1.1 Goal 1 Telephone Screening Script

Attachment 1b Goal 1 Telephone Screening Script OMB #: 0925-0647

Expiration Date: 01/31/2015

Telephone Screening Script

Incoming caller:

Center for Interdisciplinary Salivary Bioscience, my name is __________________, how may I help you? OR: calling someone back who has left a message:

My name is ________________, and I am a project coordinator at the Center for Interdisciplinary Salivary Bioscience. I am calling because you expressed an interest in our study titled “Evaluating the potential of saliva as a research specimen for use in the National Children's Study” by voice or email. Is now a good time to talk?

The project is a component of a much larger study that will focus on maternal and child health. The project is focused on learning more about the types of measurements that can be made using saliva, with the idea that if we can learn enough from saliva that the mothers and children in the larger project may not have to give blood samples as often. That would increase the chances that mothers and children will participate in that project. The study director is Dr. Douglas A. Granger of the JHU Schools of Medicine, Nursing, and Public Health

We will be collecting information about you during this phone call. Your taking part in this phone call is completely voluntary.

Your information will only be seen by researchers at Johns Hopkins. We try to make sure that the information we collect from you is kept private and used only for the research study we are discussing. If you do not agree to continue the phone call, it will not affect your care at Johns Hopkins, nor will your private health information be kept if you are not enrolled in the study.

May I ask you a few questions to see if you are qualified for this study?

If no, then thank them for their time and end the conversation politely.

If yes, then continue with the following:

To be included in the study, you need to be between the ages of 18 and 35 years old. Is this true for you?

If no, then thank them for their time and end the conversation politely. If yes, continue:

If you are currently taking prescription medications other than birth control, you are not able to participate. For females: If you are pregnant you are also not able to participate. Are any of these conditions true for you?

If yes, then thank them for their time and end the conservation politely.

If no, then continue with the following:

I’d like to give you some additional details. Your involvement would be one-time only. It would involve a one-hour visit to _________________clinic on the Johns Hopkins Medical Institutes Campus. At the clinic you will complete the project consent form, and you’ll be asked to answer a short questionnaire that will take you less than 15 minutes, and to donate saliva, blood, and urine. It is important that you do not consume milk or dairy products for at least 20 minutes prior to the visit. No major meals should be consumed for at least 1 hour prior to the visit. You must not brush your teeth within the 45 minutes prior to the visit. It is advisable for you to drink plain water prior to the visit in order to be able to donate a sufficient amount of saliva and urine.

Upon arriving, you will be given a chance to review and sign the consent form and to ask any questions you may have. Next, you will answer the questionnaire. The questionnaire asks questions about your behavior and health. The questions focus on issues that might influence your saliva sample.

Next, saliva will be collected by asking you to gently force the saliva pooling in your mouth thru a straw into a tube. We will ask you to donate 1 tablespoon of saliva. This may take 10-15 minutes.

Then, in a private restroom, we will ask you to void urine into a collection container. This will take about 3-5 minutes.

Lastly, a professional will collect approximately 2 tablespoons of blood using procedures just like those that would be used in your doctor’s office. This procedure involves venipuncture which can be associated with slight discomfort as a thin needle is inserted into a vein in your arm. The process typically takes 5 minutes.

To thank you for your time, you will receive a total of $50.00 for completing this study at the conclusion of your visit. You may receive partial payment if you decide to stop your participation in the project before completing all of the steps.

There is no cost associated with participating in this study, but you will need to have transportation to and from the Johns Hopkins Medical Institutes Campus. Your samples will be de-identified; therefore data from the samples will not be available to you.

Do you have any questions?

If yes, address questions, if no, then continue with:

Do you think you would like to take part in this research? If no, thank them for their time and end the call politely.

If yes, schedule an appointment to clinic and give directions. Contact for additional information about the study itself: Anjali Sivan, 443-287-4581.

Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0647*). Do not return the completed form to this address.