SUNY Upstate Medical University Stephen J. Glatt, Ph.D. Stephen V. Faraone, Ph.D. 315-464-7742 315-464-3113 Study Title: Longitudinal Family/Molecular Genetic Study to Evaluate Research Domain Criteria Consent / Authorization Form INTRODUCTION We invite you to take part in a research study at SUNY Upstate Medical University Before you decide to take part, please take as much time as you need to ask any questions and discuss this study with anyone at SUNY Upstate Medical University or with family, friends, or your personal physician or other health professional. You may keep an unsigned copy of this consent and authorization form to think about your decision or discuss with your family, friends, or primary care doctor before making your decision whether or not to take part in this research study. WHY IS THIS STUDY BEING DONE? The purpose of this research is to study new ways of classifying mental disorders based on observable behavior and genetics to ultimately diagnose these disorders better. To accomplish this we will compare children who are typically developing to children who are being seen by their clinician for a behavioral, developmental or psychiatric disorder. You are being asked to participate in this research study as a parent of a child between the ages of six and twelve. There are several characteristics within disorders that are sometimes shared or unique to each disorder called constructs. These can include things such as anxiety, memory-loss, or difficulty sleeping. We would like to determine what, if any, of these constructs you may have. Participation in this study will involve answering several questionnaires about your behavioral health. It will also involve several minor tasks that assess the same thing. Genes are composed of the genetic material called DNA. DNA (deoxyribonucleic acid) is the part of the cell that is responsible for providing hereditary characteristics (such as eye color) and is used to build proteins. Several genes have been discovered that may be associated with the previously mentioned constructs. -1-
We would like to also study your DNA to determine whether your genes are related to these constructs. In addition, we would like to study your RNA (ribonucleic acid), which are the transcripts that are written off from the DNA in your genome. Looking jointly at the DNA and RNA will let us get a better view of the biology underlying the behavioral measures we are taking. Participation in this study will also involve donating blood. This study includes collecting questionnaires, task observations, and blood samples, and medical information from 700 families including children ages 6-12, their full sibling ages 6-12 years, and biological parents. Questionnaires and task observations will be used to measure constructs, while blood samples will be used for genetic testing. 2800 subjects (700 families) are expected to participate in this research study. This study is funded by a grant from the National Institute of Mental Health. In addition, The National Institute of Mental Health (NIMH) would like to help scientists learn more about the process of human diseases such as mental illnesses. We are gathering mental health information, cells and genetic material, or DNA and RNA, from you in order to make this research possible. NIMH will store the mental health information, cells and DNA in a central location called a repository or bank. For this study, we may be storing your information in 2 different repositories. One for your blood (this one is called the NIMH Repository and Genomic Resource) and one for the information collected about you (this one is called the NIMH Research Domain Criteria Database or RDoC db). RDoC db is a computer system run by the NIMH that allows researchers studying mental health to collect and share information with each other. With an easier way to share, researchers hope to learn new and important things about mental health conditions more quickly than before. The NIMH will make these data available to other scientists who want to do research on what causes these illnesses. Any use of these materials would first need to be reviewed and approved by NIMH. We are asking your permission to contribute your mental health information and blood specimen to the above described repositories for use in future research. Allowing us to contribute your data and blood specimen is optional. You may still participate in this study even if you do not agree to contribute your data and blood to the NIMH repositories. WHY ARE YOUR CELLS AND DNA IMPORTANT FOR RESEARCH? Scientists can learn a lot from studying cells, DNA, RNA and health information from people with and without different medical conditions. These are used for research on what causes the medical conditions and potential treatments for those conditions. It is important for scientists to be able to keep cells growing for future use, so that new experiments can be compared with experiments done before. -2-
To do this, scientists can introduce your cells to certain factors that turn them into other kinds of cells (a process called reprogramming) that can be kept alive, grown and stored indefinitely in the laboratory and in cell banks/repositories. There are different kinds of reprogrammed or induced cells. Most commonly, a factor can be introduced to blood cells to make something called a lymphoblastoid cell line (LCL), which can be grown for a long time and be used to isolate DNA to study different genes. Your cells can also be reprogrammed to pluripotent stem cells, which can become many other different kinds of cell types, such as muscle, nerve, and liver cells that are affected in a particular disease. Induced pluripotent stem cells (ips cells) can be derived from many different kinds of donated samples, such as skin, blood, or hair. These cells would be created at the NIMH Repository and Genomic Resource. This is different from embryonic stem cells, which are also pluripotent but can only be derived from embryos. Sometimes cells can be reprogrammed