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UKPID Registry, PIS and Consent form for parents and children, Version 1, June 2010
YOUR LETTERHEAD
UK Version of the ESID Online Patient and Research Registry
(MREC Number: 04/MRE07/68)
PATIENT INFORMATION SHEET FOR PARENTS AND CHILDREN
For the maintenance of patient data on an internet database for research.
Introduction
Your child is being invited to take part in a research study. Before you decide whether or not you
would like to give your consent to your child’s participation, it is important for you to understand why
the research is being done and what it will involve. Please take time to read the following information
carefully. Ask us if there is anything that is not clear or if you would like more information.
Background
The UK Primary Immunodeficiency Network (UKPIN) and the European Society for
Immunodeficiencies (ESID) are both multidisciplinary non-profit organisations of medical & scientific
doctors and all those caring for patients with Primary Immunodeficiencies (PID). The main aims of
both organisations are to exchange ideas and information between doctors, nurses, biomedical
investigators, patients and their families concerning Primary Immunodeficiency diseases and also to
promote research on causes, mechanisms and treatment of these disorders.
ESID have created the “ESID Online Patient- and Research-Registry” and UKPIN has adopted this
system as a UK National Registry for PID: The project is called the “UK Version of the ESID Online
Patient and Research Registry”, with the short title UKPID Registry. This is a coded Internet database
and is protected by passwords to prevent any unauthorised access. Furthermore, all the information
put into the database will be anonymous i.e. the patient identification will be confidential – it will not be
possible for your child’s data to be linked to your child except by the staff in our centre. In a medical
emergency the treating doctors could retrieve a specific patient’s data using a highly protected
encryption code.
The aim of this project is to compile clinical and laboratory data on all patients with Primary
Immunodeficiency disorders (PID) in order to provide improved methods for diagnosis, a more helpful
classification for better prediction of disease progress (prognosis) and for more efficient means of
treatment.
We plan for this database to be continuous on long-term scale, leading to better understanding of
these disorders and so that the lives of patients with PIDs will be improved.
The UKPID Registry runs on a dedicated server in the UK. There is, however, the possibility of a
yearly export of the data to the international ESID version, running on secure servers in Germany.
Thus, the UK data could be useful for international research, which is especially important in the field
of rare diseases, such as PIDs, where there may not be sufficient numbers of patients in one country
alone to perform adequate research.
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Version 1 / June 2010
UKPID Registry, PIS and Consent form for parents and children, Version 1, June 2010
What does the study involve?
If you agree to your child’s participation in the project, we would ask you to sign a consent form
allowing your child’s medical data to be entered and stored in coded form, anonymously on the
password-protected database. These coded data can be made available to medical and scientific
doctors that specialize in treating PID patients, to laboratories that are researching the causes of PID
and to epidemiologists to analyse whether or not there are environmental factors involved.
The study does not require any additional procedures.
You can choose whether or not to export your child’s data to the international ESID Online Database
and whether or not to allow pharmaceutical companies who are developing improved treatments to
have access to a limited sub-set of this coded data on the international version.
Are there any benefits in taking part in the study?
The study will not affect how your child’s disease is treated in the near future. It is possible that this
study may help us learn more about immunodeficiency though. This knowledge could help your child
and other patients in the future and may lead to the development of more treatments for
immunodeficiencies.
What will happen to the results of the research study?
There will be annual reports on the outcome of analysis of the data published on the open UKPIN
website (www.ukpin.org.uk) and respectively on the open ESID website (www.esid.org). The results of
analysis may also be published in scientific and medical journals. All patient information will be kept
anonymous and your child will not be identified in any publication.
It is up to you to decide whether or not your child should take part. If you agree, you will be given this
information sheet to keep and be asked to sign a consent form once you have had time to ask
questions. We will ask your child to sign again once they are around age 16-18.
You are still free to withdraw from the study without giving a reason. This would not affect the standard
of care your child receives and the data can be deleted from the database if you wish so.
Thank you for considering participating in this study. If you have any questions about the study please
contact:
….insert contact person in your centre…..
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Version 1 / June 2010
UKPID Registry, PIS and Consent form for parents and children, Version 1, June 2010
YOUR LETTERHEAD
UK Version of the ESID Online Patient and Research Registry (MREC: 04/MRE07/68)
PATIENT CONSENT FORM for persons under 16 years of age
For the maintenance of patient data on an internet database for research
INFORMATION
Please initial boxes
1. I confirm that I have read and understand the information sheet dated ..............
(version ......) for the above study.
2. I have had the opportunity to ask questions and have no more concerns.
3. I understand that my child’s participation is voluntary and that I am free to withdraw at any time
without giving any reason, without my child’s medical care or legal rights being affected.
CONSENT
I give my consent that confidential data relating to my child’s PID (Primary Immunodeficiency disease), obtained
in the course of the research project “UKPIN version of the ESID Online Patient- and Research-Registry”, can be
compiled and evaluated as described in the Patient Information Sheet.
Please define the scope of your consent

I give my complete consent
(this means that your child’s coded data may be stored on the UK version and also exported
to the international [ESID]version for research and that it may be made available to
pharmaceutical companies developing or improving medication)

I give my consent for both versions but NOT for pharma companies
(this means that your child’s coded data will be stored on the UK version and also exported
to the international version for research but that it may NOT be made available to
pharmaceutical companies developing or improving medication)

I give my consent for the UKPIN version only
(this means that you refuse the transmission of your child’s coded data to the international
ESID Online Database and to pharmaceutical companies developing or improving medication)

I agree that the Database Manager may have access to my medical notes to obtain
information for data entry.
______________________________
Name of parent or guardian (print)
________________
Date
____________________________________
Signature of parent or guardian of patient
______________________________
Name of patient
________________
Date
____________________________________
Signature of patient (optional)
_____________________________
Name of person taking consent
(if different from doctor involved)
________________
Date
____________________________________
Signature
_____________________________
Name of doctor involved
________________
Date
____________________________________
Signature
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Version 1 / June 2010