CUBRIC Information Sheets and Consent Forms – Guide for Researchers
The following pages show example templates of info/consent/debrief forms for a
CUBRIC study on healthy volunteers using anatomical MRI.
Purple text in boxes is project-specific, and needs to be modified for each research study.
Text written in black must not be modified. This is because, in some cases, it is required by
Ethics committee or has been recommended by the University’s solicitors for legal reasons.
For each research project volunteers should be given the following:
1) Volunteer information Sheets (see Appendix 1) for an MRI study. This information
pack needs to be given to the volunteer at least 24 hours before they come to
CUBRIC.
2) The CUBRIC safety screening forms for MRI are contained in the relevant CUBRIC
Rules and Procedures document. The first screening form should ideally be sent to the
volunteer at least 24 hours in advance of them coming to CUBRIC. The volunteer should
be instructed to read the screening form – but not fill it in until they come to CUBRIC.
3) A consent form for MRI. Appendix 2.
4) A debriefing form. Appendix 3.
6) A participant database consent form. Appendix 4.
The MRI consent forms will initially be lodged with the CUBRIC administration team who
will photocopy them for CUBRIC records. The original will then be returned to the Lead
Researcher.
Note that the current versions of these forms have been modified in light of recent discussions
with the University’s solicitors, Morgan-Cole. So, although the consent forms contain all the
information detailed on the Psychology Ethics Committee’s consent template, CUBRIC’s forms
also contain extra statements that go beyond the basic template.
Appendix 1 – Anatomical MRI Volunteer Information Sheet
Anatomical MRI Volunteer Information Sheets
Study title
TITLE
Introduction
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 if there is anything that is not clear or if you would like more information.
Take time to decide whether or not you wish to take part.
Thank you for reading this.
What is the purpose of the study?
Study Description
Why have I been chosen?
As a volunteer you responded to our request for healthy adult subjects to participate in the study.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information
sheet to keep and be asked to sign the attached consent form. If you decide to take part you are still free to
withdraw at any time and without giving a reason.
How many scanning sessions are involved?
You will be asked to visit CUBRIC once:
1. For an anatomical MRI scan – this will take about an hour of your time. You will be in the MRI scanner for
around 25 minutes.
What do I have to do before the scanning sessions?
There are no restrictions on lifestyle or diet before taking part in this study. As the scan can be quite long, you may
wish to use the toilet before the scan.
What are the possible benefits of taking part?
This study involves the recording of typical brain function. Since we are only studying healthy volunteers, there is
no intended clinical benefit to you from taking part this study. The scans are not intended to provide a medical
diagnosis or a clean ‘bill of health’ – and the person conducting your scans will not be able to comment on the
results of your scans.
What happens if you find something unusual on the scan?
The researchers involved do not have expertise in MRI diagnosis, as they are psychologists or allied scientists and
are not doctors. You should not regard these research scans as a medical screening procedure. Occasionally
when we image healthy participants, the researchers may be concerned that a potential abnormality may exist on
the scan. In this case, we will ask a neurological consultant, such as a neuroradiologist, with MRI expertise to
examine the scans, and if appropriate a report can be forwarded to your GP. However, in most cases a
neurological consultant will not look at the images.
It is important that you realise that these scans will not provide any information that may help in the diagnosis of
any medical condition. If you do have any health concerns, you should contact a qualified medical practitioner in
the normal way.
Are the procedure and results confidential?
All information which is collected about you during the course of this research will be kept strictly confidential. We
may share the data we collect with researchers at other institutions, but any information which leaves the CUBRIC
centre will have your name and address removed so you cannot be recognised from it. Any information about your
identity obtained from this research will be kept private. In any sort of report we might publish we will not include
information that will make it possible for other people to know your name or identify you in any way. You will be
simply referred to by your gender, age and possibly some characteristic such as left or right handedness.
What will happen to the results of the research study?
Where appropriate, the results of this study will be presented at medical and scientific conferences and published