directly to one specific type of cell, such as an induced neuronal cell (in cell), which completely bypasses the pluripotent stage. Cells, DNA and RNA obtained from you may be used in different types of research, for example: Looking at the DNA and RNA sequence/genetic code in your cells Altering some of the DNA within these cells Testing in animals to model diseases and treatments Developing and testing new drugs and treatments Techniques and uses that we cannot predict at this time HOW WILL YOUR CELLS, DNA AND INFORMATION BE STORED AND SHARED? Cells, DNA, and RNA and mental health data collected from you will be stored at the repository as a national resource. This will include information about your family structure, age, sex, and medical symptoms (if applicable). This may also include genetic information derived from the analysis of your DNA. Your cells, DNA, and this information, including RNA data will be stored in a coded way to keep your personal identity a secret. You should know that it is very likely that these cells will be stored for many years, as they can be grown indefinitely. Any request for these materials from the repository would first need to be reviewed and approved by NIMH. The NIMH will provide this health information and biomaterials to qualified scientists, universities, private companies, and other institutions around the world to study the causes of disease. These scientists may not be currently working on this research right now. Society and medical research will benefit from sharing these cells and information among many researchers and institutions. The information collected in the Research Domain Criteria database (RDoC db) will include your age, sex, diagnosis (if applicable), questionnaire, test and genetic results. During and after the study, the researchers will send information about your health and behavior and in some cases, your genetic information, to RDoC db. However, before they send it to RDoC db, they will remove information such as name, address, and phone number, and replace that information with a code number. Other researchers nationwide can then file an application with the National Institutes of Mental Health to obtain access to your study data for research purposes. -3-
Experts at the National Institutes of Mental Health who know how to protect health and science information will look at every request carefully to minimize risks to your privacy. You will not be able to retrieve your donated samples or cells from the researchers for personal use. CAN YOU PLACE LIMITS ON THE USE OF YOUR CELLS? By agreeing to have your blood deposited in the NIMH Repository and Genomic Resource, you agree to the terms and limitations described in this consent form. We are not able to honor personal restrictions. For example, you may not place limits on the types of diseases that may be studied with your cells. If you have questions about these terms, please feel free to ask us. WHAT DOES YOUR PARTICIPATION IN THIS STUDY INVOLVE? If you agree to participate in this study and you qualify to be included in the study, you will be given a set of questionnaires and computer tasks about your mental and behavioral health. The screening (1), questionnaires (3), and computer tasks (3) should take up to 3 hours. You will then have 10.50 teaspoons of blood drawn by venipuncture, which is a routine procedure used for obtaining blood samples. A needle is inserted into a vein in the arm and a blood sample is withdrawn. Although one venipuncture is usually sufficient, a second one may be necessary if the first one is not successful. Your blood samples will be coded. This means that these samples can be linked back to you. Your specimen(s) will be assigned a random ID number and stored at SUNY Upstate Medical University and the NIMH Repository and Genomic Resource (with your permission). Only Drs. Glatt and Faraone and the project data manager will have the key to the code to link your personal information to the genetic results. While the venipuncture blood draw is the preferable method, in the extreme case, where someone is not able to complete the blood draw, an option to complete a saliva collection for the DNA extraction will be offered. Including wait time at the Clinical Research Unit, it should take no more than 15 minutes for the blood draw. The blood draw, screening, questionnaires and computer tasks can be accomplished in 1 visit. We will keep confidential your name and any other personal information we learn about you. We will take the following steps to ensure confidentiality. Your name, birth date, and other personally-identifying information will be removed from your data and samples. They will be linked to your samples only by code number. The code key for the samples will be stored in password-protected database under control of Drs. Glatt and Faraone and the project data manager. Medical information, samples, and cells that are shared with others will be coded and will not include identifying information (name, address, telephone number, or personal identification number). -4-
Only Drs. Glatt and Faraone and the project data manager will be able to trace your samples and information to you. Your coded DNA samples and RNA data may be analyzed at another laboratory, but they will not have the key to the code. Only Drs. Glatt and Faraone and the project data manager will have the key to the code to link your personal information to the genetic results. Information about Genetic Research Your blood will be tested for genetic factors related to developmental, behavioral, or psychiatric disorders and the information obtained may reveal genetic information about you. This information will be kept confidential. For example, in cases where parents and children are both tested, the test may disclose the possibility that the father is not the biological parent. This information will be kept confidential and not revealed to you. Some tests reveal information that may affect a person s ability to get life insurance. There is a very small chance that the tests done under this study would affect your ability to get life insurance. Since the significance of these tests is not known for you, we will not release the results of any genetic testing. No formal counseling will be provided under this study. WHAT ARE THE RISKS FOR PARTICIPATING IN THIS STUDY? Blood drawing: may cause pain and/or bruising at the location on your arm where the blood was taken. On rare occasions, it may cause lightheadedness or fainting and an infection. Psychological Risk: Occasionally, a person will experience some anxiety or distress when completing the questionnaires or playing the computer-based game. If you feel distressed in anyway, the person administrating the test will stop the test. Privacy: There is a potential risk to your privacy. Because your genetic sample and information is coded and your ID changed prior to deposit in the repository, the risk of identification is extremely small. Only Drs. Glatt and Faraone and the project data manager will have the key to the code which links your unique study number and your personal information. All data made available for public use via RDoC db or the NIMH Repository and Genomic Resource will only contain a code number, such that your identity cannot be readily discovered or otherwise associated with the data by the repository staff or other researchers. WHAT ARE THE BENEFITS FOR PARTICIPATING IN THIS STUDY? There is no direct benefit to you for participating in this research study; however, the data and specimens collected in this study may be helpful in the future to learn about how to diagnose mental disorders using behavior and genetics. -5-
VOLUNTARY PARTICIPATION / STUDY WITHDRAWAL: There is no obligation for you to participate in this study. Your participation in this study is entirely voluntary and you may refuse to participate or discontinue participation at any time without penalty or loss of benefits to which you would normally be entitled. Your decision about whether or not to participate in the study will not affect the care you or your child receive(s) or your relationship with SUNY Upstate Medical University. You have the right to withdraw your permission (revoke authorization) to participate in the study and for us to use and share your health information and blood sample, by contacting the investigator in charge of the study: Stephen Glatt, Ph.D. SUNY Upstate Medical University 750 E. Adams St. Syracuse, NY 13210 315-464-7742 This means that no further health information will be collected and the blood sample will be destroyed. Once authorization is withdrawn, your blood sample and test results that are deposited in the NIMH repositories will be destroyed, but cannot be destroyed from researchers who have already requested them. WHAT ARE THE ALTERNATIVES TO PARTICIPATING IN THIS STUDY? If you decide not to participate in this study, no questionnaires/computer games will be administered and no blood will be taken for research purposes. You may choose to participate in this study and not agree to have your research information and blood sample deposited in the NIMH Repository and Domain Criteria Database. ARE THERE ANY COSTS FOR PARTICIPATING IN THE STUDY? There are no costs to you or your insurance carrier for participating in this study. WILL YOU BE PAID FOR YOUR PARTICIPATION? You will be compensated in the amount of $50 per subject or $200 per family of four. In addition, bus fare incurred as a direct result of this study will be reimbursed with pre-paid bus passes; and parking fees will also be paid. In some research using human blood or tissue, the specimens and their parts may enable researchers to develop medical tests or treatments, which have commercial value. There are no plans to provide you with any money that may result from any such commercial tests or treatments. -6-
WHAT IF YOU HAVE QUESTIONS? If you have any questions about the research, or in the case of injury, please contact Dr. Stephen Glatt at (315) 464-7742. If you have any questions about your rights as a research subject, please contact the SUNY Upstate Medical University Institutional Review Board Office at (315) 464-4317. WHAT IF YOU ARE INJURED? In the event of illness or physical injury resulting from taking part in this research study, medical treatment will be provided at University Hospital. You will be responsible for any costs not paid by your insurance company. No other compensation is offered by SUNY Upstate Medical University. SUNY Upstate Medical University has no plans to give you money if you are injured. You have not waived any of your legal rights by signing this form. CONFIDENTIALITY OF RECORDS AND AUTHORIZATION TO USE/SHARE PROTECTED HEALTH INFORMATION FOR RESEARCH: If you agree to participate in this research, identifiable health information about you will be used and shared with others involved in this research. For you to be in this research we need your permission to collect and share this information. Federal law protects your right to privacy concerning this information. When you sign this consent form at the end, it means that you have read this section and authorize the use and/or sharing of your protected health information as explained below. Your signature also means you have received a copy of Upstate s Notice of Privacy Practices. Individually identifiable health information under the federal privacy law is considered to be any information from your medical record, or obtained from this study, that can be associated with you, and relates to your past, present, or future physical or mental health or condition. This is referred to as protected health information. Your protected health information will be kept confidential. Your identity will not be revealed in any publication or presentation of the results of this research. We will do everything we can to keep others from learning about your participation in this study. To further help us protect your privacy, we have obtained a Certificate of Confidentiality from the United States Department of Health and Human Services (DHHS). With this Certificate, we cannot be forced (for example by court order or subpoena) to disclose information that may identify you in any federal, state, local, civil, criminal, legislative, administrative, or other proceeding. Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation purposes. -7-
