895 lines
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<h1 class="page-title">NIH to enhance tribal engagement efforts for precision medicine research</h1>
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March 29, 2021
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<p>Tribal leaders inform <em>All of Us</em> Research Program’s next steps to include tribal communities</p>
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<p>The National Institutes of Health will expand and strengthen commitments to respectfully engage American Indian and Alaska Native (AI/AN) people and support their inclusion in the <em>All of Us </em>Research Program, a landmark health research effort that aims to find more precise ways to prevent and treat disease. In response to tribal leader input gathered from a nearly two-year consultation process, <em>All of Us</em> will initiate specialized education efforts for researchers, take steps to ensure the perspectives and needs of AI/AN communities are integrated into the program, and support ongoing engagement activities with Tribal Nations to pave the way for expanded collaborations in the future.</p>
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<p>“We have a real opportunity to help address underrepresentation in research and uncover factors that contribute to health disparities,” said <em>All of Us</em> Chief Operations Officer Stephanie Devaney, Ph.D. “But we must go about things in the right way, in partnership with communities. For us, engaging in Tribal Consultation is a critical element in fostering the ongoing dialogue needed to achieve those goals.”</p>
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<p><em>All of Us</em> seeks to build one of the largest and most diverse biomedical resources in history, with 1 million participants nationwide. The program has a special focus on engaging communities that have been left out of past research, such as American Indians and Alaska Natives, to close information gaps and help increase health equity.</p>
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<p>In its consultation report, <em>All of Us</em> leaders reaffirmed a set of baseline commitments to Tribal Nations, including rules to never recruit on tribal lands or disclose participants’ tribal affiliations without a tribe’s agreement. Further, the program committed to continue holding back the data and samples of self-identified AI/AN participants from researchers for an additional six months; that allows time for participants to learn more about the Tribal Consultation, speak with their tribal leaders, and decide whether to remain or withdraw—before any AI/AN information is ever shared for research.</p>
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<p>The program also highlighted plans to create a training for researchers on the responsible use of AI/AN data, and to explore hosting workshops with AI/AN researchers and community members to learn more about tribal communities’ research priorities. These steps add to the work the program has already done to expand representation of tribal members within its governance.</p>
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<p>There are 574 federally recognized tribes within the United States, each with their own governments and laws. The formal Tribal Consultation process supports engagement with Tribal Nations on a government-to-government basis, respecting tribal sovereignty.</p>
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<p>The <em>All of Us</em> consultation was one of the most extensive Tribal Consultations that NIH has held to date, encompassing multiple events across the country, a formal request for information, and comment periods for tribal leaders to weigh in on draft proposals. The consultation was scaled to match <em>All of Us’s</em> national scope, but also reflects a growing momentum across the agency to expand tribal engagement efforts generally.</p>
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<p>In some cases, <em>All of Us</em> did not incorporate recommendations from tribal leaders. For example, some tribal leaders recommended that the program give self-identified AI/AN participants the opportunity to opt in or out of each study involving AI/AN data. However, the program determined that individual study consent would not be compatible with the program’s “data passport” model, which is specifically designed to encourage broad exploration of the dataset by approved researchers and enable thousands of studies across different health topics. <em>All of Us</em> explains its approach to broad data use in the consent process so prospective participants understand this element of the program before signing up. The program has now added more details on its website so that current and potential AI/AN participants know about tribal leaders’ perspectives, too.</p>
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<p>“We know tribal leaders have many different views about participation in research, and that’s why we’re committed to a robust consent process and encouraging all members of tribal communities to speak with tribal leaders,” said Michael Hahn, <em>All of Us’s</em> tribal engagement lead. “We hope this consultation is a signal to tribal leaders that we’re listening. These initial discussions were an important step forward on our way to future engagement efforts, as we seek to continue building relationships with Tribal Nations. We’re committed to working together to make <em>All of Us</em> an inclusive program that benefits AI/AN participants and their communities.”</p>
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<p>To read the report and learn more, visit <a href="/tribalengagement">http://www.allofus.nih.gov/tribalengagement</a>.</p>
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<p>“<em>All of Us</em>” is a registered service mark of the U.S. Department of Health & Human Services.</p>
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<div class="text-center"><strong>###</strong></div>
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<p><span> </span></p>
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<p><strong>About the <em>All of Us</em> Research Program:</strong> The mission of the <em>All of Us</em> Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the United States to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit <a href="http://www.joinallofus.org/">www.JoinAllofUs.org</a> and <a href="http://www.allofus.nih.gov/">www.allofus.nih.gov</a>.</p>
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<p><strong>About the National Institutes of Health (NIH):</strong> NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <a href="https://www.nih.gov/">www.nih.gov</a>.</p>
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