What is the Precision Medicine Initiative?
The Precision Medicine Initiative (PMI) is a bold research effort 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 will engage one million or more volunteers living in the U.S. to contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of evidence-based and more precise preventive care and medical treatment.
When can I sign up to join the All of Us Research Program?
The program is launching in stages, beginning with a beta testing phase and then a national rollout anticipated in Spring 2018. Before we open enrollment nationally, we want to make certain that all systems are successfully up and running, and our processes are well in place to ensure a good experience for participants. Following launch, we will make continuous improvements and updates to the program based on participant feedback and emerging scientific opportunities and technological advances.
NIH will announce when enrollment opens nationwide, and we hope you will sign up then.
Why should I join?
To develop tailored treatments and prevention strategies, researchers need more data about the individual differences that make each of us unique. By enrolling in the All of Us Research Program and sharing information, you can help ensure that your community is included in the studies that lead to improved health for future generations.
In addition, All of Us will also share data and information we collect about you, as well as certain study results, to help you know more about yourself.
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 All of Us Research 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. If you have an electronic health record, we may ask for access. We may ask you to go to a local clinic or drug store 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 might ask you to give samples, like blood or urine at the 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 pdf | 119.85 KB and the PMI Data Security Policy Principles and Framework pdf | 387.12 KB.
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 the program 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.
The All of Us Child Enrollment Scientific Vision Working Group has released its report to inform the development of our strategy for enrollment of children. Read the Working Group’s report pdf | 772.7 KB. More information will be available in coming months.
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 research program will seek to extend that success to many other diseases. Importantly, the research program 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 progress with precision medicine, 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 of the All of Us Research Program, we hope to accelerate our understanding of disease onset and progression, treatment response, and health outcomes.
What funding opportunities are available for researchers?
Visit the Funding page for details on all funded projects, active and archived funding opportunities, and background documents and notices related to these funding opportunities.
Where can I find materials about the program to share with my community?
The All of Us Research Program offers free downloadable materials to help community members spread the word about the program. See our community resources.