Precision Medicine, also known as “genomic” medicine, is a miraculous new medical model for customized healthcare. It is the study of a person’s genes/DNA and its effects on health. This information genetics/gene helps diagnose, form, and measure treatment plans and make prognosis/prediction of likely outcomes.
Accessing the historical implications of AOU, program director Karen Dotson said, “We are three years into what is planned to be a ten-year effort. Precision medicine will determine and evaluate needed interventions; reveal new treatments and devices that are safe and effective in treating various disease categories. The projected arsenal of data collected will enable fresh approaches to improve medical outcomes in treating the 30,000 known diseases and address those challenges to medical professionals yet to come. For the first time in history, genetic samples from one million recruited volunteers from around the U.S., ages 18 and older, will contribute to the largest, most diverse database for medical research in history.
Volunteer Participant Recruits Share
Participants answer health surveys, donate DNA samples and share their electronic health records.
Despite the interruptions resulting from COVID-19, Dotson is encouraged, “So far, over 350,000 people have consented to participate; 270,000 recruits, of which more than half are people of color, have shared their electronic health records and submitted blood, urine, and DNA samples. Health care is not one size, one medicine, or one treatment fits all. It must be customized to match the genetics of individuals.
African Americans and other people of color are not usually included in most research, so this is a good thing. Furthermore, the need for AOU is supported by predictions from the U.S. Census that in 30 years, America’s nonwhite population will increase by 50%. And increasingly, representatives from different medical disciplines agree that not including people most affected by disease in research could overall worsen future health outcomes. AOU, as the name implies, means everyone from different cultures, races, ages, sexes, socioeconomic backgrounds, lifestyles, and experiences. Social scientists also point to the high cost of racial and ethnic health disparities.”
Enrollment and Engagement Partners
The All of Us Research Program is partnering with leading institutions, organizations, community partners, and participant representatives across the country to reach its goal.
Mayo Clinic is the official national biobank where genetic samples are secured in a cloud-database. Marshfield Clinic Research Institute, University of Wisconsin-School of Medicine and Public Health, and Gundersen Health System are also essential partners. AOU is administered through Froedtert/Medical College of Wisconsin, Clinical and Translational Science Institute. Public health agents, health advocates, and community-based organizations are also members of this collaboration to recruit participants, disseminate scientific findings, and guide clinical practice in communities.
Core Values Of Aou
“Understandably, some people may have concerns about involvement in this FREE program. But it’s a new day. Ensuring that volunteer recruits know and understand the truth about all aspects of their involvement is an essential value of this program. Participants are partners in this process, with access to their files at all times.
AOU literature confirms that most medical treatments have been designed for the average patient. I can not overstate the fact. We know that health care is not one size, one medicine, or one treatment fits all. That’s why AOU has embraced the future of medicine which is a customized approach to healthcare.”
Dotson’s final thoughts, “it’s not unreasonable to believe that findings of the National Institutes of Health ALL OF US Research Program’s, like the immortal cells of Henretta Lacks
(www.hopkinsmedicine.org), will have lasting benefits for humanity.”
Phone: (844) 842-2855
(Department of Health & Human Services Author manuscript, More than Tuskegee: Understanding Mistrust about Research Participation Darcell P. Scharff, Ph.D., Katherine J. Mathews, MD, MPH, MBA, Pamela Jackson, MA, R.N., Jonathan Hoffsuemmer, MPH, Emeobong Martin, MPH, and Dorothy Edwards, Ph.D.)
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When asked if he agreed with this assessment, Zeno Franco, Ph.D., Co-Pi of the National Institutes of Health, ALL OF US RESEARCH PROGRAM Wisconsin, said,
Yes. We are familiar with the historical issues in research, i.e., the Tuskegee Study of Untreated Syphilis in Black males (1932-1972) and Henrietta Lacks. The problem is that sometimes, biomedical researchers want to view that as ancient history. We’re doing a better job now. But that history is real for people, and it’s hard to get over. Other concerns are related to future issues. They are the same for Black, Hispanic, and mixed-race folks. People of color are involved on every level of AOU. This research is bound by law to treat participants with honesty, choice, and justice. Precautions are in place with the federal government to guarantee that personal information is only shared with people and institutions associated with AOU. Our research falls under the Genetic Information Nondiscrimination Act (GINA) of 2008 — Title II makes it illegal to discriminate against employees or applicants because of genetic information.
In their 2021 Annual Letter, “The Year Global Health Went Local,” Bill and Melinda Gates addressed the worldwide impact of COVID-19 and how global collaboration and scientific innovations are fueling treatments. Is it possible that AOU research will benefit local health and also global medical outcomes?
Absolutely. It’s logical to think that the AOU approach to medicine will be beneficial for healthcare worldwide. AOU does something that most genetic research has not. We request genetic information, including data covering electronic health and personal health behaviors. With this information, we can look at interactions between genetics, environment, and personal health. Under certain circumstances, genes can change. Disparities transform how we think about health problems and confirm the need to match therapies to a patient’s genetics. Certainly, this approach to medicine can positively impact ‘local’ and global health outcomes.
What has been your learning curve in this whole process?
That’s an interesting question. I’m a behavioral scientist and a clinical psychologist. But at this point, my work is mostly community engagement. I’m not a geneticist. As a result, it’s been interesting trying to teach myself. I’m always thinking, what does precision medicine look like? What is the future of medicine? Some of the information is so complicated. I’m trying to understand how to communicate what I’ve learned to a community audience that enables them to see this research arena’s value.
Traditionally, women, not just black women, have been excluded from clinical trials. Is there a focus on recruiting women as participants in AOU?
You are right. Maybe not intentionally, but women have been systematically excluded from biomedical research. However, the name of this research program, ALL OF US, clearly defines our goal — to include everyone 18 and over. We don’t intend to repeat mistakes of the past. So, yes, there is an emphasis on recruiting women. Women are leaders in their communities and families, so they will be the ones to get their significant others and adult children to participate. Our social media followers are predominantly women.
How are you supporting and establishing meaningful relationships with Wisconsin communities?
We are developing personal connections to community-based organizations and leaders by supporting their efforts to service residents. We have hired minority-owned media companies, and since April 2020, delivered masks throughout Wisconsin. We’re also working with community health leaders to provide information, in Spanish and English, which speaks to their concerns We have been a silent partner in many activities to reduce the spread of COVID. A series of virtual meetings on various health issues that disproportionately affect minorities was also made available to the public.
Zeno Franco, Ph.D., is an Associate Professor of Family Medicine and Research at Froedtert/Medical College of Wisconsin | Site Co-Pi, National Institutes of Health, Wisconsin ALL OF US RESEARCH PROGRAM.