ASSESSMENT OF MAGNETIC RESONANCE IMAGING PROTOCOLS WITH HEALTHY VOLUNTEERS

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1 SHEFC BRAIN IMAGING RESEARCH CENTRE FOR SCOTLAND Department of Clinical Neurosciences The University of Edinburgh Western General Hospital Crewe Road Edinburgh EH4 2XU Tel: Fax: INFORMATION SHEET ASSESSMENT OF MAGNETIC RESONANCE IMAGING PROTOCOLS WITH HEALTHY VOLUNTEERS Thank you for your interest in this important work. Medical researchers need to know more about how normal healthy brains work so that they can continue to improve the treatment of people who become ill, and work towards prevention of brain diseases. Magnetic Resonance Imaging (MRI) uses a combination of powerful magnets and radio waves to create very high quality pictures of particular parts of the body. MRI does not use X-rays, and no drugs or injections will be involved if you agree to be scanned. Although MRI techniques are already very well developed for taking pictures of the brain, less is known about how our body chemistry behaves during illness, how blood flows through our brains, and how our brains actually work. This Centre s scanner is dedicated to finding out more about these things. If you agree to join the study, we will check that it is perfectly safe for you to be scanned. Although MRI is normally a very safe method of taking pictures, we do not scan people who have a heart pacemaker or who have had surgery involving the insertion of metal clips into the brain, or people who have metal fragments in their eyes, perhaps as a result of their job. Neither will we scan you if there is a chance that you might be pregnant. On the other hand, the metals used in operations such as hip replacements are very rarely a reason not to undergo scanning. The Radiographers will check if you are in any doubt. When you come to the Centre for your scan, a changing cubicle will be provided. You will be asked to place any metal objects, such as keys, watches, coins and credit cards, in a locker. Please do not wear any make-up or talc, and be prepared to remove contact lenses if you use them. You may be asked to wear a wrap-around gown while you are in the scanner.

2 You will be asked to lie on the scanner bed for up to one hour. Usually it takes less time. While you are in the scanner, a series of pictures will be taken. Most volunteers coming to this Centre will have pictures taken of their brain, but many will have scans of their spine or heart, or another area of their body. If you have volunteered for a functional MRI scan, pictures will be taken of how parts of the brain begin to work harder during certain activities. You will be asked to carry out a simple task while lying in the scanner so that pictures can be taken while you are performing the activity. The task may involve listening to things, looking at images, or doing simple arithmetic, for example. The scanner makes quite loud noises while it operates. For your comfort, you will be provided with ear plugs or headphones, and it may be possible to play music into the Scanner Room if you wish. If at any stage shortly before or during your scan, you become worried, or wish to ask a question, you will be able to speak to one of the Radiographers, who will use an intercom to keep in touch with you. Of course you do not have to take part in this study, and you may withdraw from it at any time. We are, though, very grateful to you for offering to help us and, if you are willing, you may be asked to come back for extra scans. Please note that we are required by a medical ethics committee to send a routine report of the scan to your Doctor. All pictures that are taken within the Centre are entirely confidential, in the same way as all other medical records are. Pictures gathered from the scanner are stored and processed using computers and, after the study is completed, will be copied onto a permanent record which might be studied again at a later time. Information gathered during your scan may be shared with other medical and scientific researchers. In these cases, people cannot be identified from their pictures, and there are strict laws that will safeguard your privacy at every stage. Further information on magnetic resonance imaging is available, if you require it, from Dr. Don Collie, a Consultant Neuroradiologist in the Hospital (Tel: ) or Dr. Colin Turnbull, the Lothian University Hospitals NHS Trust Patient Services Director for Radiology (Tel: ). Neither person is involved in this study, and so will be able to give you independent advice. Otherwise, the Centre s Facility Co-ordinator or one of the Radiographers will be happy to try to answer any other questions that you might have. They can be contacted at the address shown at the top of the front of this information sheet. Once again, many thanks.

