UNIVERSITY OF CALIFORNIA, IRVINE
ADDENDUM CONSENT
PET SCANS WITH 18F-FDG AND MRI FOR RESEARCH
Department of Psychiatry & Human Behavior
Brain Imaging Center
(949) 824-7872
Title of Study--required
Headings with (*) are required for all studies
IMPORTANT: BEFORE FINALIZING & PRINTING THIS DOCUMENT REMOVE THIS TEXT & ALL RED AND BLUE INSTRUCTIONAL TEXT
RESEARCH TEAM AND SPONSORS
Lead Researcher:
Name and Title
Department
Telephone Number:
24 Hour Telephone number:
(Required for medical studies and clinical investigations)
Other Researchers:
(List only those researchers qualified to be involved in the informed consent process)
Name and Title of other researchers
Study Location(s):
Study Sponsor(s):
PURPOSE OF STUDY
Because you already have agreed to participate in a study called [insert study title], you are being asked to volunteer for extra research procedures that will help the researchers examine your brain using imaging techniques called positron emission tomography (PET) and magnetic resonance imaging (MRI).
PET scanning involves injection of a substance called fluoro-de-oxy-glucose (18F-FDG), which is a radioactive sugar-like compound, followed by repeated blood sampling. MRI uses a strong magnet to take pictures of the brain. The MRI pictures of your brain will help the researchers to understand the PET scan results.
The purpose of these extra procedures is to help the researchers understand how human brains work in general and also, more specifically, to find out whether the study you are in is affecting your brain metabolism in any way. [To customize, insert the purpose of the PET scans vis-à-vis the specific hypothesis-driven protocol.] The PET scans and the MRI are not part of your treatment. They are only for research. Participation in these extra procedures is optional, and you can still stay in the study identified above even if you do not want to do the PET scans and MRI.
SUBJECTS
To help the researchers figure out if it is safe for you to do these extra procedures, they will ask you about any other radiation exposure you may have had (including diagnostic or treatment x-rays), and whether you have a history of head injury, kidney or bladder disease, or any other serious medical conditions.
If you have surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) or if I have a pacemaker or other pieces of metal in my body (shrapnel, metal filings, etc., you cannot participate in the MRI procedure.
If you are or become pregnant, you will not be able to do the PET scans or the MRI because there is a chance that they might be risky for your developing baby. If you are female and physically capable of getting pregnant, you will have a urine pregnancy test at no cost to you before each of the PET scans. If you wish, you also may have one at no cost before the MRI procedure.
PROCEDURES
If you agree to these extra procedures, you will have [insert # from 1 to 4] PET scan(s) and [insert # 1 or 2] MRI(s). One PET scan and one 1.5 Tesla MRI (the kind done in most clinical testing) will be done during the first week of the study. You will be asked to do [another or insert # from 2 to 3] PET scan(s) later [and another MRI—if applicable], probably during the [insert # day/week/month] of the study.
If you decide to do the PET scans, you will report to the Brain Imaging Center at the University of California, Irvine campus. The PET scanner is a large, donut-shaped machine that detects radioactivity. To do the scan, you will have a small plastic tube (intravenous line) inserted into each arm. A customized plastic chin holding mask will be made to minimize my movement during the scan. You will be asked to lie in the PET scanner for about 20 minutes. You will then receive an injection of a radioactive substance called 18F-FDG through a tube in one arm. After the injection of 18F-FDG, blood samples will be drawn from the tube in your other arm. No more than five tablespoons (2 ½ oz.) of blood will be taken per PET scan. The blood samples are used to measure the amount of FDG and glucose (sugar) in your blood. These measurements are needed to make an accurate image of your brain's activity.
After about 30 minutes, you will be asked to urinate (which greatly reduces the radiation dose to your bladder and other internal organs), and then you will be moved back into the PET scanner. You will be asked to lie still on a table with your head and neck in the machine and with your face in the chin holding mask for about one hour. The whole process should last about two hours for each PET scan. The FDA has approved the PET scan device for certain diagnostic purposes. This research is not one of those approved purposes.
If you decide to do the MRI, you will report to the [UCI Medical Center in Orange or the UCI campus in Irvine] on a different day. The MRI is a machine that takes a picture of your brain using a large magnet. The MRI scanner is like the PET scanner but the donut device is bigger and surrounds the whole body. The MRI scanner also makes a loud, pounding sound. You will be asked to lie in the MRI scanner for about 40 minutes. The FDA has approved 1.5 T MRI for taking pictures of brains.
RISKS AND DISCOMFORTS
The radioactive imaging material used in the PET scanning procedure, 18F-FDG, is not burned up normally by the body. Only small doses will be used for the PET scans so the risk will be limited. All of the 18F-FDG will be passed out of your body in your urine or will radioactively decay away within 48 hours after the scan. Most of it will be gone from your body within the first 7 hours.
The scanning and injection of the 18F-FDG will expose you to a small dose of radiation, so there is a chance that you risk of developing cancer in the future may go up by a small amount. If you have had a PET scan or been exposed to radiation for medical care or while participating in other research studies during the past year, please tell the researchers before your scan. This will allow them to make sure that your total radiation exposure does not go over safety guidelines. If you should want to participate in any future study that involves the use of x-rays or radioactive drugs, you should tell the researcher who is performing that study about your PET scans and discuss your previous radiation exposure.