in journals. You will not be identified in any report or publication. The results of this study will also help us to design
future research projects, and possibly lead to new methods of diagnosis for neurological conditions.
Who is organising and funding the research?
Most of our research is funded by the UK government through the research councils and the Higher Education
Funding Council for Wales. Some of the researchers who may be involved are funded by charitable organisations.
Who has reviewed the study?
This study has been reviewed and approved by the Cardiff University School of Psychology Ethics Committee.
Contact for Further Information
[LEAD RESEARCHER]
The following pages describe the MRI scanning procedure in more detail. Please
read them carefully.
The MRI Recording Session
What is MRI?
Magnetic resonance imaging (MRI) is a well-established technique for imaging the body and brain using strong
magnetic fields and low energy radio waves to make pictures of the inside of the human body non-invasively. MRI
does NOT use ionizing radiation and there is NO need for you to have to take any drugs or medication.
This study is restricted to completely non-invasive procedures: no injections are involved.
Before you go into the scanner we will also tell you exactly how long we expect your scan to take, so that you can
decide whether you are happy to lie still for that long - remember that you are free to withdraw from this study at
any time, without giving a reason.
Please note that the MRI studies we perform are not diagnostic procedures and cannot be regarded as any kind of
health check. The researchers who scan you will not be medical doctors and will not be looking for any kind of
clinical abnormality in the data.
If you do have any health concerns, you should contact a qualified medical practitioner in the normal way.
A picture of a volunteer in the CUBRIC MRI scanner
What will I have to do during the MRI scanning session?
We can acquire up to 3 scans in a scanning session, during which you are asked to keep your head as still as
possible, this is easiest if you relax. All that we need you to do is to keep still. During the study the Researchers,
who will also ensure your comfort, will constantly monitor you.
We will need you in the MRI lab for approximately 1 hour in total. The first twenty minutes or so will be spent
setting-up the equipment and making sure that you are in a comfortable position in the scanner. The actual
scanning session lasts up to 25 minutes.
The scan itself:
1. First, you will be asked to sign a consent form and are free to decline to take part at any point.
2. Because MRI involves a very strong magnet, you will first be asked a set of safety questions to make sure
that you don’t have anything in your body that might be affected by the scans, such as a pacemakers and
other implanted devices, or metal in your body (e.g. shrapnel from war injuries). You will be asked to
remove all metal objects from your person including keys, coins, jewellery and watches as these distort
the images and also can become potentially dangerous projectiles if they are attracted into the magnet.
You will also need to remove credit cards and travel-cards, belts and under-wired bras. It might be best
for you to bring a change of clothes – sweatshirt and jogging pants are ideal. We have our own private
changing room for volunteers. Your valuables will then be locked away for security reasons. If you are
wearing make-up you may be asked to remove this as well.
3. The Researcher will check again that it is suitable for you to have a MRI scan by going through a
screening questionnaire. The scan format will then be explained to you.
4. Once all the safety issues have been dealt with, you will be asked to lie in a magnetic resonance (MR)
scanner while images are acquired. The scanner consists of a large magnet with a tunnel, and you will be
inside this tunnel. A radio-frequency coil will be placed around your head. These coils are used to transmit
and receive radio waves (just like the waves used in radio or television broadcasts) as part of the imaging
process. Unlike some other types of scanners, an MR machine does not use x-rays or other harmful
radiation, and there is no known risk even if you have a very large number of scans.
5. While the scanner is acquiring images it can be very noisy, so you will be given earplugs and/or ear
defenders to wear.
6. Three scans will be performed. The first two are very short (less than a minute). The final, main, scan lasts
around 10 minutes.
1. The Researcher will be able to talk to you via an intercom in between the scans. You will be given an
alarm bulb so that you can call us at any time during the scan, if something is wrong or you want to come
out. The Researchers will be able to see you at all times through the control room window.
2. All we ask, is that you keep your head very still at all times, stay awake and most importantly, try to relax!
Some further advice:

