|This is a sample consent form. It cannot be used without completion, appropriate revision and IRB approval.
The form consists of two parts:
CONSENT TO PARTICIPATE IN RESEARCH
Structural & Functional Magnetic Resonance
You are asked to participate in a research study by list investigators here, from the departments of list departments here and the Division of Brain Mapping at the University of California, Los Angeles. You have been asked to participate in this study because you are a healthy volunteer. Your participation in this study is entirely voluntary. You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate.
Purpose of StudyReplace the following with information pertinent to your study
This study is designed to evaluate the effectiveness of advanced magnetic resonance imaging technology. Specifically, using this technology, we hope to accomplish the following:
You will be asked also to review the attached appendix (Magnetic Resonance Procedures - Appendix") that describes the procedures involved in the study. Your understanding and approval of these procedures is required if you are to participate in this study. During the MRI scan, you may be asked to perform various tasks. Depending on the specific needs of the experiment, these may include:
Anticipated Benefits to Subjects
You may receive no direct medical benefit from participating in this study.
Anticipated Benefits to Society
Information derived from these studies may help physicians diagnose and treat brain diseases more readily.
Alternatives to Participation
This study is not being performed to improve your condition or health. Alternative procedures for making images of brain function are in use, or are being developed, that use radioactive tracers or which use surface electrodes. These procedures are not being used in this study because they use ionizing radiation or because they are not of sufficient image quality and/or dependability to offer distinct advantages over the methods used in this study. You may receive MRI scanning without participating in this study if your physician so orders.
Neither you, nor your insurance company, will be billed for your participation in this research.
Payment for Participation
Subjects will not be paid for participation in this research.
Privacy and Confidentiality
The only people who will know that you are a research subject are members of the research team and, if appropriate, your physicians and nurses. No information about you, or provided by you during this research, will be disclosed to others without your written permission, except:
When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity.
Since the anatomical pattern of the human brain may be uniquely identifiable, in a fashion similar to fingerprints, sharing of such data among scientific investigators could potentially lead to your unique identification. Such identification would require sophisticated tools but is within the realm of current technologies. As such, data sharing is an important part of this scientific project, you will also be asked to sign an additional release form addressing this issue.
Emergency Care and Compensation for Injury
If you are injured as a direct result of research procedures, not done primarily for your own benefit, you will receive medical treatment at no cost. The University of California does not provide any other form of compensation for injury.
Participation and Withdrawal
Your participation in this research is entirely VOLUNTARY. If you choose not to participate, that will not affect your relationship with UCLA (or the UCLA Medical Center), or your right to health care or other services to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without prejudice to your future care at UCLA.
Withdrawal of Participation by the Investigator
The investigators may withdraw you from participation in this research if circumstances arise which warrant doing so. The investigators listed above will make the decision and let you know if it is not possible for you to continue. The decisions may be made either to protect your health or safety.
During the course of this study, you will be informed of any significant new findings (either good or bad) such as changes in the risks or benefits resulting from participation in the research or new alternatives to participation, that might cause you to change your mind about participating. If such new information is provided to you, your consent to participate will be re-obtained.
Identification of the Investigators
If you have any questions about the research, or if you experience a research-related emergency, please contact any of the investigators listed below:
|List investigators and phone numbers here|
Rights of Research Subjects
You may withdraw your consent at any time and discontinue participation without penalty. You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you have any questions regarding your rights as a research subject, you may contact the Office of Protection of Research Subjects, UCLA, Box 951694, Los Angeles, CA 90095-1694, (310) 825-8714
Signature of Research Subject or Legal Representative
I have read, or someone has read to me, and I understand the information provided above. I have been given an opportunity to ask questions and all of my questions have been answered to my satisfaction. I have been given a copy of this form and the Subjects Bill of Rights.
By signing this form, I willingly agree to participate in the research it describes.
|Name of Subject||Date|
|Signature of Subject or Legal Representative|
Signature of Investigator
I have explained the research to the subject or his or her legal representative, and answered all of his or her questions. I believe that he or she understands the information described in this document and freely consents to participate.
|Name of Investigator||Investigator Signature||Date|
Consent to Undergo a Magnetic Resonance Procedure
You are being asked to review this appendix because you are participating in a research study that involves magnetic resonance imaging (MRI) with a specialized imaging instrument. This MRI device utilizes a powerful magnet.