You should know that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about you or your involvement in this research. If an insurer or employer learns about your participation and obtains your consent to receive research information, then we may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your privacy. You should also know that the researchers may take steps, including reporting to authorities, to prevent you from seriously harming yourself or others; for example, in the case of child abuse or neglect. Finally, the Certificate does not prevent the review of your research records under some circumstances by certain organizations for an internal program audit or evaluation. Why is it necessary to use/share your protected health information with others? The main reason to use and share your health information is to conduct the research as described in this consent form. Your information may also be shared with people and organizations that make sure the research is being done correctly, and to report unexpected or bad side effects you may have. What protected health information about you will be used or shared with others as part of this research? We may use and share the results of tests, questionnaires, and interviews. We may also use and share information from your medical and research records. We will only collect information that is needed for the research. Who will be authorized to use and/or share your protected health information? The researchers, their staff and the staff of Upstate Medical University participating in the research will use your protected health information for this research study. In addition, the Upstate Institutional Review Board (IRB), a committee responsible for protecting the rights of research subjects, and other Upstate Medical University or University Hospital staff who supervise the way the research is done may have access to your protected health information. The researchers and their staff will determine if your protected health information will be used or shared with others outside of Upstate Medical University for purposes directly related to the conduct of the research. With whom would the protected health information be shared? Your protected health information may be shared with: Federal agencies that supervise the way the research is conducted, such as the Department of Health and Human Services Office for Human Research Protections, or other governmental offices as required by law. All reasonable efforts will be used to protect the confidentiality of your health information. However, not all individuals or groups have to comply with the Federal -8-
privacy law. Therefore, once your protected health information is disclosed (leaves Upstate Medical University), the Federal privacy law may not protect it. For how long will your protected health information be used or shared with others? There is no scheduled date at which this information will be destroyed or no longer used. This is because information that is collected for research purposes continues to be used and analyzed for many years and it is not possible to determine when this will be complete. Can you withdraw authorization to collect/use/share your protected health information? You have the right to withdraw your permission (revoke authorization) for us to use and share your health information, by putting your request in writing to the investigator in charge of the study. This means that no further private health information will be collected. Once authorization is revoked, you may no longer participate in this research activity, but standard medical care and any other benefits to which you are entitled will not be affected. Revoking your authorization only affects uses and sharing of information obtained after your written request has been received, but not information obtained prior to that time. Even after you withdraw your permission, Upstate Medical University may continue to use and share information needed for the integrity of the study; for example, information about an unexpected or bad side effect you experienced related to the study. Can you have access to your health information? At the end of the study, you have the right to see and copy health information about you in accordance with the SUNY Upstate Medical University policies; however, your access may be limited while the study is in progress. PLEASE MAKE YOUR CHOICE BELOW REGARDING THE OPTIONAL PARTS OF THIS STUDY: 1. Do you agree that your research information and blood sample can be deposited in the NIMH repository and genomic resource and NIH research domain criteria database? Please initial your choice: Yes No 2. If you are currently enrolled in therapy, do want us to send your therapist or clinician the Adult Self Report (ASR), based on a questionnaire that you complete about yourself. This information can be useful for clinicians in diagnosing and treating problematic behaviors. Please initial your choice: Yes No -9-
3. May we contact you during or after this study to see if you might be interested in future related research studies? Please initial your choice: Yes No CONSENT TO PARTICIPATE IN RESEARCH & AUTHORIZATION TO USE AND SHARE PERSONAL HEALTH INFORMATION: The nature and the purpose of the above Research Study have been explained to me; I have agreed to participate in the research study. I also agree that my personal health information can be collected, used and shared by the researchers and staff for the research study described in this form. I will receive a signed copy of this consent form. Signature of Parent Subject Signature of Person Obtaining Consent/Authorization Date Date Name of Person Obtaining Consent Date -10-