Download Consent Form - Genetics of Learning Disability (GOLD)

Cambridge Institute for Medical Research
Department of Medical Genetics
Wellcome Trust/ MRC Building
Hills Road
Cambridge
CB2 0XY
Tel +44 1223 762609
Fax +44 1223 331206
Email [email protected]
http://goldstudy.cimr.cam.ac.uk/
Dr F L Raymond MA DPhil FRCP
Reader in Neurogenetics and
Honorary Consultant in Medical Genetics
CONSENT FORM
Whole Genome Sequencing
Genetics of Learning Disability (GOLD) Study
Chief investigator: Dr Lucy Raymond
Please tick boxes
1. I confirm that I have read and understand the information sheet dated July 2010
(GOLD.07/10) for the above study and have had the opportunity to ask questions.
2. I understand that my participation is voluntary and that I am free to withdraw at any time,
without giving any reason, without my medical care or legal rights being affected.
3. I agree to take part in the above study.
4. I understand that sections of any of my/my child’s medical notes may be looked at by
responsible individuals from the GOLD Study, University of Cambridge or from regulatory
authorities where it is relevant to my child taking part in research. I give permission for these
individuals to have access to my records.
5. I understand that a blood and/or saliva sample will be taken and used to analyse the DNA
extracted from it.
6. I consent to a further blood test and/or saliva sample to be taken if needed and the
establishing of a lymphoblastoid cell line from my blood sample.
7. I understand that the research team will contact me if they find a genetic variation from all
of the research that they have done, which they believe may explain my child’s learning
disability in order to explain the finding and to discuss possible further studies.
8. The DNA sequencing techniques used in this research will also reveal large amounts of
information about other, unrelated, genetic variations which may point to my child’s risk of
other diseases in the long term. However, I understand that the techniques used in this
research are not of the same high standard as those used in the clinic. Therefore, the
research results are not accurate enough to be used for diagnostic testing without lots of
extra work and knowledge.
9. I understand that I will NOT be told about any genetic variations which are identified as a
by-product of this research which are not the cause of my child’s learning disability.
10 I agree that research on the samples provided by my child to identify their cause of disease
can continue in the unlikely event of my child’s death.
Version: GOLD 07/10 – July 2010
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11. I understand that my child’s identity will remain confidential to the doctors and nurses in
the study team. No genetic data will be released with patient identification attached. Other
people will only have access to genetic and personal information that could identify me if I
give further specific consent AND this is approved by a medical research ethics
committee.
12. I agree that the genetic information produced by studying my child’s DNA may be placed in an
electronic archive with no connection to their name or other personal identifier. I understand
that this archive will only be accessible to appropriate doctors and researchers who have
been approved by a committee set up to ensure the results are only used to advance
scientific and medical understanding. However, I understand that researchers could identify
me from the deposited information if a second DNA sample was tested from me by another
person. However, all scientists who access this information must sign a form agreeing not to
try and identify individuals. If they did try to identify someone, they would be subject to
disciplinary proceedings. All researchers involved in this project are also bound by
professional obligations, data protection law and the legal obligation of confidentiality.
13. I understand that neither I, nor my child will benefit financially if this research leads to the
development of a new treatment or medical test.
Name of child
(BLOCK CAPITALS)
Signature
Date
Address
Name of parent/guardian
(BLOCK CAPITALS)
Signature
Date
Name of researcher
Signature
Date
1 copy for patient; 1 copy for researcher; 1 copy to be kept in hospital notes
Version: GOLD 07/10 – July 2010
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