Tribal IRBs shape research in native populations

IRBs can point out potential harm to communities

Across the country, Native American communities have begun setting up their own research processes — in some cases, their own separate IRBs — to review research proposals involving these unique populations.

The processes differ from place to place, but have the same goal: Ensuring that research proposals don't cause harm to either individuals or the community as a whole, and that they return maximum benefit to the tribes and communities they study.

In many cases, IRBs or other review processes were formed as a result of past research that the communities saw as harmful. William Freeman, MD, MPH, CIP, human protections administrator at Northwest Indian College in Bellingham, WA, says some tribes burned by previous experiences with researchers set up new review processes to gain control over how their members and their community are used in research.

"When tribes establish their own IRBs, it transforms the situation so they feel confident that their issues of protecting maximizing benefits to communities will be met in this process," Freeman says.

'The committee that said no'

That advocacy for the community can make an IRB or review committee extremely choosy about the projects it allows — at least until it has educated researchers about its expectations, says Mary Frances Oneha, APRN, PhD, director of quality and performance at the Waianae Coast Comprehensive Health Center, Waianae, HI.

"We were actually known as 'the committee that said no' for the longest time," she says. "Because many of the proposals that came to us did not take into consideration the process or challenges that community health centers currently face or what has gone on in this community in the past."

But both Oneha and Freeman say tribal and community IRBs have been able to establish cooperative relationships with outside researchers and IRBs, bringing a new perspective to the protection of research subjects and the communities to which they belong.

Freeman, who previously chaired the national Indian Health Service (IHS) IRB, says the current federal regulations pertaining to research have a major omission — the protection of communities, rather than simply individuals.

He says research done badly or good research disseminated without care can do real harm to communities. For example, in the 1970s, researchers went to Barrow, AK, to study the effects of alcoholism. The resulting study, whose results were reported in Eastern U.S. newspapers, caused problems for Barrow's attempts to sell development bonds on Wall Street and left many community members feeling stigmatized.

In 2004, the Havasupai tribe in Arizona sued Arizona State University, alleging that researchers who had come to their tribe to do genetic research on diabetes also did schizophrenia and migration research on the tribe without permission. "I have been told that experience has really riled the Havasupai tribe — if anybody wants to do research now on the Havasupai people, you can just forget it for a while," Freeman says.

In addition, groundbreaking CDC research on the 1993 hantavirus that affected the Four Corners region of the Southwest exposed the Navajo people living in that area to unwanted invasions of their privacy, Freeman says.

Over the objections of Navajo health officials and Freeman at the IHS, researchers published papers that explicitly named Navajo chapters that were affected by the disease. Freeman says he had suggested using anonymous place names (Community A, Community B, etc.) or geographic information systems (GIS) codes, to no avail.

While characterizing the CDC's work as an incredible scientific achievement, he says many Navajo people felt harmed by the disclosure of the Navajo place names. As a result, the Navajo Nation established its own IRB.

Tribal IRBs, review committees

The controls that tribes place on research vary, Freeman says. Tribal governments in general may prohibit researchers from entering the reservations, which in effect stops the research. Some tribes have IRBs in addition to a tribal government, and the two often work in tandem.

In some instances, tribes coordinate with a nearby tribal college or university IRB. Freeman's own IRB at Northwest Indian College is in the process of coordinating with the Lummi Nation to possibly develop a combined IRB.

For researchers who wish to study the Native Hawaiian population served by the Waianae Coast Comprehensive Health Center, Oneha says the health center's IRB is only part of the review process. While she notes that the health center IRB does not control all research within the community, it does control any research involving the health center.

Proposals submitted to the center first must go through a review committee that asks many of the hard questions about protecting the community and returning results to people later: What is the community involvement? What collaborative arrangements have been made? How will the data be used? What is the dissemination process?

By the time the study reaches the IRB, that process is not much different than it would be at any other institutional review board, she says.

When a proposal is rejected through this process, it's often because researchers haven't thought through the demands it places on the health center's resources, or it involves a medical condition that isn't a priority for the community, Oneha says.

Freeman says that when tribal IRBs and outside IRBs review the same study, both can bring added value to the process.

He cites one example, in which a study of organ donation was improved by issues raised by both the tribal review and the university IRB.

"Every tribal IRB I know of appreciates any other IRB that's involved," Freeman says. "It's not seen as an either/or — it's seen as an addition. Many tribal IRBs want to see the university IRB approval first, before they even look at it. University IRBs where there's a fair amount of research being done with tribes are increasingly recognizing the authority of tribal IRBs and [acknowledging] that they have perceptions, understandings and concerns that their own IRB and researchers may not have."