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The National Institutes of Health (NIH) is treading carefully and erring on the side of communication and inclusion in asking American Indian and Alaska Natives to participate in the All of Us precision research initiative.
As part of this ambitious project, the NIH is seeking the DNA of 1 million Americans that reflect a broad diversity of racial and socioeconomic conditions. The precision medicine initiative will use whole genome sequencing and other cutting-edge tools to create, aggregate, and analyze individual health data for years into the future. (For more information, see the April 2018 issue of IRB Advisor.)
A Native American working group has delivered a report to the NIH about the complex issues to be addressed if tribes are to participate. The report is under review and the NIH currently has a moratorium on soliciting Native Americans to participate in the project until the issues are addressed.
“We are in the very early stages of information gathering and consulting so we can meaningfully engage these important communities,” says Alyssa Cotler, MPH, director of communications and marketing for the NIH All of Us Research program. “We’d be happy to have a discussion with you at a later time after we’ve completed our consultation.”
The report says many tribal nations are reluctant to participate in biomedical research due to “historical transgressions by both the federal government and researchers. The history of the government’s mistreatment of tribal nations includes forcible removal of tribes from their lands and attempts to eliminate their way of life, their social structure, and their culture.”1
Among the various examples cited about researchers, tribes report being misled about a study’s aims, publication of negative health information like use of alcohol, and subsequent use of biospecimens by later researchers that did not consult the native Americans.
“Tribes have also reported that researchers who have conducted studies on tribal lands failed to report to the tribe on their results,” the report states. “This has left tribal members feeling that they were used for the researcher’s own professional advancement and that they received no benefits in return.”
However, Native Americans have incentives to participate. They have a history of health problems brought on by poverty and social disparity, including a shorter life expectancy, high rates of liver disease and cirrhosis, diabetes, and suicide. In another striking example cited in the report, the infant mortality rate in American Indians and Alaska Natives is 60% higher than in whites.
Cynthia Pearson, PhD, a professor in the school of social work at the University of Washington in Seattle, is developing a curriculum to teach people about ethical research with American Indian and Alaska Natives.
“This is an excellent report, well thought out, and put together by a very astute group of individuals,” says Pearson, who is not on the NIH panel. “It clearly and succinctly covers some of the most important issues to consider when conducting research with American Indian and Alaska Native communities.”
The report1 by Tribal Relations Working Group outlines a series of themes and conditions that must be addressed by the NIH if native Americans are to participate in All of Us. These include:
• showing respect for tribal sovereignty;
• acknowledging that tribes — not genetics — establish an individual’s membership;
• acknowledging the history that American Indians and Alaska Native individuals and communities have had with the government;
• remaining responsive to the indigenous community as the program continues.
In addition, the plan for the All of Us Research to use a single IRB of record for the program may run afoul of tribal communities.
“While a single IRB may be sufficient for other populations, because of tribal sovereignty, NIH’s single IRB requirement does not apply to tribal nations,” the working group reported. “Therefore, All of Us must also obtain approval from a tribal and/or Indian Health Service (IHS) IRB, as applicable, when recruiting on tribal lands or at a tribal facility. When a tribe has an IRB, they have jurisdiction first, before the IHS IRB. When recruitment for research takes place on tribal lands, the tribe and the tribal IRB have jurisdiction.”
The program should seek to build trust through frequent contacts and provide cultural sensitivity training to address the ethical and cultural issues of Native Americans, the panel advised.
Spero M. Manson, PhD, director of the Centers for American Indian and Alaska Native Health at the University of Colorado Anschutz Medical Campus, is co-chairman of the tribal working group. He spoke to IRB Advisor about the obstacles and opportunities to Native American involvement in All of US in the following interview.
IRB Advisor: The report cites several historical examples of indigenous people being misled or misused in the context of human research. How did we get to the point now where you are trying to facilitate a way to join the All of Us project?
Manson: Under Dr. Francis Collins’ leadership, work proceeded — now 20 years ago — to map the human genome. American Indian and Alaska Native communities did not participate to the extent that was desired by the NIH. It was largely because of the lack of attention to all the sensibilities that surround research in native communities. There is a long historical set of circumstances that we recapitulate in the report. To Dr. Collins’ credit, when that work on the human genome translated into the precision medicine initiative, and now the All of Us research program, he realized that he needed to encourage outreach and education to American Indian and Alaska Native communities.
We knew this could enable us to examine the interaction of our genomic, lifestyle, and behavioral factors that contribute to risk, and ultimately may help us target therapeutics more effectively in addressing a wide spectrum of various kinds of diseases and disorders.
IRB Advisor: So, your committee was formed in part to guide and facilitate this NIH outreach.
Manson: The NIH began soliciting tribal communities’ input about concerns, and the types of recommendations that might follow from those concerns, to ensure appropriate and full engagement in the All of Us Research program. That’s the history behind the formation of the tribal working group. Our membership represents tribal communities, providers, family advocates, etc. We met beginning in October 2017 by phone repeatedly — and then ultimately face to face in March 2018 — to identify the major areas of emphasis that a guidance document of this type should have.
