Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
1
Appendix III
Participant Information Sheet and Consent Form (TMS)
Information Sheet
Project title
[INSERT SPECIFIC PROJECT TITLE]
What is the purpose of this research?
We are investigating what happens when we temporarily disrupt activity in part of the human brain using
Transcranial Magnetic Stimulation (TMS). In particular, we are interested in effects on [INSERT TOPIC].
Who is conducting and funding this project?
[NAME AND EMAIL ADDRESS OF PI] is conducting this research with the assistance of:
[INSERT NAMES OF ALL OTHER MEMBERS OF THE RESEARCH TEAM]
The project has been funded by [INSERT FUNDING BODY]. The protocol has been approved by the
University of Edinburgh Psychology Research Ethics Committee.
Who can participate?
You must be at least 18 years old and under 60 years old to participate in the experiment. You
cannot participate if:
- You have metal implants in your head, though fillings are acceptable
- You have been diagnosed with depression, alcoholism, a neurological disorder or suffer from
sleep deprivation
- You suffer from epilepsy or syncope (fainting spells, blackouts)
- You are taking any medication other than oral contraceptives or allergy medication
- You are, or might be, pregnant
What is involved for the participants?
This first session is a screening interview where you, as a candidate for participation in the study, must
carefully read this information sheet. Please ask the researchers any questions you may have. You will
have to sign this consent form at the end of this sheet before the session can continue.
If you choose to proceed and sign this form, the next thing you will do is complete three questionnaires:
the Brain Stimulation Study Suitability Questionnaire (BSSSQ), Depression Anxiety Stress Scale ( D A S S )
and Alcohol Use Disorders Identification Test (AUDIT).
If your answers to the questionnaires indicate you can take part in the study, and if, after all your
questions have been answered, you are interested in taking part, we will conduct a brief introduction to
the task you will perform during the TMS sessions.
[THIS PARAGRAPH ONLY FOR STUDIES REQUIRING A STRUCTURAL MRI] Next, you will be
contacted by email to arrange the structural MRI scan, which will take place at the General Western
Hospital in Edinburgh. No special dietary precautions or medication need to be taken prior to or during
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
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the scan, but you should wear loose fitting clothing that does not contain metal. Otherwise gowns will
be provided in a private changing area since metal cannot be taken into the scanning room. Some
cosmetics contain small amounts of metal so make-up should not be worn. As jewellery, purses,
hearing aids and any other metal-containing items cannot be taken into the scanning room, you will be
able to keep them in a secure locker outside. The MRI scan itself lasts about 20 minutes, but you will
attend as part of a group of 3 people so you should expect to spend about an hour at the hospital.
During the scan you will lie flat and keep your head still. The machine is very loud so you must wear the
hearing protection provided.
Next, we will schedule three or four TMS sessions (preferably on consecutive days). During the 24 hours
prior to the session you should not drink alcohol. Prior to each session you will remove metal
containing items from your person and store them in a secure cabinet away from the TMS equipment.
In each session, you will perform a simple task, which will be accompanied by the administration of
TMS. Your eye-movements may be tracked by a computerised eye-tracker as you do the task. A
chinrest is provided for head support.
Following each session, you will remain in the laboratory for 15 minutes and complete an Adverse Effects
Questionnaire. Each session should take just over one hour. On the final session you will receive a full
debriefing about the specific research question and hypotheses of the study.
[THIS SECTION ONLY FOR STUDIES REQUIRING A STRUCTURAL MRI]
What are the risks related to MRI?
MRI is a well-established and completely safe technique for non-invasively looking inside the human
body. Over 400 million MRI scans have been performed worldwide. It is not painful and does not
use ionising radiation (unlike X-rays). It involves using a very strong magnetic field to temporarily
align properties of the same types of molecules in the brain. The scanner measures how this
alignment affects radio frequencies passing through the brain. It does not move or chemically change
any molecules and thus does not affect brain function. Radio frequencies continually pass through our
bodies in everyday life, for example, transmitting radio and TV programmes. Magnetic fields, even very
strong ones, have been repeatedly shown to be harmless to human beings. The scan will be performed by
a trained radiographer, using standard procedures.
Due to the high magnetic fields involved, people with metal objects or medical implants inside their
body cannot take part. The scanner requires participants to lie flat and still in the scanner for the
duration of the scan and thus people who suffer from claustrophobia should not take part.
What are the risks related to TMS?
Within well-established guidelines that we follow, TMS is very safe and has been used in hundreds of
studies all over the world during the past 30 years. In this study, application of TMS will involve a trained
researcher placing the TMS coil on the appropriate position against your head and a current being fed to
it (the current stays within the coil, which is electrically isolated). Through electromagnetic
induction, this current generates a magnetic field that in turn creates a small electric field across part
of your brain, slightly influencing activity at that location. This influence is very localised and slightly
enhances or reduces activity, rather than changing what part of the brain is activated at what time.
Unfortunately, TMS cannot safely be used with people who have metal implants in their head, as the
implants can conduct currents from the magnetic field.
