September 2024

The All of Us Research Program

All of Us and the All of Us logo are registered service marks of the U.S. Department of Health and Human Services.

About All of Us

What is the NIH All of Us Research Program?

The All of Us Research Program is a historic, longitudinal effort to gather data from at least one million people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, socioeconomics, environment, and biology, we hope that researchers will one day uncover paths toward delivering precision medicine – or health care that is based on an individual.

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People Have Different Disease Risks

The All of Us Research Program is part of the broader Precision Medicine Initiative.

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Kinds of questions this resource may help answer

Or develop pain medicine that potentially may not be addictive?

How may we prevent the chronic pain that affects more than 50 million adults across the U.S.?

Or may develop better treatments for diabetes, which affects over 10% of Americans–or may potentially prevent diabetes altogether?

Or may help researchers develop more cancer cures that will work the first time, so we may skip painful trial-and-error chemotherapy?

Or may slow or potentially stop different kinds of dementia?

Or may drive sustainable interventions that may support health equity?

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Innovative aspects of All of Us

• Diversity at the scale of at least one million people: demographically, geographically, medically, and especially those underrepresented in biomedical research.
• Diversity of data types collected longitudinally: �clinical, environmental, genetic, behavioral, socioeconomic.
• Focus on participants as partners: included in governance, invited to co-invent systems and give input into the science, choice to receive all data and information back.
• Resource for all: broadly accessible with information for the public and researchers, open-source software and tools.

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All of Us learns from, and partners with, other large research programs; sharing knowledge and data is key!

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What is the promise for participants?

• An opportunity to improve the health of future generations.
• Learn about your own health when you share information about yourself for research.
• Find out about research powered by the data you've shared.
• An opportunity to ensure that your community is included in the studies that lead to new understandings of what affects people's health.
• A chance to learn about additional research opportunities that may interest you.

This is a long-term relationship and the value to participants (and researchers) will grow over time.

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What is the promise for researchers?

• The opportunity to save time and resources and accelerate research that may improve health by leveraging:
• A rich resource of data, including biospecimens and increasingly robust electronic health records.
• A longitudinal dataset that will follow participants as they move, age, develop relationships, and try treatments.
• A diverse cohort of participants, including people with a range of health conditions, from different backgrounds and across the country.
• Data that is already cleaned and curated.
• Robust computing and analytic tools to support complex data analyses in a secure data environment.
• A group of engaged participants who may be eager to participate in ancillary studies.
• The ability to easily share workspaces and analyses with research partners and reviewers.
• The chance to learn from the program’s pilots and experiments and leverage innovations for other studies and cohorts.

More than 12,000 researchers so far, from 880+ institutions,

have registered to access All of Us data and tools.

As of August 2024

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What is expected for providers?

• Over time, precision medicine research may increase scientific evidence and improve guidelines to enable precision medicine opportunities for more people and conditions:
• Better understanding of the impact of genetic, environmental, and lifestyle factors on health.
• Increased knowledge of differences in risk factors and response to treatments among diverse populations.
• More information on the development of conditions that may allow for earlier detection.
• Deeper understanding of different conditions that may allow for better stratification.
• Innovations that may make it easier to share electronic health records with other providers and patients.
• New knowledge to help address health disparities, increase patient engagement, and understand the usefulness of consumer health devices and apps.

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Current protocol

Enroll, Consent and Authorize EHR

Answering�Surveys

Physical Measurements*

Provide�Biosamples*

• Online, interactive consents
• Includes authorization to share Electronic Health Record (EHR) data
• Consent to Get DNA Results

• Current surveys focus on lifestyle, health history, social determinants of health, emotional health and well-being, and more.
• Additional surveys will be released on an ongoing basis

• Blood pressure
• Heart rate
• Height
• Weight
• BMI
• Hip circumference
• Waist circumference

• Blood (or saliva)
• Urine specimen
• Biosamples will be stored at the program’s biobank

*Based on diverse sampling �and capacity

• Share data from wearable fitness devices, starting with Fitbit
• More integrations under development

Wearables and Digital Apps

*Based on diverse sampling �and capacity

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Supporting Materials

(image links to 30-second version of video on YouTube; open notes section for links to 60- and 90-second versions)

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All of Us anthem video

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Precision medicine is an emerging approach for personalized health care that takes into account individual variability in lifestyle, socioeconomics, environment, and biology.

