Title of Project: Psychometric properties of instruments used to assess falls efficacy and balance in people with lower limb amputation.
Name of Researcher: Dr. Cleveland Barnett
Contact Details: Telephone: 01158483824 or email email@example.com
We would like to invite you to take part in a research study. Before you decide, we would like you to understand why the research is being done and what it would involve for you.
Please take time to carefully read the following information and talk to others about the study if you wish.
Please ask us if there is anything that is not clear or if you would like more information. We would like to know if you would like to take part in this research study.
General Data Protection Regulation (GDPR) Statement
We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Nottingham Trent University will keep identifiable information about you until the study is finished. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained, unless you specifically want this information to be removed. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting firstname.lastname@example.org; 01158483824.
What is the purpose of this study?
The risk of falling is a major health issue for people with lower limb amputation. The tools used to assess the fear of falling have not been assessed to see if they are fit for purpose for use with people with amputation.
This project will assess these tools to see if they are appropriate to use in the future.
Why have I been invited?
You have been invited to take part in this study as you use a lower limb prosthesis or could act as a matched control.
Do I have to take part?
No. Participation in this study is entirely voluntary.
If you do decide to take part in this study, you will be free to stop taking part at any time without giving reason. This will not affect your care, your future treatment or your legal rights in any way.
What will happen if I decide to take part?
If you decide to take part in the study, you will provide Dr. Cleveland Barnett (Tel: 01158483824 or email: email@example.com) with your preferred contact details. He will talk to you about the study and you will then be invited to complete the survey either online or by post.
Are there any costs involved?
What do I have to do?
You will need to complete two surveys (this is the first), with multiple questions, in the space of under 10 days. We will contact you to complete the second survey using the contact details provided and the unique receipt number you receive at the end of completing this survey.
Are there any risks involved?
The risk associated with taking part in this study is minimal. You will not be asked to disclose any information that you are not comfortable sharing.
What happens when the research study stops?
The results from the study will be published in scientific and clinical publications, as well as being presented at international conferences. You will not be identified in any of this material to preserve your confidentiality. Once the study is over, all personal information that could identify you will be destroyed. We will only keep the research data that would allow others to check and verify our findings. These will be deposited in the NTU Data Archive, which is an archive of research data and will preserve data for at least ten years. Anonymous data e.g. survey responses will be available for future research. This means that other researchers will be able to request to access and use the data for studies not involving NTU. You may request a copy of any published results from Dr. Cleveland Barnett.
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. Please contact Cleveland.firstname.lastname@example.org
All personal information and data that could be used to identify you from the study will be kept strictly confidential. Your name and details will not be disclosed at any time and you will be assigned a code number to identify you in the study. All data and information will be kept on record electronically on a password protected cloud-based storage.
Dr. Cleveland Barnett has responsibility to safeguard the data and information and only those individuals involved with the study will have access to these sources.
All data and information will be kept by Dr. Cleveland Barnett at Nottingham Trent University for the duration of the study. Please be aware that, when giving consent to participate, you are agreeing with the conditions outlined above.
Your participation in this study is voluntary. You are allowed to withdraw from the study at any time without reason. This will not affect any future treatment, or any legal rights. Withdrawal is totally without prejudice.
For more advice on the project please contact Dr Cleveland Barnett, 01158483824 or email email@example.com.
Who is organising the study?
Dr. Cleveland Barnett, School of Science and Technology, Nottingham Trent University.
Thank you for your time and I look forward to speaking to you soon.
Dr. Cleveland Barnett
School of Science and Technology
Nottingham Trent University