t obligatory.
What are the potential advantages of participating?
Taking part on this examine affords you a chance to contribute in analysis about ache at peri-menopause, which is a poorly understood matter. Analysis individuals report feeling a way of satisfaction in realizing that their participation contributes to science and to work which may be priceless to others sooner or later.
What are the potential disadvantages and dangers of participating?
This examine is just not anticipated to create any drawback or dangers – as it’s based mostly on interviews and won’t intervene with scientific therapy. Nonetheless, interviews can generally deal with subjects which are delicate and could also be upsetting. Ought to this be the case, the researcher reserves the correct to pause the interview till settled, and individuals have the correct of withdrawing from the examine at any time. Ought to a scenario emerge that poses a threat to a participant’s security or to 3rd events, the related particulars can be shared with emergency companies and/or the participant’s scientific group.
Any legal exercise or well being concern regarded as a direct security threat to you’ll outcome within the acceptable companies being notified. Any legal exercise or well being concern which isn’t a direct threat can be escalated to the scientific group.
Regarding the present COVID-19 pandemic, the analysis and scientific groups will monitor the security of conducting face-to-face interviews. Analysis employees can be vaccinated and respect nationwide authorities and public well being pointers. As well as, researchers will put on a face masks sanitise palms frequently.
What if one thing goes fallacious?
Within the unlikely occasion that one thing does go fallacious, that you’re harmed in the course of the analysis and this is because of somebody’s negligence then you’ll have grounds for a authorized motion for compensation towards UCL or your NHS Belief however you’ll have to pay your authorized prices. The traditional Nationwide Well being Service complaints mechanisms will nonetheless be accessible to you (if acceptable).
Ought to you will have a criticism throughout your time within the examine please contact a member of the examine group (particulars under) or the Affected person Recommendation and Liaison Providers at your treating belief:
UCLH: phone 0203 447 3042, e mail uclh.friends@nhs.web.
Royal Free Hospital: 020 7472 6446 or 020 7472 6447 (Monday-Friday, 10am to 4pm) or 020 7472 6445 (24 hour answerphone), e mail rf.friends@nhs.web
Do I’ve to participate?
Collaborating in analysis is totally voluntary, and your resolution won’t have an effect on your scientific care in any approach.
What’s going to occur if I don’t need to keep on with the examine?
Participation in analysis research is voluntary. Do you have to resolve to not take part this won’t affect your scientific care. For those who take part and alter your thoughts at a later date, you will have the correct to withdraw from the examine and the researcher will clarify the method concerning the usage of your knowledge. For those who resolve to withdraw, you’ll be able to both enable any knowledge collected thus far to be analysed as a part of the examine or you’ll be able to ask for it to be deleted. If you need your knowledge to be deleted you’ll have as much as one week after knowledge assortment to withdraw your consent for knowledge for use. Outdoors of this window, anonymised knowledge can be retained for examine functions. As a result of evaluation course of decoupling particular data from particular person interviews is just not potential. No additional knowledge can be collected or every other analysis procedures carried out in relation to you when you have been to resolve to withdraw.
How will my data be stored confidential?
Your private data can be stored safe consistent with GDPR and NHS pointers and can be pseudonymised. The interviews can be audio-recorded, transcribed and saved securely throughout the UCL Information Protected Haven, a safe knowledge storage portal.
The researchers use a UCL accredited transcription firm, who’re formally registered Information Controllers and are registered on the UK Authorities Information Safety Public Register. Researchers will add the audio-recordings and obtain the finished transcripts by way of the transcription firm’s encrypted UK-based server. Recordings and transcripts of these recordings can be deleted from the transcription firm’s servers inside 60 days of completion.
After transcription, the audio-recording can be deleted, and the anonymised transcripts of the interviews can be archived securely at UCL for ten years, in accordance with UCL pointers. No references to identifiable data can be made in analysis studies.
What’s going to occur to the outcomes of this examine?
The outcomes of the examine can be shared with the analysis group, the funders and the individuals in a primary occasion. They may subsequently be shared with the scientific neighborhood via analysis papers and conferences. As well as, our affected person advisors have expressed the want that outcomes be disseminated with major care suppliers comparable to GPs, so an advert hoc report can be shared via acceptable media.
Who’s organising and funding this examine?
This examine is a part of the researcher Catherine Borra’s doctoral coaching, which is funded by the Financial and Social analysis Council, and the Organic and Biotechnological Analysis Council. Catherine Borra has a background as a clinician working in ladies’s well being and ache administration. The Chief Investigator of the examine is Prof Sahra Gibbon, UCL Anthropology.
How have sufferers and the general public been concerned on this examine?
Sufferers have helped form the preliminary examine questions via interviews, and 4 reviewers have commented on the protocol and paperwork of this examine.
Who has reviewed this examine?
This examine has been reviewed by a steering committee and exterior reviewers consisting of ache and menopause specialists, and scientific analysis specialists.
What to anticipate in the course of the consent course of
Through the consent course of, the researcher will verify that you’ve got understood the data on this sheet and that you’ve got had the chance to deal with questions you’ll have. You can be required to offer written consent and you’ll obtain a replica of your signed kind.
Additional data and get in touch with particulars
Catherine Borra (examine researcher)
Prof Sahra Gibbon (Chief Investigator)
Alexandra Potts (UCL Information Safety officer)
Information Safety Privateness Discover
The controller for this venture can be College Faculty London (UCL). The UCL Information Safety Officer offers oversight of UCL actions involving the processing of non-public knowledge, and could be contacted at data-protection@ucl.ac.uk
This ‘native’ privateness discover units out the data that applies to this explicit examine. Additional data on how UCL makes use of participant data could be present in our ‘normal’ privateness discover:
For individuals in analysis research, click on right here or observe https://www.ucl.ac.uk/legal-services/privateness/ucl-general-research-participant-privacy-notice
The knowledge that’s required to be supplied to individuals below knowledge safety laws (GDPR and DPA 2018) is supplied throughout each the ‘native’ and ‘normal’ privateness notices.
The lawful foundation that can be used to course of your private knowledge is: ‘Public job’ for private knowledge.
Your private knowledge can be processed as long as it’s required for the analysis venture. If we’re capable of anonymise or pseudonymise the private knowledge you present we’ll undertake this, and can endeavour to minimise the processing of non-public knowledge wherever potential.
If you’re involved about how your private knowledge is being processed, or if you want to contact us about your rights, please contact UCL within the first occasion at data-protection@ucl.ac.uk