The National Institutes of Health has awarded Stanford researchers Mitchell R. Lunn, MD, and Juno Obedin-Maliver, MD, $2.1 million in funding for the first year to recruit, retain, research and improve practices for representing LGBTQ+ people in the All of Us Research Program. The project is expected to last five years.
The All of Us Research Program, which officially launched in 2018, aims to catalog electronic health data, survey questions, blood, urine and genetic samples from at least 1 million people in the United States. The samples are stored in a biobank, and the data, which doesn't include participants' identifying information, are publicly available for researchers who wish to investigate all sorts of questions related to medicine and health, such as whether certain genes determine how different people respond to a medication. Stanford University has been involved in the program since 2019.
When the NIH initiated All of Us, it emphasized that this collection would be different than any before it. Not only would it be large and comprehensive, it would also truly reflect the diversity of the country's population.
For decades, scientists have pointed out that many clinical trials have focused exclusively on white, heterosexual men. Though women and people of color have been included more often in recent years, many underrepresented groups are still left behind, limiting the medical community's knowledge of how best to care for them.
Scientists know, for instance, that cisgender women metabolize certain drugs differently than cisgender men do, said Obedin-Maliver, but that's far from the only gender disparity researchers are learning about. For example, if a transgender person receives gender-affirming hormone therapy, it can alter their muscle mass and metabolism, leading them to process drugs differently than cisgender men or women who don't take those same hormones.
It's not known how these changes may affect treatment outcomes.
To address knowledge gaps, the All of Us Research Program includes more than 295,000 participants who have completed initial steps of the program. Of those, more than 80% are from groups traditionally underrepresented in biomedical research, including people of color, people of low socioeconomic status, people in rural communities, as well as LGBTQ+ people among others, explained Lunn.
Advancing LGBTQ+ health
Lunn and Obedin-Maliver are the directors of Stanford's PRIDEnet, a national network comprised of groups and individuals that aims to accelerate LGBTQ+ health research in different studies and in different settings. Their team has helped support and encourage LGBTQ+ people to register for All of Us, in which 10-14% of the 405,000+ enrolled participants are from the LGBTQ+ community.
But inclusion requires more than just recruiting participants.
The primary goal of Stanford's involvement is to help ensure that LGBTQ+ people are represented and understood within the program through active engagement and representation. Lunn, Obedin-Maliver and their team help ensure, for example, that the materials produced, and the research conducted reflect the experiences of LGBTQ+ people. That means making flyers that use inclusive language and imagery, training researchers to think about how different groups might experience health outcomes, and encouraging researchers to investigate questions that will benefit the health of these communities. Lunn and Obedin-Maliver are also helping to pilot the research tools to develop best practices for using these data.
"Because LGBTQ+ people haven't been systematically included in research in meaningful and intentional ways in the past, the field of LGBTQ health research is really nascent. And there are some things that inspire us to think about research differently," said Obedin-Maliver.
Many researchers, for instance, who study pregnancy start by narrowing the pool of potential participants to cisgender women before asking who has had a pregnancy.
"But we know that men who are transgender can get pregnant and have babies. And we would imagine that their experience of being pregnant and giving birth is probably different than the standard experience," Obedin-Maliver said. "These scenarios are important to consider so you don't make mistakes and exclude a whole bunch of people by assuming that all the people who are pregnant identify as women."
Lastly, a crucial aspect of the new work will be to ensure that research results are disseminated in a way that benefits all of the participants and are ''not just living in medical journals," said Obedin-Maliver.
"These programs have the capacity to really catalyze different insights and experiences across the medical mission," she said.
Sign up to participate in the program.
The Stanford award is supported by NIH award number OT2 OD025276.
Photo by Jasmin Sessler