University of Pennsylvaia Consent Guidelines宾夕法尼亚大学同意原则.docVIP

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University of Pennsylvaia Consent Guidelines宾夕法尼亚大学同意原则.doc

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University of Pennsylvaia Consent Guidelines宾夕法尼亚大学同意原则

University of Pennsylvania RESEARCH suBject Informed Consent Form Protocol Title: Insert Title of Research Study or Acronym Principal Investigator: Insert Name of the Principal Investigator Address Insert Phone Numbers Emergency Contact: Insert Emergency Contact Insert Phone Number/Pager, etc. Why am I being asked to volunteer? The subject is being invited to participate in a research study and why he/she is being asked to volunteer Participation is voluntary The subject will get a copy of the consent form and should ask questions The subject will be asked to sign this form if consent is given to participate (optional) Include some information about the study such as “a study of “X” (drug or device, etc.) in patients with “Y” disease. You are being invited to participate in a research study. Your participation is voluntary which means you can choose whether or not you want to participate. If you choose not to participate, there will be no loss of benefits to which you are otherwise entitled. Before you can make your decision, you will need to know what the study is about, the possible risks and benefits of being in this study, and what you will have to do in this study. The research team is going to talk to you about the research study, and they will give you this consent form to read. You may also decide to discuss it with your family, friends, or family doctor. You may find some of the medical language difficult to understand. Please ask the study doctor and/or the research team about this form. If you decide to participate, you will be asked to sign this form. What is the purpose of this research study? A concise explanation of the purpose of the research, incorporating any intent to assess safety +/- efficacy A Clarification that the drug/device is investigational. Can note that the drug/device is approved for another indication if applicable, but must clarify that the use of the drug/device in this study is experimental. How long will I be in the stud