If you suffer from any neurological conditions, such as epilepsy or routinely suffer from migraines please
let us know before you come for your scan – you will not be scanned if you have these conditions.

Wear soft, loose but warm clothing which preferably has no metal fixings. The scanning room is slightly
cool (for computer comfort).
What are the side effects of taking part?
This research involves minimal risk. No serious side effects of being in an MRI scanner have been reported
despite millions of scans worldwide. Although the possibility of long-term effects cannot be completely ruled out,
the weight of experience and opinion is against this.
A few people have reported minor side effects including dizziness, mild nausea, a metallic taste in the mouth, and
the sensation of seeing flashing lights. These side effects, if experienced, go away soon after you leave the
magnet. If you experience any of these or others please let us know as soon as possible.
What are the possible disadvantages and risks of taking part?
Some people find being inside an MR scanner claustrophobic although this is less so with the latest, more
compact systems like those available at CUBRIC. In addition to the 3 Tesla MR machine, CUBRIC also has a
‘mock’ scanner that reproduces, as far as possible, the look and feel of the real MR machine. You will be asked to
lie in this ‘mock’ scanner and will have ample opportunity to acclimatise yourself. When you confirm that you feel
comfortable lying inside the mock scanner we will move to the real scanner. If you find the experience in either
scanner unpleasant, just let us know straightaway and we will stop and take you out of the scanner.
Are there any restrictions for those wishing to take part?
Because MRI involves a very strong magnet, some people are excluded. These include people with pacemakers
and other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have
had certain types of surgery. Knives and other metal objects can cause an injury if they are taken near the
scanner and pulled out of someone’s hand or pocket by the strong magnetic field; this is unlikely to happen,
though, as everyone who goes near the scanner (including yourself, and all the members of staff) are asked to
remove everything from their pockets and not carry anything metal with them.
Although MRI is not known to affect the unborn child, we exclude subjects who may be pregnant just to be on the
safe side.
The changes in the magnetic field that are used to make the images and other measurements usually happen very
fast. This causes the magnet to vibrate, making the loud noises for which we provide you with ear plugs. In very
rare cases, if you are particularly sensitive to these changes, you may also feel a ‘tickling’ sensation in your back
or shoulders. This may be slightly uncomfortable, but will not be painful, and is not in any way harmful. If you feel
this happen and want us to stop the scan, just let us know and we will take you out of the scanner. (If the
magnetic field changes were made still stronger or faster the same effect could happen to your heart, which might
be dangerous, but the scanner has built in safety features to make sure it always operates at much lower levels
than the level at which this could occur).
The radiofrequency waves we use to create the MR scans can cause your head and body to warm up slightly.
This is not a problem, and you usually won’t notice it at all, as your blood flow will increase slightly to take the heat
away; we also keep the scanner room quite cool so that you always remain comfortable. (If you find it too cool,
we can provide a blanket!).
In some circumstances, the changes in the magnetic field could make an electric current flow through some of
your body. You wouldn’t feel this (it’s not like an electric shock) but if two parts of your body were touching (for
instance if you had your legs crossed) then in very rare occasions it is possible that the current might burn you.
This can only happen if you make a circular loop with your arms or legs, so we will always ask you to lie with your
arms to your sides, and your legs uncrossed, which stops this from happening. We will also always make sure
that any electrical leads or other cables that might cause similar problems are kept well away from you.
Also, if you have a neurological condition, such as epilepsy, or routinely suffer from migraines, you should not be
scanned.
[PROJECT SPECIFIC EXCLUSIONS]
Appendix 2 – MRI Consent Form
CUBRIC, SCHOOL OF PSYCHOLOGY, CARDIFF UNIVERSITY – MRI UNIT CONSENT FORM
RESEARCH PROJECT TITLE
NAME OF PARTICIPANT ………………………
Sex: M / F Date of Birth:………………………
Please read the Volunteer Information Sheet and then read the following statements carefully and then add your
signature. If you have any questions, please ask the person who gave you this form. You are under no pressure to give
your consent and you are free to withdraw from the MRI examination at any time. By signing the form you are agreeing
to the following:
 I understand that I am to take part in a functional MRI experiment in which I will be placed in the scanning
machine for up to an hour, while my brain activity will be measured by the machine. During the scan I will
be shown visual stimuli designed to activate specific parts of my visual cortex. I will make responses using
button-boxes and my eye-gaze position will be tracked using an infra-red camera system.
 I confirm that I have read and understand the MRI Volunteer Information Sheet and have had the
opportunity to ask questions about it.

I understand that upon completion of the study, I will receive £x for my participation. However, I
understand that if I choose to stop at any time during the study, I will receive £x for my participation.

I understand that participation in this study is entirely voluntary and that I can withdraw from the study at
any time without giving a reason, and without loss of credit / payment (as applicable).

I understand that I am free to ask any questions at any time and that I am free to withdraw or discuss my
concerns with the lead researcher ([LEAD RESEARCHER]).

I also understand that at the end of the study I will be provided with additional information and feedback
about the purpose of the study.

I understand that I can talk to the operators via an intercom and that I will be given an alarm “squeeze
ball” that I can squeeze at any time to end the scan and signal to the operator.

I understand that I can require, for any reason and at any time, that I be immediately removed from the
MRI machine.

I understand and agree that the MRI scan is not a medical screening procedure and that the researchers
are not qualified to provide a clinical diagnosis or identify potential abnormalities. However, if the
researchers are concerned that there may be a potential abnormality on the scan, I consent to them
disclosing the scan to a specialist neuroradiologist to provide a radiological report on the scan. I further
consent to the results of this report being disclosed to my General Practitioner, if appropriate.

