Participants with COVID-19, and those who experienced COVID-19 in the past, are needed to record their breathing with their own smartphone.
You are invited to participate in a UCD research study, funded by Science Foundation Ireland.
Thank you for taking time to read this.
Home monitoring of respiration in COVID-19 patients using smartphone technology.
Dr. Emer Doheny, Insight Centre for Data Analytics and Neuromuscular Systems Research Group, Electrical and Electronic Engineering, University College Dublin
Prof. Madeleine Lowery, Insight Centre for Data Analytics and Neuromuscular Systems Research Group, Electrical and Electronic Engineering, University College Dublin
Dr Silke Ryan, Respiratory Consultant, St. Vincent's Hospital, Dublin and School of Medicine, University College Dublin
What is the purpose of this study?
The aim of the study is to develop a new method to remotely monitor breathing using the microphone in your smartphone. Breathing rate is an important vital sign and is altered in many lung and heart conditions. It is of particular interest in patients suffering from COVID-19. A way to monitor breathing using smartphones will help healthcare providers to monitor patients while they are self-isolating due to Covid-19.
Why am I invited to participate?
You are invited to participate in this study because:
(A) you have been diagnosed with COVID-19
(B) you have not been diagnosed with COVID-19 and you do not have any of the following symptoms of COVID-19
a fever (high temperature - 38 degrees Celsius or above)
any kind of cough
shortness of breath (breathing difficulties)
loss or change to your sense of smell or taste
Have you been in close contact with anyone with a confirmed case of COVID-19 in the last 14 days?
What will happen if I volunteer?
Your participation is entirely voluntary. If you initially decide to take part you can subsequently change your mind without difficulty. Furthermore, your doctor may decide to withdraw you from this study if they feel it is in your best interest.
If you agree to participate, you will be requested to record 90 seconds of your breathing using your smartphone microphone. You should position your phone as shown in Figure 1, and try to relax and breathe normally during the recording period.
Figure 1. Hold your phone horizontally, with the base of the phone 2 cm from your mouth.
If you agree to participate in a secondary validation test, you will also be asked to perform the 90 s recording, while also wearing a respiratory inductance belt around your chest to measure how you breathe.
After you have made the recording, please email your recording to . The researchers will save your microphone recording, but they will not save your email address. Your email will be deleted and your email address will not be recorded.
You will also be asked to complete a questionnaire (using google forms). This de-identified questionnaire will:
Record your age and sex (male/female)
Record your phone manufacturer and model (e.g. iPhone 5/Huawei P20)
Record details of any issues/difficulties with your recording
Record any feedback you have for the researchers
Check that you do not have any of the COVID-19 symptoms/risks (listed above).
Confirm that you consent to participate in this study.
Are there any benefits from my participation?
You will not benefit directly from taking part in this study but the information we will obtain may help to develop new remote methods to monitor breathing. These methods may help doctors to better monitor patients within their home using the technology available in smartphones. No analysis of wellbeing or illness will be made from your recording and no feedback will be given.
Are there any risks involved in participating?
There are no risks associated with this study, other than those associated with the day to day use of your phone. The risks associated with mobile phone usage have been summarised for the public by the HSE in their Health Finder on-line service (Risks of Mobile Phone Usage ). As the breathing data will be recorded as audio files, it is possible that background noises containing personal information could also be recorded. To avoid this, you will have the chance to delete any recordings that may contain this type information and to re-record your data. Your audio recordings will be saved and your email will be deleted.
Your email address will not be saved. Your online questionnaire will be linked to your audio recording, and will not include your name or email address.
What happens if I do not agree to participate?
You are free to decline to participate in this study.
Your identity will remain confidential. A study number will be used to identify you. Your name will not be published or disclosed to anyone. The researchers will not have access to your personal information and only anonymised data which will be used and stored in this study. All recorded data will be retained by the researchers in a secure location.
The researchers are adequately insured by virtue of their participation in the Clinical Indemnity Scheme, or through their research institutions.
Who is organising and funding this research?
This study is organised by the Insight Centre for Data Analytics, University College Dublin in Collaboration with St. Vincent’s University Hospital and patientMpower ltd. The study is funded by Science Foundation Ireland.
All UCD employees involved with this study are subject to Data Protection and Confidentiality measures.
Has this study been reviewed by Ethics Committee?
The St. Vincent’s Healthcare Group, Ethics and Medical Research Committee have reviewed and approved this study.
Name: Dr Emer Doheny
Research participant's rights
Confidentiality & Data Protection
This Participant Information and Consent Form provides guidance and information to Home monitoring of respiration in COVID-19 patients using smartphone technology research participants regarding the processing of the research participants’ personal data. St. Vincent’s University Hospital is committed to protecting and respecting your privacy. This Participant Information and Consent Form together sets out the basis on which any personal data we collect from you or that you provide to us will be processed by us an independent data controller. Please read this Participant Information and Consent Form carefully to understand our treatment and use of your personal data.
The processing of your personal data will be in compliance with the Data Protection Acts 1988 to 2018 (as amended) and the General Data Protection Regulation (the “Data Protection Legislation”).
Please note that agreeing to participate in a research program with St. Vincent’s University Hospital, you acknowledge that you have read, understood and agree to this Participant Information and Consent Form.
