Routing for UAS619

mainintro
You are invited to participate in this important research study because you are a member of the Understanding America Study. We encourage UAS members of all ages, in varying health, from all across the country to participate, to ensure broad representation.
keyinfo1
1. What is this study about?

The goal of this project is to contribute valuable insights into what factors influence your life. For example, how and why health, happiness, cognitive decline, social, and economic factors vary between people and over one’s life. If you decide to participate, you will be asked to provide a saliva sample for analysis. Saliva samples contain cells, which in turn contain DNA. DNA serves as the 'instruction book' for the cells that make up our bodies.

Information based on the DNA extracted from your saliva can assist researchers in exploring the connections between genes and other things we’ve asked about in the surveys such as health and behaviors.

Taking part in this project is voluntary. There are no direct benefits to you from participating in this project in the Understanding America Study. You can continue to take UAS surveys whether or not you decide to participate.

The project is sponsored by the National Institutes of Health (NIH).
Group of questions presented on the same screen
keyinfo2
2. What am I being asked to do?

You will be sent a collection kit to gather a saliva sample in the privacy of your own home. Instructions will be included to guide you through the collection process. You will seal and package the sample, and then use a supplied pre-paid envelope to anonymously send the sample to a lab at the University of Michigan for processing. Providing the sample will take only about three minutes of your time.
keyinfo3
3. Do I have to participate?

Your involvement in this project is entirely voluntary. You do not have to participate, and you can stop at any time. Declining to participate will not affect your standing in the Understanding America Study.
keyinfo4
4. Are there any risks?

There are no known risks in providing samples of DNA data for genetic analysis. There are some perceived risks associated with providing DNA, related to confidentiality. Researchers using the data may be able to identify groups you belong to (like an ethnic or racial group or whether you are part of a population that might have a higher risk for a particular disease).

We explain next how we will follow strict data protection protocols and other protections that are designed to address those risks and to maintain your confidentiality.
End of group of questions
Group of questions presented on the same screen
keyinfo5
5. What are the benefits?

There are no direct benefits to you for participating but your contribution will help researchers learn more about factors that affect, for example, health, happiness, cognitive decline, social, and economic factors. In this way, others may benefit from the knowledge gained from this study.
keyinfo6
6. Is everything about me kept confidential?

Preserving your privacy and the confidentiality of the sample you provide is of the highest concern to us. The study will never release or share your sample, or your genomic data, in any way that links it to your identity.

The sample and the genetic data will be tagged with a sample number, that is different from your UAS ID. This sample number is all that is used to identify your sample. The UAS will not share the link between the sample number and your name or your UAS ID with anyone. Only UAS staff will correspond with you about the project.
keyinfo7
7. How will my sample, and information from my sample, be used?

Saliva samples will be processed at the University of Michigan. DNA will be extracted from the saliva and stored in a repository for future analysis. We may use the saliva collected for this study for whole genome sequencing which involves mapping all of your DNA.

The extracted DNA will be sent to a laboratory to create digital versions of the data which can then be combined with other UAS data (from surveys or other UAS projects) that you have provided for research. Researchers using the combined data will not have access to any names or identities, and will not be able to identify you.

Data will be shared with the research community. The digital data from your sample may also be placed in a national database called a “repository” maintained by the National Institutes of Health (NIH). No names or other identifiers are included anywhere in this repository. The database contains genomic data collected from studies around the country. Researchers approved to use the database agree to requirements and legal restrictions designed to protect your privacy and confidentiality.

Your saliva sample is collected for research purposes only and will not be used for profit. Your individual results will not be shared with you.
End of group of questions
Group of questions presented on the same screen
keyinfo8
8. Are there any special protections for confidentiality?

In addition to everything else we do to protect your privacy, the UAS holds a Certificate of Confidentiality from the National Institutes of Health that provides additional protection of your identity. This Certificate allows the UAS to refuse to share your data in the unlikely event of a lawsuit that asks us to reveal your identity. The Certificate cannot be used to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. More information about Certificates of Confidentiality and the protections they provide is available at: https://grants.nih.gov/policy/humansubjects/coc.htm.

