The first step is talking with AI/AN people and tribal governments about what they need from a research program.
The All of Us Research Program is committed to including people of many different backgrounds, especially those who have been left out of or left behind by health research in the past. Previous health research has not included many American Indian and Alaska Native (AI/AN) people, so the research results may not reflect their health or experiences. This means that AI/AN people may not benefit from research discoveries. All of Us wants to help change that—and it’s very important to us to do it right. The first step is talking with AI/AN people and tribal governments about what they need from a research program.
The first step is talking with AI/AN people and tribal governments about what they need from a research program.
The All of Us Research Program began formal meetings called “consultations” with Tribal Nations in 2019 about including AI/AN participants in the program. The input from Tribal Nations helped All of Us decide how to proceed. Read on for more details about our plans.
Tribal Sovereignty and Research Participation
Federally recognized tribes in the U.S. are sovereign nations. That means they have their own governments and their own laws. All of Us will respect tribal sovereignty by working with Tribal Nations to make sure that any health research that uses program data or samples from members of a Tribal Nation is done in a way that respects tribal customs, culture, and laws. All of Us will also work with tribes to support research that matters to them.
All of Us has committed to never recruit program participants on tribal land without the permission of the tribe. All of Us will also not list a participant’s tribe in the program database except when participants enroll in partnership with their tribe.
Because some ZIP codes belonging to tribal lands or other places where many AI/AN people live could make it easier to identify participants, All of Us does not include ZIP codes in its public Data Browser, and the program includes only limited geographic information in the data that researchers use.
After September 30, 2021, data and samples from all AI/AN participants who wish to stay in the program will be added to the database.
Some All of Us participants marked that they were AI/AN when they signed up for the program. All of Us wants to make sure that AI/AN participants are treated fairly and that their data and samples are used in a way that respects participants’ culture and laws. We decided not to add those participants’ data to the database right away. If AI/AN participants gave blood, urine, or saliva, we also set those samples aside. First, we wanted input from tribal leaders about how to use the data and samples respectfully. Now that our plans are final, participants have a chance to learn more and speak with their tribal leaders before deciding whether to stay in the program. After September 30, 2021, data and samples from all AI/AN participants who wish to stay in the program will be added to the database.
After September 30, 2021, data and samples from all AI/AN participants who wish to stay in the program will be added to the database.
Cultural Sensitivity
All of Us takes special care with samples from AI/AN participants. If an AI/AN participant withdraws from All of Us or passes away, we will wait to hear from them or their family about what to do with their samples. If they no longer want their samples used for research, we will dispose of the samples after a blessing ceremony held by traditional healers, elders, or invited tribal community members.
Data Access, Use, and Protection
We work hard to keep our data and samples private and safe. We remove any obvious identifiers from data used for research. This means that names, addresses, and other identifying information are separate from the health information.
When someone joins All of Us, they agree to let health researchers study their data and samples. If someone decides to join, their information will be available for many research studies. We will work with Tribal Nations to make sure that tribal leaders and members understand this part of the program. When All of Us makes an agreement with a tribe, we will work with that tribe to create a way for the tribe to review possible research studies involving them.
Some tribal leaders are concerned about how conclusions made about AI/AN participants might hurt tribal communities as a whole.
Some tribal leaders are concerned about how conclusions made about AI/AN participants might hurt tribal communities as a whole. Researchers must agree not to use All of Us data to do studies that could cause harm or stigma for individuals, groups, families, or communities. The program’s Resource Access Board (RAB) will monitor the database and the people who use it. If someone breaks this rule, the RAB will review the case. The program will also tell the National Institutes of Health’s Tribal Advisory Committee (NIH TAC).
Some tribal leaders are concerned about how conclusions made about AI/AN participants might hurt tribal communities as a whole.
All of Us will make a list of experts who can review any research that proposes using samples or data from AI/AN participants. We will also work with tribal leaders to help train researchers how to use this data. And we will increase the number of AI/AN researchers using the data.
Representation
We want to be sure that AI/AN people feel truly represented in All of Us. That is why we are working to include more AI/AN people in our program. Our RAB, Institutional Review Board, and Biospecimen Access Policy Task Force all have AI/AN members. We also consult AI/AN experts through groups such as our Tribal Collaboration Working Group to make sure we are doing things right.
Privacy
By studying how people’s genes, environment, and life circumstances affect health, researchers can learn more about why people get sick and how to help people stay healthy. All of Us wants to find out more about how these factors connect. But we recognize that some kinds of data, including DNA, must be handled with extra care. Right now, we are not using DNA data from AI/AN participants. We want people to have time to learn more and talk with their tribal leaders before they decide whether they want to stay in the program and get their DNA results. After September 30, 2021, DNA from AI/AN participants who choose to stay in All of Us will begin to be added to the database.
All of Us has put rules in place to help protect this sensitive data. Researchers who want to use the All of Us database have to agree that they will not try to find out who our participants are or what tribe they are from. Our Committee on Access, Privacy, and Security is also working to help us lower the risk of anyone being identified.
Researchers who want to use the All of Us database have to agree that they will not try to find out who our participants are or what tribe they are from.
Publications and Partnerships
In the future, researchers who use data from AI/AN participants may need to show the program their results before publishing. We will tell the NIH TAC when results about AI/AN health are published. We will list these publications on our Tribal Engagement webpage.
Tribal leaders have recommended that All of Us work with researchers and institutions that have trusted relationships with tribes, such as the Tribal Epidemiology Centers and Native American Research Centers for Health (NARCH) grantees. As our program works to make those connections, we are also planning to work with experts in research with tribal communities to create a researcher training workshop and an AI/AN research priorities workshop.
What Do AI/AN Participants Do Next?
All of Us encourages current and potential AI/AN participants to speak with their tribal leaders.
If current AI/AN participants want to stay in All of Us, they do not have to do anything. We will begin sharing their data and samples with researchers after September 30, 2021.
If current AI/AN participants decide that they do not want to stay in the program, they can withdraw by September 30, 2021, to avoid having their data or samples ever shared with researchers. After that date, they can still withdraw at any time and tell All of Us to not use their data or samples in any future studies.
If you identify as AI/AN and want to participate in All of Us, we ask that you:
