All of Us Research Program Primary Consent Form

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June 20, 2018

Consent to Join the

All of Us Research Program

Principal Investigator: Joshua Denny, MS, MD

Vanderbilt University Medical Center

2525 West End Ave, Suite 1475

Nashville, TN 37203

Sponsor: National Institutes of Health

This form is for people age 18 or older.

This form tells about the All of Us Research Program (All of Us). It explains

what we will ask you to do if you join. Please read this form carefully. If you

have questions, there is a list of people you can ask at the end of this form.

We will give you a copy of this form if you want one.

What is All of Us?

All of Us is a health research program funded by the U.S. government. If

you join, we will gather data about you. We will combine it with data from

other people who join. Researchers will use this data for lots of studies. By

looking for patterns, researchers may learn more about what affects

people’s health.

We hope that 1 million people or more will join All of Us.

How long will All of Us last?

All of Us will last for at least ten years. If you decide to join, you can

withdraw (quit) at any time.

What will you ask me to do?

If you decide to join All of Us, we will gather data about you. We will gather

some of the data from you directly. We will gather some of the data from

elsewhere.

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Data that we will gather from you directly:

1. Basic data

We will ask you for data like your name and date of birth. Once a year

we will ask if you have moved, or changed your phone number or email

address. We will ask for the phone number or email address for a friend

or family member as a backup in case we need to reach you. We might

use social media or public listings to help us keep your contact

information up to date.

2. Health data

We will ask you questions about your health, family, home, and work.

This will take about 30-60 minutes. From time to time, we will ask you

follow-up questions about your health. We may ask the same question

more than one time, so we can see if there are any changes. You do not

have to answer any question you do not want to answer.

3. Physical measurements

We may ask you to go to a local clinic to be measured. If you are asked,

you can decide yes or no. You can say no and still take part in All of Us.

If you say yes to being measured, it will take about 15 minutes. All of Us

trained research staff will do the measurements. We will measure your

height, weight, hips, and waist. We will check your blood pressure and

heart rate. We may ask you to have other measurements over time.

4. Samples

We may ask you to go to a local clinic to give a blood sample. If you are

asked, you can decide yes or no. You can say no and still take part in All

of Us.

If you say yes to giving a sample, we will use a needle to draw about 3

tablespoons of blood from your arm. We may ask you to give a urine

sample (“pee in a cup”). We may ask for other samples, like saliva

(“spit”).

Researchers will study your samples. They may measure things that

naturally occur within our bodies, for example, cholesterol. They may

look for signs of outside factors that affect health. For example,

environmental toxins, medications, or drugs.

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Researchers may also want to study your DNA. DNA is in your blood

and other samples. Genes are made of DNA. Our hair color, eye color,

and risk for some diseases depend on our genes.

Genes are passed from parents to kids. Half of your genes came from

your mom and half came from your dad. If you have kids, each of them

will get half your genes. In this way, your genes also tell about your

family.

Researchers will use many methods to study your samples. Because All

of Us will last for ten or more years, some of the methods may not even

be invented yet.

We will store your blood, urine, and saliva samples in the All of Us

biobank. The biobank is a secure storage place for samples. We will

store your samples at the biobank until they are used up by researchers

for different studies. If your samples get used up, we may ask you to

give more. You can say yes or no.

What researchers learn from studying your samples will be added to the

All of Us databases.

5. Fitness trackers

If you have a fitness tracker (like one to count the steps you take in a

day), you might be able to share data from it with All of Us. If you don’t

have a fitness tracker, we may ask you to use one that we give you. You

can say no and still take part in All of Us.

Data that we will gather from elsewhere:

1. Electronic health records

If you have electronic health records, we may ask for access. If you are

asked, you can decide yes or no. You can say no and still take part in All

of Us, but it might limit what other data we ask to collect from you. For

example, if you say no, you might not be asked to give samples.

There will be a separate form called the HIPAA Authorization for you to

sign if you decide to give us access. We will see data about your health

problems, test results, medical procedures, images (such as X-rays),

and medicines you take. Health records can contain sensitive data. For

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example, they may tell us about your mental health, genetic conditions,

or use of alcohol or drugs. They may contain sexual or infection data,

including HIV status.

2. Data about your health from other sources

We will add data from other sources to the data you give us. For

example, environmental data and pharmacy records. This will give

researchers more data about factors that might affect your health.

There are two ways we will add data from other sources to your All of Us

record:

• Based on where you live and work

We will add data about your area based on where you live and work.