3 SHEFC BRAIN IMAGING RESEARCH CENTRE FOR SCOTLAND FORM VOLUNTEER CONSENT MAGNETIC RESONANCE IMAGING CONSENT FORM FOR HEALTHY VOLUNTEERS Research Project Principal Investigator I have read the Information Sheet that has been provided to me, and this Consent Form, and have been given the opportunity to ask questions about them. I am satisfied that I have all the information that I need to provide informed consent. As a volunteer, I understand that I am not being scanned at the request of a Doctor for any specific medical condition. I understand that my Doctor will be informed of my participation in this study, and know that he/she will be provided with a routine clinical report. I know of no reason why I should not undergo Magnetic Resonance Imaging scanning or take part in the study. I know that I am under no obligation to take part in the study and I can withdraw at any time. I agree that medical images obtained during my scan may be stored and processed using computers and, after the study is completed, that these may be copied onto a permanent record which might be studied again at a later time. I agree that information gathered during my scan may be shared with other medical and scientific researchers, subject to strict laws and University policies intended to safeguard my privacy. I agree to participate in the study.

4 Signature of volunteer Name of volunteer (please print in block capitals) Witnessed by (signature) Name of witness (please print in block capitals) Date Name of Volunteer s GP GP s address CN Number (for use by SBIR Centre staff) Both copies of this form must be brought to the Centre on the day of scanning. The pink copy is to be retained within the Centre; the volunteer should retain the white copy.

5 SHEFC BRAIN IMAGING RESEARCH CENTRE FOR SCOTLAND SCREENING FORM #1 SCREENING FORM FOR USE BY PATIENTS AND VOLUNTEERS ENTERING THE CENTRE S MAGNETIC RESONANCE IMAGING CONTROLLED AREA Surname First name(s) Home address Date of Birth Home telephone number Business telephone number CIRCLE THE CORRECT RESPONSE TO ALL OF THE QUESTIONS BELOW (IF YOU HAVE DIFFICULTY READING OR UNDERSTANDING THIS FORM, SOMEONE WILL HELP YOU) Do you have a cardiac pacemaker or artificial heart valve? YES/NO Do you suffer from any heart disease or rhythm disorder? YES/NO Have you had any recent surgery of any type (within the last six months)? YES/NO Have you ever, at any time in your life, had any operations to your head YES/NO (e.g. vascular clips, a cochlear implant, or a shunt)? Have you ever had metal fragments (e.g. shrapnel) in any part of your body? YES/NO Have you ever had any metal fragments in your eyes? YES/NO

6 Do you now, or have you ever worked with metal and had an injury YES/NO that required medical attention? Could you be pregnant? YES/NO Are you breast feeding? YES/NO IF THE ANSWER TO ANY OF THE ABOVE IS YES, PLEASE CONTACT THE DEPARTMENT BY TELEPHONE BEFORE YOUR APPOINTMENT DATE. Have you had any metal implants (e.g. joint replacement, YES/NO Harrington rods etc.)? Do you wear dentures, a dental plate, a brace, contact lenses or a hearing aid? YES/NO Do you suffer from epilepsy or diabetes? YES/NO Do you have an IUCD or sterilisation clips? YES/NO Do you have any metallic implants or foreign metallic objects in your body other than those mentioned above? If so, please state below: How much do you weigh (Stones and pounds, or kilogram units are equally acceptable)? Reasons why it might not be safe for me to undergo Magnetic Resonance Imaging scanning have been explained to me, and I have been given the opportunity to ask questions about them. I am satisfied that I have all the information that I need to provide informed consent. I know of no reason why I should not undergo Magnetic Resonance Imaging scanning or take part in the study. I have removed all credit cards incorporating magnetic strips, and loose metallic objects (e.g. coins, keys, badges, jewellery, hearing aids, watches, cell-phones, pagers etc, and documents held together with paper clips or staples), and given these to a member of staff for safe-keeping while I am being scanned. Signature of Patient (or Guardian) Date Name of Radiographer CN Number (SBIRC use only)