PARTICIPANT INFORMATION

In the coming weeks, over 100 000 people will receive an invitation for participation because their names will be drawn at random from the adult population in Norway.

How to take the blood spot test 

Instruction video

Do you want to participate in the research project “Covid-19 and Immunity in Norway (Korona og immunitet i Norge) – a study on blood antibodies and immunity in Norway”?

Aims of the project and why you are being contacted

We are asking you to participate in a national research project aimed at surveying how many people in Norway carry antibodies for SARS-CoV-2 (Covid-19) in their blood and therefore have probably been infected with the virus already. The leader of this project is Professor Torkjel M. Sandanger from the Department of Community Medicine at UiT The Arctic University of Norway in cooperation with the Norwegian Institute of Public Health (NIPH), the University of Oslo, Oslo University Hospital, Norwegian Research Center (NORCE), Imperial College, London and London School of Hygiene & Tropical Medicine, London. You are receiving this invitation because your name is among those who have been randomly drawn from the National Population Register. It is extremely important that those who have been selected to participate have been chosen randomly such that we obtain an accurate picture of the presence of antibodies among people living in Norway.  Therefore, it is equally important that you participate irrespective of whether you have been diagnosed with the infection, unsure if you have been infected, or do not think you have been infected.

By participating, you are making an important contribution to research on the ongoing Covid-19 pandemic. You will also receive a direct result for whether you carry blood antibodies for Covid-19.

Our project website (uit.no/koronaimmunitet) will be updated to show you our progress and research findings.

What does this project entail for you?

You become a participant by signing the consent form at the bottom of the page, answering a questionnaire, and providing a blood spot sample taken in the comfort of your own home. Those who provide this blood sample and return it will receive a result as to whether they tested negative or positive for antibodies. You can expect your result to be available after approximately four weeks on the laboratory’s website (www.vitas-reports-no), where you enter your test-specific number that comes with the test kit sent to you.

The test is to be taken at your own home by placing two drops of blood on a special piece of paper and sending this to a laboratory for analysis of antibodies for SARS-CoV-2 (Covid-19). In the test kit package, you will also find a set of instructions for how to prick your finger with the lancet and collect two drops of blood. A instructional video can also be found on our website (www.uit.no/koronaimmunitet/video). The purpose of answering the questionnaire is so that we can collect information about possible symptoms or other illnesses you may have or have had, as well as additional information related to the outbreak. The questionnaire should take 5-10 minutes to complete.

 As part of this project, we will be collecting and registering your information. Information from the questionnaire will be registered and linked with the results from the blood sample you have provided. This information will then be linked to national health registries to study whether the spread of the virus can be connected to, for example, underlying disease or drug use. It is important that we understand epidemics and pandemics such that we are better prepared for the future. By participating, you can therefore participate in:

• Providing knowledge about the prevalence of antibodies for SARS-CoV-2 in the entire population
• Provide an important contribution towards bettering our knowledge of how to deal with pandemics now and in the future
• Receive a result as to whether YOU have produced blood antibodies and are probably immune to the virus

Possible advantages and disadvantages

Your participation is advantageous because you will be contributing to a better understanding of how Covid-19 spreads in the population and how many people have produced antibodies for SARS-CoV2 (Covid-19). This knowledge will enable improved handling of future pandemics by the government and healthcare system to the benefit of the Norwegian population. You will also receive your result from the blood sample (i.e. if you carry blood antibodies, you have probably been infected with Covid-19 already). A possible disadvantage is that you can experience discomfort when pricking your finger with the lancet to provide two drops of blood.

Voluntary participation and right to withdraw your consent

It is voluntary to participate in this project. If you wish to participate, you must sign a declaration of consent, which you will find linked to the received SMS. You can, at any time and without providing a reason, withdraw your approval. This will not lead to any negative consequences for you if you do not wish to participate or later wish to withdraw yourself. If you wish you withdraw your consent, your health information and your blood sample will not be investigated any further. You can also request that your health information we collected about you is deleted or disclosed within 30 days and that your blood sample is destroyed. The right to destruction, deletion or disclosure does not apply when the material or information is anonymized. This access can also be restricted if the information has already been included in the analysis.

Please contact the project leader (see contact information at the bottom of this page) if you later wish to withdraw yourself or have questions about the project.

If you forgot to respond to the request for participation, you will be sent a reminder via SMS within one week.

What happens to your information?

Your registered information will only be used for the purposes described. The information is planned to be used until 2023. Any extensions in the use and storage time of information can only take place after approval from the Regional Committee for Medical and Health Research Ethics (REK) and other relevant authorities. You have the right to access your registered information and the right to have any errors in the information corrected. You also have the right to access the security measures for information processing. You may raise a complaint regarding the processing of your information to the Norwegian Data Protection Authority and the Privacy Ombudsman at UiT The Arctic University of Norway (email: personvernombud@uit.no).

Your name, address, and personal number is saved together with a connection key at the Services for Sensitive Data (TSD) – a secure storage location (www.uio.no/tjenester/it/forskning/sensitiv/) that complies with the strictest laws regarding the treatment and storage of sensitive research data. No person who works with the project will have access to this information. Those who will handle the data in the project will only receive a serial number for each person, such that no participant can be identified.

Your information collected from the questionnaire will be stored for five years after the end of project for control purposes.

What happens to your blood samples?

The blood sample that you provide on the special paper will be sent to the VITAS laboratory in Oslo. The project purchases these services from the laboratory. They are only aware of the number on your envelope, not your identity. All positive samples will be re-analyzed at Oslo University Hospital (OUS) to verify the result. All samples will be stored at OUS until the end of the project. Since positive findings are double-checked, it can take up to four weeks before the test results are made available on the website (www.vitas-reports.no).. If you do not find your test result there, it is not ready yet. Results are posted continuously as the laboratory processes samples. If you have questions about your blood samples, you can contact the project group (you will find contact details at the bottom of this page). To ensure your participation, you must complete and return your test within 10 days from receiving your package with the test kit. As it takes several weeks before we know who has sent in their tests, we will send a kind reminder to everyone one week after we send the test kits out to you.

Insurance

Should injury or complications occur as a result of the finger prick, a claim for compensation may be made cf. the Health Research Act § 50. Any claim for compensation must be sent to the project leader. UiT The Artic University of Norway is self-insured.

Potential follow-up project in the future

It may be necessary to follow-up on the same group of participants again at a later time, both to check how many people have been newly infected and to see whether the amount of antibodies in the blood has changed since the first sample. We therefore hope we can contact you again to ask you to provide a blood sample at a later time.

Funding

This research project is funded by the Research Council of Norway and UiT the Arctic University of Norway. There are no conflicts of interest between funding and the project.

Approval

The Regional Committee for Medical and Health Research Ethics has made a research ethics assessment and approved the project. [Project number 154985].

UiT The Arctic University of Norway and project leader, Torkjel M. Sandanger, are responsible for the privacy of this project. We will process your information based on your approval.

Contact information

If you have questions concerning the project or wish to withdraw from participation, please contact the project leader, Torkjel M. Sandanger, or project staff member, Bente A. Augdal, via email: korona-antistoff@uit.no or via telephone: 77646638 between 10:00 and 13:00 Monday, Tuesday, and Wednesday.

If you have questions about privacy, please contact the Privacy Ombudsman at UiT The Arctic University of Norway (email: personvernombud@uit.no).

If you have questions regarding whether data security and the way we work within the project is compliant with laws and regulations and safeguards your security, please contact the Norwegian Data Protection Authority (email: postkasse@datatilsynet.no).

Thank you for participating!