All of Us Research Program Protocol

What Is All of Us?

The All of Us Research Program is a large project at the National Institutes of Health (NIH). It collects health information from many different people in the United States. The goal is to help scientists learn why people get sick or stay healthy. By studying things like genes, where people live, and how they live, scientists hope to create better, more personalized health care in the future.

What makes the All of Us Research Program different:

  • Size: The program wants to enroll more than one million participants.
  • Participants: It welcomes people from many backgrounds, especially groups that have not been well-represented in health research before.
  • What is collected: The program collects many types of information, such as health surveys, samples like blood, and data from fitness devices over time. It may collect more or less information in the future based on funding.
  • Length of study: The program will last 10 years or more.
  • Researcher access to data: Some data is open to everyone, some is for approved researchers, and some is for highly trained researchers only.
  • Main goal: The main goal is to build a large health database. Scientists will use this information to study how biology, lifestyle, and environment affect health and disease.

Joining the Program

Program timeline:

  • The study lasts 10 or more years.
  • Participants share updates over time.
  • Information about participants can come from surveys, electronic health records (EHRs), or wearable devices (such as a Fitbit).

Who can join:

  • Adults 18 and older who live in the U.S. or its territories.
  • Children began joining in 2023, starting with infants and young children. Older children are added over time.
  • People who are incarcerated, those who cannot give consent, or children who are not in an approved age group cannot join.

How people join:

  • Through health care provider organizations (HPOs)—for example, where they see their doctors.
  • On their own using the website.

The program works respectfully with Tribal Nations. It will not make decisions affecting tribes without talking with them first.

Getting Consent

  • All consents are completed on a computer, tablet, or smartphone.
  • People join by giving informed consent in person or online.
  • Parents give permission for their children to be participants.
  • The consents include videos, screens to read, and an electronic signature.

Information We Collect

Participants contribute five types of information to the All of Us Research Program:

Surveys (Participant Provided Information)

Participants answer questions about:

  • Personal and family health
  • Home and community life
  • Money, jobs, and access to health care
  • Social and environmental factors

Parents may answer surveys for their children depending on the age of their children.

Electronic Health Records

If participants agree, their doctor or health system can share medical information such as:

  • Diagnoses
  • Medicines
  • Lab and imaging test results
  • Doctor visit notes
  • Vital signs

More types of medical information may be added over time.

Physical Measurements

These may include:

  • Height and weight
  • Blood pressure
  • Heart rate
  • Waist or hip size
  • For children: head size and other age-appropriate measurements

Biospecimens (Samples)

Participants may give blood, urine, or saliva. Samples may be collected at a clinic or at home with a kit.

Digital Health Data

Some participants may share data from phones, apps, or wearable devices (like fitness trackers such as a Fitbit).

What Participants Receive

Participants can see some of their own information—such as surveys and measurements—through their online Participant Portal .

How Data Is Used and Protected

For detailed information about data privacy protections, see Data and Privacy .

Core Dataset

Scientists can study information such as:

  • Survey answers
  • Physical measurements
  • Digital readings
  • Genetic information
  • Electronic health record data

Personal details like names are removed before researchers see the information.

Research Access

The All of Us Research Hub is open to everyone. There are three access levels:

  • Public: Basic information anyone can view.
  • Registered: For approved researchers.
  • Controlled: Highly sensitive data, accessible only to approved researchers.

Researchers use secure computers and cannot download participant data.

Biospecimen Storage

All samples are prepared at the place where they are collected, then transported at 4°C to the Mayo Clinic Biobank, where they are divided into smaller portions, frozen at -80°C, and stored safely.

  • Blood: About 50 mL collected in adults (less from children, based on weight).
  • Urine: About 50 mL collected in adults and children who are able to provide a sample.
  • Saliva: Collected if participants cannot give blood.

Genetic Data and Sample Use

The program is creating genetic information from samples for researchers to use in their studies. More types of tests may be added later. Researchers may apply to use samples; because samples are limited, access is carefully managed.

Keeping Data Safe

All data is protected by encryption, secure cloud storage, and strict privacy rules. Only approved people can access the data for research.