I have completed the initial screening form and have been told that it is safe for me to be scanned.

I understand that the information provided by me will be held confidentially, such that only the researchers
can trace this information back to me individually. The information will be retained for up to 10 years when
it will be deleted/destroyed. I understand that I can ask for the information I provide to be
deleted/destroyed at any time.
I, ___________________________________(NAME) consent to participate in the study conducted by School of
Psychology, Cardiff University.
Signed:
Date:
Do not write beneath this line, For Staff Use Only
CUBRIC UNIQUE IDENTIFIER:………………………………
Statement by the Researcher carrying out the scan:
I certify that the above participant signed this form in my presence. I am satisfied that the participant fully understands the
statement made and I certify that he/she had adequate opportunity to ask questions about the procedure before signing.
Signature…………………………
Name………………………
Date ……………
Appendix 3 –MRI Debriefing Sheet
Anatomical MRI Debriefing Sheet
Study title
STUDY TITLE
Thanks
Many thanks for taking part in this study. We hope it was interesting. Please feel free to ask the Researcher any
questions you have about what happened.
Please note that some of the information contained on this form is a repeat of what might be found on the
Volunteer Information Sheet, which you should already have and can keep.
What was the purpose of the study?
COPY OF PROJECT DESCRIPTION FROM THE INFORMATION SHEETS
Please note that the data analysis can be very lengthy and time-consuming, so the Researcher may not be able to
give you any feedback as to what the data shows.
What happens if you find something unusual on the scans?
The researchers involved do not have expertise in MRI diagnosis, as they are psychologists or allied scientists and
are not doctors. You should not regard these research scans as a medical screening procedure. Occasionally
when we image healthy participants, the researchers may be concerned that a potential abnormality may exist on
the scan. In this case, we will ask a neurological consultant, such as a neuroradiologist, with MRI expertise to
examine the scans, and if appropriate a report can be forwarded to your GP. However, in most cases a
neurological consultant will not look at the images.
It is important that you realise that these scans will not provide any information that may help in the diagnosis of
any medical condition. If you do have any health concerns, you should contact a qualified medical practitioner in
the normal way.
Are the procedure and results confidential?
All information which is collected about you during the course of this research will be kept strictly confidential. We
may share the data we collect with researchers at other institutions, but any information which leaves the Cardiff
University Brain Repair and Imaging Centre will have your name and address removed so you cannot be
recognised from it. Any information about your identity obtained from this research will be kept private. In any sort
of report we might publish we will not include information that will make it possible for other people to know your
name or identify you in any way. You will be simply referred to by your gender, age and possibly some
characteristic such as left or right handedness..
What will happen to the results of the research study?
Where appropriate, the results of this study will be presented at medical and scientific conferences and published
in journals. You will not be identified in any report or publication. The results of this study will also help us to design
future research projects, and possibly lead to new methods of diagnosis for neurological conditions.
What do I do if I am unhappy with the way I was treated or with something that happened to me?
In the first instance, you should contact the leader of the Research Project:
[LEAD RESEARCHER CONTACT DETAILS]
If you are still unhappy, you should contact the relevant Ethics Committee:
Psychology Ethics Committee Secretary
School of Psychology
Cardiff University
Tower Building
Park Place
Cardiff
CF10 3AT UK
Tel: 029 2087 4007
Fax: 029 2087 4858
Email: psychethics@cf.ac.uk
Who has reviewed the study?
This study has been reviewed and approved by the Cardiff University School of Psychology Ethics Committee.
Contact for Further Information
[LEAD RESEARCHER CONTACT DETAILS]
Appendix 4: Participant database consent form
Participant database consent form
I am willing for my name and email address to be held in a list (database) so that I may be contacted
about future studies conducted by CUBRIC researchers.
I understand that I am consenting only to receive information, and am under no obligation to take part in
any future studies.
I understand that the list will be used only for the purpose described here, will be held by CUBRIC staff,
and only researchers carrying out studies approved by the School of Psychology Ethics Committee will
be able to use it to contact me about their studies. It will not be made available to anyone else.
I understand that if I do not wish to volunteer for any studies, my name will be removed from the list
automatically after 2 years
I understand that I may remove my name from the list at any time by emailing Angela Reardon
[reardona@Cardiff.ac.uk] or Beth Weeks [WeeksB5@cardiff.ac.uk] and that any contact I receive due to
the list will contain details of how to remove my name from the list.
I, ___________________________________(NAME) consent to enter my email onto the list held by
CUBRIC, School of Psychology, Cardiff University
Signed:
E-mail address:
Date: