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By Gary Evans
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians (NCAI.) A key part of the dialogue is letting American Indian/Alaska Native (AI/AN) Tribal Nations ask questions and express concerns about the project.
In a June 3, 2019 webinar,1 Native American leaders outlined the general concerns of their people. Eric Dishman, PhD, director of the All of Us research program, fielded questions from indigenous community members. The All of Us project aspires to collect DNA from 1 million people, including populations that traditionally have been exploited and misled about human research. The invitation to participate comes with the acknowledgement of unethical research in the past.
One example of how research on indigenous people can go horribly wrong is the case of the Havasupai Native American tribe in Arizona, which lost their lands to white settlers and fell into mental health and addiction issues. Researchers conducting a study ostensibly on diabetes and other health problems in the tribe subsequently published findings on their high rates of schizophrenia and alcoholism, much to the consternation of the Havasupai. (For more information, see the December 2016 issue of IRB Advisor.)
“We have been working with community partners all around the country to talk explicitly about historic examples of the absolute failure and wrongdoing of federal and other researchers on tribal communities and other diverse groups,” Dishman said. “We put together some materials that train people clearly to understand what new laws and protections are in place so we can never allow those atrocities to happen again.”
Indigenous people “have been studied quite a bit. Some of the experiences of that have not been positive,” said Aaron Payment, EdD, chair of the Sault Ste. Marie Tribe of Chippewa Indians, and first vice president of the NCAI. “Tribal communities are a little reluctant and very skeptical — and rightfully so. Concerns that we have are human samples and how those are used, and the cultural appropriateness of how to approach people in our tribal communities with research. Also, making sure that our data are not just aggregated to expose our vulnerable populations. We must make sure the data are used responsibly.”
With those considerable caveats, Payment expressed a strong interest in the All of Us research, both individually and in its potential to improve the health of indigenous people.
“I share this personally; I have an Indian and mixed physiology,” he said. “I exercise and I am vegan, and I still have elevated blood pressure and cholesterol. I am very keenly interested to figure out what it is specifically that I need to do to live my best healthy lifestyle. I have chronic disease in my family and I am doing my best to try to fight that off. I think precision medicine is really going to help us pinpoint what exactly we need to do.”
Spero Manson, PhD, co-chair of the Tribal Collaboration Working Group of the All of Us Research Program, said tribal sovereignty must be recognized and respected if indigenous people are to participate. The working group released a report2 that remains under review as the NIH moves forward cautiously in light of past mistakes.
“We know that the All of Us program has a single, dedicated IRB, but many of our tribal nations have their own institutional review boards that serve a wide variety of different purposes,” Manson said. “We feel strongly that these review boards ought to have equal footing with the All of Us program’s dedicated IRB. These considerations need to be taken into careful account as work unfolds in reservation lands.”
Further, the Indian Health Service has jurisdiction in off-reservation programs where its staff, resources, or facilities remain involved in any matter related to recruitment of Native Americans, he emphasized.
“Also, there has been an enormous amount of discussion about the care and safeguards that need to be taken to address the unique aspects of the storage and access to biospecimens [from] native communities,” Manson said. “Lastly, the notion that the protections and benefits accrue not only to the individual but to the tribes themselves. There is a real responsibility to engage our communities in ensuring that the kinds of questions that we believe are a priority are carefully considered and are part of the research agenda.”
Nearly a quarter-million people have joined All of Us since it began May 6, 2018, Dishman said. That includes some 150,000 people who have completed the initial protocol, with 80% of them from historically underrepresented groups in research. However, the program is not currently recruiting AI/AN participants. People may sign up individually, but the NIH is holding off on active recruitment in tribal communities until the ongoing meetings and discussions reveal an ethical path forward.
Dishman gave the following interview for IRB Advisor, which has been edited for length and clarity.
IRB Advisor: Regarding minimization of risk for stigmatizing research, what will be your power to terminate research that is determined to be unacceptable? Also, will a tribal representative serve on the board that evaluates what is stigmatizing?
Dishman: The Research Access Board — which you will hear us call the RAB — will include AI/AN representatives from our consortium. We are just starting to form that group now. They have been working on policies for a while. There are many ways in which this program is different, but one of them is the nature of requiring the researchers to really post details about their research before they get started with it. Our RAB will be able to stop research or take access away in an extreme case if someone is performing inappropriate research. But because all that is public, anybody could come along and say, “I do not really understand what this researcher is doing” and ask our board to review the research more closely. That is the kind of transparency that we want to make sure is out there so that anybody can look, see that something just does not make sense, and the RAB can take a look.