This appendix describes only the activities and risks related to the MRI. The details regarding your participation in the research study are described in the consent form to which this form is attached. However, your consent to participate in the MRI procedures is required before the magnetic resonance portion of the study may begin. You should read the information below and ask questions about anything you do not understand before deciding whether or not to participate.
If you agree to undergo an MRI, the amount of time you spend on the MRI procedures will be from one to three hours. The amount of time you spend in the MRI device will be two hours or less. You will be asked to have a series of MRI pictures taken of your head. These pictures are made with an MRI device that uses radio waves and a large magnet to create the images. The MRI pictures will be made while you lie on a narrow bed placed inside of a large magnet. During the MRI scan, you may be asked to perform various tasks. Please refer to the Procedures section of the attached study consent form for details regarding these tasks. During parts of the scan, you will be asked to remain very still for periods of up to 30 minutes (though most procedures will be much shorter).
The following may all be part of your exam, depending on the specific requirements of the research:
You may be asked to complete a brief questionnaire that will require two to three minutes of your time. You have the right to refuse to answer any question that you may not wish to answer.
Potential Risks and Discomforts
The MRI scanning procedure requires that you be confined in a small partially enclosed space. Some individuals find this to be uncomfortable and may exhibit symptoms of claustrophobia including nervousness, sweating or other minor discomfort. The sound of the MRI scanner can be quite loud; you will be given special ear plugs to minimize the noise. In addition, the magnetism of the machine attracts certain metals; therefore, people with these metals within their bodies (such as pacemakers, infusion pumps, aneurysm clips, metal prostheses, joints, rods, or plates) will be excluded from the study. The metal in dental fillings is less responsive to magnetism and is therefore allowed. The MRI technician will ask you if you have any metals within your body. You will be expected to notify the investigator conducting the study of any metal in your body, other than dental fillings. There are no other known side effects resulting from exposure to the MRI scan.
If the MRI component of your study does NOT offer diagnostic or therapeutic opportunities of DIRECT benefit to the subject, the following paragraph is recommended:
Although there is no evidence that participation in this study by a pregnant woman would be harmful to her fetus, current guidelines for the use of MRI in clinical settings recommend that MRI studies be delayed until after the pregnancy when possible. Consequently, we request that women who are pregnant, or think that they might be pregnant, not participate in this research study.
Alternatively, if the MRI component of your study does offer diagnostic or therapeutic opportunities of DIRECT benefit to the subject, the following paragraph is recommended:
Although there is no evidence that participation in this study by a pregnant woman would be harmful to her fetus, current guidelines for the use of MRI in clinical settings recommend that MRI studies be delayed until after the pregnancy when possible. If you are pregnant, or think that you might be pregnant, you should advise the researchers conducting this study of that fact so that they can determine whether it is better to go ahead with the MRI study now or to wait until you are no longer pregnant.
Because this is a research procedure, there may be risks that are currently unforeseeable. In the studies performed so far, there have been no significant risks reported in animals or humans for similar exposures.
Use and Sharing of Magnetic Resonance Data
Magnetic resonance data collected in the Brain Mapping Center is archived in digital form, and is subject to review for scientific purposes by the investigators and their colleagues, as part of ongoing efforts to extend and improve the technologies of Magnetic Resonance imaging and spectroscopy and our understanding of the brain.
The anatomical folds in the human brain appear to be unique for each individual in the population. As such, sharing of data where this pattern can be analyzed three-dimensionally could potentially allow your data to be identified by someone who already knows the folding pattern of your brain. This is analogous to the way fingerprints can be used to identify individuals in the population, if such fingerprints are on file and associated with your name. In the unlikely circumstance that, for clinical or other purposes, an MRI scan of your brain associated with your name or other identifying information (such as a scan for medical reasons) were compared to data shared through this research study, your identity could potentially be revealed. This is an unlikely but possible circumstance. Since your MRI data may be shared among scientific investigators, used in scientific databases of imaging data or assessed by clinical colleagues for normality, it is important that you recognize this unlikely but potential avenue of identifying you from your brain anatomy. To verify that you understand this potential avenue of identification, you will be asked to sign a separate form attached to the informed consent that specifically allows the release and data sharing of your MRI scan.