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Risk of Suicidality in Women with Polycystic Ovary Syndrome (PCOS)

Project [P96175]

PARTICIPANT INFORMATION STATEMENT

You are being invited to take part in a study looking at the psychological distress associated with the symptoms of Polycystic Ovary Syndrome (PCOS). Lenita Wambeek, Trainee Clinical Psychologist at Coventry University is leading this research as part of a doctoral thesis.

Before you decide to take part, it is important you understand why the research is being conducted and what it will involve. Please take time to read the following information carefully.

What is the purpose of the study?

We know from previous studies that many women with PCOS may experience psychological difficulties, but we do not yet know how serious these are.  It may be that levels of distress impact on people’s wellbeing and these may be serious enough to cause problems such as depression and suicidal thoughts. It is hoped that by understanding more about the link between psychological distress and PCOS, we will be able to make health practitioners more aware of these difficulties and suggest better forms of support to PCOS sufferers.  

Who can take part?  

We are looking for people who meet the following criteria:

  1. Have a formal diagnosis of Polycystic Ovary Syndrome
  2. Aged between 18 and 40 years old

Do I have to take part?

You will be asked to fill out an online survey, which takes about 15 minutes to complete.  The survey is completely anonymous as no identifying data about you is recorded.  Your participation in the survey is entirely voluntary.  If you start the study but don’t wish to continue at any point, you can simply exit the study by closing the browser.

Can I skip questions I do not want to answer?

Yes, but it is really important to the study that you try and answer every question. Your answers are important and will help us develop a clearer understanding of the level of psychological distress that people with PCOS may be experiencing. If you do not wish to answer a question, just answer ‘I do not wish to answer this question’.

Are there any risks associated with taking part?

The project has been reviewed and approved through the formal Research Ethics procedure at Coventry University. The risks involved in taking part relate to the fact that answering the questions may cause you to become upset or cause you to worry about your current or future physical health.  

The questionnaire starts by asking some very general questions about you including: your age, ethnicity, relationship status and your education. You will be asked for your height and weight, as research suggests that Body Mass Index (BMI) is a relevant factor in psychological distress. It then asks about your PCOS symptoms and how they affect you.  There are then four sections looking at your psychological wellbeing with regards to depression, your quality of life, your views of yourself and others and your experiences of self-harm and suicidal thoughts (if any).

The risks involved in taking part relate to the fact that answering the questions may cause you to become upset. 

For further information, or if you have any queries, please contact the lead researcher, Lenita Wambeek (wambeekl@coventry.ac.uk).

If you have any concerns that cannot be resolved through the lead researcher, please contact Dr Anthony Colombo, Research Director (a.colombo@coventry.ac.uk). 

If you feel any distress after completing the survey or would like further support or information regarding your PCOS, you can use the following resources:

If you are feeling acutely distressed or actively suicidal, we would strongly encourage you to contact:

  • The Samaritans
    Telephone: 116 123 (Service available 24/7)
    Email: Jo@samaritans.org (24-hour response)
  • NHS 111
  • If there is an immediate danger to life, you should contact 999 emergency services

What are the benefits of taking part?

By sharing your experiences with us, you will be helping us understand more about the link between psychological distress and PCOS, so that we can make health practitioners more aware of these difficulties and suggest better forms of support to PCOS sufferers.   

What will happen with the results of this study?

The results of this study may be summarised in published articles, reports and presentations.   All key findings will always be made anonymous.

Data Protection and Confidentiality

Your answers will be treated confidentially and the information you provide will be kept anonymous in any research outputs/publications.  Your data will be processed in accordance with the General Data Protection Regulation 2016 (GDPR) and the Data Protection Act 2018.  Your data will be held securely on the Coventry University OneDrive storage facility and will only be viewed by the researcher/research team.  All data will be deleted by October 2026. 

Can I withdraw my data after I have completed the study?

You are free to withdraw your questionnaire responses from the project data set until the end of November 2020. The data will be fully anonymised in our records on 1st December 2020. At the end of the survey, you will be prompted to save the webpage, this will contain your unique participant number.  If you wish to withdraw, you may contact the lead researcher (contact details below) and give them the participant number. Please also contact the Faculty Research Support Office (email researchproservices.fbl@coventry.ac.uk; telephone +44(0)2477658461) so that your request can be dealt with promptly in the event of the lead researcher’s absence.  You do not need to give a reason. A decision to withdraw, or not to take part, will not affect you in any way.

You should note that your data may be used in the production of formal research outputs (e.g. journal articles, conference papers, theses and reports) prior to this date and so you are advised to contact the university at the earliest opportunity should you wish to withdraw from the study.  

Data Protection Rights

Coventry University is a Data Controller for the information you provide.  You have the right to access information held about you. Your right of access can be exercised in accordance with the General Data Protection Regulation and the Data Protection Act 2018. You also have other rights including rights of correction, erasure, objection, and data portability.  For more details, including the right to lodge a complaint with the Information Commissioner’s Office, please visit www.ico.org.uk  Questions, comments and requests about your personal data can also be sent to the University Data Protection Officer - enquiry.ipu@coventry.ac.uk

Making a Complaint

If you are unhappy with any aspect of this research, please first contact the lead researcher, Lenita Wambeek (wambeekl@coventry.ac.uk). If you still have concerns and wish to make a formal complaint, please write to Dr Anthony Colombo, Research Director, Coventry University, Coventry, CV1 5FB. Email: (a.colombo@coventry.ac.uk).  

In your letter/ e-mail please provide information about the research project, specify the name of the researcher and detail the nature of your complaint.

Thank you for taking the time to participate in this survey. Your help is very much appreciated.

 

I have read and understood the above information. I agree to take part in this questionnaire survey.  I confirm that I am aged 18 or over.