09 April 2015, Version 9
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DPIM: DNA Polymorphisms in Mental Illness
Participant Information Sheet
Chief Investigator: Dr Andrew McQuillin (tel. 020 3108 2188 fax: 020 3108 2194)
You are being invited to take part in a research study. Before you decide, 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 and discuss it with others if you wish. Ask us if there is anything that
is not clear or if you would like more information.
Why have I been chosen?
We are inviting people over the age of 18 who have a clinical diagnosis of mental illness, alcohol
dependence syndrome, Giles de la Tourette Syndrome or Dementia.
We hope to recruit approximately 10,000 participants in total.
What does participating in DPIM involve?
You are asked to provide a blood or saliva sample and information for a research project. A single
blood sample of up to 70 millilitres (mls) (7 tubes) or a saliva sample of approximately 4 mls (1
teaspoon) is taken. The information on your family, medical and psychiatric history will be obtained
from your hospital case notes or from general practitioner records and from a short interview, if
needed. We will contact a member of your clinical team and tell them in confidence that you have
agreed to participate. We may also send you an invitation letter to participate in a survey that can be
answered online, by post or by phone. This will entail a short questionnaire on your current and past
history of attention, and concentration.
The purpose of DPIM
The research project is trying to find out the genetic and other causes of mental illness. We intend to
study the serum in your blood for immune and any other causes of mental illness and to study the
DNA in your blood for genetic causes of mental illness. DNA is the genetic material that determines
how proteins are made in the body and is the material passed on from parents to children
determining inherited traits such as eye colour and hair colour. DNA is a long chain of chemicals
which can change in sequence. A DNA polymorphism or mutation is a variation in the DNA chemical
sequence that someone has inherited from their parents or has occurred spontaneously. These
variations may influence the way the DNA affects the body such as increasing the risk for a disease.
What happens after you are involved?
The project is being carried out by Dr Andrew McQuillin at University College London. The blood or
saliva sample or cells made from you blood sample that you give to us will be tested in the
laboratory at University College London and may be made available world-wide to other scientific
collaborators, charities or commercial companies for further medical research. White blood cells
from your blood sample may be made into a living growth of white cells that can be cultured and
multiplied. Your sample will be used indefinitely or until you make a request for it to be withdrawn.
You should be aware that in the unlikely event that your DNA was to become of commercial value in
the future, you would not be able to claim financial reimbursement.
Possible further research:
A very small proportion of the people who have donated blood or saliva and may later be asked to
volunteer for further research such as a family study in their relatives or an MRI (magnetic
resonance imaging) scan. You may withdraw from having an MRI scan at any time. An MRI scan
consists of lying down in a room on your own with your head in the circular space of the scanner for
about 10 minutes. We will be outside looking at you through a window. The scanner assembly
moves whilst you remain still. Some noises may come from the scanner. You will be expected not to
move during the scan, but you can press a button to contact us at any time and we will be in the
room within a few seconds. The scan will enable us to measure variations in size of the brain and
relate these to DNA changes. You may terminate the scan at any time and we will ensure that you
have your relatives or carers known to you present, before and after the scan, if that is what you
want
How your information is stored:
All the information related to you and to your blood or saliva sample will be confidential – your
sample will be given a code number and the key to this will be securely held by the Chief
Investigator. It will then be stored in a secure and safe place, where people not involved in this
research have no access. The blood or saliva test will not directly benefit your treatment and your
future care will be unaffected whether or not you withdraw at any time. The tests that will be
carried out on the DNA from your blood or saliva sample are to find out inherited, hereditary or
genetic influences on psychiatric illness that may have been passed on to your family members. Your
name will not be used in any way when the results of this research are made known or identified in
relation to any DNA samples.
What happens if you no longer want to be involved?
You do not have to take part in this study if you do not want to. If you decide to take part you may
withdraw by speaking to your local researcher or contacting the Chief Investigator of the study
without having to give a reason. Your decision whether to take part or not will not affect your future
care and management in any way. You can withdraw your blood sample and DNA and ask us to
destroy your DNA and any information about you that we hold at any time. Your blood sample and
DNA will not be used at any time for any other purpose than for research which aims to find the
causes of mental illness.
Our research approval:
All proposals for research using human subjects are reviewed by a research ethics committee before
they can proceed. This proposal was reviewed by The Metropolitan MREC, one of 13 national
research ethics committees, and has given its approval.
Legal matters:
In the event that you wish to claim compensation for any medical complications arising from the
taking of blood from you or due to negligence caused by the doctors, researchers or NHS Clinical
Studies Officers involved in the research project; both the NHS and the University as well as all the
individual doctors all have insurance from which you may receive compensation. The Insurance
cover comes from three sources. One is through the NHS which is sponsoring this research; the
other is through University College London which also insures all it’s staff doing medical research.
Lastly all the medical doctors doing the research also have personal liability insurance in case they
cause harm to you.
Insurance matters
If you have private life assurance or private medical insurance your participation in this research
should not have any effect on your insurance status. If you have any doubts please check with your
insurer first.
Questions:
If you have any questions about the research project, please contact Dr Andrew McQuillin, who will
be responsible for security and access to your data.