Request for participation in the health research project: Corona and Covid-19 Study in Agder and Telemark (COVITA)
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This is a request to you who have 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 goal of the study is to investigate how antibodies against the virus develop in the population of Agder and Telemark. It is also a goal to map symptoms and medication use both in those who test positive and those who test negative. In addition, it is a goal to find out how what we are exposed to in our work and environment affects the risk of getting the coronavirus, in order to better identify vulnerable groups. This knowledge is now greatly needed in the work of managing new waves of the pandemic. The questionnaire will provide more knowledge the more people respond and will be an important contribution to planning infection control measures in Agder and Telemark going forward.
translation:You've already had a blood test, and we are now asking you for a new one. You will then receive requests for blood tests approximately every six months (a total of four blood tests) over a period of two years. When you are tested, you will also receive a short questionnaire about any ailments you've experienced recently and a few other questions related to possible risk factors for covid-19. It takes about 10 minutes to fill out 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, the University of Leiden, Netherlands, and the University of Aarhus in Denmark.
If you have any questions about the questionnaire, you can call, text, or email the project worker in the study: phone: 953 69 315, email: SARM@sthf.no
What does the project involve?
The study is based on answers from a short questionnaire you receive when you are tested for antibodies against the virus. The questionnaire maps the prevalence of illness and symptoms. A few questions about risk factors for infection have been added, concerning your health, medication use, and your work and immediate surroundings. The questionnaire takes 10 minutes to complete. Participation is voluntary. In addition, we will use the answers from the virus and antibody tests that we take from you.
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In the project, information about you will be de-identified (see more info below). By consenting to the study, you also consent to the information from the virus/antibody tests and the questionnaire being linked with information from the following national registries: National Register of Citizens, System for Vaccination Control – National Vaccination Registry, Norwegian Patient Registry, Notification System for Infectious Diseases, Prescription Registry, Registry of Causes of Death, Municipal Patient and User Registry / Control and Reimbursement of Healthcare Refunds, Norwegian Intensive Care Registry, Statistics Norway, Norwegian Influenza Survey, Helsenorge.no, and Registry of Adverse Reactions to Vaccination.
Possible advantages and disadvantages
translation:Benefits of participating in the study: It is important to know more about how many people have experienced respiratory problems and other possible coronavirus-related ailments recently, and how many have not. Even more important is to learn more about how many people are developing immunity and how long it lasts after having the illness, as well as which factors may increase the risk of coronavirus infection. You can contribute to this by participating in the study. The study can also help politicians and healthcare professionals to better plan and implement 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 concerned about filling out a questionnaire. If this applies to you, we are available by phone to answer questions and provide advice. Some may experience slight discomfort during blood sampling, but such discomfort is rare. If needed, healthcare professionals will always be available to follow up with you during and after the blood sample.
Voluntary participation and the opportunity to withdraw consent
Participation in the project is voluntary and you can withdraw at any time without giving any reason. If you wish to withdraw later, all information about you will be deleted. If you wish to participate, you sign a consent form, complete the questionnaire, and provide a blood sample.
If you were to change your mind and wish to withdraw from the project, you can request that collected samples and information be deleted, unless the information has already been incorporated into analyses or used in scientific publications.
If you wish to withdraw or have questions about the project, you can contact the project staff by phone: 953 69 315 (9:00 AM - 3:00 PM).
What happens to information about you?
The information registered about you will only be used as described in the purpose of the study. You have the right to access the information registered about you, and the right to have any errors in that information corrected. All information will be processed without names, date of birth, or other directly identifying information. The information is then de-identified. A code links you to your information through a name list that only a small number of project staff at Telemark Hospital have access to. When the results are published, all information will be anonymized.
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The project manager is responsible for the daily operation of the research project and ensuring that information about you is handled securely. Information we collect about you will be stored in locked archives and in computer systems protected by security routines at Telemark Hospital. Telemark Hospital, represented by the managing director, is the data controller. Information about you will be anonymized or deleted, at the latest in 2031.
Insurance
All participants in the study are insured through the Norwegian Patient Injury Compensation Scheme.
Disclosure of information to others
By participating in the project, you consent to the release of de-identified information to project staff affiliated with Telemark Hospital, South Norway Hospital, the Norwegian Institute of Public Health, and the University of Oslo. You also consent to the sending of de-identified information to our partners in England, the Netherlands, and Denmark. The code that links you to your personally identifiable information will not be released.
: Economics
The study is funded through 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), case no. with REK (2020/146469).