7.3 Could the researchers take me out of the study even if I want to continue to participate? Yes. There are many reasons why the researchers may need to end your participation in the study. Some examples are: The researcher believes that it is not in your best interest to stay in the study. You become ineligible to participate. Your condition changes and you need treatment that is not allowed while you are taking part in the study. You do not follow instructions from the researchers. The study is suspended or canceled. 8. Financial Information 8.1 Who will pay for the of the study? Will I or my health plan be billed for any costs of the study? The study will pay for research-related items or services that are provided only because you are in the study. If you are not sure what these are, see Section 4.1 above or ask the researchers for a list. If you get a bill you think is wrong, call the researcher’s telephone number listed in Section 10.1. You or your health plan will pay for all the things you would have paid for even if you were not in the study, like: Health care given during the study as part of your regular care Items or services needed to give you study drugs or devices Monitoring for side effects or other problems Deductibles or co-pays for these items or services. If you do not have a health plan, or if you think your health plan may not cover these costs during the study, please talk to the researchers listed in Section 10 below or call your health plan’s medical reviewer. By signing this form, you do not give up your right to seek payment if you are harmed as a result of being in this study. 8.2 Will I be paid or given anything for taking part in this study? 8.3 Who could profit or financially benefit from the study results? The company whose product is being studied: The researchers conducting the study: trial
10.1 Who can I contact about this study? Please contact the researchers listed to: Obtain more information about the study Ask a question about the study procedures or treatments Talk about study-related costs to you or your health plan Report an illness, injury, or other problem (you may also need to tell your regular doctors) Leave the study before it is finished Express a concern about the study Principal Investigator: Mailing Address: Telephone: Study Coordinator: Mailing Address: Telephone: You may also express a question or concern about a study by contacting the Institutional Review Board listed below: University of Michigan Medical School Institutional Review Board (IRBMED) 2800 Plymouth Road Building 520, Room 3214 Ann Arbor, MI 48109-2800 Telephone: 734-763-4768 (For International Studies, include the appropriate .) Fax: 734-763-1234 e-mail: If you are concerned about a possible violation of your privacy or concerned about a study you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111. When you call or write about a concern, please provide as much information as possible, including the name of the researcher, the IRBMED number (at the top of this form), and details about the problem. This will help University officials to look into your concern. When reporting a concern, you do not have to give your name unless you want to. 11. record of Information provided 11.1 What documents will be given to me? Your signature in the next section that you have received copies of all of the following documents: This "Consent to be Part of a Research document. (Note: In addition to the copy you receive, copies of this document will be stored in a separate confidential research file and may be entered into your regular University of Michigan medical record.)