It is possible that you could become claustrophobic (very upset and afraid of being in a small space) during the PET scans or MRI. Although this does not happen very often, it may be uncomfortable for you. If this happens, you can choose to stop any of the scanning procedures at any time.
No short-term ill effects have been reported for MRI scans to date. Longer-term risks are being studied at this time. The effects of MRI on pregnant women and children under age two are not known. The loud, pounding sound made by the MRI can be uncomfortable. You will be offered the option of wearing earplugs to decrease the noise.
The needle sticks and insertion of the intravenous lines for injection of 18F-FDG and blood sampling may cause some discomfort and possibly some local bruising, swelling, dizziness, and—on rare occasions—fainting or infection.
There may be other risks from these procedures that are currently unforeseen.
BENEFITS
Subject Benefits
You will not benefit directly from doing these extra scanning procedures.
Benefits to Others or Society
Information developed from these scans may help the researchers to better understand any brain effects produced by the research study in which you are participating.
COMPENSATION, COSTS AND REIMBURSEMENT
Compensation for Participation
For participating in these extra scanning procedures, you will be paid $50.00 per PET scan and $50.00 for the MRI. The maximum total compensation for all [insert #] procedures is $ [insert amount].
Costs
There will be no cost to you for any of these procedures.
Compensation for Injury
If you are injured as a direct result of your participation in this study, you will be provided reasonable and necessary medical care to treat the illness or injury at no cost to you or to your insurer/third party payer. The University of California does not routinely provide any other form of compensation for injury. It is important that you report any suspected study-related illness or injury to the research team listed at the top of this form immediately.
CONFIDENTIALITY
Subject Identifiable Data (Explain whether subject identifiers will be linked to the research data.) Examples include:
· All identifiable information that will be collected about you will be removed at the end of data collection.
· All identifiable information that will be collected about you will be removed and replaced with a code. A list linking the code and your identifiable information will be kept separate from the research data.
· All identifiable information that will be collected about you will be kept with the research data.
Data Storage (Describe how the data will be maintained)
Examples include:
· All research data will be maintained in a secure location at UCI. Only authorized individuals will have access to it.
· All research data will be stored on a laptop computer that [is password protected or has encryption software.]
· All research data will be stored electronically on a secure [computer or network] with [encryption or password] protection.
Data Access (Explain who will have access to the research data) UCI Standard language
The research team, authorized UCI personnel, the study sponsor (if applicable), and regulatory entities such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP), may have access to your study records to protect your safety and welfare. Any information derived from this research project that personally identifies you will not be voluntarily released or disclosed by these entities without your separate consent, except as specifically required by law. Research records provided to authorized, non-UCI entities will not contain identifiable information about you, and you will not be identified personally in any publications and/or presentations that result from these scans.
Data Retention (Explain how long the research data will be maintained)
Examples include:
· The researchers intend to keep the research data until analysis of the information is completed.
· The researchers intend to keep the research data until the research is published and/or presented.
· The researchers intend to keep the research data for approximately __ years.
· The researchers intend to keep the research data indefinitely.
· The researchers intend to keep the research data in a repository indefinitely. Other researchers will have access to the data for future research.
OTHER INFORMATION
Any specimen(s) (i.e., blood, urine) obtained for the purposes of these scans will become the property of the University of California, Irvine (UCI), and that once you have provided the specimens you will not have access to them. The urine (females only) will be used for a pregnancy test and will be discarded after use. The blood also will be discarded after use.
The brain scans will be used for the main study and also for general research about how brains work. Such use may result in inventions or discoveries that could become the basis for new products or diagnostic or therapeutic agents. In some instances, these inventions and discoveries may be of potential commercial value and may be patented and licensed by the University. You will not receive any money or other benefits derived from any commercial or other products that may be developed from use of these scans.
The researchers may end your participation in the PET scans or MRI (even if you want to continue) if they feel it is unsafe for you, if you are injured or become ill, or if you do not follow the instructions properly.
IF YOU HAVE QUESTIONS
If you have any comments, concerns, or questions regarding the conduct of this research please contact the research team listed at the top of this form.
[Insert text if the study is a clinical investigation] - A 24 hour number is also listed on the top of this form to report any health concerns or unanticipated problems you may experience after normal hours or on weekends.
If you are unable to reach a member of the research team listed at the top of the form and have general questions, or you have concerns or complaints about the research study, research team, or questions about your rights as a research subject, please contact UCI’s Office of Research Administration by phone, (949) 824-6068 or (949) 824-2125, by e-mail at or in person at University Tower - 4199 Campus Drive, Suite 300, Irvine, CA 92697-7600.
VOLUNTARY PARTICIPATION STATEMENT
You should not sign this form unless you have read the attached “Experimental Subject’s Bill of Rights” and have been given a copy of it and this consent form to keep. Participation in this study is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your future relationship with UCI or your quality of care at the UCI Medical Center. Your signature below indicates that you have read the information in this consent form and have had a chance to ask any questions that you have about the study.