For example, we may add data about the number of people in your

area. We may add pollution data. We may add data like how close

you live to the nearest grocery store or park.

• Based on data that identifies you

We will use data that identifies you like your name and date of birth to

add data that is specific to you. For example, we may add data from

pharmacy records or health insurance records. If you have had

cancer, we may add data from cancer registries.

If you have a social security number, we may ask you for it to help

with adding data. It is optional. Even if we ask, you do not have to

give us your social security number. You can say no and still take

part in All of Us.

These other sources can contain sensitive data. For example, they may

tell us about your mental health, or use of alcohol or drugs. They may

contain sexual or infection data, including HIV status. Because of this,

we will ask the All of Us ethics committee to review and approve each

data source before we add it.

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What will you do with my data and samples?

We will store your data and samples securely, along with the data and

samples from all the other people who take part in All of Us. Researchers

will use the data and samples to make discoveries.

We will create a public database on the All of Us website. The data in the

public database will be about the group. It will not include data about

individual people. It will not include your name or other data that directly

identifies you. Everyone will be able to use the public database to make

discoveries.

We will also create a scientific database. The scientific database will have

individual-level data and samples. Access to this database will be

controlled. Researchers will have to be approved by All of Us to use this

database. These researchers may be from anywhere in the world. They

may work for commercial companies, like drug companies. They may be

citizen scientists. Citizen scientists are people who do science in their

spare time. Their research may be on nearly any topic. You can learn more

about the research being done at www.joinallofus.org.

Except if you withdraw (“quit”) or there are limits imposed by law, there is

no limit on the length of time we will store your samples and data.

Researchers will use your samples and data for research long into the

future.

What else will you ask me to do?

We may ask if you want to hear about chances to take part in other studies.

You can say yes or no to taking part in other studies. You can say no and

still take part in All of Us.

What are the risks of taking part in All of Us?

The main risk of taking part in All of Us is to your privacy. A data breach is

when someone sees or uses data without permission. If there is a data

breach, someone could see or use the data we have about you. Even

without your name, there is a chance someone could figure out who you

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are. They could misuse your data. We believe the chance of this is very

small, but it is not zero.

We will gather data from you through the All of Us app and/or website. You

may be asked to wear a fitness tracker. There is a risk to your privacy

whenever you use an app, website, or fitness tracker. In general, there is

no additional risk to your privacy if you use any of them as part of All of Us.

That said, we will be gathering many different types of data in your All of Us

record. If there is a data breach, there may be additional risk to your

privacy because of the amount of data in your All of Us record.

Researchers will use basic facts like your race, ethnic group, and sex in

their studies. This data helps 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 race, ethnic group, or sex as you. However,

there is a risk that others could use this data to support harmful ideas about

groups.

If you give a blood sample, the most common risks are brief pain and

bruising. Some people may become dizzy or feel faint. There is also a

small risk of infection.

Taking part in All of Us 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.

What will you do to protect my privacy?

Your privacy is very important to us. We will take great care to protect it.

Here are a few of the steps we will take:

• Data we have about you will be stored on protected computers. We

will limit and keep track of who can see this data.

• We will limit who is allowed to see information that could directly

identify you, like your name or social security number.

• In order to work with your health data researchers must sign a

contract stating they will not to try to find out who you are.

• We will tell you if there is a data breach.

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• All of Us has Certificates of Confidentiality from the U.S. government.

These will help us fight legal demands (such as a court order or a

request from federal, state, or local law enforcement) to give out

information that could identify you.

Will you ever give out my name or other information

that identifies me?

There are a few times when we might need to give out your name or other

information that identifies you.

• We will give out information about you to protect your health or the

health of others.

o If we learn or suspect that you are being abused.

o If we learn or suspect you are abusing, neglecting, or have

abandoned someone who depends on you for care, like a child

or dependent adult.

o If we learn that you plan to harm yourself or someone else.

o If we learn that you have a disease that is a risk to public

health, like measles.

• We will give out any data needed to meet U.S. research laws and

regulations. This may include information that identifies you.

Once your information is shared with All of Us, it may no longer be

protected by patient privacy rules (like HIPAA). However, it will still be

protected by other privacy rules. These include the rules that researchers

must follow to access the All of Us scientific database.

Are there any benefits?

All of Us is not medical treatment. It is a research program. You will not get

direct medical benefit from taking part in All of Us.

