SHIVERS-II Influenza Cohort Study

Frequently Asked Questions (FAQs)

ESR

Question / Answer
Who is ESR? / “ESR”stands for the Institute of Environmental Science and Research. It has health scientists who monitor infectious diseases inNew Zealand.
What is the National Influenza Centre? / The National Influenza Centre is part of ESR and is located in Upper Hutt.
The Influenza Centre employs scientists and public health researchers who work on influenza and other respiratory viruses.

Study Purpose and Participant Role/Rights

Why is this study being done? / We are trying to understand how the immune system responds to the flu virus infection and the flu vaccine using more modern immunological concepts and assays. This can help us figure out better ways to protect people from the flu in the future.
Who is doing the study? / Your General Practice isworking on this study with the National Influenza Centre at ESR.
Other organisations involved are listed on the patient information sheet. They include the St. Jude Center of Excellence for Influenza Research and Surveillance (Memphis, USA), the Universities of Otago and Auckland, the Capital and Coast District Health Board, Regional Public Health, Compass Health, and the United States National Institutes of Health.
What am I agreeing to if I participate? / If you agree to take part, you are completing a brief questionnaire, allowing us contact you weekly for a few months about whether you got a flu shot and have had cough and fever, providing two blood samples. If you have cough and fever, we will take a respiratory swab (nose/throat) and some blood. If you get a flu shot,you givesome blood.
You are always free to leave the study at any time without any reason.
Do I have to do all the study activities? / No, you can say no to any study activity at any time.
And you are always free to leave the study at any time without any reason.
What happens if I change my mind and don’t want to be in the study? / You can withdraw from the study at any time without affecting your health care.
The research team will remove your name from the study records and destroy your samples.
Will I get paid to take part in this study? / To cover the costs of study activities (email/text messages, completing the online questionnaire, and going to collection centre), you will receive a gift card worth $30 after every blood draw.
Who do I ask if I have questions during the study? / You can email the study nurses at:.
If you have concerns about the study, contact the New Zealand Health and Disabilities Advocate at Freephone0800 555 050.
You can alsocontact WhānauCare Service at Freephone: 0800 999 442.

Blood Samples

How many blood testswill be done? / We are asking you to do two blood tests, one at the beginning of the study and one after the winter.We will ask you to do an additional blood test if you get a flu shot and/or you have a cough and fever.
When do I have the blood test done? / For the first blood test, it would be helpful if you could visit the collection centre within a week of completing the questionnaire.
For the other blood tests, we will remind you when it is time to go, if needed.
Where do I go to have my blood testdone? / You can go to one of the participatingSouthern Community Laboratory (SCL) Collection Centres. The blood collection centres and their hours of service are listed on the Laboratory Specimen Request Form.
Who will take the blood sample? / Staff who work at blood collection centres will do the blood collectionat the beginning and end of the study.
If you have cough and fever and/or get a flu shot, study nurses will visit you todo the bloodcollection.
Do I need to an appointment? / You do NOT need to make an appointment.
How long will it take to have the blood taken? / It will take just a few minutes.
What do I take with me? / Take the Laboratory Specimen Request Form/Consent Form (two-sided) that you received in the mailed study packet. It is also here and it will also be available at the participating SCL sites.
Is it OK to say a blessing at my blood collection? / Yes, you are welcome to say a blessing (karakia) during your blood collection.
How much blood will be taken? / We will take only a small sample. It is about 15mls of blood.
Where does the blood go after? / The blood goes to the National Influenza Centre (NIC) at ESR in Upper Hutt.
Some blood may be sent to the St. Jude Center of Excellence for Influenza Research and Surveillance (Memphis, USA) for more complex testing that cannot be done here at NIC.
What do they test the blood for? / We will use immune assays to measure changes in antibodies, immune cells and genes that encode special parts of these immune cells when exposed to the flu virus or the flu vaccine.
Why do I need to give blood more than once? / We need to compare immune cells before exposure to the flu virus or the flu vaccine and after these exposures. These changes provideinsightson how the body responds to the flu virus or vaccine.
Why do my samples have to be stored for 10 years? / Research studies are required to keep samples for this amount of time as some tests may need to be rechecked or clarified.
Research Ethics Committees also require that samples are kept for this long.
Is my blood only being used for this study or can it be used for other studies? / Your blood will only be used for theSHIVERS-II study, and in the case of a flu epidemic or pandemic to help us to take actions to try to less the impact of such an event.
How are my samples disposed of? / If any of your sample is not used up beforehand, it will be destroyed at the end of the 10 year storage period using normal laboratory procedures.
Laboratory staff will heat the blood samples at a very high temperature (autoclave) to destroy them.

Nose or throat swab

Is it OK to say a blessing at my respiratory swab collection? / Yes, you are welcome to say a blessing (karakia) during your respiratory swab collection.
Where does my swab go? / Your nose or throat swab will be sent to the National Influenza Centre at ESR. The laboratory is based in Upper Hutt.
What do they test the swab for? / Thelaboratory staff will test the swab forthe flu and other viruses that can cause respiratory illnesses like colds and sore throats.
Why does my swab have to be stored for 10 years? / The lab stores the swabs for 10 years in casethey need to check the results.
Research Ethics Committees also require that samples are kept for this long.
What happens to my swab after it has been tested by ESR? / At the end of the storage period, your swab will be destroyed using by normal laboratory procedures.
The swab is heated to high temperatures (autoclaved) to destroy it.

Reporting of Results and Confidentiality

How is my privacy protected? / When we report the results of the study, we will group the results from participants together so that none of your personal informationcan be identified (anonymised). Only researchers working on the project will analyse the results from the study.
How do I know I can’t be identified through my blood samples or respiratory swabs? / Your blood samples and respiratory swabswill be tagged with a unique reference number rather than your name. Only authorised members of the research team can link this reference number to your name.
What will happen to the study results? / Results will be summarised in a study report. Thisreport will be shared with New Zealand health professionals and public health agencies. Results will be also presented at health conferences and published in medical journals. The ESR SHIVERS-II website will include links to these documents.Information collected for the study on individual participants will be posted on the study funder website (US NIH), but will include NO identifying information and will only be limited pieces of information.
How is my information stored? / Information gathered through SHIVERS-IIis stored electronically and securely. SHIVERS-II researchers use computer networks which are password protected and only accessible to people involved in the project.Paper copies of some information may sometimes be used. These are stored securely in a locked cabinet and periodically sent for archiving with a secure storage facility.
The only other individuals who have access to this information aside from the SHIVERS-II researcherswould be the study funding agency (US National Institutes of Health and their agents), the ethics committees that approved the study, and governmental regulatory agencies that make sure that studies are being conducted correctly.
Can I check my study information? / Yes, you can email or contact the study principal investigator (Sue Huang at 04-529-0600) to check your study information.

CEIRS Protocol DMID 17_0108 SHIVERS-II1Version 1.0 24-Jan-2018