FREQUENTLY ASKED QUESTIONS

The 10,000 Families Study is looking at the influences of genetics, lifestyle, and environment on health and illness.  Family studies help us understand health across the lifespan and transmission of risk and protective factors from one generation to another, as well as differences within families and across communities.

Only by knowing what causes or protects against disease can public health and healthcare professionals take action to best prevent diseases from harming people and to improve quality of life. Further, we want to do a study that is focused on Minnesota: people from every part of the state, including its large rural and immigrant populations.

The 10,000 Families Study provides an opportunity to gather information that can be used to develop better advice on how to live a healthy life and to guide policies to promote health and reduce illness.

10KFS is based at the University of Minnesota. A team of experienced researchers from the School of Public Health and Medical School are leading it, along with multiple staff and volunteers. The researchers are experts in things like epidemiology (the study of disease and health patterns, causes, and control), genetics, biostatistics, and laboratory medicine. 

We currently receive funding from the National Cancer Institute and the University of Minnesota Masonic Cancer Center, Medical School, and School of Public Health.

We had the idea and started to put together the study in late 2017.  The study should run for many years to see what health conditions emerge and who stays healthy over time. Families can participate for as long as they choose. The longer they stay with us, the more we learn for healthcare and public health.

• Anyone of any age (children under age 18 are enrolled by their parent or guardian).
• Adults who understand what participation involves and are able to make an informed decision.
• Minimum of two people per family to enroll. The more the merrier! 
• The person who starts the enrollment process for the family needs to live in Minnesota, but other family members can live in North Dakota, Iowa, South Dakota, or Wisconsin.
• Adoptive and step-relatives and spouses and partners are welcome!
• We never ask about legal status, and we do not ask for social security number. 

There is no requirement about health - Participants can be in perfect health, suffer from any disease or condition, be in recovery from, or be a survivor of an illness. 

There is no requirement about health insurance - Participation in the study does not have any cost. The study does not provide care or treatment of any kind either.

We ask participants to give about 2.5 hours of their time:
• to complete an initial online health questionnaire and consent & HIPAA forms (1 hr)
• to take part in a health visit for physical measurements and samples (1.5 hrs)
Note: Some additional time to send-in wristband and set-up+send-in radon test.

About every two years, we will invite you to give us a brief update on your health status.  You can withdraw from the Study at any time. Please refer to the question “How will you contact me and how often?” for details on future contact.

Our main way of communication is via email--though we occasionally reach-out by phone or text. If you are the person to start the participation process for your family, you will receive email messages asking you to invite other family members. You will receive email requests to fill out the online health questionnaire and to register for the Health Visit for yourself and any children you have under age 18.

About every two years, we will invite you to give us a brief update on your health status, and later we will follow-up for health measurements in a Health Visit or by mail. You also will receive study news and updates.

• All personal information is protected on the University’s secure servers.
• The National Institutes of Health has granted a Certificate of Confidentiality (CoC) to legally protect participants' personal information. Learn more about the Certificate of Confidentiality at CoC.
• Biological samples are stored in a secure laboratory at the University.
  • This includes any blood, saliva, urine, stool, hair and nail clippings. 
• Investigators and staff are trained in confidentiality, privacy protections, and research ethics. Only the study team can see your confidential information. 
• The University of Minnesota Institutional Review Board (IRB) monitors and approves all processes and changes to the 10,000 Families Study. 
• The IRB exists to ensure adequate protection of research participants.
• Any data and information we share with other researchers or laboratories will not include information that can be used to identify you and will be combined with data gathered from other participants.
• It is your choice whether to allow the release of your results (or your child’s) to your health provider and/or other third party (does not include genetic tests). You can indicate your choice on the consent form (or on the parental consent form for a child under age 18).

For more detailed information about privacy and rights, read the Consent, Assent and other Privacy documents

A consent form is a legal document that includes essential information about the research study. It allows you, the participant, to make an informed decision before joining the study. The consent form describes what information and samples you will be asked to provide. It also explains how your data will be used by the research team, who will have access to the data, and how the study works to maintain your privacy. The consent form also describes the risks associated with participation. 

You must complete the consent form to participate in the study. By signing the consent form, you are confirming that you understand what is required for participation in the study, along with the risks of participation. Each participant must complete a consent form. A parent or guardian must complete the form for any child under 18.

Consent, Assent, and other privacy documents.

