Information leaflet and informed consent for Adults: potential participants for CoughWatchSA
STUDY TITLE: Digital Participatory Surveillance for Respiratory Illness in South Africa - CoughWatchSA
Each participant must read this document and sign the attached informed consent before any further study-related procedure is done
This consent will apply to for prospective participants.
Institution: National Institute for Communicable Diseases (NICD), South Africa; funded by a grant from the Centers for Disease Control and Prevention (CDC), Atlanta, United States of America and Sanofi Pasteur
Investigator: Prof Cheryl Cohen 011 386 6593, daytime and 082 803 8093, afterhours
Hello, my name is Prof Cheryl Cohen. I am the Head of the Centre for Respiratory Disease and Meningitis (CRDM) at the NICD) in Johannesburg. I would like to invite you to think about participating in our study. I would like to thank you for considering participating in this study.
- Before you agree to take part in this study, we would like you to read this information sheet about the study.
- Please make sure you understand what you need to do.
- You should also make sure you understand the purpose of the study, the study procedures, benefits, risks, discomforts, and precautions as well as the alternative procedures that are available to you, and your right to withdraw from the study at any time.
- This information leaflet is to help you to decide if you would like to participate. You need to understand what is involved before you agree to take part in this study.
- If you have any questions, do not hesitate to contact me.
- You should not agree to take part unless you are satisfied with all the procedures involved.
- If you decide to take part in this study, you will be asked to accept the terms and condition by checking the accept checkbox at the end.
Background/Purpose
Surveillance (looking out for diseases) allows us to obtain laboratory confirmation of cases of respiratory illness (like influenza (flu)) from patients consulting primary health care facilities. This data is useful for quantifying the burden and severity of respiratory illness in South Africa. We also use this information to document the timing of the flu season and what other respiratory pathogens are circulating (like COVID19). However, many people do not consult a clinic or general practitioner for their flu like symptoms. Because of this we may underestimate the number of cases of flu and other respiratory illness each year. We are introducing a new and innovative way to collect information on flu like symptoms from people in the community. In this study we want to collect information on symptoms related to respiratory illness, including demographic data (age, gender, area you live in), symptoms (cough, fever, runny nose, chest pains fatigue and the like), underlying medical conditions (like high blood pressure, diabetes), and vaccines you may have had (influenza and COVID19). After you have agreed we will ask you to complete a simple questionnaire at baseline and then every week for the 6 months of the flu seasons.
Length of study and number of participants
- The study is only being performed in South Africa only.
The surveillance will run over three winter influenza seasons between April – October over the following years: 2023, 2024 and 2025.
- The study may be extended if there is a new respiratory virus outbreak
- At least 1500 participants will be enrolled in the study
- If you live in South Africa and are at least 18 years old, you are eligible for enrolment. You will also have the opportunity to enrol your children in the study
Study procedures:
- If you agree to take part in this study, you will first be asked questions about your age, gender, occupation, underlying medical conditions, whether you smoke or drink, influenza and COVID19 vaccination status
- Only a weekly basis, once you have agreed to participate in the study we will send you a symptoms questionnaire where we will ask you to provide us with information on whether you have experienced any symptoms related to respiratory illness, like cough, headache etc.
- If you have experienced any symptoms, we will ask you questions about when the symptoms first appeared, what kind of medical or alternative help did you seek, whether you had a test for influenza or COVID19 and the result if you did.
- We will ask you to register on the web application if you agree to participate in this study using your email address and we will provide you with an opportunity to use your Whatsapp number to receive notifications on your phone. We would like to use your email address or Whatsapp number to send you a weekly reminder to complete the symptoms questionnaire.
- The questionnaire will not take approximately 10 minutes of your time to complete.
Your rights as a participant
Your participation in this study is entirely voluntary and you can decline to participate, or stop at any time, without stating any reason.
Expected duration of participation
We will request that you participate in the study for the duration of the study period i.e. April – October in 2024 and the same period in subsequent years. The total amount of time requested for your participation in this study is approximately of 10 minutes a week for completing the short questionnaire.
Risks of this study
In this study, we are collecting your email address and/or Whatsapp number, which may potentially identify you. Both the email address and/or your Whatsapp number will be stored in an access-controlled database, where only the database administrators will have access to it. The email address and Whatsapp number will be stored in a separate table and separated from the study data. Our collaborators are a team of researchers at the Institute for Scientific Interchange in Italy. Your email address and/or Whatsapp number will not be shared with collaborators and confidentiality will be maintained by separating your email address from the data you provide in the program.
