UKPID Registry, PIS and Consent Form for Young Persons (age 11-15), Version 1.1, 6th November 2015
YOUR LETTERHEAD
UK Version of the ESID Online Patient and Research Registry
(MREC Number: 04/MRE07/68)
PATIENT INFORMATION SHEET FOR YOUNG PERSONS
For the maintenance of patient data on an internet database for research.
Introduction
You are being asked to take part in a research study. Before you decide whether or not to do this
it is important that you understand why the research is being done and what it will involve. Please
take time to read this information and if there are any questions that you would like answered or
further information that you would wish to have, please do not hesitate to get in touch with us.
Background to the Research
Primary Immunodeficiency Disorders, or PIDs for short, are problems in the immune system,
which people are born with, (otherwise known as genetic). The immune system consists of
antibodies and cells in the blood (white blood cells), which help us fight off infections. A person
such as you, with a PID, may have problems producing the correct antibodies or white blood cells.
At this hospital and other hospitals in the UK we look after children with PID problems and provide
help to diagnose and treat these conditions. There are similar hospitals in other European
countries.
The UK Primary Immunodeficiency Network (UKPIN) is a non-profit making organisation for
doctors, nurses, scientists and other people working with PID patients to exchange information
about PIDs, which can benefit patients and their families by helping to give a better understanding
of the cause of PIDs and the best treatments.
The European Society for Immunodeficiencies (ESID) is a similar organisation but it covers
almost all countries in Europe.
Because many PIDs are very rare, it is helpful to store information on large numbers of people
with these problems. The information helps us recognise and investigate patterns of illness and
how effective treatments are.
To store this information, we use computer programmes called registries. These programmes
enable us to share information and data.
The UKPID registry has been set up on the Internet and we would also like to send the data to the
ESID database, which is held in Germany. This will help by contributing information (data) on UK
patients with rare disorders to a larger European database. Both the UKPID registry and the ESID
database are secure so that no one other than your own team of doctors and nurses can get
access to information about you. It is also anonymous, that means your name is not recorded.
Other people can only access information with permission and after being given a special
password.
The aim of our project is to join up clinical and laboratory (scientific) information (data) on all
patients with PIDs in the UK and in Europe, which will help us to provide improved methods for
diagnosis and more efficient ways to treat problems.
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UKPID Registry, PIS and Consent Form for Young Persons (age 11-15), Version 1.1, 6th November 2015
Why have I been chosen to participate?
Since you have one of these PIDs, we would like to enter your data into the registry. We are
hoping to be able to collect data on all the patients who are seen at our Hospital.
What does the study involve?
If you agree to take part, we will ask you and your parents to sign a form giving consent for your
data to be included in the UKPID registry and in the ESID database as well. We would also ask
you to sign the attached form. When you are older, around age 16-18 we will ask you to sign
again as an adult. If you want to withdraw at any time, you can do so and this will not affect your
medical care. You can also ask to see what information we have got stored on you and we will
arrange this free of charge. You can also decide to have your data included only in the UK and
not in the bigger European database. If you agree, we will also send certain anonymous
information to pharmaceutical companies who are trying to develop better treatments for PIDs.
We will ask you and your parents to sign in a separate place to confirm that you are happy for this
to happen.
We will also ask you and your parents to sign in a separate place that you are happy to allow the
Database Manager to visit occasionally to check your notes to make sure that the information
stored is correct and to help with data entry.
We have signed an agreement with UKPIN and also with ESID to ensure confidentiality is
maintained. The release of information to other researchers will require written agreement and
UKPIN will arrange this. Before any research goes ahead it has to be checked by a Research
Ethics Committee. They make sure that the research is fair. Your project has been checked by
the West Midlands Research Ethics Committee (MREC).
What are risks and benefits of taking part?
The study will not affect how you are treated in the future and it will not require any additional
procedures. We will use special coding and only certain professionals will be allowed to view
your data.
It is possible that in the future, this study will help us learn more about PIDs and this may lead to
improvements in treatment that can be offered.
What will happen to the results of the research studies?
There will be yearly reports on the analyses of the information and these will be published by
UKPIN (www.ukpin.org.uk) and ESID (www.esid.org) on it’s Website. The results of analysis may
also be published in scientific and medical journals. All patient information will continue to be
anonymous (no names involved) and will not be identifiable in any publication.
What happens next?
It is up to you whether or not you wish to take part in this study. If you would like to take part, we
will ask you and your parents to sign the attached consent form and return it to us. If you decide
to take part, you are still free to withdraw from the study without giving a reason and any
information we have about you can be deleted. If you withdraw, this will not affect the treatment
that you receive. If you have any questions or want any further information, please do not
hesitate to contact your usual consultant or nurse.
Thank you for considering taking part in this study.
Yours sincerely
….insert contact person in your centre…..
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UKPID Registry, PIS and Consent Form for Young Persons (age 11-15), Version 1.1, 6th November 2015
YOUR LETTERHEAD
UK Version of the ESID Online Patient and Research Registry
(MREC Number: 04/MRE07/68)
PATIENT CONSENT FORM FOR YOUNG PERSONS
For the maintenance of patient data on an internet database for research.
Name of Researcher:
Please initial boxes

I have understood what the project „UKPID Registry” is all about, all my questions have been
answered and I understand the answers. I am happy for my laboratory values and medical
information to be entered into an internet database for research.

I understand that I can say no to taking part in the study at any time, without giving any
reason.

I would like my data to be stored in the UK and also on the bigger ESID database
o
I also agree that a part of my data is made available to pharmaceutical
companies.

I would like to add my data to the UKPID Registry only

I agree that the Database Manager may have access to my medical notes to obtain
information for data entry.
_________________________
Name of the young patient (print)
______________
Date
________________________________
signature of the young patient
_________________________
Name of parent or guardian
______________
Date
________________________________
signature of a parent or guardian
_________________________
Name of doctor involved
______________
Date
________________________________
signature of the doctor involved
_________________________
Name of person taking consent
(if different from doctor involved)
______________
Date
________________________________
signature of person taking consent
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