We are inviting healthy volunteer adults (aged 18 years or older) who do not have symptoms of COVID-19 infection to join the COVID-19 research study cohort. Our Information Sheet gives information about the research study.
The NUI Galway SalivaScreen Research Study was approved by the NUI Galway Research Ethics Committee on 30/11/20 [REC Application Ref No: 2020.08.016]
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. Covid-19 modelling indicates that recurring infection cycles of covid-19 transmission will continue to occur everywhere, requiring ongoing suppression measures and rapid roll-out of vaccines. Exit strategies from covid-19 lockdown are needed to allow economies/society to function, and require low-cost, high-throughput surveillance systems for SARS-Cov-2 serial screening. Our research project is developing a surveillance system for SARS-Cov-2 serial screening based on saliva sampling (which can be more rapid and robust than the current nasal swab approach). The output of this project 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.
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). The research project is funded by funded by the 2020 Science Foundation Ireland COVID-19 Rapid Response Research and Innovation Funding Call.
Who can provide saliva samples to this study?
Healthy volunteers over the age of 18 can provide saliva samples to this research project if they do not have covid-19 symptoms or knowingly harbour any communicable disease that can be transmitted via contact with saliva samples. Saliva samples will not be accepted from covid-19 vulnerable groups including:
- elderly aged ≥ 70 years, persons in residential care, homeless people
- Solid organ transplant recipients
- People with specific cancers:
- people with cancer who are undergoing active chemotherapy or radical radiotherapy for lung cancer
- people with cancers of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at any stage of treatment
- people having immunotherapy or other continuing antibody treatments for cancer
- people having other targeted cancer treatments which can affect the immune system, such as protein kinase inhibitors or PARP inhibitors
- people who have had bone marrow or stem cell transplants in the last 6 months, or who are still taking immunosuppression drugs
- People with severe respiratory conditions including cystic fibrosis, severe asthma, pulmonary fibrosis/ lung fibrosis/ interstitial lung disease and severe COPD.
- People with rare diseases and inborn errors of metabolism that significantly increase the risk of Infections (such as SCID, homozygous sickle cell).
- People on immunosuppression therapies sufficient to significantly increase risk of infection.
- Women who are pregnant with significant heart disease, congenital or acquired.
- Do I have to provide saliva samples to this research study?
Participation in this research study is entirely voluntary. As a 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 volunteer, you will be asked to read and sign the Consent Form. Next, we will indicate to you how to donate your saliva sample(s). We will ask you to donate repeat saliva samples, at regular intervals (e.g. twice per week) over a period of time.
What will happen to the saliva samples I give?
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) in our high-throughput rapid surveillance system for SARS-Cov-2 serial screening 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 necessary researchers on this project in the 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 saliva samples 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 faster and more high-throughout covid-19 testing.
Can I know the results obtained from my study samples?
Your samples will be taken for research purposes and therefore there will be no feedback or other test results provided to you on a sample by sample basis. In the event that any of your saliva samples yields a positive indication for SARS-CoV-2 in our surveillance screen, you will be contacted by email and/or telephone and advised to follow HSE Guidelines, including advised to get an official SARS-CoV-2 test conducted in an official clinical HSE testing centre.
Are there any payments and what happens if an invention is made using my sample/data?
Your donated samples 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 leader, Prof. Charles Spillane at Charles.email@example.com and/or the Research Ethics Committee of the National University of Ireland Galway firstname.lastname@example.org