(Form to be on headed paper)

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THE BART’S OXFORD (BOX) FAMILY STUDY: Understanding the causes of type 1 diabetes
Stage 1 Consent Form
One form per family member
for adults (16+yrs) and parents on behalf of children (under 16yrs)
Chief Investigator:
Dr Kathleen Gillespie
Local researcher:
Centre number:
Participant identification number:
Participant name (in capitals):
Please initial each box to show your agreement
I confirm that I have read the information sheet dated 07.07.15 version 1.1 for the above study. I know what
will happen and the possible benefits and risks. I have had the opportunity to consider the information, ask
questions and have had these answered satisfactorily.
I understand that my (or my child’s) participation is voluntary and that I/we are free to withdraw at any time
without giving any reason and without my (or my child’s) medical care or legal rights being affected.
I agree for my (or my child’s) blood samples to be given for testing and storage, including the extraction and
storage of DNA and islet autoantibody testing. I understand that all tests done on my (or my child’s) blood or
DNA will be relevant to diabetes research.
I agree that if I (or my child) have previously given a blood sample to the ADDRESS-2 register that the BOX study
may access the results obtained from islet autoantibody testing, and that BOX may access a share of my stored
blood for further testing that is relevant to diabetes research.
Please send me home sample collection kits for the following boxes I have initialled:
A finger prick capillary blood kit (for islet autoantibody measurement)
b) A mouth swab collection kit
(for the study of type 1 diabetes genes)
A urine collection kit
(for C-peptide (UCPCR) measurement)
I understand that I can choose whether I wish to be given blood test results for islet autoantibody measurement
(future risk of developing diabetes) and have understood the potential advantages and disadvantages and had
any questions answered satisfactorily. I also understand that I will not be given the results from any genetic
measurements carried out on my or my children’s DNA.
Islet autoantibody blood test markers:
my (or my child/children’s) islet autoantibody markers
No, I would not like to know my (or my child/children’s) islet autoantibody markers
Yes, I would like to know
Existing family consent form.
Version 1.1 (07.07.15)
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I agree that my (or my child’s) stored blood, serum, DNA, and urine samples, and the results obtained from
testing these samples can be used in diabetes research and related autoimmune conditions that have been
approved by the BOX Management Committee, and been given independent ethical approval. I understand
that my (or my child’s) samples and related information will be made anonymous before being used by
researchers who are not part of the study team.
I understand that any samples I (or my child) give will be coded and made anonymous by the BOX management
team before they are sent to international research laboratories for additional testing.
I understand that there is no set time limit on the duration that my (or my child’s) samples can be stored for
future diabetes research. They will be kept as long as the Box study has current ethical approval unless I decide
that I want my (or my child’s) samples to be destroyed.
The following statement is only applicable to the family member who has developed type 1 diabetes:
I understand that relevant sections of my (or my child’s) medical notes may be looked at by a researcher, from
regulatory authorities or from the NHS Trust where it is relevant to my (or my child) taking part in this research.
I give permission for these individuals to have access to my (or my child’s) records.
I agree to my (or my child’s) GP, and where relevant my (or my child’s) diabetes doctor being informed of my
(or my child’s) participation in the study. (optional)
I give my permission that information held and maintained by The Health and Social Care Information Centre
and other central UK NHS bodies may be used to help contact me via my (or my child’s) general practitioner
(GP), in the event that I can’t be contacted by the channels I have provided. (optional)
I agree (or on behalf of my child) to take part in stage one of this study.
I am happy to be contacted about future studies and know that I (or my child) am under no obligation to take
Thank you for your help in this study.
Participant signature:
Name (Block Caps):
(If aged under 16, a parental signature is required below)
Parent signature:
Name of person taking consent signature:
Name (Block Caps):
Name (Block Caps):
Existing family consent form.
Version 1.1 (07.07.15)
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