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Acceptability of the Female Condom.

Study Title: The female condom: awareness, experiences and acceptability among women and men from the United Kingdom - Questionnaire phase.

 

Researcher: Amber Warren

ERGO number: 54628                                                                      

 

You are being invited to take part in the above research study. To help you decide whether you would like to take part or not, it is important that you understand why the research is being done and what it will involve. Please read the information below carefully and ask questions if anything is not clear or you would like more information before you decide to take part in this research. If you are happy to participate you will be asked to sign a consent form.

 

What is the research about?

 

My name is Amber Warren and I am a MSc Health Psychology student at the University of Southampton. As part of my degree, I have to complete an original project. For my project I want to be able to understand the attitudes and experiences surrounding the female (internal) condom. The purpose of this study is therefore to assess the familiarity, knowledge and experiences of the female condom and attitudes towards its acceptance and usage in sexually active men and women from England.

 

Why have I been asked to participate?

 

You have been asked to participate as someone who is aged between 18-40, sexually active, fluent in English and have shown an interest in completing this study through advertisement.

 

What will happen to me if I take part?

 

You will be asked to complete a questionnaire lasting no longer than 15 minutes. All of the information provided will remain anonymous. This questionnaire will begin by asking you demographic questions such as your age, ethnicity, gender and sexual orientation, to find out more about you, but this information will not lead you to be identified. You will then be asked about your knowledge, use, and attitudes towards the female condom and other methods of contraception.

 

At the end of completion of this questionnaire, you will be asked whether you will be interested in attending the second stage of this study which involves a focus group with myself and other participants at a later date to discuss the topic further.

 

Are there any benefits in my taking part?

 

Although there are no direct benefits of taking part, if you are a University of Southampton Psychology student you can obtain 2 research credits on completion of the questionnaire. Your participation will also help improve our current understanding of the female condom as a method of contraception and protection against sexually transmitted infections.

 

At the end of this survey you will be asked if you are interested in taking part in the second part of this research which involves a focus group with myself and other participants. You will be reimbursed £20 or 18 research credits for its completion.

 

Are there any risks involved?

 

There is minimal risk in your participation. There is the possibility of experiencing mild distress or embarrassment due to the personal nature of the questions asked and images shown. These may cause you possible discomfort. You are reminded that you can withdraw from the survey at any time up until you submit your answers. There will also be contact details of a range of support services provided at the end of the survey.

 

What data will be collected?

 

All of your questionnaire responses will be anonymous. Your data will be stored in password protected, encrypted files on the University of Southampton's secure server.

 

If you wish to be distributed research credits for your completion of the questionnaire, please enter your student ID when prompted to in the survey. This will be stored separately from your questionnaire responses so your answers will not be linked to your identification.

 

If you wish to be contacted about the second phase of focus groups mentioned in the above section, your name and email address will be recorded, but these will be stored separately from your questionnaire responses on a secure database only accessible to the main researcher.

 

Will my participation be confidential?

 

Your participation and the information we collect about you during the course of the research will be kept strictly confidential, meaning no one will be able to identify you, or any others discussed, from the collection, analysis or report on the questionnaire. Your answers will remain anonymous on a password protected website which only I will have access to, and then downloaded onto a password protected computer. You will be asked to provide your student ID number and email address, but these will be solely used for the purpose of providing you with research credits and contacting you for the later stage of this study.

 

Only members of the research team and responsible members of the University of Southampton may be given access to data about you for monitoring purposes and/or to carry out an audit of the study to ensure that the research is complying with applicable regulations. Individuals from regulatory authorities (people who check that we are carrying out the study correctly) may require access to your data. All of these people have a duty to keep your information, as a research participant, strictly confidential.

 

Do I have to take part?

 

No, it is entirely up to you to decide whether or not to take part. If you decide you want to take part, you will need to tick the consent box at the end of this page.

 

What happens if I change my mind?

 

You have the right to change your mind and withdraw at any time without giving a reason and without your participant rights being affected. 

 

You may withdraw from the study at any point by exiting the questionnaire window. Your data will not be submitted if you withdraw prior to completion of the questionnaire. However, due to the anonymity of the data, you cannot withdraw your answers after these have been submitted. However, you are reminded that this data remains anonymous.

 

All data will be kept in compliance with the University of Southampton’s Data Protection policy, meaning the recordings will be stored at the University for 10 years after the project is finished. After this 10-year period, they will be destroyed.

 

What will happen to the results of the research?

The findings of this study will be written up as part of my dissertation, which is part of my degree in Health Psychology at the University of Southampton.

 

Research findings made available in any reports or publications will not include information that can directly identify you without your specific consent.

 

Where can I get more information?

 

If you have any further questions please contact me, Amber Warren, at apw2g16@soton.ac.uk or my supervisor Professor Cynthia Graham at: c.a.graham@soton.ac.uk

 

What happens if there is a problem?

 

If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions.

If you remain unhappy or have a complaint about any aspect of this study, please contact the University of Southampton Research Integrity and Governance Manager (023 8059 5058, rgoinfo@soton.ac.uk).

 

 

Data Protection Privacy Notice

 

The University of Southampton conducts research to the highest standards of research integrity. As a publicly-funded organisation, the University has to ensure that it is in the public interest when we use personally-identifiable information about people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use information about you in the ways needed, and for the purposes specified, to conduct and complete the research project. Under data protection law, ‘Personal data’ means any information that relates to and is capable of identifying a living individual. The University’s data protection policy governing the use of personal data by the University can be found on its website (https://www.southampton.ac.uk/legalservices/what-we-do/data-protection-and-foi.page).

 

This Participant Information Sheet tells you what data will be collected for this project and whether this includes any personal data. Please ask the research team if you have any questions or are unclear what data is being collected about you.

 

Our privacy notice for research participants provides more information on how the University of Southampton collects and uses your personal data when you take part in one of our research projects and can be found at http://www.southampton.ac.uk/assets/sharepoint/intranet/ls/Public/Research%20and%20Integrity%20Privacy%20Notice/Privacy%20Notice%20for%20Research%20Participants.pdf

 

Any personal data we collect in this study will be used only for the purposes of carrying out our research and will be handled according to the University’s policies in line with data protection law. If any personal data is used from which you can be identified directly, it will not be disclosed to anyone else without your consent unless the University of Southampton is required by law to disclose it.

 

Data protection law requires us to have a valid legal reason (‘lawful basis’) to process and use your Personal data. The lawful basis for processing personal information in this research study is for the performance of a task carried out in the public interest. Personal data collected for research will not be used for any other purpose.

 

For the purposes of data protection law, the University of Southampton is the ‘Data Controller’ for this study, which means that we are responsible for looking after your information and using it properly. The University of Southampton will keep identifiable information about you for 10 years after the study has finished after which time any link between you and your information will be removed.

 

Thank you for taking the time to read the above information sheet and considering your participation to the research.