Do you and your household members want your saliva to be tested frequently so you can rapidly detect any new cases of covid-19 in your household?

Each of your household members can now join our NUI Galway ā€“ HSE study as a research volunteer for their saliva to be tested twice a week, for the next three weeks.

Each household member will need to register to join the study via the purple “I consent” button above.

In this Research Study, which is a collaboration between NUI Galway and HSE West, we are using saliva-based PCR screening to test twice a week all the household members in households that have identified positive Covid-19 cases.

The study aims to determine whether saliva-based Covid-19 screening can be used to rapidly test a saliva sample of each member of a household twice a week so that the household can know if new members of the household become infected.

We are inviting research volunteers who are members of a household where someone in the household has had a recent positive Covid-19 test. The aim is to test the saliva of all members of a household twice a week so that the household can rapidly identify any new cases and also track who is infected. The study will collect saliva samples from participating households twice a week.

Why is this research being done?
The novel coronavirus pandemic (Covid-19) continues to impact on the lives of people all over the world, including in Galway. The Covid-19 disease is caused by a virus called the SARS-CoV-2 virus. Our overall SalivaScreen research study is developing systems for SARS-CoV-2 serial screening based on saliva sampling (which can be easier for sampling than the current nasal swab approach). The output of this study may be an easier system for Covid-19 screening using saliva, which can be used for a range of purposes (including rapid-testing of households who have infected members). The intended outcome will be a high-throughput system for SARS-CoV-2 serial screening based on rapid saliva sampling and testing.

How does this study work?
Each member of the household participating in the study will be asked to sign a consent form and complete a short questionnaire.

Once the consent form and short questionnaire have been completed, each participating volunteer from the household will be provided with a SalivaScreen sample pack. Each sample pack will contain 6 tubes for providing 6 saliva samples over a three week period, saliva sampling instructions, and details on how the samples will be collected from your household. One member of each household will be asked to act as the primary contact for the volunteer, but all household members must register to join the study via the purple “I consent” button above.

The saliva samples of each household member will be collected from your household before 10am, on a twice per week basis for 3 weeks.

If any member of your household tests positive for Covid-19 in the saliva testing, they will be referred by the HSE for swab testing.

More about this study

Who can provide saliva samples to this study?
Research volunteers over the age of 5 years can provide saliva 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, Director of HSE West. The SalivaScreen research project is 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 need to read and electronically sign register via 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 twice a week. Note that we can only test saliva samples of household members who have registered to join the study via the purple “I consent” button above

What will happen to the saliva sample I provide?
You will provide your saliva sample twice a week in a tube (provided to you), where volunteers are provided with clear instructions on how to provide high quality saliva samples. Your saliva samples will be heat inactivated prior to being stored in Prof. Spillaneā€™s lab. The SalivaScreen study will use your saliva sample in its individual form and in a pooled form (with other saliva samples) to develop a high-throughput for SARS-Cov-2 serial screening of households based on rapid saliva sampling. 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 NUI Galway and HSE partners. 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 household Covid-19 saliva-screening research study?
Twice a week you and your household members will be tested for covid-19 and your household will be notified of existing and any new cases. You will be making a contribution to science and the future development of improved Covid-19 testing and screening systems that can benefit your household and future households.

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

Your samples will be taken for research purposes. In the event that your saliva sample tests positive for the SARS-CoV-2 virus at any point during the three weeks, you will be notified and advised to follow the latest HSE Guidelines, including referral for swab based testing to confirm any new cases in your household. The study will also be measuring the level of virus in the saliva of all infected members of the household over time and so requires that infected members of the household provide saliva samples also twice per week.

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.