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NIH – Precision Medicine Initiative®

What is the Precision Medicine Initiative®?

In his January 2015 State of the Union address, President Obama announced the Precision Medicine Initiative (PMI) — a bold new 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 UsSM Research Program?

NIH’s All of Us Research Program is a major piece of the President’s 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 data-based and more precise preventive care and medical treatment.

When can I sign up to join the All of Us Research Program?

Enrollment for the All of Us Research Program will begin in 2017. Before we begin enrollment, we need to solidify the details for this historic program. NIH will widely publicize when enrollment is open, and we hope you will sign up.

Can anyone sign up?

Yes, anyone living in the United States will be able to participate.

What would be expected of me if I enroll in the All of Us Research Program?

Volunteers will be asked to share data from their electronic health records and health questionnaires. Participants may be asked to provide health data on lifestyle habits and environmental exposures as well. Participants will also undergo a standard baseline physical evaluation and provide blood and urine samples.

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

The White House has developed the PMI Privacy and Trust Principles(link is external) and the PMI Data Security Policy Principles and Framework(link is external) to guide all PMI activities, including the All of Us Research Program. Maintaining data security and privacy will be paramount to maintaining participants’ trust and engagement. The program will engage teams of privacy experts and employ rigorous security testing models, develop participant education with regard to privacy and potential re-identification risk, and clearly articulate response plans in the case of a privacy breach.

The PMI Working Group made recommendations for security and privacy of individual information as well, including establishing safeguards against unintended release of data and penalties for the unauthorized re-identification of participants. These recommendations are intended to ensure the proper use of the data and to set the foundation of trust between participants and researchers.

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 study group, and participants 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. All of Us is expected to reflect the broad diversity of the United States, eventually including all life stages.

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

The All of Us Research Program will begin enrolling participants in 2017 and reach one million volunteers within three to four years. All of Us aims to continue enrolling participants well beyond one million participants.

What do we hope to learn?

The PMI Working Group developed a set of high-value scientific opportunities based on input from four public workshops and two requests for information. A large-scale cohort of one million or more participants who contribute genetic, environmental, and lifestyle information over a long period of time will allow researchers 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.

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.

How can I support the President’s overall Precision Medicine Initiative?

We are looking to a broad range of stakeholders to learn about new or expanded initiatives and programs aimed at enabling new ways to improve health and treat disease — and ways to use this information to inform our precision medicine efforts going forward. You can visit is external) to sign up for updates and share information on the activities that you are engaged in to advance precision medicine.