[Schulman ICs are prepared in font size 12] INFORMED CONSENT TITLE: PROTOCOL NO.: SPONSOR: INVESTIGATOR: SITE ADDRESS: 24 HR. TELEPHONE #: INTRODUCTION Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the proposed research study. This consent document describes the purpose, procedures, benefits, risks, discomforts and precautions of the study. It also describes the alternative procedures that are available to you and your right to withdraw from the study at any time. No guarantees or assurances can be made as to the results of the study. If you are not completely truthful with your Investigator regarding your health history, you may harm yourself by participating in this study. BACKGROUND AND PURPOSE You are being asked to participate in this research study because you have [disease/condition]. In lay terminology, describe relevant background information and rationale for conducting this study. The purpose of this research study is to: test the safety and effectiveness of the study drug, [drug name]. insert protocol objectives in lay terminology [Include the investigational aspect. For example, if not a marketed product: This is a research study to test a new investigational drug. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). If marketed product: This study drug may be available by prescription for [state indication]. If marketed product, but an investigational use for the study: The use of [drug name] in this study is investigational. An investigational use is one that is trial
procedures you undergo while in the study) and record it on study documents. The Investigator will keep this personal health information in your study-related records (that we will refer to as "your study records"). In addition, the Investigator may obtain, and include in your records, information regarding your past, present and/or future physical or mental health and/or condition. Your Investigator may ask you to sign a separate authorization to obtain some or all of your medical records from your doctor. Your study records may include other personal information (such as social security number, medical record numbers, date of birth, etc.), which could be used to identify you. Health information that could identify you is called "Protected Health Information" (or "PHI"). [Please note: You must list any other PHI that may be used or disclosed.] Under federal law (the "Privacy Rule"), your PHI that is created or obtained during this research study cannot be "used" to conduct the research or "disclosed" (given to anyone) for research purposes without your permission. This permission is called an "Authorization". Therefore, you may not participate in this study unless you give your permission to use and disclose your PHI by signing this Authorization. By signing, you are agreeing to allow the Investigator] and staff to use your PHI to conduct this study. [Please note: This document must be study-specific. You must list any other uses of PHI by the Investigator that are specific to your study.] By signing this Authorization, you also are agreeing to the Investigator to disclose PHI as described below: The sponsor of this study and anyone working on behalf of the sponsor to conduct this study (referred to as "the sponsor"). The sponsor will analyze and evaluate the PHI and may use it to develop new tests, procedures and commercial products. The study staff will assign a code number and/or letters to your records, which means that you will not ordinarily be identified in the records sent to the sponsor. The sponsor may, however, look at your complete study records that identify you. In addition, the sponsor may visit the study site to oversee the way the study is being conducted and may review your PHI during these visits to make sure the information is correct. The Institutional Review Board ("IRB") may have access to your PHI in relation to its responsibilities as an Institutional Review Board. [Please note: You must list other persons or classes of persons,