RESEARCH INFORMATION SHEET

You are asked to participate in a research study conducted by Adam Leventhal, Ph.D. and associates from the Department of Preventive Medicine at the University of Southern California. Your participation in this research study is voluntary.

The purpose of the study is to examine how genetic factors (gene differences among individuals) and emotions affect people’s short-term responses to certain medications. These medications are all FDA-approved drugs, but they may include drugs regulated by the federal government as controlled substances because of their potential for abuse.

This study takes place in two parts. The first part is a screening session which consists of questionnaires filled out online. If you meet certain eligibility requirements based on these questionnaires, you may be asked to take part in the main study, which consists of an in-person eligibility screening and two medication administration visits. Participation in the screening session and main study are both optional.

You will be asked to complete several brief questionnaires a few questionnaires about your medical history and background. These questionnaires are commonly used in research and clinical practice. Because some of the questionnaires are available only in English, one of the requirements for participation is that you must be able to read and speak English fluently. As a result, this document and all other study materials are available only in English. You are invited as a possible participant in the screening for the study because you are a normal volunteer. Approximately 1000 normal volunteers will take part in the screening portion of this study.

Only people who meet certain criteria based on these questionnaires will be asked to take part in the main study. During the main study, the drugs described in the above section will be given in two separate sessions. For each of the two sessions, participants will be randomly assigned (like pulling a number out of hat) to take a standard dose of one of the following types of drugs: sedative/tranquilizer, stimulant/appetite suppressant, anti-depressant, or placebo (a capsule with no active drug). Participants in the main study will also complete questionnaires that ask about thoughts and feelings, complete computerized tasks, and have physical responses measured.

If you participate in the main study, you will be asked to provide a sample of skin cells from the inside of your cheek or a saliva sample. For the cheek cell sample, yYou will do this yourself by rubbing a swab on the inside of your cheek. For the saliva sample, you will collect the sample yourself by expelling some of your saliva into a container This sample will be stored in a freezer so that we may test your DNA for genes.

Today, you are participating in the screening portion of the study only. If following today’s screening you are invited to participate in the main study, all of the procedures, potential risks and benefits, and confidentiality of the main study will be explained to you in greater detail at that time. You will be asked to sign a consent form in person for the main study. You can choose to participate in today’s screening and then later decide not to participate in the main study.

During this screening portion of this study, some of the questions on the questionnaires may be of an embarrassing or sensitive nature and may make you uncomfortable. Therefore, you can choose to skip or stop answering any questions you do not wish to answer.

You will not receive any direct benefit from taking part in this study. However, we hope the information learned from this study will help people in the future.

You will not receive any payment for the screening portion of the study. If you are invited to take part in the main study and are found eligible to participate, the total possible payment you may receive for completing the main study will be $195, and the least you will earn for completing the entire main study will be $185.

The investigator and the Institutional Review Board (IRB) will keep your records private. The IRB is a research review board that is made up of professionals and community members who review and monitor research studies to protect the rights and welfare of research participants. Officials sent by the Research Advisory Panel of California or the sponsor who is the National Institutes of Health (NIH), may look at your research records. Your records will be kept confidential unless the law requires us to share these records. All information obtained from you, including results of the genetic analysis, will be identified only by a code number. A cross-index of your name (with address and telephone number) and your code number will be kept in a separate locked location, available only to the University of Southern California investigators and employees on this study. Your particular answers and data are confidential. We may publish the information from this study in journals or present it at meetings. If we do, we will not use your name.

A Certificate of Confidentiality has been obtained from the Federal Government for this study to help ensure your privacy. This certificate means that the researchers cannot be forced to tell people who are not connected with the study, including courts, about your participation. The Certificate does not represent an endorsement of the research project by the Secretary of Health and Human Services. Also, if any of the following conditions exist, the Confidentiality Certificate does not authorize any person to which it applies to refuse to reveal identifying information concerning you as a research participant. If you ask us to disclose information, we will do it. A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about you or your participation in this research. Also, we may voluntarily disclose, to anyone we think needs it, information about anything that might put you or another person in danger. In addition, if we learn about abuse of a child or elderly person or that you intend to harm yourself or someone else, or about certain communicable diseases, we will report that to the proper authorities. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). Finally, if you enter the study after the Certificate has terminated you will be so informed and the researcher may no longer rely on the Certificate to protect your confidentiality.

What are my rights if I take part in this study, and what will happen if I decide not to participate?

Your participation in this study is voluntary. Your decision whether or not to take part will not affect your current or future care at USC. You are not giving up any legal claims or rights. If you do decide to take part in this study, you are free to change your mind and stop being in the study at any time.

You may contact Adam Leventhal, Ph.D. at 626-457-4158 with any questions, concerns, or complaints about the research or your participation in this study. If you feel you have been hurt by taking part in this study, please contact Adam Leventhal, Ph.D. at 626-457-4158. If you have questions, concerns, or complaints about the research and are unable to contact the research team, or if you want to talk to someone independent of the research team, please contact the Institutional Review Board (IRB) Office at 323-223-2340 between the hours of 8:00 AM and 4:00 PM. (Fax: 323-224-8389 or email at irb@usc.edu). If you have any questions about your rights as a research participant, please also contact the Institutional Review Board Office at the numbers above or write to the Institutional Review Board at the LAC+USC Medical Center, General Hospital, 1200 North State Street, Suite 4700, Los Angeles, CA 90033.