Notice Board

Our GP practice is taking part in a large observational study on pandemic flu and we would like to invite you / your child to take part in this study.

Pandemic flu (also know as swine flu in this case) is the term given to a new type of flu virus that few, if any, people have full resistance to naturally and which spreads across the globe rapidly.

The purpose of this study is to assess the vaccines safety in real life conditions as soon as the vaccine is used as part of a national vaccination programme.

This study will also look to identify:

If the vaccine causes any local reactions in a smaller group of participants,

How often you / your child attends a medical setting due to adverse events

If you are unwell following vaccination

What happens during pregnancy (if applicable)

This information is essential to help us understand how the vaccine against this strain of flu is being handled by the individual receiving it.

We would like to invite you / your child to take part as you / your child may be suitable to receive the vaccination if you / your child is registered at this GP practice.

What will happen to you/your child if you/your child takes part and what will you/they have to do?

A member of the study team will review the medical history of you/your child to ensure that you are suitable to take part in the study.

During the period of the study (approx 7 months) you agree to take part / allow your child to take part and to report any adverse events, visits to the doctors and pregnancies as explained to you by the study team. You may also agree to complete, or allow your child to complete, two diary cards.

Each time you / your child sees the study doctor / nurse for vaccination (this may be either once or twice depending on the number of vaccinations you / your child require) you will be asked a number of questions to make sure that you / your child is well. At these visits you / your child may be given a diary to be completed for a period of time after each vaccination. This will be described to you by the study doctor / nurse.

In addition to the 1 or 2 visits to see the study doctor / nurse, you / your child will be contacted by telephone a total of 4 times at different times during the 7 months of the study. This is to check that you / your child is well and to check that you / your child is completing the diary card (if applicable)

Do you / your child have to take part?

It is up to you to decide whether or not you / your child wants to take part. Participation in this study is voluntary and deciding not to take part will not affect your / your child’s current or future care.

If you decide that you / your child will take part you are still free to withdraw yourself or your child at any time and without giving a reason. This will not affect you or your child’s routine care in any way but we would ask you to discuss this with the study doctor / nurse first,

Expenses and payments

You / your child will receive no payment or expenses for your / your child’s participation in the study. There are no additional costs in taking part in this study than you would have if you / your child did not take part in this study.

What are the possible disadvantages and risks of taking part?

This is an observational study: it doesn’t involve any medical procedures, administration of medication or collection of samples outside routine practice.

What are the possible benefits of taking part?

No direct clinical benefit to you / your child can be guaranteed by taking part since you / your child would receive vaccination as routine care. However, by taking part, you / your child will provide the study sponsor and other important groups with useful information that will help ensure that the vaccine is suitable to use.

Does this remain confidential?

Yes, your / your child’s involvement in this study will remain confidential. The full details of this confidentiality are explain in the information sheet that you / your child will be provided if you decide to participate in this study.

What do you do now?

Thank you for considering taking part in this study. If the information in this letter has interested you and you are considering the participation of yourself or your child, please contact us by telephone (020 8765 4900). Members of the research team will be happy to discuss the study with you and answer any questions you may have.