Information Sheet
Study title: MRI and Inflammatory Biomarkers in First Episode Psychosis
We would like to invite you to take part in our research study. Before you decide whether you
wish to participate, it is important for you to understand why the research is being done and
what it would involve for you.
I will go through the information sheet with you and answer any questions you have. We would
suggest this should take about 10 minutes. Talk to others about the study if you wish.
Part 1 tells you the purpose of this study and what will be asked of you if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Part 1: This tells you the purpose of the study and what will be asked of you if you take
part.
What is the purpose of the study?
Earlier studies say that healing processes (like inflammation or immunity) are different in people
with psychosis. We aim to study these processes in people suffering with psychosis and in the
general population in order to understand any these process in detail. We will be using state-of–
the-art technology to analyse blood. We would like to use magnetic resonance imaging (MRI) –
a way of taking pictures of the brain - to see if we can understand more about the brain in
people with psychosis. Psychosis is a condition in which people can lose some contact with
reality.
Who are we looking for to take part?
Anyone suffering with a first episode of active psychosis in Cambridgeshire, aged between 13
and 35 years is welcome to take part in our study. We aim to recruit 40 volunteers with
psychosis and 40 without.
Do I have to take part?
No, it is up to you whether you want to take part. If you do we’ll ask you to sign a form saying
you agree to take part. You’ll get a copy of that along with this information sheet to keep. If you
decide you don’t want to do the study anymore, you can stop at any time without giving us a
reason. Any future health care you receive will not be affected by your decision to leave this
study.
What would participation involve?
When you arrive at the Wolfson Brain Imaging Centre we will discuss what will happen and you
will have a chance to ask as many questions as you like. You would then have an interview
about your health (including drug use), have a blood sample taken, have an MRI scan and do
questionnaires and some memory tests. The whole process will not take more than five hours in
total. Researchers may also look at your medical records, now and again within the next year.
The blood sample is 115ml, about 8 tablespoons of your blood. This is about four to five times
larger than a regular blood test but it is just a quarter of a blood donation. We ask for this
Version H2.0 Date 05/07/13
amount of blood because we aim to study several different cell types. You are welcome to come
with someone (friend, family member or carer) when you have the test.
The MRI scanner is a large magnet that takes pictures of the brain. It is very safe. The first part
of the scan will be a routine clinical scan. This scan will be reported by a specialist doctor and
made available to the doctors and nurses looking after you. In the second part of the scan we
will ask you to perform some simple tasks, like listening to sounds or remembering things. Full
instructions will be given and there will be plenty of opportunity to ask questions at the time. If
you find it unpleasant or uncomfortable, we will stop the scanning. The MRI scan will take less
than one hour.
What happens to the blood?
The blood will be sent to a laboratory where chemicals and different types of blood cells
involved in immunity and inflammation will be measured. We will extract the DNA (the genes or
hereditary information) in the blood and also the RNA (the DNA which is currently active) from
your blood. With your consent, the components that are leftover after the initial analyses will be
frozen and stored. It may be used in the future for other research.
What are the possible benefits and risks of taking part?
We hope that understanding the role of inflammation in psychosis will lead to better treatment
strategies in our lifetimes. It is unlikely that the blood tests or the MRI will have any implications
for you personally but there is a small chance we could identify a possibility of a previously
undetected illness, such as an autoimmune disease, immunodeficiency or a tumour. Minor
changes are sometimes found in completely healthy people. On extremely rare occasions, we
might find something that should be investigated further. If so, we will contact your family doctor
who will then follow this up with you. There are no other risks involved in taking part. The only
inconvenience might be the mild discomfort and bruising from when blood is taken. We will
provide refreshment after blood is taken.
There are no known problems with MRI scanning. However, the space inside the scanner is
quite small, and noisy. You will have the chance to have a good look at this space before
scanning starts. If you have metal in your body, we will not allow you to take part in the study,
because the strong magnetic field in the scanner could cause these objects to move and cause
injuries.
No one knows if there is any risk from the magnet to unborn children in a pregnant woman. To
be on the safe side we won’t allow you to take part in the study if you are pregnant or are
thinking of becoming pregnant. The MRI machine is loud when turned on, and may cause some
discomfort. Therefore you will be given and must wear earplugs. There will be a squeeze-ball
and a microphone in the scanner so that you may stop the testing if you become uncomfortable
at any time. The study will be ended early if you want for any reason.
Code of practice
Participation in the study is entirely voluntary and you may withdraw consent at any time without
explaining why. If you chose not to participate, this will not affect your current or future
health care.
You will receive £50 for the time and trouble involved in taking part in this study. You will also
be re-imbursed for travel costs.
If the information in Part 1 has interested you and you are considering participation, please read
the additional information in Part 2 before making any decision.
Version H2.0 Date 05/07/13
Part 2: This part gives you more detailed information about the conduct of the study.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any point and all identifiable data and samples will be
destroyed.
What will happen to the results of the research study?
Your confidentiality will be maintained so that paper or electronic records and blood samples
will follow ethical and legal practice and all information about you will be handled in confidence.
Your GP will be informed that you are taking part in this study and the result of any significant
assessments. Paper records and blood samples will be stored securely and electronic records
will comply with the requirements of the Data Protection Act. The data will be kept securely for a
minimum of 10 years in accordance with good research practice and will not be used for any
purpose other than what is described in the study. The results of this study will be disseminated
in a scientific journal and invited talks, but all data will be anonymised and we would never
reveal any identifying information. A summary of the findings will be sent to you at the end of
the project.
If you would like to take part or require further information about this study, please
contact: Dr. Julia Deakin at [email protected] or 01223 768008.
What if I am unhappy with any aspect of the study:
If you are unhappy with any aspect of the study you should ask to speak to the researcher who
will do their best to answer your questions (see details below). If you remain unhappy and wish
to complain formally, you can do this by contacting:
Marie McKearney
PALS and Complaints Co-ordinator Freephone 0800 376 0775 | T 01223 726774 or by email
to [email protected]
Are there compensation arrangements if something goes wrong?
Insurance for negligent and non-negligent harm under the University's Clinical Trials policy has
been arranged.
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics
Committee, to protect your interests. This study has been reviewed and given favourable
opinion by the NRES Committee East of England – Cambridge South.
Who is organising the study?
The study is being organised by Dr. Julia Deakin, Clinical Lecturer at the Department of
Psychiatry, University of Cambridge.
Thank you for considering taking part.
Dr. Julia Deakin
Herchel Smith Building for Brain and Mind Sciences.
Forvie Site | Robinson Way | Cambridge Biomedical Campus | CB2 0SZ
Tel: 01223 768008 or [email protected]
Version H2.0 Date 05/07/13