Information Sheet – Survey for helping COVID-19 detection

COUGH Bank data collection study

Novoic

Summary

You are being invited to record cough and voice samples to be submitted and stored in a research database (the ‘Cough Database’). The Cough Database will be used to help us and other researchers develop algorithms to detect COVID-19 from voice. You will be asked to respond to a series of questions about your health-related parameters and health status. You will also be asked to record a set of voice prompts. You may terminate the session at any time, without submitting your information.

Your voice samples and the information you provide may be used for research purposes, and may be shared with other researchers as described in this information sheet.

In this research study we will use information from you. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.

Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.

At the end of the study we will save the data for future research. We will make sure no-one can work out who you are from the reports we write.

This information pack tells you more about this.

The data collection is organised by:

Novoic Ltd.

Gemma House 39 Lilestone Street, Marylebone, London

United Kingdom

NW8 8SS

Chief Investigator:

Emil Fristed

Contact: emil@novoic.com

What is the purpose of the study?

This study aims to collect cough and voice samples from COVID-19-infected human subjects, and controls, along with minimal related demographic and medical information, to help the development of algorithms detecting COVID-19 from voice and cough.

Given the widespread nature of the disease and the severe shortage of testing facilities around the world, if such a system were to be developed, it would give millions of people the ability to monitor themselves cheaply, and potentially save thousands of lives.

In order to develop robust detectors for COVID-19 using voice, a large-scale collection of voices from thousands of diagnosed COVID-19 patients will be necessary. By consenting to this collection, you will be contributing to that effort.

Importantly, this study is not providing you with any health advice or diagnosis regarding COVID-19 or any other conditions – it’s only purpose is to help the development of diagnostic algorithms potentially used in the future.

How will we use information about you?

We will need to use information from you for this research project.

This information will include your

  • age;
  • gender;
  • height and weight;
  • ethnicity and native language;
  • whether you’ve been tested with COVID-19;
  • the date and location of your test(s);
  • any contact history with COVID-19 patients;
  • travel history;
  • smoking history;
  • other respiratory, neurological and neuro-muscular ailments you may have.
  • coughing and deep breathing recordings you submit;
  • Recordings of sustained phonation of long vowels you submit.

People will use this information to do the research or to check your records to make sure that the research is being done properly.

We will not collect your name or contact details, or personally identifiable information from you. Your data will have a code number instead.

We will keep all information about you safe and secure.

When you submit your survey, the data you submitted will receive a random unique identifier, with which we will identify it in future development work. We will not know that that identifier belongs to you. The data is used anonymously in all future development or research analyses.

Information will only be held electronically. With your permission, we will store your voice samples in the Cough Database, a research database to be used in the future for research purposes. We will hold your data for 5 years initially, then we may apply for ethical approval to keep storing your data further to contribute to research work longer. You will not be notified about this potential extension, as we don’t collect data we could use to contact you.  If we do not apply or receive further approvals for maintaining the database, the data will be securely destroyed.

Analysis and development on the recorded data will in most cases be carried out automatically, without manual contact with the data. Authorised persons may look at the data collected for the study. This is in order to check that the development work is being carried out correctly.

Authorised persons will be from the sponsor organisation (Novoic Ltd.) or notified bodies, regulatory agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA) or their representatives.

Once we have finished the study, we will keep the data as part of the research database we’re collecting. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

You can withdraw from filling out the study at any point during the survey, before submitting your information. The information you input before you submit the survey will not be saved.

You can ask us at any time to delete the data you submitted by emailing covid@novoic.com with your request. You will need to quote the ID that appears on the last screen of the survey. We will not be able to delete your data based on your name or any other personal information only (as that is not recorded).

Where can you find out more about how your information is used?

You can find out more about how we use your information:

Expenses and payments

You will not be paid for your taking part in the study. Taking part of the study is not costing you money.

Requirements for participation in the data collection

Participation in this study is limited to individuals age 18 and older.

Participation is welcome from participants who have been tested positive or negative for COVID-19, or from participants who have not been tested yet.

If you show severe symptoms of COVID-19 and/or in a serious or critical condition, please do not participate in the study and ask for immediate medical assistance.

What are the potential risks of taking part in this study?

The risks and discomfort associated with participation in this study are not expected to be greater than those ordinarily encountered in daily life or during other online activities.

If you encounter elevated levels of discomfort during the assessment, you are encouraged to interrupt the assessment and not complete the study.

What are the benefits of participating in this study?

We don’t expect direct personal benefits from filling out the questionnaire, but the help may be of value to humanity.

Will the data I submit be shared to use future research or development work?

In the future, we may use the data (including the cough and voice recordings) for our future research studies or development work, or we may distribute the data (including the voice and cough recordings) to other researchers for development of their similar tools. We would do this without getting additional informed consent from you (or your legally authorized representative).

Will the data I submit be used for commercial purposes?

While we do not currently have plans for it, the data you submit may in the future be used for commercial research. No companies other than us and our well-vetted high quality partners will use this data for commercial research. Please only take part in the study and submit data if this is something you consent to.

Is my participation voluntary?

Your participation is voluntary and you are free to withdraw and leave the survey without submitting at any time.

You can withdraw from filling out the study at any point during the survey, before submitting your information. The information you input before you submit the survey will not be saved.

You can ask us at any time to delete the data you submitted by emailing covid@novoic.com with your request. You will need to quote the ID that appears on the last screen of the survey. We will not be able to delete your data based on your name or any other personal information only (as that is not recorded).

By now you’ll know how much we care about conversations here at Novoic.

If you want to have one with us, let us know here!
Commercial and academic partnerships welcome.
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