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 MEG and 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 a MEG and 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/MEG 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 MEG. Appendix 2.
4) A consent form for MRI. Appendix 3.
5) A debriefing form. Appendix 4.
6) A participant database consent form. Appendix 5.
Please note that as the study involves both MRI and MEG, the volunteer should consent to each procedure separately, immediately before they are scanned.
The MRI and MEG 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 – MEG and anatomical MRI Volunteer Information Sheet
MEG and 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?
We are a group of scientists studying how the brain processes visual information. At the back of your brain, in the occipital region, there are a group of brain areas that deal with different aspects of the visual world. We are interested in finding out exactly what type of visual stimulus activates each part of the brain, and the relative timing of activation as it moves around the brain. With that in mind, we will measure activity from various parts of your brain while you are shown different types of visual stimuli on the computer screen. For this we will use two different brain scanners – a Magnetic Resonance Imaging (MRI) system and a Magnetoencephalography (MEG) system. This will require two visits to our brain imaging research centre, CUBRIC. We need to use two different scanners because each provides a different view of your brain. MRI can tell us the structure of your brain, MEG can tell us where activity occurs in the brain and the timing of this activity i.e how information moves around your brain and when activation occurs.
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 twice:
1. For an MEG scan – this will take 1-2 hours of your time in total. You will be in the MEG scanner for around 45 minutes.
2. 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 MEG and 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 MEG or 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 two scanning procedures, MEG and MRI, in more detail. Please read them carefully.
The MEG Recording Session
What is MEG?
MEG is an acronym for Magneto-Encephalo-Graphy and is a non-invasive technique that measures the magnetic fields generated by neuronal activity of the brain.
Because magnetic fields pass through the skull and scalp as if they were transparent, they can be measured outside of the head using the MEG scanner. The magnetic field is extremely small but can be detected by sophisticated sensors that are based on superconductivity.
The magnetic fields from the brain are so small that electrical noise from the building and distant moving objects, such as cars on nearby roads, can “swamp” the signals we are trying to record. For that reason the MEG scanner is housed in a specially shielded room and we will need to shut the door to this room before the recording starts.
MEG produces an “activity map” or “functional image” of your brain. Importantly, an MEG scanner can accurately track the timing of activity as it moves around your brain. There are no side effects and it doesn’t hurt – in fact you will not even be in contact with the scanner. Importantly, MEG does not produce radiation of any sort – it is simply a passive recording device.
Please note that the MEG 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.
An example of a volunteer being scanned using MEG while viewing a visual stimulus
MEG is shedding light on some of the fundamental workings of the human brain. Studies that involve healthy volunteers form the basis of this and are a vital part of our research program. Through such work, we are learning about typical brain function in areas such as language, vision, movement, memory, thought and emotion.
Who cannot have an MEG scan?
Anyone who has a cardiac pacemaker, metallic implants in the upper half of their body or a history of metal entering the eye will not be suitable for an MEG study. This is because the metal will cause interference to the MEG signal that is recorded.
Also, if you have a neurological condition, such as epilepsy, or routinely suffer from migraines, you should not be scanned as the bright flashing visual stimuli may cause you some problems.
[PROJECT SPECIFIC EXCLUSIONS]
What will I have to do during the MEG scanning session?
The Researcher will explain in detail exactly what tasks you will have to carry out whilst being scanned. Most of the tasks are very simple, such as looking at visual stimuli, thinking about what you are viewing, etc. You may also have some buttons to press to indicate responses as part of the task. In some studies your eye movements will be recorded using a camera.
We can acquire several scans in each 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 and perform the task to the best of your ability. During the study the Researchers, who will also ensure your comfort, will constantly monitor you.
We will need you in the MEG lab for approximately 1-2 hours 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 chair/bed. The actual scanning session lasts up to one hour during which you will not feel anything. The best thing to do is just relax.
The scan itself:
1. Before entering the MEG shielded room, you will be asked to remove any metal objects from your person including keys, coins, jewelry and watches. 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.
2. The Researcher will check again that it is suitable for you to have a MEG scan by going through a screening questionnaire. The scan format will then be explained to you.
3. You will be taken into the MEG room and asked to sit down on a special chair, which moves up towards the MEG scanner. Three special devices, called head localiser coils, will then be placed around your head/face. This allows us to see exactly where your head is in relation to the scanner whilst your brain activity is recorded. You will then be moved up towards the scanner so that the top of your head is inside the helmet. Several checks associated with the specific study will then be carried out.
4. For the experiment itself, you will view a computer screen on which different visual stimuli will be shown to you. In the main these will be simple geometrical shapes or patterns that may be moving or flashing. Nothing distressing in nature will appear on the computer screen, although if you do not like seeing bright images or flashing lights, you may find the images slightly unpleasant. If so, you can stop the scan at any time.