Newswise — Three years after the National Institutes of Health (NIH) launched its 10-year All of Us Research Program, a regional team led by University of Miami Miller School of Medicine faculty has achieved remarkable success in recruiting members of minority communities including Black and Latino participants.
Despite the challenges of the COVID-19 pandemic, more than 24,000 volunteers from the Southeast region have enrolled in the national landmark program, including a high percentage of minorities who are under-represented in medical research. Now, the program has reopened for the enrollment of new participants.
"Traditional medical research has been based on people with European ancestry," said Henri R. Ford, M.D., M.H.A., dean and chief academic officer of the Miller School. "It's time we changed that. For personalized care to become a reality, all our communities need to be represented in medical research. I'm proud that the Miller School and UHealth – the University of Miami Health System are partners in this initiative."
All of Us is the most extensive and most inclusive research program undertaken by the National Institutes of Health. By asking one million or more volunteers across the nation to share different types of health and lifestyle information, the initiative aims to speed up health research breakthroughs to improve health outcomes and deliver precision and personalized medicine to patients.
With its expertise in genetics and genomics and its location in one of the most ethnically diverse counties in the nation, the Miller School is the lead partner in the study's SouthEast Enrollment Center (SEEC), which includes the University of Florida, and Emory University and Morehouse College of Medicine in Georgia. There are nine other academic consortia across the nation, as well a the Veterans Administration and several Community Health Centers that are also enrolling participants that reflect the geographic, ethnic, racial, socioeconomic, age, and gender diversity of the U.S.
"The All of Us Research Program, an NIH flagship initiative, has selected the University of Miami as one of its 10 national lead sites - one of the largest grants the Miller School has ever received," said Stephan Züchner, M.D., Ph.D., professor and the SEEC's lead principal investigator (PI), who chairs UM's Dr. John T. Macdonald Foundation Department of Human Genetics and co-directs the John P. Hussman Institute for Human Genomics. "This is allowing us to truly make a contribution to the inclusion of ALL Americans into research studies, regardless of race, income, zip code, etc. Only such a diverse national research program at an unprecedented scale has the scientific power to unlock personalized medicine for rare and common ailments, well-being, aging, and more. Consequently, the benefits of this research will ultimately benefit 'all of us'."
Ongoing enrollment success
The Southeast region has enrolled more than 24,000 participants in Florida and Georgia, including 11,000 from Miami-Dade, said Olveen Carrasquillo, M.D., M.P.H., professor of public health sciences, chief of the Division of General Internal Medicine, and an All of Us PI who serves as the SEEC's participant engagement lead. "More than 70 percent of our participants have diverse minority backgrounds, and in Miami-Dade, that percentage is even higher — about 85.5 percent," he added.
During the pandemic, All of Us enrollment was paused as program staffers were engaged in vaccine trials. "Now, more than ever, the COVID-19 pandemic has highlighted the need and urgency of health research," said Dr. Carrasquillo. "All of Us is creating a significant resource for researchers to be able to understand the patterns of COVID-19 and get a fuller picture of how it spread in the U.S. Some groups of people are being hit harder than others. It's important to find out why."
Noting that the All of Us regional team includes more than 110 faculty and staff, Dr. Züchner said, "This is an outstanding team effort. It takes time to build a collaborative research program that can recruit thousands of participants. This is a marathon, not a sprint."
First-time access to genetic data
As part of the All of Us Research Program, NIH recently released a Researcher Workbench with tools and health data to drive new biomedical discoveries. For the first time, researchers have access to information about All of Us participants' experience with the COVID-19 pandemic through answers to survey questions on mental health, social distancing, and economic impacts.
"The opening of the Researcher Workbench allows scientists, physicians, and qualified students and trainees from the University of Miami to access more than 280,000 biomedical datasets, soon complete with genomic data," said Dr. Zuchner.