IRB Advisor: While you do include recommendations, the report also raises a lot of issues that the NIH needs to be aware of in involving indigenous people in research.
Manson: It was clear that the document needed to perform several different functions. One is, we were constantly impressed by the lack of remembrance or just simple ignorance surrounding these issues in tribal communities. We thought it was really important to highlight some of the key factors regarding tribal sovereignty and matters of historical traumatic circumstances in terms of research with native communities. There was careful attention to that.
It has also been our experience that many people — not just at NIH, but throughout the federal government — are not aware of the structure, process, and organization in tribal communities. We saw a major role of this document of being one of education — placing the research experience of tribal communities within that historical context. There are a series of recommendations in there that are meant to encourage inclusion of American Indian and Alaska Native representation in domains around governance, protections, and review.
IRB Advisor: You note that the report has gone through a government-tribal reconciliation process. Why is that important?
Manson: Federally recognized tribes represent domestic sovereignties and thus constitute a form of government that our federal government needs to acknowledge and work with as co-equals.
IRB Advisor: What stage are you at now with this process?
Manson: Letters are being drafted to tribal leaders across the country about this particular guidance document. This is a strategy for engaging tribal leadership and other representatives of tribal communities to make sure that they are aware of it, that they have access to it, and that they have an opportunity to provide comment. That will take the next three to four months, and at that time, we anticipate it will be largely adopted in its current form.
Then it will return to NIH, and assuming that they concur and adopt it, the current moratorium on the outreach recruitment of engagement of American and Alaska Native people in the All of Us research program will be lifted. It’s important to note that the NIH felt so strongly about the importance of this kind of guidance and critical nature of the relationship with tribal communities that they put a moratorium on the recruitment of all American Natives until this guidance document has been fully vetted by tribal leadership.
IRB Advisor: So you took that as a show of good faith?
Manson: I think the NIH moratorium on recruitment of American and Alaska Natives in the All of Use program is a very clear indication of the nature of their commitment to doing it right. We are taking time and making sure that it is very adequately presented to tribal leadership in a meaningful and authentic way.
IRB Advisor: Can the historical atrocities be overcome? Can enough trust be restored that you will get good participation from these indigenous communities?
Manson: Absolutely, we are already seeing some indications of that emerge. It is not across the board yet because I think there were some communities violated more fully and aggressively than others. We see different levels of trust being established across the county. This is another move to attempt to do that more broadly and nationally. I think that the attention the NIH has given to this matter in the context of this precision medicine All of Us research program is being well received by the tribal communities.
IRB Advisor: The report notes that tribes may have individual IRBs that need to be respected and brought into the process.
Manson: As part of the outreach program, there will be discussion on mutual collaborations between tribal IRBs and community boards and the All of Us program. One of the recommendations in the report is that there actually be an American Indian or Alaska Native appointed to the All of Us research IRB. So that presence is there at the highest level of review. I think there are a variety of different options that are available, none of which are likely to be a panacea. We just have to navigate our way through these matters.
IRB Advisor: It may surprise some not familiar with tribes and indigenous ways that membership to a certain tribe is not necessarily dependent on a DNA test from some of the popular swab kits on the market.
Manson: Yes, people use these and say suddenly ‘I’ve realized I’m 30% Native American. How do I go about acting on that and become a tribal member?’ There is a misconception about how American Indian and Alaska Native tribal membership is defined and implemented. As a part of their sovereignty, each tribe is authorized to development their own criteria for membership.
In the vast majority of tribes, it is something called “blood quantum,” which is a percentage of hereditability or heritage that can be documented through descent in birth records. The Bureau of Indian Affairs is the central archive for all of that information. So in some tribes you have to be able to demonstrate a 25% blood quantum, and in other tribes, it is 50%. There are also tribes that don’t have a blood quantum criteria. For example, the Cherokee Nation of Oklahoma. Their criteria is that you are able to demonstrate descent from one of the original signatories to the Dawes Act in the late 1800s, which was the federal action that actually defined the relationship between the federal government and the Cherokee Nation. So, you can see then that estimates of ancestry as reflected in these DNA assessments don’t align with tribal definitions.
IRB Advisor: How do you view this process as an individual Native American?
Manson: I and my family are from the Turtle Mountain reservation in North Dakota. We are from the Pembina Chippewa tribe. It is very much a part of one’s identity, but I am also a father, a grandfather.
We talk these days about identify in terms of intersectionality. That means there are different aspects of who we are that come together in a variety of different ways to understand our place in the world culturally and otherwise. Identity is very important, but it is identity in context: understanding how that identity can pose risk or serve to protect one from the contemporary pressures that modern day life poses for Indian people.
1. Malerba L, Manson S, Brilliant M, et al. Considerations for Meaningful Collaboration with Tribal Populations: The Tribal Collaboration Working Group Report to the All of Us Research Program Advisory Panel. April 4, 2018. Available at: https://bit.ly/2C66FDA.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.