We have two different initial health questionnaires:
• one for adults, and
• one for children under the age of 18.

They mainly cover four areas: health habits, personal and family health including health history, environmental exposures including residential history, and daily life. The study’s initial health questionnaire collects in-depth information. The adult questionnaire takes an average of 45 minutes, while a child’s questionnaire takes about 30 minutes for the parent or guardian to complete. The questionnaire to update two years later is much shorter (about 15 minutes)!

Yes, you can. You will receive  a code to return to your questionnaire as many times as necessary until you are able to complete it. If you cannot find your code, please email us at  [email protected] or call (612) 301-2726, and we will provide it.

We need you to fill out one initial questionnaire when you begin your participation in the study.  About every two years we will ask you for updated information to learn about any changes. For example, we will ask you about your current health, new family members, etc.

We aim to make health visits as convenient as possible for people to participate. Visits are held at The Advanced Diagnostic and Research Laboratory, part of The University of Minnesota's Twin Cities campus. Visits are typically held on Fridays and Saturdays. There is free, convenient parking on-site and nearby access to the light rail. For participants in South-East Minnesota, we also offer health visits at the Hormel Institute.

When you sign-up for a health visit we will ask if you/your family will need free passes for public transportation, or other accommodations.

We also offer mobile health visits. If you have a mobile visit, a kit will be mailed to you directly and a phlebotomist will visit you/your family to conduct the visit. Currently, this option is available for participants who live more than 40 miles from the Twin Cities, but we hope to offer this option for everyone, regardless of location in the future.

Although genetic testing is planned, we have not yet started it. Our genetic profiles and sequencing may reveal something about your ancestry, but we are mainly looking at genes related to health conditions.

Measurements and Sample collection Info-graphic:
We measure height, weight, waist, hip circumference, blood pressure, and pulse, and ask people to give samples of saliva or blood, and urine, at the health visit (See Sample collection Info-graphic for detailed information). 
These samples allow us to run common tests and to test for environmental exposures, and later in the study we will do genetic testing.

We give people the following to do at home after the health visit:
• A stool sample kit (not required for mobile visits)
• A wristband to wear for 7 days to detect chemical exposure
• A radon test kit (mailed in winter, which is the best time of the year to do the test)

• Receiving results from some testing done at the health visit and some environmental tests, when available
• As a participant you are helping make sure that study findings reflect and benefit the whole community, and you are also contributing to science!

• $30 e-gift card - awarded after you complete your health visit:
  • $15 credited for completing the questionnaire (adult or child)
  • $15 credited for completing the health visit (adult or child)
• $5 e-gift card - after returning your wristband
• $5 e-gift card - for sending back your home radon test (One per household only)

The study does not provide healthcare for any health condition participants have or that we identify during normal study activities. However, we recommend that you take any abnormal results we find to your healthcare provider. If you do not have a healthcare provider we can give you recommendations of healthcare resources in the community.

You will receive results of your radon test.  Also, we will send you some results of your physical measurements.

Genetic testing hasn’t begun yet. You might choose to receive genetic test results that show increased risk for a serious health condition for you or your child under age 18. However, we will only give you this information if there are steps that you can take to keep this condition from happening. These types of conditions are very uncommon in the population. The option to receive those results can be found on the consent form. 

Here is a link to the Consent, Assent, and privacy documents

We will share study updates, as well as related health news from other sources. That information will be shared through our newsletter, videos, articles, and other ways. We are committed to sharing study findings in collaboration with our partner organizations and supporters. Our goal is to discover and share information that improves health across communities.

We gather information on participants’ race, ethnicity, and national origin in our eligibility screener and our online questionnaire. People can choose more than one option or mixed race/ethnicity. We will report a summary of our Study demographics, but never report individuals’ or families’ information.

We know some communities have been harmed by health research in the past. We are building relationships with community leaders, with whom we will work to create a statement of ethics that reflects our commitment to avoid repeating those harms. We are and will continue to seek community guidance in our study processes and future sharing of results.

We want to hear ideas and thoughts about our study, news we share, what we are doing right, and what we could do better.

You can fill-out our online contact form, email us at [email protected], or call us at 612-301-2726. You can talk with our 10KFS team at health visits, events or elsewhere. Feel free to speak-up! Your opinion is important to us!

This research has been reviewed and approved by an IRB within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants’ Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to z.umn.edu/participants.