The history of research in this country has been led by individual researchers who often focus on specific diseases or health needs and—especially in the case of pharmaceutical research—have suffered from the limitations of narrow and noninclusive populations. In some cases, this has been a prudent approach because the disease, treatment, and progression may have had limited distributions. In many cases, fears about how to best protect participants from underrepresented groups have led researchers to constrict study populations intentionally, resulting in findings that are widely applied without sufficient evidence of efficacy or sensitivity to individual differences. Added to a history that unfortunately includes the inappropriate treatment of research participants and inattention to privacy, suspicion by underrepresented minority populations has only just begun to be addressed and overcome. The extent of disparity in representation of diverse populations has been vast. This barrier has been a significant limitation for understanding and addressing health disparities.
An understanding of the value of big data as a tool to tackle persistent and recalcitrant health disparities led the National Institutes of Health (NIH) to launch the All of Us research campaign in 2016 as part of its Precision Medicine Initiative, with eight core values (NIH, 2016):
- Participation is open to all.
- Participants reflect the rich diversity of the United States.
- Participants are partners.
- Trust will be earned through transparency.
- Participants have access to their information.
- Data will be accessed broadly for research purposes.
- Security and privacy will be of the highest importance.
- The program will be a catalyst for positive change in research.
The lack of diversity among research participants has serious ethical and research consequences. This includes impeding our ability to generalize study results, creation of medical advancements of effective therapies, and preventing some populations from experiencing the benefits of research innovations and accessing high-quality care.
In the absence of data on health progression, effects of health treatments, and general health patterns that vary by population, assumptions have been about efficacy of treatments. This can result in misapplication of interventions, uneven and unexpected outcomes, and increases in the vulnerability of unstudied populations to unequal burdens of health disparity.
The All of Us research attempts to correct some of the data deficiencies while raising the profile on the need to diversify the research data across all populations. In fact, the NIH's goal is to “recruit volunteers from all life stages, health statuses, races [and] ethnicities, and geographic regions to reflect the country's diverse places and people” (Cohen, 2018). The NIH has set a goal to recruit 1 million volunteers and has additionally set some population-specific goals that set this NIH effort apart from typical medical research in aiming toward specific recruitment targets to correct the current imbalances:
- Recruit 50% of participants from racial and ethnic minority communities.
- Recruit 75% of participants from groups that have been historically underrepresented in research.
Progress in Recruitment
The 1 million participant goal is aggressive. Regional consortia of health organizations are collaborating on recruitment with the help of multilingual resources available from the NIH All of Us website. Many regions are making great progress with recruitment as health care providers rally around an effort believed to accelerate health knowledge exponentially. The SouthEast Enrollment Center, composed of a group of health care provider organizations in Florida and Georgia, had enrolled nearly 9,000 participants by May 2019. The population composition of enrollees is 80% Black and Hispanic, and 30% of enrollees earn low incomes. The participation agreement is extensive. All participants must complete a health visit and a survey and provide the required health specimens. Although these commitments complicate recruitment, consistency and completeness of data is critical.
NIH has an outreach and listening tour strategy to get the word out through the regional consortia, health professions, professional organizations, and specific population efforts such as the listening and presentation forums provided for Tribal organizations. This summer, NIH public consultation meetings about the research have been held specifically to reach out to tribal organizations. Meetings have been held in Nevada, California, Colorado, Nashville, and Washington, DC, specifically for the purpose of raising awareness and to recruit participants from the many tribal nations.
As of July 2019, more than 230,000 people have enrolled as participants nationwide, including 175,000 who have completed all requirements. Of those, 80% are from groups historically underrepresented in biomedical research. All participants will receive information back about themselves, a stunning reversal of traditional methods showing a commitment to research transparency that is largely unprecedented (NIH, 2019).
What Is a Professional Development Leader to Do?
There are many ways to support this research program, and professional development leaders are in a unique position to be key influencers. Nurses have direct relationships and exposure to all of the populations needed to make these data complete and comprehensive. Unfortunately, without education about why such a project matters, what it involves, and why individual participants should care, that access and trust cannot be fully exercised. Researchers in health organizations are well informed about the project and nurses who are actively engaged in professional organizations are likely to hear about it. Journals offer additional outreach opportunities, but for nursing staff who do not routinely access journals and are not professionally active, it is only through their clinical educators and professional development leaders that this kind of information gets the exposure it needs. This research might make a good topic for a newsletter article, or it can be a strong element in a research class or an evidence-based practice initiative. When nurses are guided to find evidence to support interventions or change practice, it quickly becomes apparent where the gaps in research are and how often those gaps are population specific. Nurses who work with underrepresented groups have relationships and access that are critical to this effort. Groups with high risk for disparities are not only from ethnic minorities. People who identify as LGBTQ experience health disparities, as do patients with substance use disorder and even individuals with chronic mental illness. Nurses can make a big difference in ensuring that recruitment includes the people nurses know are inadequately served by our health services systems.