Benefits of this study
There is no direct benefit to you for participating in the study. However, your participation in this study may contribute to information about flu and other respiratory infection in your community. This may allow us to potentially respond earlier to increases in suspected cases.
Confidentiality
We will keep your information confidential by doing the following: All information obtained during the course of this study, including personal data and research data will be managed and stored confidentially. Your email address will be stored as a masked-input in a separate table from the analysis data. Your data will be stored and linked to a unique studyid, separate from the email address. The database is a password protected database with only the study team having access to the data. Data that may be reported in scientific journals will not include any information that identifies you as a participant in this study. Your data will be collected, processed and stored according to the South African Protection of Personal Information (POPI) Act of 2013.
Withdrawal from the study
Your participation in this study is entirely voluntary and you can decline to participate, or stop at any time, without stating any reason. Your withdrawal will not affect your access to other medical care.
Reimbursement for Participation
You will receive a R 10 airtime voucher for each weekly symptoms questionnaire submitted.
Incentives
If you submit all 4 surveys in a month you will be entered into a lucky draw. 8 lucky people will win R1000 each every month.
Ethical approval
- This study protocol has been submitted to the University of the Witwatersrand, Human Research Ethics Committee (HREC) and written approval has been granted by that committee.
- This study is sponsored by Centre for Diseases Control and Prevention (CDC) Atlanta. I do not have any financial or personal interests with this organisation that may bias my actions
- If you want any information regarding your rights as a surveillance participant, or complaints regarding this surveillance programme, you may contact Prof. Paul Ruff, Chairperson of the University of the Witwatersrand, Human Research Ethics Committee (HREC), which is an independent committee established to help protect the rights of research participants at (011) 274 9200.
- For surveillance information you can contact Prof Cheryl Cohen, National Institute for Communicable Diseases at +2711 386 6593 and +27 82 803 8093
STUDY TITLE: Digital Participatory Surveillance for Respiratory Illness in South Africa – CoughWatchSA
- I hereby confirm that I have read and understood the terms and conditions for my participation in the CoughWatchSA study – Digital Participatory Surveillance (DPS) for Respiratory Illness for South Africa
- I am aware that the results of the study, including confidential information will be anonymously processed into a study report.
- In view of the requirements of research, I agree that the data collected during this study can be processed by NICD or research partners.
- I may, at any stage, without prejudice, withdraw my consent to participate in the program.
- I agree to use my WhatsApp number if I would like to receive notifications for the surveys. I also acknowledge that I am not required to use my WhatsApp number and may refuse to do so, without prejudice.
- I have had sufficient opportunity to ask questions through provided support email and communications channels from NICD, and (of my own free will) declare I am prepared to participate in the study
- I am aware that I will not be paying for my own mobile data to access the online survey
- By clicking Accept, I agree to:
- Fill in the intake questionnaire which includes basic demographic information, lifestyle related questions and medical related questions like vaccine history and comorbidities.
- Complete and submit a weekly follow-up symptoms questionnaire that will include symptoms related to acute respiratory tract infections (ARI).
- I accept the terms above and provide consent to participate in the CoughWatchSA application
CoughWatchSA Privacy PolicyVersion 2
Wits Health Consortium (Pty) Ltd, with registered office at 31 Princess of Wales Terrace, Parktown, 2193, Johannesburg, South Africa (hereinafter “WHC”), is currently conducting a Sanofi Pasteur funded Study entitled “CoughWatchSA” with a secondary component called “Home Self-Swab Pilot Study”: Community ARI Surveillance to Supplement Sentinel Surveillance for Respiratory Illness in Republic of South Africa (FLU00177)” (“the Study”). WHC in its capacity as Sponsor and Data Controller of the Study brings to your attention, pursuant to The Protection of Personal Information Act 4 of 2013 (“POPIA”, this Privacy Policy).
This Privacy Policy outlines the practices and procedures for the collection, use, disclosure, and protection of personal information in relation to the Study. This Policy applies to all participants, researchers, and any other individuals or entities involved in the Study. Please read this Privacy Policy carefully to understand how personal information will be handled.
