The All of Us Research Program aims to advance precision medicine by building one of the largest research resources of its kind. To complete this undertaking, the program strives to partner with at least one million participants from diverse backgrounds. When All of Us first launched the Researcher Workbench in 2020, the program created the Resource Access Board (RAB) to hold All of Us researchers accountable to the program’s data access and use policies, which help the program protect the data that participants share.
About the RAB
The RAB has two roles: reviewing research projects to ensure compliance with the Data User Code of Conduct (DUCC) and helping researchers with questions about program policies. The RAB includes experts in clinical research, bioethics, community-engaged research, and data privacy, as well as Participant Ambassadors. The RAB also draws on outside experts when needed.
How the RAB Reviews Workspaces
When researchers begin a project in the Researcher Workbench, they must create a workspace description. These descriptions are publicly available in the Research Projects Directory. Anyone may request a review of a project through the directory. The RAB reviews workspaces upon request or as part of a routine workspace audit.
After review is initiated, the RAB will examine the workspace to determine whether there are any violations of the DUCC. If there are no violations, the research may continue. If the RAB finds a violation or has concerns about a potential future violation, then they can take a number of actions, including requesting changes to the research. For serious violations, the RAB may also recommend that the program sanction the researcher, end the project, have the researcher’s account disabled, or take other measures as needed.
Oversight Curbs Stigma and Bias
When reviewing workspaces for violations of the DUCC, the RAB looks carefully at whether projects may potentially be discriminatory or stigmatizing to any individuals, groups, or communities.
“A main focus of our work is helping researchers who may not have considered the implications of their research questions,” said RAB Co-Chair Harvey Murff, M.D., M.P.H., professor of medicine at Vanderbilt University Medical Center. “For example, researchers sometimes misuse race as a variable. Let’s say that a researcher hypothesizes that race influences willingness to get screened for a medical condition. That difference may appear to be because of race but may really be caused by something else, such as living closer to a screening facility.”
Researchers may make similar assumptions when working with genetic data. However, a person’s genetic makeup is only one of the factors that influence their health. “Your essence is more than your genome,” said RAB Co-Chair Stephen Sodeke, Ph.D., DBe, a bioethicist and professor of bioethics and allied health sciences at Tuskegee University. “Your essence is the way you function in life, which also depends on the structural and environmental challenges that you may face. All of those factors together can influence your health.”
By not considering how multiple biological, social, and environmental factors may affect health, scientists can draw overly narrow or even false conclusions. At times, these flawed conclusions can create and perpetuate stigma, leading to discrimination or other negative outcomes. The RAB helps researchers determine when their projects could result in stigma and provides detailed feedback to help prevent that.
“We take a nuanced approach in thinking about how research design could affect communities and participants, how it could harm or stigmatize them, or how it could lead to loss of privacy,” said NIH RAB Liaison Subhashini Chandrasekharan, Ph.D., team lead for ethical, legal, and social issues in the All of Us Policy Office. “Furthermore,” added Katherine Blizinsky, Ph.D., director of the All of Us Policy Office, “the RAB helps researchers find the right language to talk about their findings. Language is critically important. We can only reap the full benefits of responsible research if we talk about scientific findings responsibly, too.”
Creating a Culture of Responsible Research
Researchers may also request the RAB’s assistance to ensure that their research complies with All of Us policies. “We have seen a lot of researchers ask for RAB assistance,” said Dr. Blizinsky. “Seeing researchers avail themselves of this support is heartening. It shows that researchers want to know how to do the right thing and are invested in building a culture of responsible research.” Dr. Chandrasekharan agreed: “The next time a researcher starts a research project on the Researcher Workbench or mentors a student, these commitments to ethical conduct are passed along.”
Together, the RAB and researchers are ensuring that All of Us lives up to its core values. Dr. Blizinsky said, “The RAB is an integral thread in the fabric of the program. I don’t think our program could exist and espouse the values that we do without a body like the RAB. It ensures that we are living up to our mission.”
This article appears in the December 2023 issue of All of Us Research Roundup. Subscribe to receive future issues of the bimonthly researcher newsletter.
All of Us is a registered service mark of the U.S. Department of Health & Human Services (HHS).