<p> Page 1 of 2</p><p>Charles Drew University of Medicine and Science Office for the Protection of Human Subjects</p><p>Pioneering in Institutional Review Board Health and Education</p><p>Consent Script to Determine Eligibility for the Research Study</p><p>[Insert title of the study]</p><p>Thank you for calling [insert name of research group or investigator] regarding [insert name of research].</p><p>I need to ask you a few questions in order to determine whether you may be eligible for the research. I will ask you about [provide examples, such as, your recent medical history]. Before I begin, I would like to tell you a little about the research.</p><p>[Briefly describe the research. For example: The research compares Drug X and placebo (sugar pill) for people with depression. If you are eligible, your participation in the research may last 6 months and may include monthly psychiatric evaluations, cognitive testing and weekly mood evaluations.]</p><p>Would you like to continue with the [conversation/screening] to find out if you can take part in the study? The [conversation/screening] will take about [estimate length of conversation/screening]. You may feel uncomfortable answering questions about your [provide examples, such as, medical history, personal life, etc.]. You do not have to answer any questions you do not wish to answer and you may stop at any time. Your participation in this [conversation/screening] is voluntary. A decision whether or not to participate in the [conversation/screening] will not affect your relationship with Charles Drew University of Medicine and Science (CDU). You will not directly benefit from taking part in the [conversation/screening].</p><p>Your answers will be confidential. No one will know the answers except for the research team.</p><p>[Briefly describe for the subject what will be done with the screening information, e.g.,</p><p>(a) If the subject does not qualify for the study: will the answers be destroyed, or kept with their name, etc.? (b) If the subject qualifies for an appointment: will the answers be kept with the research record if the subject decides to participate in the research project and sign the research informed consent form?]</p><p>Would you like to continue with the [conversation/screening] to find out if you qualify for the study?</p><p>[If yes, continue with the screening]. </p><p>Date of Preparation: CDU IRB#:</p><p>Rev. 4/09 Form 125 Page 2 of 2</p><p>INSERT SCREENING QUESTIONS WITHIN THIS SECTION.</p><p>[If no, thank the person and hang up].</p><p>[If yes, include the following at the end of the screening]:</p><p>Thank you for answering the screening questions. [Indicate whether the person is eligible, requires additional screening at the clinic, or is not eligible and explain why.]</p><p>Do you have any questions about the [conversation/screening] or research? I am going to give you a couple of telephone numbers to call if you have questions later. Do you have a pen? If you have questions about how the investigators decide whether you can take part in the study, you may call Dr. [insert name] and [s/he] will answer your questions.</p><p>If you have questions about your rights as a research subject, please call the Charles Drew University of Medicine and Science, Office for the Protection of Human Subjects, at (323) 563-5902.</p><p>Thank you again for your willingness to answer our questions.</p><p>Date of Preparation: CDU IRB#:</p><p>Rev. 4/09 Form 125</p>