1. Purpose of data collection
During the study data will be collected related to the feasibility, logistics and acceptability of participatory surveillance for influenza-like illness (“ILI”) through electronic data forms and surveys on a web application. Symptoms reports on ILI will be collected on a weekly basis to determine suspected reported cases of ILI. Analysis of health-seeking and testing behaviour conducted. SARS-CoV-2, influenza and RSV samples will be collected from participants who are eligible for home-based testing and analysed. Influenza positive samples will be typed and sequenced. As a secondary objective, if vaccine coverage and case and control numbers are sufficient then vaccine effectiveness estimates will be calculated for influenza and SARS-CoV-2 vaccine using a test-negative case-control study design. The information collected will be used for scientific research, academic purposes, and to fulfill any legal or regulatory requirements.
2. What data is collected and processed during the study?
The personal data that is collected through the questionnaires and processed in the subsequent analyses are:
- basic demographic information: your age, gender, postal code, province, employment status, highest education level, healthcare worker and educator status,
- information on lifestyle factors: smoking status, alcohol consumption, household size and number of rooms used for sleeping, average number of daily contacts, use of public transport, type of health care sought (private or public)
- information on your current medical underlying conditions; and
- information about the seasonal influenza and COVID19 vaccines you have undergone.
- Data on any symptoms reported on a weekly basis, including follow-up questions related to onset date of symptoms, history of fever, any care sought, any tests done for influenza and COVID19, any medication taken, changes in routine due to illness.
3. How is my data collected
The Study may collect personal information through various methods, including:
- Participant questionnaires and forms through CoughWatchSA app
- Satisfactory surveys and participant feedback
- Laboratory tests and samples
4. How will my personal data be processed?
Your contact information (email address and username you signed up with) will be stored separately from your responses to the questionnaires. Your replies will be associated with a unique identifier that cannot be traced back to your contact details (through a pseudonymisation process). Only WHC and Fondazione Instituto per l’Interscambio Scientifico - I.S.I (the entity administering the CoughWatchSA Platform) will have access to your identifiable information, and only for purposes of the Study. The answers to the questionnaires and your unique identifier (without any identifiable information) will be shared with study collaborators and the study team, who will analyze your data with the prior authorisation of WHC. The information to decipher your unique code will never leave the platform. Your identity and any information which will be able to identify you, will therefore not be available to any researcher and will never appear in a scientific publication or presentation.
5. What will happen to the information collected about me during the study?
WHC can appoint authorised persons (researchers) to analyse the data collected on the CoughWatchSA Platform. Those authorised to process will only have access to the pseudonymised data (i.e. your answers and study identifier) as described above. Authorised persons may use pseudonymised personal data solely for research purposes. If a researcher wishes to use the data for research not yet described in this document, such research must be approved by an Ethics Committee. WHC may grant external researchers (who are not involved in this study) access to the pseudonymised data for purposes of the Study. All data collected under the Study will be processed in accordance with POPIA and subject to your written informed consent.
6. What are my rights with respect to my data?
You have the right to ask WHC what data has been collected and what it is used for in this study. You have the right to:
- access and control this data
- delete your data
- request the correction of data if they are incorrect
- limit the processing of your data
- object to the processing of your personal data
- revoke consent to the processing of personal data. Your personal data that has already been collected before the withdrawal of consent will be retained to prevent any misinterpretation of the study results
- propose a complaint to the Ethics Committee, the Information Regulator and / or the Deputy Information Officer of WHC. You can exercise your rights by writing to the CoughWatchSA study team at the following email address coughwatchsa@nicd.ac.za.
If you have questions about how your personal information is protected you may contact Adél Venter, the Deputy Information Officer of Wits Health Consortium (Pty) Ltd on popia@witshealth.co.za or Information Regulator – POPIAComplaints@inforegulator.org.za / enquiries@infroregulator.org.za.
7. What will be the use of the results of the study?
The interim results of the study are published regularly on our websitecall_made in the form of anonymous statistics. Furthermore, the results of the statistical analyses may be published in specialised medical journals in the form of aggregated and anonymous data. References to any scientific publications will be published on the Influweb.org website and made available to study participants.
8. Will my data be used for any purpose other than the study I am participating in?
The study results will only be used to answer the scientific questions in this study. Any additional or future research outside the study must always be approved by a recognised Ethics Committee in South Africa.
9. How long will my data be kept?
After the study, your responses to the questionnaires will be kept for the maximum period permitted by law. This will also be the case if you withdraw from the study before its completion.
10. Changes to this Privacy Policy
WHC reserves the right to update or modify this Privacy Policy as necessary to reflect changes in research practices or applicable laws and regulations. Changes may be communicated to participants, but will in any event be posted on the Study's website.
By participating in the Study, you acknowledge that you have read and understood this Privacy Policy and consent to the collection, use, and disclosure of your personal information as described herein.
