The academic medicine community is playing a crucial role inlaunched this week by the National Institutes of Health (NIH). The initiative, an ambitious effort to collect detailed health information on more than 1 million Americans, tackles the complex question of how genetic, environmental, and behavioral influences affect the onset and treatment of disease.
Not only are medical schools and teaching hospitals involved in collecting and storing participants’ health data and biospecimens, but researchers at academic medical centers across the country will have an opportunity to analyze the data to discover new medical insights.
“The data provided by one million participants will provide opportunities for researchers—including academics and citizen scientists—who want to understand how and why different people experience certain diseases and conditions while others do not, and why many people respond differently to treatments and prevention methods that will help accelerate medical breakthroughs,” NIH Director Francis Collins, MD, PhD, said in his testimony to a House of Representatives subcommittee on April 11. Congress authorized nearly $1.5 billion toward the effort over 10 years as part of the 21st Century Cures Act.
Below are key insights into how the program works, the role of academic medical centers, and how you can get involved.
How All of Us differs from other studies
While several large-scale efforts in precision medicine are already underway, including the Million Veteran Program (see sidebar) and the Geisinger National Precision Health Initiative, the NIH hopes to build a participant pool that is reflective of the diversity of the U.S. population. In particular, researchers hope to recruit participants who have been historically underrepresented in biomedical research, including women, the elderly, low-income participants, and people of color. The program is open to anyone 18 and older—sick or healthy—who lives in the United States, and could expand to include children by 2019.
How the program works
Participants can enroll in the program through NIH partnerships with more than 120 health care provider organizations across the country, as well as via a direct volunteer pathway. Once enrolled, participants are asked to fill out health surveys and authorize access to their electronic health records. They may also be asked to go to a partner site to provide blood and urine samples and have physical measurements taken, as well as provide data from smartphones and wearable fitness trackers. More than 24,000 individuals already provided this information during the program’s beta testing phase. Program leaders plan to capture genomic data from select participants beginning in early 2019, according to a recently issued report.
Academic medical centers play a key role
Tuesday, May 08, 2018
Million Veteran Program Already Yielding Insights
As enrollment gets underway for the NIH All of Us initiative, another precision medicine program has already enlisted more than 650,000 participants and launched 20-plus research projects. The Million Veteran Program, which began in 2010, seeks to learn how genes, military exposure, and lifestyle affect the health of veterans.
In particular, researchers hope to learn which genes put people at risk for diseases such as cardiovascular or kidney disease and contribute to illnesses that affect veterans disproportionately, like post-traumatic stress disorder (PTSD). Studies show that up to 30% of Vietnam War veterans suffer from PTSD and as many as 20% of veterans from the wars in Iraq and Afghanistan show symptoms of the illness in any given year. Already, the trove of health data collected has launched at least a dozen important studies, including research exploring the genetic variants that increase veterans’ risk for suicidal behavior, the genes related to tinnitus, and PTSD risk factors.
Several essential pieces of the All of Us program infrastructure are located at academic medical centers. The Mayo Clinic serves as the biobank, the repository that will store and manage biospecimens for research use. Vanderbilt University Medical Center functions as the primary Data and Research Support Center, which will be critical in organizing and providing access to the massive amounts of data collected from participants. Many academic medical centers are also involved as health care provider organizations and will be encouraging patients to enroll in All of Us to create the inclusive participant population essential to the program’s success.
How data is protected
The NIH is committed to ensuring the privacy of participants’ health data, officials said. The program is based on a set of privacy and trust principles that were developed with community input. All obvious personal identifiers will be removed, and the data will be encrypted and stored on a secure platform. Researcher access to data will be granted in tiers, and data use will be audited and publicly reported.
Many ways to get involved
Health care providers are encouraged to learn more about how their patients can participate in All of Us, and individuals can also sign up to take part in the program. Researchers and citizen scientists can learn more about future scientific opportunities by connecting with the NIH to receive further updates. The program is on track to launch a researcher portal in 2019, which will facilitate use of the health data collected during the program. Finally, academic medical centers can stay up to date on upcoming funding opportunities on the All of Us website.