Currently, 75% of participants whose data is in the Researcher Workbench come from communities that are historically underrepresented in research, such as people of color (about 50%) and sexual and gender minorities, according to NIH. The workbench encompasses various data types, including survey responses, physical measurements, electronic health records (EHRs), and wearable fitness data.
A new baseline
Along with genetic information, the All of Us research program is collecting vital data about individual lifestyles and environments that can affect how individual genes are expressed and impact overall health outcomes. "This is one of the most exciting aspects of the research program," Dr. Carrasquillo said. "Studying DNA is a key part of this effort, and participants will be contributing to many future studies to improve the health of everyone."
Rosario Isasi, J.D., M.P.H., research associate professor of human genetics, added that obtaining gene samples from participants will help identify causes of disease and potential new therapies. "There is also the issue of justice," said Isasi, a lawyer/bioethicist and a principal investigator supporting ethics/regulatory aspects of the research program and co-chair of the All of Us Committee on Access Privacy and Security (CAPS). "We all contribute to biomedical research through our taxes, and we all are all a part of humanity. The hope is to address the shortcomings of the past and support meaningful discoveries for everyone within a robust ethical framework."
Benefits of enrolling
Jacob L. McCauley, Ph.D., associate professor of human genetics and pathology, and director of the Hussman Institute's Center for Genome Technology, agreed with the importance of keeping All of Us participants engaged in the ongoing research program.
"We are really excited that participants have started receiving some of their genetic results from the biosamples that they have donated," said McCauley, a principal investigator who is leading logistics and other SEEC efforts and serves on the Biospecimen Access Policy Task Force. "The initial results will provide insights into the participants' genetic ancestry and traits, with additional health-related results coming at a later phase. This is one of the first opportunities to return value to our participant partners in this groundbreaking research program."
Dr. McCauley added one of the benefits of participating is that participants can get their DNA results over time. "When we process your DNA, we will be able to check your DNA for information of interest to each individual," he said. "Some examples include ancestry, traits, or certain health-related DNA results that you can then discuss with your health care provider."
Lessons for the future
The success of the All of Us recruitment campaign may also provide valuable lessons for future clinical trials, according to Dr. McCauley. "We hope to leverage our team's outreach efforts," he said. "For instance, much of our success has been our ability to build face-to-face relationships, explaining our research program, answering questions, and gaining participant trust."
Looking ahead, Dr. Ford said he looks forward to the findings from the 10-year research program, which will help clinicians create individual prevention, treatment, and care plans for patients of all races and ethnic groups. "This vital initiative will improve healthcare for generations to come," he said. "I invite you to participate in the All of Us research program because we are one U!"
The All of Us team at the University of Miami is now accepting new participants – just call 305-243-8380 to book an appointment. "We have implemented procedures to ensure everyone feels safe," said Dr. Carrasquillo. "That includes a COVID-19 Symptom Checker prior to arriving, complete sanitation of clinic space after each participant, and reengineering spaces to allow for physical distancing and prevent overcrowding. A reminder that no visitors are currently allowed on campus."
All participants will receive $25 cash after completion of their visit. To complete the visit, participants must create an account at JoinAllofUs.org and fill out the necessary enrollment and consent forms. The online process, which takes about 30 minutes, includes watching informational videos and answering several health surveys. While online, participants will need to give their consent, agree to share their electronic health records, decide whether they want information about their DNA, and agree to have their physical measurements taken (height, weight, blood pressure, etc.), and give blood and urine samples.
Participants who complete those steps will be invited later to a University of Miami site to provide their physical measurements, including height, weight and blood pressure, and blood and urine samples. The data, which will be encrypted and subject to robust privacy safeguards, will be used to build the national All of Us database. The program will contact participants about new surveys and additional ways to share information over time.
The SouthEast Enrollment Center is supported under NIH funding award #1OT2OD025285. "All of Us" is a registered service mark of the U.S. Department of Health and Human Services.