That said, you may indirectly benefit from taking part in All of Us. For

example, we will provide ways for you to get access to all the data you

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share with us and some of the results about you. This information may be

interesting to you. You may learn about your health. You will be able to

share your All of Us information with your healthcare provider if you

choose. You will have the option to learn about additional study

opportunities. Finally, you will be helping researchers make discoveries that

may help future generations.

Are there any costs?

There are no direct costs to taking part in the All of Us Research Program.

However, we will do various medical tests as part of this study. We will give

you the results. You can decide to seek follow up care on your own

because of these results. If you receive follow-up care, your doctor will bill

you or your insurance company per usual practice. If you do not have

insurance, or if your insurance will not pay, you will be responsible for the

cost of follow-up care.

Are there any payments?

If we ask you to be physically measured and give samples and you decide

to do it, we will offer you a one-time payment of $25.

Researchers will use your data to make discoveries. If any of their studies

lead to new tests, drugs, or other commercial products, you will not get any

profits. These inventions will be the property of the researchers who

develop them.

Will I be able to see my data?

Yes, you will be able to see some of the data we collect about you. This

includes:

• Any data you give us, like your health data.

• Your physical measurements.

• Some measurements from your samples.

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You will be able to share this data if you choose. For example, you might

want to share your All of Us data with your family or your healthcare

provider.

Will I find out the results of the research?

Results explain or interpret data. All of Us involves two kinds of results:

results about you and results about the group.

1. Results about you

We may tell you if there are results about you. You will be able to

choose if you want to see these results.

• Results that might change your medical care

These are results that could be used by a healthcare provider to take

better care of you. For example, if any of your physical

measurements are outside of what we would expect, we will tell you

so you can follow-up with your healthcare provider. You will have to

pay for the cost of follow-up care with your own healthcare provider.

• Results that would not change your medical care

These results might be interesting to you, but a healthcare provider

probably would not use them to take better care of you. For example,

these results might come from tests that are still experimental.

2. Results about the group

These are reports of what researchers learn about health from studying

data from all the different people in the All of Us Research Program. You

can get these reports, as well as general news and updates about All of

Us at www.joinallofus.org.

What if I get injured?

If you think you have been injured because of taking part in All of Us,

were injured as a direct result of taking part in All of Us:

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• You will not have to pay for any immediate medical care to treat your

injury.

• Beyond your immediate medical care, we will not pay for your injury.

• If you need follow-up care to treat your injury, you and/or your

insurance will have to pay for it.

• If you have any long-term costs to treat your injury, you and/or your

insurance will have to pay them.

• You do not give up any of your legal rights if you take part in All of Us.

Do I have to take part?

Taking part in All of Us 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.

If you decide to join All of Us, 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 app or website, or use the contact information at the end of this

form to call or write to us.

If you withdraw, your samples will be destroyed. Your data will not be used

for new studies. However, if researchers already have your data or

samples for their studies, we at All of Us cannot get it back. Also, we will let

researchers check the results of past studies. If they need your old data to

do this work, we will give it to them.

Even if you withdraw, we will keep your name and contact information. We

keep this information so we can follow U.S. research laws and regulations.

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Who can answer my questions?

If you have questions about:

Please contact the:

The All of Us Research

Program.

All of Us Support Center

Hours: Mon-Sun, 7am-10pm ET

Phone: 1-844-842-2855

Email: help@joinallofus.org

Chat (website or app):

www.joinallofus.org

Languages: English and Spanish

Your rights as a research

participant.

All of Us Institutional Review Board

Phone: 1-844-200-8990

Email: AoUIRBContact@emmes.com

Address:

401 N. Washington Street, 7

Floor

Rockville, MD 20850

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I know and agree that:

• My data will be stored in the All of Us databases.

• If I give a blood, urine, or saliva sample, it will be stored at the All of

Us biobank. This includes my DNA. Information that researchers

learn by studying my samples will be stored in the All of Us

databases.

• Researchers will do studies using the All of Us databases and

biobank. Their research may be on nearly any topic.

• If my samples are used up, I may be asked to give more blood, urine,

or saliva. I can say yes or no.

• My contact information may be used to tell me about other studies.

• I can withdraw (quit) at any time. There is no penalty if I withdraw.

Please check the box below if you agree to take part:

□

I have read this consent form (or someone read it to me). I

understand the information in this form. All of my questions

have been answered. I freely and willingly choose to take part

in the All of Us Research Program.

Sample

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Please check the box below if someone from All of Us helped you with

completing the consent process:

□

I received help from All of Us to complete the consent process.

Sample