When you go to get tested, would you be willing to give a saliva sample at the same time as you are swab sampled to help NUI Galway & HSE to explore saliva for Covid-19 testing?

Join our NUI Galway – HSE study as a research volunteer!

In this Pilot Study, which is a collaboration between NUI Galway and HSE West, we are comparing swab-based testing with saliva-based testing for Covid-19.

If you test positive, we would then invite you and your household members to be screened by saliva-testing twice each week for three weeks. This follow on part of the study would be to understand better the transmission dynamics of Covid-19 within households where there has been a confirmed case of the virus.

All volunteers must be aged 5 years or older.

Why is this research being done?
The novel coronavirus pandemic (COVID-19) is affecting the lives of people all over the world. The COVID-19 disease is caused by a virus called the SARS-CoV-2 virus. Our research study is developing systems for SARS-CoV-2 serial screening based on saliva sampling (which may be easier than the current nasal swab approach). The output of this project may be an easier system for covid-19 screening using saliva, which can be used for a range of purposes (including better understanding of how the virus can spread in households). The intended outcome will be a high-throughput rapid surveillance system for SARS-CoV-2 serial screening based on rapid saliva sampling. If successful, the research may contribute to the development of faster and more high-throughput surveillance screening systems for COVID-19.

More about this study

Who can provide saliva samples to this study?
Research volunteers over the age of 5 years can provide saliva or swab samples to this research project.

Saliva samples will not be accepted from COVID-19 vulnerable groups.

Who is doing this study and who is sponsoring and funding it?
This study is led by Prof. Charles Spillane (Genetics & Biotechnology Lab, NUI Galway) and conducted in collaboration with Dr. Breda Smyth, HSE West. The research project is funded by funded by the 2020 Science Foundation Ireland COVID-19 Rapid Response Research and Innovation Funding Call.

Do I have to provide saliva samples to this research study?
Participation in this research study is entirely voluntary. As a research volunteer, it is completely up to you to decide whether or not you wish to provide saliva samples to this research study.

What happens next if I agree to join this study?
If you decide to join as a research volunteer, you will be asked to read and electronically sign (i.e. click yes) our consent form (which you can find at the top & bottom of this page). We also provide Saliva Sampling Instructions to you on how to provide your saliva sample when you arrive for your Covid-19 testing appointment.

What will happen to the saliva sample I provide?
Swab samples will be taken by trained personnel using HSE protocols. Saliva samples will be collected in sterile tubes, where volunteers will be provided with clear instructions on how to provide high quality saliva samples. Saliva samples will be heat inactivated at 95oC for 5 min prior to being stored in Prof. Spillane’s lab.
We will use your saliva sample in its individual form and in a pooled form (with other saliva samples) to develop a high-throughput rapid surveillance system for SARS-Cov-2 serial screening based on rapid saliva sampling. If we collect a swab sample from you it will be used for comparisons between different testing methods. Your personal details will never be released and your samples will be anonymised and kept in secure locations.

Will my details be kept confidential?
Yes. Best ethical and legal practice will be followed to ensure that all your information will be handled in confidence. Your samples will be labelled with a unique sample study number. Access to your personal details will only be available to SalivaScreen researchers on this project in the NUI Galway SpillaneLab. De-personalised data about your sample will be stored in a secure electronic archive (hard-drive). You will not be identified personally in any report or publication arising from the analysis of your samples and/or data.

What are the risks and disadvantages of joining the research study? 
You will encounter no significant risks or disadvantages from contributing your saliva sample to this research study.

What are the benefits of joining the research study?
There will be no direct benefit to you, but you will be making a contribution to science and there may be a benefit to the future development of improved Covid-19 testing and screening systems.

Can I know the results obtained from my saliva study samples?

Your samples will be taken for research purposes and therefore there will be no feedback or other test results provided to you. In the event that your saliva sample (or an RNA extract from a sample) yields a positive indication for SARS-CoV-2, you will be contacted and advised to follow the latest HSE Guidelines, including advised to get an official SARS-CoV-2 test conducted in an official clinical HSE testing centre (where this is available under the latest Guidelines).

Are there any payments and what happens if an invention is made using my sample/data?
Your donated saliva sample and related information are given as an absolute gift, i.e. without receiving a payment and without conditions, even in the event of your incapacity or death.

What if I no longer want to be in the research study?
You are free to withdraw from
participation in the research study at any time without giving a reason. If you choose to withdraw, you can either
(1) ask us to stop further contact with you, but allow us to continue accessing your existing saliva samples for the Covid-19 research study, or (2) you can ask us to also stop further use of your data and destroy your remaining samples.
Any research already done with your data and samples cannot be undone.

Who do I contact for further information?
If you would like more information or have any queries, contact the project leaders, Prof. Charles Spillane (NUI Galway) at charles.spillane@nuigalway.ie , Dr. Breda Smyth (HSE West) at Breda.Smyth@hse.ie and/or the Research Ethics Committee of the National University of Ireland Galway ethics@nuigalway.ie.

A PDF version of this information sheet is available here.