Researchers assessing the demographic statistics of All of Us Research Program participants prioritized enrolling racial, ethnic, and other minorities that, historically, have been underrepresented in clinical trials.1
The All of Us Research Program set goals of enrolling at least 1 million participants and increasing diversity in research.1
“One of the most interesting parts of this research is that there is an enormous amount of evidence for some groups, like racial minorities. But other groups, such as sexual minorities, are understudied and unrecognized,” says Brandy M. Mapes, MLIS translational research manager at Vanderbilt University Medical Center.
The researchers also prioritize enrolling participants from other minority groups, including:
- people with inadequate access to medical care;
- people with an annual household income below 200% of the federal poverty line;
- people who live in rural or nonmetropolitan areas;
- people with less than a high school education or equivalent;
- people with cognitive or physical disabilities;
- people who are intersex or identify as a sexual minority.
The researchers concluded studies need to incorporate more diverse factors as key variables to ensure inclusion and identify barriers that limit research participation.
“Researchers are not asking those questions that help us to track those characteristics when doing studies,” Mapes says.
For example, with race and ethnicity, the traditional model asks whether a person is white, Black, Asian, and Hispanic, but does not drill down into ethnic/racial categories, she explains.
“There is a lot of diversity within that. We’re not able to drill down, so we’re not getting that someone is Middle Eastern, for example,” Mapes says. “Also, we see researchers asking about race and ethnicity as a single question.”
Sexual Diversity Needs More Representation
In the area of sexual health and sexual orientation/gender, there are areas with poor data collection. “It’s not always because people don’t want to be asked, but because researchers feel uncomfortable asking, or they don’t imagine that is something they should ask as a variable in their study,” Mapes explains.
A study that included more variables related to underrepresented minorities of various types would have multiple benefits. “It would be a more inclusive approach. People would feel more invited to participate,” Mapes says. “We don’t know what would be discoverable unless we provide them with enough variations and diversity of data to try it out. Researchers could do a significant amount of work on health disparities if they just had the data.”
In addition to asking for more questions related to diversity as key variables, research programs and IRBs could encourage investigators to be open to changing criteria for enrollment to enable more diversity.
For example, due to COVID-19, researchers might require participants to have access to broadband internet at home. This could prevent some rural and low-income people from enrolling in the study.
“You just need to figure who you are looking for in exclusion/inclusion criteria,” Mapes says.
IRBs and researchers should look at whether the hypothesis could be answered with a change in the exclusion criteria and whether certain groups are excluded based on their proposed study design.
“Also, there is a lot of pressure to expedite timeline. Researchers have to work quickly,” Mapes says. “But that doesn’t mean we cannot take a step back and be mindful about what we’re designing and make it more inclusive, even if it means doing a little more work or taking some extra time.”
Increase Diversity in Data Collection
With the pandemic and social justice protests happening in 2020, there is an opportunity for the research community to acknowledge this moment. Collecting diversity data can help motivate researchers and IRBs to make big changes that could lead to more inclusive research projects and clinical trials, she explains.
In one sense, this has already happened: “There are traditional barriers to digital resources, but right now, we’re seeing more people adopt digital resources and technology out of necessity,” Mapes says. “During the pandemic, this is a wonderful opportunity for researchers to leverage that. More people are using it than they did before, so researchers can leverage that with more success than before.”
IRBs and experienced researchers can lead the effort to improve enrollment diversity through example. “I’m fortunate to have great mentors who showed me different strategies for ensuring diversity,” Mapes says. “There are a few things we’ve seen work well, including consulting with community representatives who have meaningful relationships with underrepresented groups.”
Studies also can provide value to participants through compensation or providing information from the study, she says.
“When everything fails, creativity, flexibility, and perseverance go a really long way,” Mapes says. “You have to be open to the possibility that you will try something new and may not see the results you want, so you will have to shift gears and try again.”
- Mapes BM, Foster CS, Kusnoor SV, et al. Diversity and inclusion for the All of Us Research Program: A scoping review. PLoS One 2020;15:e0234962.