You have been invited to take part in this study because you are 18 years of age or older and we believe that your views about non-invasive brain stimulation (NIBS) techniques will help inform our approaches to participant recruitment and the messages we use around these techniques. Before you decide to take part, we would like you to understand why the study is being performed and what it would involve for you. Please contact the Principal Investigator if you have any questions, or would like to clarify any points that are not clear.
1. What is the purpose of the study?
This study is looking to understand the perceptions of NIBS techniques, particularly transcranial electrical stimulation (tES), as a general medical device and for improving the control of eating behaviours. Gaining knowledge of these perceptions is important for recruiting participants to research studies, and can help improve the discussion of these techniques between researchers, clinicians and members of the general public or patient populations.
2. Do I have to take part?
Participation in this study is entirely voluntary – it is your choice to volunteer. We will describe the study in this information sheet, and if you agree to take part we will ask you to provide consent.
3. What will I need to do and what measures will be taken?
We’re looking for a minimum of 160 individuals to share their views on tES. You will be asked to complete a short survey that will take approximately 20 minutes, and will ask questions relating to your understanding of NIBS and the use of these techniques.
4. How am I compensated for my time?
On completion of the survey you will be given the opportunity to enter a free prize draw to win one of three £50 vouchers. Entering this prize draw is voluntary. To enter this prize draw, you will need to provide your name and email address. The winners of the prize draw will be decided once all data has been collected. Please note, the winners of these vouchers have the right to stay anonymous.
5. What are the possible benefits of taking part?
By participating in this study you will help us to understand any potential barriers that exists and prevent individuals participating in studies that involve NIBS. We are particularly interested in transcranial direct current stimulation (tDCS), a form of tES that involves the delivery of a weak electrical current to the brain via two electrodes that are placed on the scalp. We are interested in the application of this technique for altering eating behaviours, and the possibility of using the technique as a treatment option for weight management. Your responses to this survey will be helping to further understand how people view these techniques in general and specifically for changing eating behaviours. Your participation in this study will also contribute to a PhD thesis.
6. What are the possible disadvantages and risks of taking part?
This study is not associated with any health and safety risks.
7. Will my participation be kept confidential?
The raw data, including the data which identifies you (e.g. name, email address), will be kept securely by the Principal Investigator and/or the research team. Your identifiable data will be kept on a secure network and will not be downloaded onto any device. To maintain confidentiality, responses will be associated with a randomly generated ID which will appear on all documents relating to the data collected during the study. Raw data will be retained for 10 years. When it is no longer needed, the data will be securely disposed. No raw data will be passed to anyone outside the named research team without your express written permission. The exception to this would be any regulatory authority who may have the legal right to access the data for the purposes of conducting an investigation in exceptional cases.
The data, when made anonymous, may be presented to others at scientific meetings, or published as a project report, academic dissertation, scientific paper, or book. It could also be made available to any sponsors of the research. Anonymous data, which does not identify you, may be used in future research studies approved by an appropriate research ethics committee.
8. What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time, without giving a reason if you do not wish to – this can be done by contacting the principal investigator, Jordan Beaumont (firstname.lastname@example.org), or the Chair of the School of Social and Health Sciences Ethics Committee, Dr. Lisa Webster (email@example.com). If you exit the survey before completion, your data is not accessible to the research team and is excluded from the study. Your data can be destroyed and will not be included in the study. At the end of the survey you will be given a receipt number, please keep a record of this number as you will need to quote this for your data to be removed from the study. We cannot remove your data from the study if you do not provide this recipe number, as there is no other identifying information to tie your data with you.
Once the experiment has been completed, anonymous research data will be analysed – at this point it will not be possible for you to withdraw your anonymous data from the study. You are free to withdraw any data that identifies you, at any point (including after data has been analysed), and this data will be destroyed.
9. Who is funding the research?
This research is funded by Leeds Trinity University. None of the researchers or study staff will receive any financial reward by conducting this study, other than their normal salary or bursary as an employee or student of the University.
10. Who has reviewed the study?
This study has been scientifically and ethically reviewed by the School of Health and Social Sciences Ethics Review Committee at Leeds Trinity University,
11. Where can I get more information?
You can contact the Principal Investigator if you have any questions, prior to or during the study. We are happy to answer any questions, however if these questions may bias the results of the study, we may request that you ask the question at a later stage. If you would like to know more about the results, please notify a researcher and your contact details will be added to a list of interested parties.
12. What if I have a complaint or any concerns?
If you have a concern about any aspect of this study, you should speak to the Principal Investigator in the first instance, if this is appropriate. Alternatively, you can contact a member of the supervisory team.
Any person with concerns or complaints about the conduct of a research study should contact Dr Lisa Webster, Chair of the School of Social and Health Sciences Ethics Committee, Leeds Trinity University, Brownberrie Lane, Leeds, LS18 5HD. Email: firstname.lastname@example.org.
Any person with concerns or complaints about data protection relating to a research study should contact the Data Protection Officer, Leeds Trinity University, Brownberrie Lane, Leeds, LS18 5HD. Email: email@example.com.
Thank you for taking time to read this information sheet, and for considering volunteering for this study. If you wish to participate, your consent will be sought. You may download a copy of this information sheet for reference.