The study includes two levels—a telephone interview and an in-person visit with blood, urine, and saliva collection. At this time, we are only able to conduct in-person visits with participants who reside in California, Washington, and Oregon and about 1 in 4 of participants who are located in other states. You will be notified in the invitation letter we mailed to you if you have been identified as eligible for the telephone interview only or both the telephone interview and the in-person visit.
The telephone interview includes:
- A phone interview with the Survey Research Group. The phone call and interview will take about 45-60 minutes of your time, and will be scheduled at a time that is convenient for you. When we call you, our number will appear as Dept. Health from a 916 area code on your caller ID.
In recognition of the time you will be contributing to this research effort, you will receive $25.00 for completion of the phone interview.
If you are eligible, the in-person visit includes: An in-person visit with a female member of the 3Gs team. The examiner will be a certified phlebotomist (a person who is certified to draw blood) or licensed practical nurse. The visit can take place at your home or place of work (or other location that you choose) and it will take about 30 minutes of your time. During her visit, she will:
- Measure your blood pressure.
- Measure your height, weight, and waist circumference.
- Collect a blood, urine, and saliva sample.
If you have a daughter(s) nine years old or older, we will ask you to discuss with her about whether she would like to participate in the in-person visit with you by providing the same samples and measurements. Daughters over 18 will also be invited to participate in the in-person visit by providing the same samples and measurements, as well as a completing a health questionnaire. If she is interested in participating or if she'd like to learn more about it, study documents can be found here. If she is under the age of 18 we will ask her to provide her assent (her agreement) for participation in the study and we will need your consent for her to participate in the study. If she is age 18 or older you will not need to consent for her to be in the study, the choice will be up to her. Your daughter(s) can also choose to participate in all or just some of the in-person visit activities.
If you participate in the in-person visit, you will receive $50.00 for completion of the home visit, for a total of $75.00. If your daughter(s) participates in the in-person visit, each will also receive $50 for their participation. If your daughter also completes the questionnaire, she will receive an additional $25.
Please contact us with any questions, comments, or changes to your contact information.
The Three Generations Study and the Child Health and Development Studies do not offer any diagnosis or treatment for illnesses. If your blood samples are tested as part of this study, you will have the option of choosing to have the results of these tests sent to you. These results are not designed for medical use and the information you receive may not suggest any actions you can take to reduce your health risk. At this time, only blood is being tested as part of the 3Gs study. Other specimens collected as part of the study will be stored for future use. Study data is stored only with your assigned study ID number. Overall results from the study will be available through study newsletters, articles on the Child Health and Development Studies website, and reports in scientific publications.
We are working with the Survey Research Group at the Public Health Institute to carry out the telephone interview. The interview will include questions about your health and health behaviors. We will also ask about your family health history and family structure, menstrual and reproductive history, and your hormone usage. Other questions we will ask include questions about your employment status, demographic information, and number of children. We will also ask for the last 4 digits of your Social Security number to identify you in the future. Study data is stored only with your study ID number and will never be connected to your name or other identifying information.
The telephone call for the interview will take a total of about 45-60 minutes. In recognition of the time you will be giving to this research effort, you will receive $25.00 for completing the telephone interview.
- Why are you asking for information about my children?
We are asking for information about your children in order to invite them to be included in this or future studies that they may be eligible to participate in. The CHDS is unique because it looks at family members together in order to study risk factors for disease.
- Why are you asking for the last 4 digits of my Social Security number?
We ask for the last 4 digits of your Social Security number in order to confirm your identity in the future. You are not required to provide this information but it is very helpful to the study team. We understand that this is sensitive and we will not share this number with anyone and we will ensure that only necessary staff have access to this information. Please see our Privacy Practices page to learn more about how we protect your confidentiality.
- What do I do if I have a problem with or complaint about the Survey Research Group telephone interview?
If you have a problem or complaint about the SRG telephone interview, please contact the 3Gs study staff as soon as possible. Please tell us the problem and give the time and date of the interview. We will inform SRG of the problem or concern and take whatever follow-up actions are necessary. We appreciate hearing from you so we can address your concerns and prevent further problems for you and other participants.
We have chosen to use Examination Management Services, Inc. (EMSI) and ClinForce to do the in-person visits for us. Because the participants of the study live throughout California and even outside of California, we need to have a way to conduct the in-person visit wherever you are located. The examiner will be a female certified phlebotomist and can come to your home, work, or another location that is convenient for you. During her visit, the examiner will measure your blood pressure, height, weight, and waist circumference. She will also take 4 vials of your blood, ask you to urinate into a urine collection cup, and ask you to spit into a saliva collection tube. If you have daughters who will be participating, the examiner will collect the same samples and measurements. The visit will take approximately 30 minutes per person. If you participate in the in-person visit you will receive $50.00 for the completion of the visit. If your daughter(s) participates in the visit, each will also receive $50 for their participation.
- How will I know if I am chosen for the in-person visit?
You will be notified in the invitation letter whether you have been identified as eligible for the in-person visit.
- Why was I chosen (or not chosen) to be invited to participate in the in-person visit?
At this time, we are only able to conduct in-person visits with participants who reside in Califonia, Washington, and Oregon and about 1 in 4 of participants who are located in other states. You will be notified in the invitation letter whether you have been identified as eligible for the in-person visit.
- I have questions about the consent forms .
Please contact us with any questions you have about the consent forms. Please make sure that you understand the consent forms and have had all of your questions answered before the examiner comes to your home for the visit.
When the examiner comes to your home (or other designated place) she will review the consent forms with you and be sure that all of your questions are answered about the activities of the home visit before you sign the forms. You may keep a copy for your own records.
Please note, the Informed Consent Form must be signed before the examiner can begin the specimen collection and measurements, and she must take our copy with her when she leaves.