A concern some people have about genetic research is that it might lead to discrimination in employment or health insurance against some groups who are found to have a higher average risk of certain health conditions. The Genetic Information Nondiscrimination Act of 2008 (GINA) provides protections against discriminatory health coverage or employment practices that could arise from findings on populations, groups and communities represented in the data.
keyinfo9
9. Will I be paid for participating?

You will receive $50 in appreciation for your participation when you mail your sample to the lab in the envelope we provide and after it is received at the laboratory.
keyinfo10
10. What if I change my mind?

You can consent to participate in this study today and then change your mind later. When we send you the kit, you have the choice whether or not to send your sample to the laboratory. After you send your sample, you can still change your mind. Simply contact the UAS help desk and let them know that you want to have your saliva sample and digital genetic data withdrawn from the study. You will be notified when the sample has been removed and destroyed. Any statistical information about your sample that has been included in the study or that has been deposited in a controlled‐access national database prior to your request for removal cannot be withdrawn. However, no new data will be created.
keyinfo11
11. Alternatives

The only alternative to agreeing to participate is to not participate in this study. Whatever you decide, your status as a valued member of the Understanding America Study will not change.
End of group of questions
keyinfo12
12. Who do I contact with questions about the study?

If you decide to participate, we will provide you with a study information sheet that includes the information you have just read, and the contact information below.

If you have questions, concerns, or complaints about the study, or if you choose to withdraw after you have decided to participate, contact the UAS helpdesk by phone (855) 872-8673 or by email (uashelp@usc.edu).

This research has been reviewed and approved by the BRANY Institutional Review Board (IRB). The IRB is a research review board that reviews and monitors research studies to protect the rights and welfare of research participants. Contact the IRB if you have questions about your rights as a research participant or if you have complaints about the research. You may contact the IRB at 516-318-6877.
if sizeof(whyrefused_order) = 0 then
whyrefused_order := shuffleArray(array(1 => 1, 2 => 2, 3 => 3, 4 => 4, 5 => 5))
whyrefused_order[6] := 6
End of if
consent := empty
refused := empty
consent1 (initial consent)
Now that you have read about the study, please answer the question below.

I have read and understood the information about this study and:
1 I agree to participate in the study
2 I do not agree to participate in the study
3 I have more questions before I can decide
if consent1 = 1 then
consent := 1
elseif consent1 = 2 then
consent := 2
refused := 1
Group of questions presented on the same screen
whyrefused (why refused)
We understand and respect that you have your own reasons for not wanting to participate, and are hoping you will share those with us. Help us learn! Check all that apply, and add your own if needed.
1 No reason, I just don't want to do it
2 It will take too much time
3 It will be too much trouble
4 It doesn't pay enough
5 I am concerned about risks to my privacy
6 Some other reason (write in):
whyrefused_other (other why refused)
STRING
End of group of questions
el_exit3
Thank you for taking the time to read about our new study and for being a part of the Understanding America Study! We will let you know when there are more UAS surveys ready for you to take.

Click "Next" to return to your panel member pages.
dummy := addToGenotyping(consent)
Exit the survey
elseif consent1 = 3 then
moreinfo
Thank you for considering participating in our study! Here are some answers to frequently asked questions.

Q: What happens to my saliva sample?
Your sample will be mailed to a laboratory where the DNA will be extracted and stored in a freezer in a secure facility. A numeric identifier is placed on the sample so the lab cannot link your name to your individual sample.

When we analyze the sample we send a small portion of the DNA to a lab at Johns Hopkins University. There they put the DNA into a special machine that can read the genetic sequence. Currently, we are looking at parts of the DNA sequence to find patterns that are associated with health, health behaviors and cognitive functioning as well as patterns associated with healthy aging and long life.

