NIH All of Us Research Program


The mission of the All of Us Research Program is simple. We want to speed up health research and medical breakthroughs. To do this, we’re asking one million people to lead the way to provide the types of information that can help us create individualized prevention, treatment, and care for all of us.

What is the Precision Medicine Initiative® (PMI)?

A bold research effort within the National Institutes of Health (NIH) to revolutionize how we improve health and treat disease. The PMI aims to leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries.

What is the All of Us Research Program?

NIH's All of Us Research Program is a major piece of the PMI. All of Us, is a landmark long-term study aimed at engaging a cohort of 1 million or more US research participants who will share biological samples, genetic data, and diet/lifestyle information, all linked to their electronic health records.  This data will allow researchers to develop more precise treatments for many conditions and diseases. Weill Cornell Medicine, Columbia, NYC Health+Harlem Hospital, and NYP will be the NYC leaders of this effort. The program began its first participant enrollments in July 2017.

Can anyone sign up?

Yes, anyone living in the United States will be able to participate, though enrollment will initially be limited to adults ages 18 years and up. Certain populations, such as children, will be included at a later time.

What would be expected of me if I enroll in the Precision Medicine Initiative Cohort Program?

If you decide to join All of Us, we will ask you to share different kinds of information over time. We will ask you basic information like your name and where you live. We will ask you questions about your health, family, home, and work. We will ask you for access to your electronic health record. You will be asked to go to a local All of Us enrollment site for a free appointment with us. At this appointment we would measure your weight, height, hips, and waist, as well as your blood pressure and heart rate. We will ask you to give blood or urine samples at this appointment.

You will be able to choose how frequently we contact you. From time to time, we may send you new questionnaires or offer other ways for you to share information about your health.

Will my health information be safe? How do you plan to ensure privacy? What about data security?

All of Us takes privacy and security concerns very seriously and abides by the PMI Privacy and Trust Principles and the PMI Data Security Policy Principles and Framework.

The program is engaging teams of experts to conduct rigorous security testing, establish safeguards against unintended release of data, and set penalties for the unauthorized re-identification of participants. In addition, the program is developing education materials for participants about potential privacy risks and our response plans in the case of a privacy breach.

Prior to launch, we will ensure that all systems meet the requirements of the Federal Information Security Management Act (FISMA), and will test all systems for any vulnerabilities. After launch, we will continue to perform ongoing security tests to protect participant data.

Will I get access to results and data from the study?

Yes. It is important for participants to have the highest levels of access to their study results, along with summarized results from across the cohort, and will be provided with tools to make sense of the results. The All of Us Research Program will ensure this is done ethically and responsibly.

Will the cohort accept children?

Yes, eventually. The inclusion of children has been central to our goals and objectives from the start.

There are special scientific and ethical considerations to take into account when involving children in research. Before proceeding, we must build in appropriate protections in the informed consent process and our enrollment and retention plans. We must also develop scientific protocols specific for children. All of Us has established a working group to inform the development of our strategy for enrollment of children. More information will be available in coming months.

How long will it take to develop a national research cohort of one million U.S. volunteers?

All of Us began enrollments in July of 2017 with plans to reach one million volunteers within five years. The NIH hopes to continue to enroll participants well beyond one million participants.

What do we hope to learn?

The All of Us Research Program will build one of the world’s largest and most diverse data sets for precision health research. With data from one million or more participants who contribute information over a long period of time, researchers may be able to:

  • develop ways to measure risk for a range of diseases based on environmental exposures, genetic factors, and interactions between the two;
  • identify the causes of individual differences in response to commonly used drugs (commonly referred to as pharmacogenomics);
  • discover biological markers that signal increased or decreased risk of developing common diseases;
  • use mobile health (mHealth) technologies to correlate activity, physiological measures, and environmental exposures with health outcomes;
  • develop new disease classifications and relationships;
  • empower study participants with data and information to improve their own health; and create a platform to enable trials of targeted therapies.

As the program develops, NIH will hold additional workshops to discuss scientific opportunities in more detail and chart future directions.

Which diseases will be studied?

This large-scale cohort will not be focused on a specific disease, but instead will be a broad resource for researchers working on a variety of important health questions. Researchers have already seen successful precision medicine approaches in treating certain types of cancers. This cohort will seek to extend that success to many other diseases, including common diseases such as diabetes, heart disease, Alzheimer’s, obesity, and mental illnesses, as well as rare diseases. Importantly, the cohort will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout their life.

How long before we see the results of precision medicine in the form of new treatments or preventions?

Precision medicine is an approach to disease prevention and treatment that takes into account individual variability in genes, environment and lifestyle to aid in the development of individualized care. This is not a new area of science. While we have seen some great progress, it can take many years to understand the contribution of a single unique variable on a given disease or treatment. It will take even more time to develop new treatments and methods of disease prevention. By launching a study of the size and scope proposed here, we hope to accelerate our understanding of disease onset and progression, treatment response, and health outcomes.


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