Screening Subjects for Research

Charles Drew University of Medicine and Science Office for the Protection of Human Subjects

Pioneering in Institutional Review Board Health and Education

Consent Script to Determine Eligibility for the Research Study

[Insert title of the study]

Thank you for calling [insert name of research group or investigator] regarding [insert name of research].

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.

[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.]

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].

Your answers will be confidential. No one will know the answers except for the research team.

[Briefly describe for the subject what will be done with the screening information, e.g.,

(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?]

Would you like to continue with the [conversation/screening] to find out if you qualify for the study?

[If yes, continue with the screening].

Date of Preparation: CDU IRB#:

Rev. 4/09 Form 125 Page 2 of 2

INSERT SCREENING QUESTIONS WITHIN THIS SECTION.

[If no, thank the person and hang up].

[If yes, include the following at the end of the screening]:

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.]

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.

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.

Thank you again for your willingness to answer our questions.

Date of Preparation: CDU IRB#:

Rev. 4/09 Form 125