IDENTITY OF THE CONTROLLER OF PERSONAL INFORMATION
For the purposes of the Data Protection Legislation, St. Vincent’s University Hospital is an independent data controller in the following circumstances:
Company/PI Name: Dr. Silke Ryan
Company/PI Type: SVUH Employee
Company Registration number: 338585
Having its registered office at: Elm Park, Dublin 4
[and Pharmaceutical company, CRO, other health agency, other universities is an independent data controller in the following circumstances:]
Company Name: University College Dublin
Company Type: University
Company Registration number: 239961
Having its registered office at: Belfield, Dublin 4
CONTACT DETAILS OF THE DATA PROTECTION OFFICER
The data protection officer for SVUH and PI is:
Orlaith McCarthy, SVUH, Elm Park, Dublin 4, Contact 01 221 3591
The data protection officer for University College Dublin:
Debbie Scanlan, Roebuck Castle, University College Dublin, Belfield, Dublin 4.
Tel: 01 716 8786
PROCESSING OF YOUR PERSONAL DATA
St Vincent’s University Hospital will process your personal data for the following purposes on the basis of your consent:
Identification e.g. name, e-mail address, age (please note this and subsequent information will be anonymised/coded once leaving SVUH)
Purpose of processing:
used for purpose of carrying out research
Where does St. Vincent’s University Hospital obtain my personal data from?
The personal data we process is obtained from you directly.
SHARING OF PERSONAL DATA
Your personal data will in particular be shared with:
*NOTE: These parties will either be acting as Processors of your information as part of this research study e.g. CROs, non-SVUH employees supporting research process or Controllers in their own right.
Person/Company/institute - Requirement for sharing
Dr. Emer Doheny, University College Dublin - To analyse the de-identified data recorded during this study for research purposes
Prof. Madeleine Lowery, University College Dublin - To analyse the de-identified data recorded during this study for research purposes
We use third party service providers who provide services including financial services, occupational health and IT services. In providing the services, your personal data will, where applicable, be processed by the service provider on our behalf.
We will check any third party that we use to ensure that they can provide sufficient guarantees regarding the confidentiality and security of your personal data. We will have written contracts with them which provide assurances regarding the protections that they will give to your personal data and their compliance with our data security standards and international transfer restrictions.
Disclosures to Third Parties
In certain circumstances, we share and/or are obliged to share your personal data with third parties outside St. Vincent’s Hospital, for the purposes described above and in accordance with Data Protection Legislation.
These third parties include but are not limited to:
the Health Products Regulatory Authority;
the Health Service Executive;
the Joint Commission International;
relevant industry bodies;
external professional advisors; and
others, where it is permitted by law, or where we have your consent.
TRANSFERS OUTSIDE THE EUROPEAN ECONOMIC AREA
We will not transfer, store or process your personal data outside the European Economic Area.
If you would like to see a copy of any relevant provisions, please contact your data protection officer (see “Contact Us” section below).
HOW IS MY PERSONAL DATA SECURED
St. Vincent’s University Hospital operates and uses appropriate technical and physical security measures to protect your personal data.
We have in particular taken appropriate security measures to protect your personal data from accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access, in connection with this research study. Access is only granted on a need-to-know basis to those people whose roles require them to process your personal data. In addition, our service providers are also selected carefully and required to use appropriate protective measures.
STORAGE OF PERSONAL DATA
We will keep your personal data for a period of 5 years. This may mean that some information is held for longer than other information.
You may have various rights under Data Protection Legislation. However, in certain circumstances, these rights may be restricted. In particular, your rights may be restricted where this is necessary: (i) for the prevention, detection, investigation and prosecution of criminal offences; (ii) in contemplation of or for the establishment, exercise or defence of a legal claim or legal proceedings (whether before a court, tribunal, statutory body or an administrative or out-of-court procedure); and/or (iii) for the performance of a task carried out in the public interest or in the exercise of official authority vested in St. Vincent’s University Hospital.
These rights may include (as relevant):
The right of access enables you to check what type of personal data we hold about you and what we do with that personal data and to receive a copy of this personal data;
The right to object to processing of your personal data where that processing is carried out on the basis of our legitimate interests. We will stop using your personal data unless we can demonstrate an overriding legitimate ground for the continued processing of this personal data;
The right to rectification enables you to correct any inaccurate or incomplete personal data that we hold about you;
The right to erasure enables you to request that we erase personal data held about you in certain circumstances;
The right to restrict processing of your personal data by us in certain cases, including if you believe that the personal data held about you is inaccurate or our use of the personal data is unlawful; and
The right to data portability enables you to receive your personal data in a structured, commonly used and machine readable format and to have that personal data transmitted to another data controller
YOUR RIGHT TO LODGE A COMPLAINT WITH A SUPERVISORY AUTHORITY
Without prejudice to any other administrative or judicial remedy you might have, you may have the right under data protection legislation in your country (where applicable) to lodge a complaint with the relevant data protection supervisory authority in your country (i.e. the Office of the Data Protection Commissioner in Ireland) if you consider that we have infringed applicable data protection legislation when processing your personal data. This means the country where you are habitually resident, where you work or where the alleged infringement took place.
CHANGES TO THIS INFORMATION
We may decide to make changes to this Participant Information and Consent Form. If a change is made, we will notify you in person of such changes. An updated Participant Information and Consent Form will be provided to you in advance of any change actually taking effect.
For further information or if you have any questions or queries about this Participant Information and Consent Form, please contact:
Orlaith McCarthy, Data Protection Officer, St Vincent’s University Hospital
Elm Park, Dublin 4
(01) 221 3591