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It is a radical shift in how each of us can receive the best care possible based on our unique makeup.

What is precision medicine?

Environment

Biology

Lifestyle

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Why do we even need the All of Us Research Program?

People/Patients

Health Care Providers

Biomedical Researchers

• Patients may not be served well by treatments designed for the “average” patient. We hope in the future that All of Us will help advance precision medicine.
• Many people and populations have been left out of biomedical research, and thus, often left out of health care solutions.
• Health problems can take years to unravel and require much trial-and-error.
• Patients may not have access to, or make use of, their own health data.

• Precision medicine research is still in the early days, so providers �do not have enough information available to provide precision care for many conditions.
• Developing individualized approaches to care often requires time.
• It can be difficult to coordinate �care between many different providers, especially with medical records and key data scattered in different silos.

• Researchers spend a lot of time and resources creating new IT systems, databases, and analytic tools.
• They also face enormous costs and time just to recruit participants.
• Data collection is often not standardized, and data can be siloed and difficult to integrate.
• A single lab’s resources may not be sufficient to answer the research questions that matter.

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All of Us mission

Our Mission

Accelerate health research, enabling individualized prevention, �treatment, and care for all of us

Nurture partnerships

for decades with at least a million participants who reflect the diversity of the U.S.

Deliver one of the largest, richest biomedical datasets that is broadly available and secure

Catalyze an ecosystem

of communities, researchers, and funders who make All of Us an indispensable part of health research

Made possible by a team that maintains a culture built around the program’s core values

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• Participation is open to all.
• Participants reflect the rich diversity of the U.S.
• Participants are partners.
• Trust will be earned through transparency.
• Participants have access to their information.

Core values

• Data is accessed broadly for research purposes.
• Security and privacy are of highest importance.
• The program may be a catalyst for positive change in research.

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How will All of Us lead to discoveries?

Participants Share Data

Participants share health data online. This data includes health surveys and electronic health records. Participants also may be asked to share physical measurements, and provide blood or saliva and urine samples. We also want to know if you will want information about your DNA.

Researchers Study Data

Researchers use the data to conduct studies. By finding patterns in the data, they may learn more about what affects people’s health.

Researchers Share Discoveries

Research may help in many ways. It may help find the best ways for people to stay healthy. It may also help create better tests that will work best for different people.

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All of Us is catalyzing innovation in the research enterprise

For participants

• Empowering people from all backgrounds �to engage and help shape the future of research.
• Committed to responsibly returning information to participants.
• Developed a network of community partners to serve as “a trusted person I can talk to.”
• Building connections with communities who have been left out of research in the past.

For researchers

• Testing digital engagement strategies to recruit and retain diverse participants.
• Opening new pathways to bring in data:
• Investments in pilots to gather rich, longitudinal electronic health records.
• Developing APIs and apps to leverage wearable health technologies.
• Empowering and democratizing research to bring “more brainpower per problem.”
• All of Us will be open to all researchers, including citizen scientists.
• Built a network of partners to make it possible for anyone, anywhere in the country to participate in biomedical research.
• Open to scientists from a wide variety of backgrounds.

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Approach to privacy and security

• Guided by privacy, trust, and data security principles developed by experts with input from the public.

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• Data warehouse is built with the most advanced security available.

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• Experts have done and will continue to do rigorous security testing.

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• Data is encrypted and direct identifiers are removed.

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• Researchers must agree to a code of conduct before accessing the data.

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• Protected by a Certificate of Confidentiality.

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• Committed to transparency in the event of a data breach.

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Safeguarding your identity and data to the best of

anyone’s abilities is our most important responsibility.

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Selected scientific opportunities

• Develop quantitative estimates of risk for a range of diseases by integrating environmental exposures and �genetic factors.

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• Identify the causes of individual variation in response to commonly used therapeutics = pharmacogenomics.

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• Discover biological markers that signal increased or decreased risk of developing common diseases.

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• Develop solutions to health disparities.

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• Use mobile health technologies to correlate activity, physiological measures, and environmental exposures with health outcomes.

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• Empower program participants with data and information to improve their own health.

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• Create a platform to enable trials of targeted therapies.

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Thank you!

Social media:

@AllofUsResearch

@AllofUsCEO

#JoinAllofUs

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Websites:

AllofUs.NIH.gov

JoinAllofUs.org

ResearchAllofUs.org

Thank you to our generous participants!