Request for participation in a health research project: The Coronavirus and COVID-19 Study in Agder and Telemark (COVITA)
This is a request for you, as someone who has had a blood test for coronavirus (SARS-CoV-2), to participate in a study on the development of immunity and risk factors for COVID-19 in Agder and Telemark. The aim of the study is to investigate how antibodies against the virus develop in the population in Agder and Telemark. Another aim is to map symptoms and medication use among both those who test positive and those who test negative. In addition, we aim to find out how our work and environment affect the risk of contracting coronavirus, so that vulnerable groups can be identified more effectively. There is a great need for this knowledge in the work to manage new waves of the pandemic. The more people who respond to the survey, the more knowledge it will provide, and it will make an important contribution to planning infection control measures in Agder and Telemark in the future.
You have already had a blood test, and we are now asking you to have another one. After that, you will be asked to provide a blood sample approximately every six months (four blood samples in total) over a period of two years. When you are tested, you will also receive a short questionnaire about symptoms you have experienced recently and a few other questions relating to possible risk factors for COVID-19. It takes about 10 minutes to complete the questionnaire.
The project is being carried out by Telemark Hospital and Sørlandet Hospital, in collaboration with Unilabs, the Norwegian Institute of Public Health, the University of Oslo, the London School of Hygiene and Tropical Medicine in England, Leiden University in the Netherlands, and Aarhus University in Denmark.
If you have any questions about the survey, you can call, text or email the project staff member at tel: 953 69 315, email: SARM@sthf.no
What does the project involve?
The study is based on responses to a short questionnaire that you will receive when you are tested for antibodies to the virus. The questionnaire maps the occurrence of illness and symptoms. A few questions have been added about risk factors for infection relating to your health, medication use, work and local environment. The questionnaire takes 10 minutes to complete. Participation is voluntary. We will also use the results of the virus and antibody tests performed on you.
In the project, information about you will be de-identified (see more information below). By consenting to participate in the study, you also consent to information from the virus/antibody tests and questionnaire being linked with information from the following national registries: the National Population Register, the System for Vaccination Control – the National Immunisation Registry, the Norwegian Patient Registry, the Norwegian Surveillance System for Communicable Diseases, the Prescription Registry, the Cause of Death Registry, the Municipal Patient and User Registry / Control and Payment of Health Reimbursements, the Norwegian Intensive Care Registry, Statistics Norway, the Norwegian Influenza Survey, Helsenorge.no, and the Registry of Adverse Reactions to Vaccination.
Possible benefits and disadvantages
Benefits of participating in the study: It is important to know more about how many people have recently had respiratory symptoms and other possible coronavirus-related symptoms, and how many have not. It is even more important to know how many people develop immunity and how long it lasts after recovering from the illness, as well as which factors may increase the risk of coronavirus infection. You can contribute to this by taking part in the study. The study may also help politicians and healthcare professionals to better plan and implement the necessary measures in Agder, Telemark and the rest of the country to prevent COVID-19 in the future.
Possible disadvantages of participating in the study: Some participants may become worried when completing a questionnaire. If this applies to you, we are available by phone to answer questions and offer advice. Some people may experience mild discomfort when having a blood sample taken, although this is rare. Healthcare professionals will be available at all times to support you during and after the blood test if needed.
Voluntary participation and the right to withdraw consent
Participation in the project is voluntary, and you can withdraw at any time without giving a reason. If you later wish to withdraw, all information about you will be deleted. If you wish to participate, sign the consent form, complete the questionnaire and provide a blood sample.
If you change your mind and wish to withdraw from the project, you may request that the samples and information collected be deleted, unless the information has already been included in analyses or used in scientific publications.
If you wish to withdraw or have questions about the project, you can contact the project staff member at tel: 953 69 315 (09:00–15:00).
What happens to information about you?
The information recorded about you will only be used as described in the purpose of the study. You have the right to access the information recorded about you and to have any errors in that information corrected. All information will be processed without your name, national identity number or other directly identifying details. It will therefore be de-identified. A code links you to your information through a list of names that only a small number of project staff at Telemark Hospital can access. When the results are published, all information will be anonymised.
More information about the blood tests: Blood samples will be taken to test whether you have antibodies to the SARS-CoV-2 virus (which causes COVID-19). If the result is negative, you will not hear from us. If you test positive, we will contact you on the day the test result is available. You will receive information and guidance if the blood test shows that you have antibodies. You will be asked to provide another blood sample six months after the first, and then every six months, four times in total. The information we collect from the questionnaire, together with the blood test results, will be treated confidentially.
The project manager is responsible for the day-to-day running of the research project and for ensuring that information about you is handled securely. Information we record about you will be stored in locked archives and in computer systems protected by Telemark Hospital’s security procedures. Telemark Hospital, represented by its Managing Director, is the data controller. Information about you will be anonymised or deleted no later than 2031.
Insurance
All participants in the study are insured through the Norwegian System of Compensation to Patients.
Disclosure of information to others
By participating in the project, you consent to de-identified information being disclosed to project staff affiliated with the project at Telemark Hospital, Sørlandet Hospital, the Norwegian Institute of Public Health and the University of Oslo. You also consent to de-identified information being sent to our collaborators in England, the Netherlands and Denmark. The code linking you to your personally identifying information will not be disclosed.
Funding
The study is funded by research grants from Sørlandet Hospital and Telemark Hospital.
Approval
The project has been approved by the Regional Committee for Medical and Health Research Ethics (REK), REK case number (2020/146469).
