The NIH says it will open national enrollment on Sunday to its All of Us Research Program, the research cohort piece of the Precision Medicine Initiative (PMI) designed to glean health and wellness data from 1 million or more Americans.
People ages 18 and older will be eligible to enroll, regardless of health status, joining the more than 25,000 participants already enrolled in All of Us as part of a beta phase carried out to prepare for the program’s national launch.
In addition to enrolling 1 million-plus participants, All of Us aims to become the nation’s largest and most diverse research cohort, with plans to “oversample” communities underrepresented in research in the past, the NIH said.
“The All of Us Research Program is an opportunity for individuals from all walks of life to be represented in research and pioneer the next era of medicine,” NIH Director Francis S. Collins, M.D., Ph.D., said in a statement. “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 personalized ways.”
All of Us participants are asked to share health and lifestyle information, including online surveys and data from electronic health records (EHRs), which the NIH said will continue to be collected over the course of the program.
The surveys will be designed to learn more about participants’ overall health and habits and where they live and work. The EHR data will offer what the NIH said will be useful information related to medical histories, side effects and treatment effectiveness.
In the future, according to the NIH, children will be able to enroll, and All of Us will add more data types, such as genetic data. Participants may be invited to share data through wearable devices—Fitbit was chosen as the program’s first wearable device in November 2017—as well as to join follow-up research studies, including clinical trials. Some participants will also 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.
However, not all participants will be asked to give physical measures and samples—in order to ensure that the program gathers information from all types of people, especially from communities underrepresented in research, the NIH said.
The agency has drawn upon more than 100 organizations to carry out the research program. The organizations have collaborated with the NIH to develop the program’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.
“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,” added Dara Richardson-Heron, M.D., the research program’s chief engagement officer.
The NIH plans to mark the launch with social media activities using the hashtag #JoinAllofUs, as well as with events in Birmingham, AL; Chicago; Detroit; Kansas City, MO; Nashville, TN; New York City; and Pasco, WA. Those events will be streamed on All of Us’ website.
