Eating 3 Meals

Attachment 9: Study Information Letter – Observational Feeding Study

NCI Feeding Study

Appointment Reminder Mailing

Dear (Personalized Salutation):

Thank you for agreeing to take part in the NCI Feeding Study. This study is sponsored by the National Cancer Institute. The goal of this study is to improve the methods to collect food intake information from individuals. This in turn will help scientists to understand the relationships between the foods we eat and our health, and to develop policies and programs for better health.

You are asked to come to Westat, our research facility, to eat breakfast, lunch, and dinner on [Day, MM/DD/YYYY], and to complete an interview on the very next day (Day, MM/DD) about your diet and health. We have enclosed directions to Westat in Rockville.

Joining this study is voluntary. You have the right to refuse to be in the study. If you agree to be in the study, you can refuse to answer any questions asked at any time. All of you responses will be kept confidential. Your answers will be combined with answers from other individuals to make totals and averages, in which no person or family can be identified.

We have included an information sheet with frequently asked questions, which may answer some of your questions. If you have any other questions about the study, please ask your interviewer, or call Westat at 800/xxx-xxxx and ask for _________________, the project supervisor. ___________ works for Westat, a research organization assisting with this study.

Thank you for helping with this important study.

Sincerely,

DIRECTIONS TO WESTAT

1650 Research Blvd.
Rockville, MD 20850
(301) 251-1500

We will meet you in the lobby of the Main Reception building 10-15 minutes prior to your scheduled interview time.

To Westat’s Main Research campus:

Take I-270 North 8 miles from the Capital Beltway to exit 6B - Route 28 (toward Darnestown).

The third light is Research Boulevard. This is just after the hotel and just before the Citibank. Turn right.

To get to Westat’s main research campus location, go less than 1/4 mile and you will see a WESTAT sign in blue on the left at the traffic light. Enter there. [The main campus is just past the Westat Telephone Research Center and just before West Gude Drive.]

Enter the parking lot—you may either go straight ahead or make a right, wherever there are spots. You may park in any unmarked spot. The Main Reception Building has a small awning and is to your right as you enter the lot. Please tell the receptionist that you are here for an interview and give your contact’s name and cell number.

The name of your contact is

Phone number:

NCI Feeding Study

Frequently Asked Questions

Q: What is the project about?

A: Information about what Americans eat allows researchers and policy makers to develop programs and inform the public about ways to stay healthy. For this reason, it is important for them to be able to collect high quality information about what Americans are eating. This project will allow researchers to compare different ways to obtain food intake information from individuals.

Q: How will the study results be used?

A: The results of this study will allow researchers to compare different ways to collect food intake information and improve on these methods.

Q: How did you get my phone number and address?

A: You registered with EurekaFacts as someone interested in participating in scientific studies. Your telephone number and address are kept confidential and will not be given to anyone. If your number is unlisted, it will remain unlisted.

Q: Why should I take part in this study? Do I have to do this?

A: Your participation is voluntary, and you may refuse to answer any questions or withdraw from the study at any time. Your answers and opinions are very important to the success of this project, as you represent others who share your knowledge and beliefs.

Q: What information will be collected from me?

A: After you have agreed to participate in the project, you will come to our research facility to eat three meals, and then return the next day to answer questions about your meals and respond to a brief survey. The meals will take about 45 minutes each, and the second day visit will take about 45 minutes.

Q: Who will see my answers? Will my information be kept confidential?

A: No one will see your individual answers. Your responses will be immediately “de-identified.” That means they will be given a code number and will not include your name, phone number or any other personal information. All names and identifying information will be removed before data are sent to study sponsors. Your answers will be grouped with those of other people who take the survey. The survey data will not be shared with anyone outside the study. Reports of results will not include your name or any other information that could personally identify you.

Q: How will I benefit from participation in the project?

A: You will receive breakfast, lunch, and dinner one day, and you will receive $120.00 for your participation in the study.

Q: Will my insurance be affected?

A: No. If you have health insurance, your responses will not affect your health insurance coverage, premium costs, or relationship with your health insurance provider in any way. The study sponsors will not know who did or did not participate in the study or be able to connect individuals with their responses.

Q: Is this study approved by the Federal Government?

A: Yes, the study has been approved by an Institutional Review Board at the National Institutes of Health (NIH), which monitors the protection of privacy and rights of participants in NIH Studies. The study was also approved by the Office of Management and Budget (OMB), the office that reviews all federally-sponsored surveys.

Q: Who do I contact if I have questions?

A: If you have more questions, you may call the study sponsors at the telephone number provided in the enclosed letter. You may also call Westat toll-free at _______________ Monday-Friday 8:00 am-11:00 pm; Saturday 11:00 am-5:00 pm; Sunday 1:00-9:00 pm.

If you have questions about the study and wish to speak with someone other than the researchers, you are encouraged to call the human subjects’ protection contact person at the ____________________________.