We’ve learned so much about coronavirus disease 2019 (COVID-19), but there’s still much more that we need to learn in order to defeat this devastating pandemic. Among the critical questions: why do some young people who appear healthy and have no history of chronic disease get very sick from the virus? And why do some people in their 80s or 90s seemingly just shrug off the infection? There’s something going on biologically, but we don’t yet have the answers.
We do, however, have some resources that will enable us to examine lots of data in search of biological clues. One of them is NIH’s All of Us Research Program, which is seeking the help of 1 million people to build one of the most diverse health databases in our nation’s history. Two years after its national launch, the program already has enrolled nearly 350,000 diverse participants from across the United States.
As its name suggests, All of Us is open to all people over age 18 in communities all around the country. An important strength of the effort has been welcoming participants from all backgrounds. Indeed, about 75 percent of people who have volunteered for the program come from groups that have traditionally been underrepresented in medical research. That includes people from many racial and ethnic minority groups, as well as those of many different ages, socioeconomic backgrounds, and geographic locations, including remote and rural areas.
Because of COVID-19 and the need for physical distancing to curb the spread of the potentially deadly virus, All of Us has been forced to halt temporarily all in-person appointments. But program leaders, including Josh Denny, chief executive officer of All of Us, and Kelly Gebo, the program’s chief medical and scientific officer, saw an opportunity to roll up their sleeves and help during this unprecedented public health challenge. In fact, Gebo reports that they’d already been hearing from many of their participant partners that they wanted to be a part of the solution to the COVID-19 pandemic.
To rise to this challenge, the All of Us Research Program has just announced three initiatives to assist the scientific community in seeking new insights into COVID-19. The program will:
• Test blood samples from 10,000 or more participants for the presence of SARS-CoV-2 antibodies, indicating prior infection. The testing will start on samples collected in March 2020 and work backward until positive tests are no longer found. This will show the prevalence of novel coronavirus exposure among All of Us participants from across the country, allowing researchers to sift through the data and assess the varying rates and timing of infections across regions and communities.
• Rapidly collect relevant information from more than 200,000 participants who have shared their electronic health records. A number of those participants have already either been diagnosed with COVID-19 or sought health care for related symptoms. The program is working to standardize this information. It will help researchers look for patterns and learn more about COVID-19 symptoms and associated health problems, as well as the effects of different medicines and treatments.
• Deploy a new online survey to understand better the effects of the COVID-19 pandemic on participants’ physical and mental health. This 20- to 30-minute survey is designed both for participants who have been ill with COVID-19 and those who have not knowingly been infected. Questions will be included on COVID-19 symptoms, stress, social distancing and the economic impacts of the pandemic. Participants are invited to take the survey each month until the pandemic ends, so researchers can study the effects of COVID-19 over time and begin to better understand how and why COVID-19 affects people differently.
As this data becomes available, researchers will look for new leads to inform our efforts to bring greater precision to the diagnosis, treatment, and prevention of COVID-19, including for those communities that have been hit the hardest. Another hope is that what is learned about COVID-19 through All of Us and other NIH-supported research will provide us with the knowledge and tools we need to avert future pandemics,
In case you’re wondering, I happen to be among the thousands of people who’ve already volunteered to take part in All of Us. If you’d like to get involved too, new participants are always welcome to join.
Usually, I share cool science advances and major medical breakthroughs on this blog. But, today, I’d like to share something a little different, something of great importance for both your health and the advancement of biomedical research: new guidelines on how you can access your own health information.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule has long supported the right of individuals to request and obtain copies of their medical records and other health information maintained by health-care professionals, medical facilities, and health insurance plans. However, due to the increasing use of online health-information technology and growing interest among Americans in being active participants in health-related decisions, the U.S. Department of Health and Human Services (HHS) recently issued much-anticipated guidance that serves to answer common questions and clarify key issues regarding access to health information under HIPAA. Think of it as a valuable personal roadmap for navigating a part of health care that is all-too-often confusing and frustrating!
Among the many reasons that people need easy, affordable access to their health records is to empower them to take more control over decisions regarding their health. Such information can help individuals improve their ability to monitor chronic conditions, stick with treatment plans, track progress in wellness programs, and identify and correct erroneous information. In addition, some people may want such access so they can directly contribute their health information to biomedical research projects. One such endeavor is the new, NIH-led Precision Medicine Initiative Cohort, in which 1 million or more volunteers will agree to share data, including information from their health records. Maintaining the security and privacy of individual information will be of paramount importance. In return, participants will have the highest levels of access to their study results, along with summarized results from across the cohort.