ABOUT PRECISION MEDICINE

If you decide to join CUPMI, we will collect relevant data such as lifestyle, health, and genetic information about you. We will gather some information from you directly when you register for the study, through study surveys, and some data from elsewhere. Data we will gather about you:

• Basic data. We will ask you for data like your name, date of birth, phone number, and email: This information will be requested as part of setting up a CUPMI Participant Portal account managed by Rymedi, a technology partner working with Clemson University on this study. When creating the Participant Portal account, you will be asked to consent to Rymedi’s Terms and Conditions.
• Health data. We will ask you questions about your health, family, and lifestyle through surveys. This will take about 15-30 minutes. You do not have to answer any question you do not want to answer.
• Saliva sample. We will ask you to give a saliva sample. We will collect 2 ml of saliva (less than one half teaspoon) by having you “spit” in a tube. The location of where your sample is collected will be recorded. The location information is only stored on Rymedi’s platform and will not be shared with researchers analyzing the samples.
• Electronic health record (EHR). We will ask permission to get information from your electronic health record; you can decide yes or no. You can say no and still take part in the study.
  
  There will be a Health Insurance Portability and Accountability Act (HIPAA) authorization form for you to sign if you decide to give us permission to request this information from your EHR. The HIPAA authorization form includes the type of information that will be shared from your EHR.

• Other data. We will add data from other sources to the information you give us (for example, environmental data). This will give researchers more data about factors that might affect your health. We will add other publicly available data about your area based on the nature of your work (for example, office or manual labor) and the school district and county you live in. For example, we may add data about the number of people in the area where you live, pollution data, and distance to the nearest grocery store or park.

This research includes data about your genes. Genes are made of DNA (deoxyribonucleic acid), which contains the instructions for your body’s development and function. This DNA information determines traits that are passed on from parent to child, such as eye and hair color and the risk/chance you will get certain diseases.

We all share more than 99.9% of our DNA with each other. The other 0.1% is what makes us different. DNA can tell us the genetics that makes us unique. Things like our hair color and eye color depend on the bits of our DNA that are different between human beings. We know what some DNA differences mean, but we still have a lot to learn. For example, we are still learning what role DNA plays in most health conditions. But for a small number of things, we already know a lot about the role DNA plays.

We know that certain differences in our DNA can affect our health. For example, certain differences in our DNA can:

• Increase our risk for some health conditions. This could include some cancers and types of heart disease.
• Increase the risk of passing specific health conditions on to our children, even if we don’t have those conditions.
• Impact how specific medicines work.

We also know that other differences in our DNA can tell us about things like:

• Where our ancestors may be from.
• How our bodies work.

The more we study our DNA, the more we will learn what DNA differences mean to us. But what truly makes us unique is not just our DNA but also the environment we live in and our health history.

A team of scientists will use your saliva sample to conduct a whole genome sequencing test, which looks at almost all your DNA.

We will store your data securely, along with the data from all other participants who take part in CUPMI. Saliva samples will be stored temporarily until they are analyzed and then they will be safely discarded. Saliva samples will not be stored for long-term use. Researchers will use the data to make discoveries about how genes and environment affect health long into the future. There is no limit on the length of time we will store your data, except if you withdraw (“quit”), or there are limits imposed by law.

Protecting your identity is a top priority for us. Your identity will remain confidential. We have designed the process with this in mind. Here are a few of the steps we will take:

• We are working with Rymedi to ensure all identifiable participant information is stored in a HIPAA compliant database. Information shared between Self Regional Healthcare and the Clemson University study team will be encrypted and transferred via secure file transfer protocol.
• A limited number of study team members will have access to identifiable information.
• Researchers conducting data analysis will only have access to de-identified information and will not attempt to re-identify in any capacity the information pertaining to any participant. Data obtained during this study will not be available to any other researchers.

The main risk of participating is in the event of a data breach. A data breach is when someone sees or uses data without permission. If there is a data breach, someone could see or use data about you. Even without your name, there is a chance someone could figure out who you are. They could misuse your data. However, we believe the chance of this happening is very small, but it is not zero. In the rare situation of a data breach, we will notify participants immediately.

Researchers will use basic facts like your ancestry, age, and sex in their studies. These data help researchers learn if the things that affect health are the same in different groups of people. These studies could one day help people of the same ancestry, age, or sex as you. However, there is a risk that others could use these data to support negative ideas about groups.

Taking part in CUPMI may have risks that we don’t know about yet. We will tell you if we learn anything that might change your decision to take part.

CUPMI is a research program. You will not get direct medical benefits from participating in this study. You will not benefit personally from giving a saliva sample for this project because this kind of research usually takes a long time to produce medically useful results.

That said, you may indirectly benefit from participating in CUPMI. For example, you may access results about where your ancestors may be from and results about the study.

In the long-term, if the study expands, researchers will be able to use the data from this study in future studies. They will look for patterns to learn more about what affects people’s health, leading them to discoveries or solutions that prevent diseases, such as cancer, heart disease, and diabetes, and improve the health of individuals and families. You will be helping researchers make discoveries that may help future generations live happier and healthier lives.

There are no direct costs to taking part in the CUPMI proof of concept/pilot study. We will not bill your insurance or charge you for running any tests on your saliva samples.

Participants will receive a one-time $25 gift card for participating in the study upon completion of enrollment surveys and saliva collection.

Your data will be used by researchers to make discoveries. If any of their studies lead to new tests, drugs, or other commercial products, you will not receive any profits. These inventions will be the property of the researchers who develop them.

1. We may tell you if there are results about you. You will be able to choose if you want to see these results.

• Ancestry related results. These results will capture your genetic ancestry. A genetic ancestry report will show where your ancestors lived. You will have a choice to tell us if you would like to receive ancestry results.
• DNA related results. You will not receive DNA results for this proof of concept/pilot study. However, if the study expands, there are plans for providing DNA results in future efforts, and you will have the opportunity to tell us now if you would like to be recontacted to decide later about receiving your DNA results.

2. We will share information researchers learn about health from studying data from people in CUPMI study. You will be able to access this information, as well as general news and updates about CUPMI via the CUPMI Participant Portal at precisionmedicine.clemson.edu.

Taking part in CUPMI is voluntary. You can choose to join or not. No matter what you decide, now or in the future, it will not affect your medical care or insurance benefits.

If you decide to join CUPMI, you can change your mind at any time. If you decide you want to withdraw (quit), you need to tell us. You can tell us through the CUPMI Participant Portal.

 If you withdraw from the study, all your information including contact information, EHR, DNA, health, and lifestyle data will be deleted and will not be part of the CUPMI database going forward.

SRH employees: Any information that is shared as part of this research will not impact your continued employment or impact any assessment or employee performance evaluation.

If you have questions or concerns about the CUPMI research study, please email the study team at cupmistudy@clemson.edu or visit the website at www.precisionmedicine.clemson.edu for additional information.

If you have questions about your rights in this research study, please contact the Clemson University Office of Research Compliance (ORC) at 864-656-0636 or via email at irb@clemson.edu. The Clemson Institutional Review Board (IRB) will not be able to answer some study-specific questions. However, you may contact the Clemson IRB if the research staff cannot be reached or if you wish to speak with someone other than the research staff.