- What do I do if the examiner doesn't show up to the appointment or I forgot and was not home at the time of the appointment?
In either situation, please call the 3Gs team as soon as possible at 1-866- 986-8241.
- What if I'm not comfortable with someone coming to my home?
The person who visits your home will have gone through a rigorous background check before being allowed to make in-person visits. The person will show you identification when she comes to your door. If you would prefer, you can ask to schedule your visit at your place of employment, or another location. We are happy to schedule your exam at the location that is most convenient or comfortable for you.
- What should I do if I change my mind after I have already agreed to the in-person visit?
If you decide you do not want to complete the in-person visit after you have completed the telephone interview, please contact the 3Gs study staff at 1-866-986-8241.
- What do I do if I have a problem with or complaint about the visit?
If you have a problem or complaint about the visit please contact the 3Gs study staff as soon as possible. Please tell us the problem and give the location, time and date of the appointment. We will take whatever follow-up actions are necessary. We appreciate hearing from you so we can address your concerns and prevent further problems for you and other participants.
If you are selected and agree to participate in the in-person visit, we will ask you to provide blood, urine, and saliva samples necessary for scientists to look at biological factors related to your health. Please see our Privacy Practices page to learn more about how we protect your confidentiality. If you are selected and agree to participate in the home visit, we will ask you to provide blood, urine, and saliva samples necessary for scientists to look at biological factors related to your health. Please see our Privacy Practices page to learn more about how we protect your confidentiality.
- Why are you asking me (and my daughter(s)) to provide a blood sample?
The blood sample is necessary in order to test for things like environmental exposures to chemicals and hormone levels in the blood. We would also like to put a sample of your blood in storage for future tests for other potential causes of breast cancer and other diseases. With your permission, we will also store a sample of your DNA obtained from the blood sample. Your blood will not be tested for illegal drugs. While your answers to the questionnaire can give a good picture of your lifetime exposures, a blood sample gives a more accurate measure of what is going on in your body at the time of the interview. Often simply being exposed to a certain chemical may not mean someone has a higher risk of disease because each individual processes the chemical differently. A blood sample allows scientists to examine the differences between exposure and how the body reacts to that exposure.
- Why are you asking me (and my daughter(s)) to provide a sample of my DNA?
If you agree, we will store a sample of your DNA for future studies. Storing DNA will allow researchers to relate information about your inherited characteristics to other information you provided through questionnaires and blood, urine, and saliva tests. Your DNA will help future scientists determine how diseases are inherited or how your DNA may be affected by the environment to change the course of a disease. Because this is a study involving three generations, your DNA will provide an extraordinary opportunity to study these types of changes over the course of multiple generations. While we are not looking at DNA for this current study, we are asking to store your DNA for future studies because we are already asking for a sample of your blood for other purposes. We are not able to list all the studies that may involve the use of your DNA at this time, because they will depend on future research developments, such as funding or new information about genes and health.
Your DNA will not be stored with any information that may identify you in any way and will be kept in a locked, secure building. DNA information will be combined with information provided by other participants to identify risk factors and potential causes of disease. DNA information will not be used for personal identification and will not be communicated to anyone, including you. If funding becomes available for research involving DNA, DNA information will be used only for research studies that are carefully reviewed and approved by appropriate scientific review boards.
- Why are you asking me (and my daughter(s)) to provide a urine sample?
The urine sample will allow us to test for certain chemical exposures that are not captured in a blood sample. We will not test for illegal drugs.
- Why are you asking me (and my daughter(s)) to provide a saliva sample?
The saliva sample will allow us to test for certain chemical exposures that are not captured in blood and urine samples. Saliva samples also provide information about hormone levels at the time of sample collection. Additionally, the saliva sample will be used as an alternative source of DNA if we are not able to obtain a blood sample. We will not test for illegal drugs.
- Why will you store my samples?
Because of the long-term nature of collecting information over several generations, we can't know which tests will be important to do in the future. One of the strengths of our study is that we will have the stored the DNA, blood, urine, and saliva samples to take advantage of future advances in health research. This means we will be able to do tests that take advantage of new and important findings as they become available on all three generations.
- What Is Oragene?
Oragene is an at-home saliva collection kit we can use to collect a DNA sample. A special solution inside the collection tube stabilizes the saliva sample, allowing CHDS to collect, transport and store the saliva sample reliably at room temperature.
- Why Are You Asking Me To Complete Oragene?
Many of our participants live out of state. The Oragene kit allows these participants an opportunity to still take part in the biological sample collection portion of the 3Gs Study. Since we will not be conducting a blood draw, the purpose of Oragene is to provide a way to collect DNA through saliva that is stable at room temperature for collection, mailing and storage.
- How Do I Use The Oragene Kit?
The Oragene collection kit is a round shallow tube with a fixative solution inside the cap. You will allow saliva to collect in your mouth for 5-15 minutes without coughing or talking. The participant will spit into the tube until it is full, approximately 2 oz. Once the tube is capped, the seal on the cap breaks and the fixative mixes with their saliva. For detailed instructions on how to use Oragene, please see these instructions.
- Will I Be Compensated For Completing Oragene?
In recognition of your time and effort, you will be compensated $15 for completing the Oragene kit. If your daughter participates in Oragene collection, she will also be compensated $15.
- How Will The Sample Be Securely Mailed?
We are using the United States Postal Service to ship Oragene kits. Using USPS makes this process convenient by allowing you to simply drop the return kit in your mailbox. The kit will be labeled with your study ID and no other identifying information. The consent form will be mailed in the same package but separate from the saliva kit. The outer packaging does not indicate biological specimens are inside and has our address for both return and delivery address, ensuring it will arrive at our office.