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The Havasupai Tribe’s 1994 lawsuit against Arizona State University (ASU) researchers and the institution illustrated some of the particular problems and challenges related to research involving Native American tribes.
The long legal battle raised questions about researchers using tissue samples without complete informed consent and without permission from the tribe. It also highlights how difficult it is to obtain and retain trust when research studies clash with cultural traditions.
“Historically, for decades now, there has been a mistrust [among native tribes] for western research and researchers, in general, because of unethical practices done in the past,” says Jyoti Angal, MPH, CIP, director of community-based research for Sanford Research in Sioux Falls, SD.
In the Havasupai case, the tribe claimed researchers failed to provide adequate informed consent for how blood samples would be used. The study began as a diabetes project, but evolved into studies of schizophrenia, migration, and inbreeding — all of which the Havasupai consider taboo topics and for which investigators had not obtained informed consent, according to the American Indian & Alaska Native Genetics Resource Center. (For more information on the study, visit http://bit.ly/1LP01ML.)
The lawsuit also claimed that ASU researchers violated civil rights through mishandling of blood samples, unapproved use of data, and violation of medical confidentiality because the tribe was named and could lead to a risk of identification of individuals.
After 16 years of court battles, ASU settled with the tribe in 2010. The tribe received $700,000 for tribal members, funds for a clinic and school, and return of DNA samples.
In recent years, tribal nations begun forming their own ethics review boards, enabling tribes to have an active voice and role in research. This trend suggests the need for IRBs to work with tribal boards to create tools and resources that will educate and inform tribal IRB members.1
Sanford Research in Sioux Falls, SD, which is part of the Collaborative Research Center for American Indian Health, is working to bring together tribal communities and researchers in the Dakotas and Minnesota, Angal says.
The Collaborative Research Center was funded by a National Institutes of Health (NIH) National Institute of Minority Health and Health Disparities grant in 2012, she says.
“We’re building capacity for tribes to conduct and govern their own research,” Angal says. “Our role is to help tribal communities that are interested in creating their review process and building their capacity to review their own research and also to streamline their research process.”
The current trend is to do more than just participate in research. Tribes want to review and authorize research conducted on their land, so this raises their interest in creating IRBs. “They don’t want a large IRB process,” she notes. “It could be a smaller, alternative community advisory board model.”
The Collaborative Research Center’s role is to work with tribes to decide what type of research review they want.
“We have six tribes we’re working with right now and four of them have IRBs; the other two are still in the process of building a process,” she says.
“We put together a tribal IRB toolkit that is available online at our website as a free download for anyone who wants to use it,” Angal says. “This toolkit was put together in response to requests by our tribal partners.”
The toolkit addresses what an organization will need to start a tribal IRB and includes answers to questions about obtaining approval from the tribal council. (For more information on the tribal IRB toolkit, see related article in this issue.)
The following is how the toolkit’s Tribal IRB Review Submission and Review Process works, according to one of the sample flow charts:
The toolkit even addresses the most basic of questions that a new IRB might ask, such as, “What do I call my IRB?”
Angal researched this question and found that federal regulatory agencies do not provide guidance on the IRB’s name. “We came to the conclusion that you can call it whatever you want,” Angal says. “But when it’s registered, it’s registered as an IRB, and that was new learning for us.”
One of the goals in developing the toolkit was to provide details about processes according to what the tribes wanted to include. For instance, the approving authorities of tribes made suggestions and reviewed drafts. This gives tribes a voice they usually lack, Angal notes.
“One of the biggest differences between academics and tribal dissemination is that, typically, publications from scientific studies do not go back to the IRB for review,” she says. “However, tribal research requires publications to come back to the tribe IRB.”
The reason for this is to prevent community harm. For example, a tribe that participated in a study involving prenatal alcoholic exposure may not want to be named in the study because of stigma, she explains.
Tribal IRBs can help make the research design stronger, and it improves community engagement in research, Angal says.
For example, when research involves the collection of biospecimens, a tribal IRB will know how biospecimens are sacred in some cultures, she says.
“You need to look at what it means culturally to them,” Angal says.
When researchers wish to collect specimens for a study, they can talk about how members of the tribe do not have to consent to future uses of those specimens if that particular study is approved. This might be a more comfortable approach for a particular tribe, she adds.
“The toolkit was created in response to a tribal request,” Angal says. “It goes back to the thought that you don’t tell people; you work with people and give them respect and help them and ask them to tell us what their needs are.”
Editor Melinda Young, Managing Editor Jill Drachenberg, Associate Managing Editor Dana Spector, Physician Reviewer Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, RN, PhD, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.