Some people find that they experience a headache during or immediately after TMS, or mild discomfort
from sitting still during the task. Slight induced twitching from the electric field can sometimes
cause soreness in the scalp muscles. These effects, when experienced, are transient and disappear
completely within a few hours (usually much less) after TMS. In extremely rare cases, TMS has induced
a seizure. In the present study, the stimulation intensity will be at a much lower level than those that
have induces seizures in the past, and is considered safe and very unlikely to result in a seizure.
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
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There are no known risks associated with the use of the computerised eye-tracker which may be
employed in the experiment.
What precautions are taken?
The screening questionnaires will minimise the risks to you as a participant, as you will not be allowed
to take part in the study if you meet any of the criteria for exclusion. As both MRI and TMS are
noisy, you will be required to wear hearing protection, which we will provide, during the MRI scan (in
studies that require such a scan) and TMS sessions.
[THIS PARAGRAPH ONLY FOR STUDIES REQUIRING A STRUCTURAL MRI] Metal objects will not be
taken into the MRI scanning room, and you will go through a check-list prior to the scan to ensure that
you are not carrying any. If you find that the MRI is causing you stress, you will be able to press a panic
button that will immediately stop the scan.
If you find TMS gives you an unbearable headache, pain or discomfort you must withdraw from the
experiment by notifying the researcher to stop administering the TMS immediately. You may also
decide to stop participating at any point for any other reason. In the event of a headache, we
can provide you with over-the-counter Ibuprofen/Paracetamol headache relief pills. As a precaution for
the unlikely event that the researchers need to call emergency services, the laboratory is equipped with
a telephone with an external line.
What are the benefits?
You will contribute to fundamental research in psychology and cognitive neuroscience. More information
will be given to you in the debriefing. This is standard practice to guard against biases in the experiment.
How is my privacy protected?
Your MRI scan will be kept on password protected computers, to which only authorised researchers will
have access. Your data from your questionnaires and brain stimulation sessions will be kept under a
reference number separate from your contact details and consent form. The data will remain in the
custody of [NAME OF PI].
How is my data used?
[IN STUDIES THAT REQUIRE A STRUCTURAL MRI] Your MRI scan will be used to localise specific brain
sites for stimulation.
Your coded (unidentifiable) recorded data from TMS sessions will be aggregated with other
participants and you will never be individually identified. The overall findings may be published in a
scientific journal, presented at conferences or form parts of research degree theses that will be submitted
for assessment. The data will remain in the custody of [NAME OF PI] so it may be used in other studies
by the research team and collaborators, but will never be sold for profit. If you experience any
negative reactions to TMS we will report these to the scientific community but you will not be identified.
How am I compensated for my time?
Your participation in this study is voluntary, but you will receive financial compensation for your time,
paid in cash:
£5 for the initial screening session.
[IN STUDIES THAT REQUIRE A STRUCTURAL MRI] £15 for the Structural MRI scan (transport to the
scanning facility will be provided from the University of Edinburgh George Square campus and return if
required).
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
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£15 for each complete TMS session, of which there will be three or four.
What are my rights as a participant?
You may decide to stop being a part of this study at any time without explanation, with no negative
consequences to you. You have the right to ask that any data you have supplied up to that point to
be discarded and not used in the study. You have the right to have any questions about the procedure
answered unless answering these questions would interfere with the study’s outcome, in which case they
will be answered when the study is completed.
Where can I get more information?
You may ask the researcher conducting the screening any questions you have prior to the start of the
study. The researchers are always happy to answer any questions about the research at any time; in some
cases, if answering the question might bias the study’s results, they may tell you that the question will
have to be answered during debriefing, after you complete your participation.
You can contact the Principal Investigator, [NAME OF PI], via email, phone or postal address:
[FULL CONTACT DETAILS OF PI]
If you would like to know more about the results please notify the researchers and your contact details will
be added to a separate list of those interested in the results.
The consent form follows on the next page.
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
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The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.
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Information Sheet and Consent Form for Transcranial Magnetic Stimulation study
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Informed Consent Form
Participant Reference Number (given by the researcher):
By signing below, you are agreeing that:
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•
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You are aged between 18 and 60 years old,
You have read and understood the information provided above,
Questions about your participation in this study have been answered satisfactorily,
You are aware of the potential risks,
You are taking part in this study voluntarily (without coercion).
Participant’s name
Participant’s Signature
Date
Witness (Researcher)’s Name
Witness (Researcher)’s Signature
I am aware that participation in this study involves:
 Completion of a structural MRI brain scan, which is routinely used as a preliminary screen for
clinical conditions and impairments of which I might not be aware.
 Completion of a questionnaire requiring me to disclose personal medical information (the
Brain Stimulation Study Suitability Questionnaire [BSSSQ]).
 Completion of two standardized tests (the Depression Anxiety Stress Scales [DASS] and
Alcohol Use Disorders Identification Test [AUDIT]), which are routinely used as preliminary
screens for clinical conditions/impairments of which I might not be aware.
I understand that these assessments are not sufficient for diagnostic purposes, nor will they be
used in this manner in this study. I also understand that the researchers cannot inform participants
of individual test results or provide scan data, but in the event that my scan reveals anything of
potential clinical concern, researchers should (tick one option and provide relevant contact
information):
__
Contact me at:
__
Contact my GP at:
__
Do nothing. I absolve the researchers of any obligation to contact me about this.
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.