Q: What happens to my DNA?
When we analyze the sample we send a small portion of the DNA to a lab at Johns Hopkins University. There they put the DNA in a special machine that can read the genetic sequence. Currently, we are looking at parts of the DNA sequence to find patterns that are associated with health, health behaviors and cognitive functioning as well as patterns associated with healthy aging and long life.

Q: What genetic markers are being extracted from saliva?
Currently, we are examining genetic markers across the entire stretch of your DNA sequence - in fact, we are measuring over 2 million markers! However, we are not testing for specific genetic-related diseases the way a doctor might do. We are helping to discover new relationships between genes and things like health, health behaviors and cognitive functioning.

Q: The consent mentions a "repository" maintained by the National Institutes of Health - What does that mean?
When we talk about a repository, we mean storage of electronic data derived from your DNA. Your actual DNA is not included. The electronic data create large files and require a lot of storage space. The National Institutes of Health (NIH) funds this project, and they also provide an efficient way to store and share the data we get from your sample. That way the data can be used by other approved scientists who are doing research on health and aging. This is called a “data repository”. No names or other identifiers are included anywhere in this repository. Scientists who receive permission from the NIH will be able to access the data from the repository. They will not have any way to connect that data with you.

Q: Will I receive my DNA results?
The results we obtain from this research do not provide information such as specific genetic-related diseases, the way a doctor might do. We are using the data to help discover new relationships between genes and things like health and behaviors. No results will be returned to you.

Q: What makes UAS's project different from other genetic studies? / What are some advantages of collecting DNA/biological data in a study like UAS?
We can connect your genetic/biological data with other data you have provided (including the answers you provide to surveys and other data collections) to better understand things health, health behaviors, and cognitive functioning.

Up until this point most of the genetic studies have been done in European-Americans only. We are working with other research groups to also understand health and aging in more groups of people such as African Americans and Hispanics.
consent2 (consent after further information)
Having read more about it, are you interested in participating in this study?
1 I agree to participate in the study
2 I do not agree to participate in the study
3 I have more questions before I can decide
if consent2 = 1 then
consent := 1
elseif consent2 = 2 then
consent := 2
refused := 1
Group of questions presented on the same screen
whyrefused (why refused)
We understand and respect that you have your own reasons for not wanting to participate, and are hoping you will share those with us. Help us learn! Check all that apply, and add your own if needed.
1 No reason, I just don't want to do it
2 It will take too much time
3 It will be too much trouble
4 It doesn't pay enough
5 I am concerned about risks to my privacy
6 Some other reason (write in):
whyrefused_other (other why refused)
STRING
End of group of questions
el_exit3
Thank you for taking the time to read about our new study and for being a part of the Understanding America Study! We will let you know when there are more UAS surveys ready for you to take.

Click "Next" to return to your panel member pages.
dummy := addToGenotyping(consent)
Exit the survey
elseif consent2 = 3 then
dummy := sendMoreInfo()
el_exit2
We will contact you as soon as possible to discuss the study and go over your questions.

Click "Next" to return to your panel member pages.
consent := 3
dummy := addToGenotyping(consent)
Exit the survey
End of if
End of if
if consent = 1 then
dummy := addToGenotyping(consent)
thanksagain
Thank you for agreeing to participate in this study! Within 24 hours you will receive a confirmation email that includes the study’s information sheet for you to keep.

Because the kit is shipped to your home address, please respond to the confirmation email to verify that we have your current address on file.

To update your address, click "Next" to return to your study page, click on the “Contact” tab at the top, then click the link to fill out the contact information form.

We will contact you when we are ready to ship the kit to your home.

Click "Next" to return to your study pages.
End of if
CS_003 (comments)
Do you have any other comments for us? Please type these in the box below. (If you have no comments, please click next to complete this survey.)

To protect your privacy, please do not write in any identifying information such as names or email addresses.

Thank you!
STRING