The National Institutes of Health (NIH) will open national enrollment for the All of Us Research Programme, a momentous effort to advance individualised prevention, treatment and care for people of all backgrounds. People ages 18 and older, regardless of health status, will be able to enroll. The official launch date will be marked by community events in seven cities across the country as well as an online event. Volunteers will join more than 25,000 participants already enrolled in All of Us as part of a year-long beta test to prepare for the programme’s national launch. The overall aim is to enroll 1 million or more volunteers and oversampled communities that have been underrepresented in research to make the programme the largest, most diverse resource of its kind.
“All of Us is an ambitious project that has the potential to revolutionise how we study disease and medicine,” Health and Human Services Secretary Alex Azar said. “NIH’s unprecedented effort will lay the scientific foundation for a new era of personalised, highly effective health care. We look forward to working with people of all backgrounds to take this major step forward for our nation’s health.”
Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. With eyeglasses and hearing aids, we have long had customised solutions to individual needs. More recently, treating certain types of cancer is now possible with therapies targeted to patients’ DNA. Still, there are many unanswered questions leaving individuals, their families, their communities and the health care community without good options.
“The All of Us Research Programme is an opportunity for individuals from all walks of life to be represented in research and pioneer the next era of medicine,” said NIH Director Francis S. Collins, M.D., Ph.D. “The time is now to transform how we conduct research with participants as partners to shed new light on how to stay healthy and manage disease in more personalised ways. This is what we can accomplish through All of Us.”
By partnering with 1 million diverse people who share information about themselves over many years, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.
“All of us are unique, but today we live mostly in an era of ‘one-sise-fits-all’ medicine,” said Eric Dishman, director of the All of Us Research Program. “I’m alive today because of precision medicine and I think everyone deserves that same opportunity no matter the color of your skin, your economic status, your age or your sex or gender. In other words, it will truly take all of us.”
All of Us seeks to transform the relationship between researchers and participants, bringing them together as partners to inform the programme’s directions, goals and responsible return of research information. These efforts include building trust among populations historically underrepresented in research. Participants will be able to access their own health information, summary data about the entire participant community and information about studies and findings that come from All of Us.
“Building a diverse participant community will be vital to the success of All of Us, so we can address the many pressing health conditions that disproportionately affect underrepresented communities,” said Dara Richardson-Heron, M.D., chief engagement officer of the All of Us Research Program. “The All of Us Research Program has the potential to help researchers better understand and begin chipping away at health disparities so that everyone can benefit from better health, better health care and exciting new breakthroughs.”
Participants are asked to share different types of health and lifestyle information, including online surveys and data from electronic health records (EHRs), which will continue to be collected over the course of the programme.
The surveys will cover a range of topics to learn more about participants’ overall health and habits and where they live and work. The EHR data will offer useful information related to medical histories, side effects and treatment effectiveness. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight. To ensure that the programme gathers information from all types of people, especially those who have been underrepresented in research, not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.
NIH has funded more than 100 organisations from community groups to health centers, academic medical centers and private companies to carry out the programme. These organisations have collaborated to develop the programme’s protocol and technology systems, to engage diverse communities, to enroll participants and to securely gather and store participants’ information and biological samples for use in research.
In future phases of the programme, children will be able to enroll and the programme will add more data types, such as genetic data. In addition, data from the programme will be broadly accessible for research purposes. Ultimately, the All of Us Research Program will be a rich and open data resource for traditional academic researchers as well as citisen scientists and everyone in between.