IRB Advisor: Who performs research audits? Will they recognize the cultural sensitivities to flag if the research has the potential for cultural harm?
Dishman: The RAB will perform audits. Many of them are experts in ethics and in issues pertaining to stigmatizing research. This is going to be something in itself that we want to certainly hear from tribal groups as well as other racial and ethnic minorities who also have been harmed by the federal government and research in the past. What should we be looking for? Computer algorithms also will look for keywords to audit the materials to make sure that something inappropriate is not occurring. This is a great opportunity in our consultation process to seek help from tribal communities. How do we know stigmatizing research when we see it, and what are the characteristics we should look for?
IRB Advisor: It is a lot of work for one person to maintain good relations with the tribes, especially for a national research program. Do you think it is possible to hire more than one tribal liaison?
Dishman: I am open to all kinds of arrangements. There is no doubt that we need a village of people — some who are feds and some who are consultants and experts in the field. We are going to build a team that is much larger than one across all those different kinds of capabilities. I can tell you that in my experience that it can be very challenging to hire into the federal government, so we need to be open to other ways of hiring people and getting that expertise on board. I completely agree this is far more than one person’s job.
IRB Advisor: How does the research benefit each tribal member if you did not have researchers accessing the data?
Dishman: Our hope is to work with and through this consultation process and work with the [Tribal Assistance Coordination Group] to develop a way where many tribes would feel comfortable with active recruitment in their own communities and nations. At that point, you would want the database to reflect that we had people signing up who not only self-identified as AI/AN but also were validated by their tribe. That is another great question to address during this consultation process. What would it take for us to do tribal affiliation correctly, to do some sort of validation? At that point, if we can figure those things out, it will be very important to include that individual’s information in the research.
IRB Advisor: There is a challenging issue regarding big data sets and the possible identification of individuals based on other available data. How do you plan to protect the identification of tribes and individuals in the data set?
Dishman: We have an entire security and re-identification team as part of what we call our DRC, the Data and Research Center. The team continues to develop anti-identification strategies across many issues, not the least of which is ZIP code, for example. You might have noticed that ZIP code, first of all, would only be accessible if you are in Tier 3 of data access as a researcher. That is the most secure area of data access. We are developing a set of not just policies but also algorithms and human-audited activities to make sure that re-identification is not occurring. It is a bit like security and hackers. People and techniques for re-identification get better, and then we develop better techniques to keep them from re-identifying. Staying on top of that science and that technology is paramount to our success over time. We have got some of the best people in the country working on that issue. As technology changes and new data types come along, we will know how to continue to focus and not let re-identification happen.
IRB Advisor: Historically, issues regarding unauthorized, secondary data use have resulted from investigators who share data with other investigators, including students, without notifying the tribes. How will this level of data use and sharing be monitored and prevented?
Dishman: That is a great concern, and one that has driven the decision to require all researchers to come to our secure domain to be able to do their research. You can imagine that is going to limit, in some cases, researchers who say, “I wanted to pull all of your data into my own tools at my university.” We are trying to put as many common tools in place so we will not have that problem. If we did not require everyone to come to the data, then the risk that the question talked about grows higher and higher. The key decision right away was to protect all of these data in an enclave where it can be monitored by both humans and algorithms to make sure the right thing is happening and the wrong thing is not happening.
IRB Advisor: If, after the consultation, tribes only want their data to be available in the Tier 3 or controlled circumstance and do not want any American Indian data available publicly, is that something the All of Us Research Program could accept?
Dishman: I think that is certainly the discussion that we ought to have. Infrastructure-wise, we have some of those capabilities now and others could be built. That is partly what we want to understand, and how, in particular, if we are doing active recruitment on tribal lands, that is a very different scenario than somebody signing up and self-identifying as American Indian/Alaska Native. We should always make that clear, as the working group report recommends. These people are sort of self-identified. I think at the point in which we are engaging tribes to recruit on tribal lands — which means you are separate, sovereign nations — we should have discussions about the things you want to see in place to facilitate that.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.