NCMH is a Research Centre, led by Cardiff, Swansea and Bangor Universities. It is being funded by Health and Care Research Wales, Welsh Government. The Director of the National Centre for Mental Health is Professor Jon Bisson.

This study has also received additional funding from the European Research Council, awarded to Professor Arianna di Florio.

Please visit the Cardiff University website for more information.

You will have the opportunity to join the study once you have read through and understood the information.   

We hope that learning more about mental ill health around menopause will lead to new ways of diagnosing, treating or even preventing this.

However, these remain long-term aims, and you will not benefit directly from taking part in this study.

The risks and disadvantages of taking part are minimal.

Some people might find answering questions about their mental health upsetting. If this happens, you can take a break or stop the study entirely.

You will also receive a link to a list of organisations that offer free listening, emotional support and information services.

We will need to use information from you for this research project. This information will include your name and contact details.

People will use this information to do the research or to check records to make sure the research is being done properly. People who do not need to know who you are will not be able to see you name or contact details. Your data will have a code instead.

Cardiff University is the sponsor and data controller of this research and is responsible for looking after your information. We will keep all information about you safe and secure by:

• making sure only members of the research team who have signed confidentiality agreements will access identifiable data
• we will follow the rules of the Data Protection Act (2018) and the General Data Protection Regulation (GDPR)

We may share data about you outside the UK or with trusted commercial partners for research related purposes to:

• maximise the potential of your data to answer related research questions. Data will only ever be used in research that has the ultimate goal of helping patients or the general public.

If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared where possible. We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

• The countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK
• We use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website
• We do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says
• We need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing
• We have procedures in place to deal with any suspected personal data breach. We will tell you and applicable regulators when there has been a breach of your personal data when we legally have to. For further details about UK breach reporting rules visit the Information Commissioner’s Office (ICO) website.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

We will keep your study data for 15 years following the end of the research project, following the guidelines from the Medical Research Council.

After 15 years, the research team will de-identify the personal data it has collected from, or about, you in connection with this research project, with the exception of your consent form.

Anonymised information may be published in support of the research project and/or retained indefinitely, where it is likely to have continuing value for research purposes.

If you have joined this study through another study at the National Centre for Mental Health, we will also link the new data to previous information that we collected about you. We will ask for your consent to do this. This is done using your original study ID number.

To make best use of resources we will share data (anonymised to exclude any personal details) with different groups of researchers from the NHS, universities and commercial companies, both within the UK and abroad.

However, we would stress that those organisations will never obtain access to personal/ identifying information (for example, your name, address, date of birth). This information will be de-identified and kept strictly confidential.

With your consent, we may also link your data to routinely collected, anonymised datasets. One example of this is the Secure Anonymised Information Linkage (SAIL) databank at Swansea University. SAIL contains anonymised health and social care data for the population of Wales. This will be linked in an anonymous format (this will not include your personal details such as your name and address) and is undertaken in line with UK General Data Protection Regulation (UK GDPR) 2018, the Data Protection Act (2018) and University Governance.

If you do decide to take part you are still free to withdraw your consent to participate in the research project at any time, without giving a reason, even after signing the consent form. Please contact us using the details at the end of this form.

We will ask you whether you want us to destroy the data collected so far and stop future communication or if we can keep the data and not contact you again. It will not be possible to withdraw any anonymised data that has already been published or in some cases, where identifiers are irreversibly removed during the course of a research project or for data linkage, from the point at which it has been anonymised.

You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

You will not have any claim to any future commercial use of results from the study in which your data has been used.

You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK:

• By viewing this Health Research Authority patient data research leaflet
• By asking one of the research team
• By sending an email to reproductivementalhealth@cardiff.ac.uk or by ringing us on 02922 515494 |02920 688371
• By contacting Cardiff University’s Data Protection Officer:
  • Email: inforequest@cardiff.ac.uk
  • Postal address: Data Protection Officer, Compliance and Risk, University Secretary’s Office, Cardiff University, 42 Park Place, Cathays, Cardiff, CF10 3BB

• by reading Cardiff University’s data protection policy:
• by reading Cardiff University’s overarching Data Protection Notice for research participants

If you require printed copies of the above-mentioned documentation and privacy notice, please contact the study team using the details above.

After this initial assessment, we may contact you every six to twelve months about completing some follow up questions.

These follow ups will be to ask you more questions about your experiences, your mental and general health and lifestyle. Sometimes we will ask for information that you haven’t given before. Sometimes we will ask you the same questions as before, so that we can see how things have changed.

As well as this possible further contact, the study team may contact you from time to time, to ask you to take part in new studies.

You may be contacted because of something that you have told us about (for example, your age). These studies may be conducted by other research teams.

We will give you more information about these studies including why the research is being carried out, what you might be asked to do and how to sign up. It is up to you to decide whether you want to take part in these new studies. It won’t affect your participation in the overall NCMH menopause survey if you prefer not to get involved.

You can tell us at any time if you would prefer not to receive information about other studies.

When you agree to take part and sign up, you will be asked to provide contact details and some other information about yourself such as your age and ethnic group.

You will also be asked to answer some questions about experiences of mental ill health around the menopause and other reproductive events you may have experienced.

First you need to join the study. This involves reading this information and then consenting below.  This should take about five minutes. Take as much time as you need to decide whether you wish to take part.

Once you have joined, you will be asked some questions. This should take about 20 to 25 minutes to finish.

We know that we get the best data if you are able to complete these questions in one go, but if for some reason this isn’t possible then you can come back to the website later because you can save your answers once you have finished a set of questions.

Ethical approval has been obtained from the National Research Ethics Service and NHS (Research and Development) permission has also been obtained.

If you have further questions about the study, please contact the study team:

National Centre for Mental Health, Cardiff University, Hadyn Ellis Building, Maindy Road, Cathays, Cardiff, CF24 4HQ.

Tel: +44(0)29 2068 8401

Email: reproductivementalhealth@cardiff.ac.uk

If you would like to discuss this study with someone independent of the study please contact:

Helen Richards, Division Manager, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University School of Medicine, Hadyn Ellis Building, Maindy Road, Cardiff, CF24 4HQ.

Tel: +44(0)29 2068 8484

Email: dpmcndivisionmanager@cardiff.ac.uk