Volume 16 Winter 2004 Issue No. 2

Blood, Lies, and Indian Rights
TCUs becoming gatekeepers for research

by Juan A. Avila Hernandez

A wayward research project shattered the trust last year between Arizona State University (ASU) and a small American Indian tribe in the bottom of the Grand Canyon. The incident brought home to tribes across the country the dangers of medical research.

A Havasupai tribal member, Carlotta Tilousi, discovered in the summer of 2003 that genetic samples from her community had been misused. Initially, tribal members had requested help with their diabetes epidemic, and university researchers responded, taking blood samples from 200 volunteers between 1991 and 1994, according to a university investigation.

Researchers said the blood samples were for diabetes-related research. In addition, however, some of the ASU researchers sought to study the links between the Havasupai genes and schizophrenia, inbreeding, and the Bering Strait theory (which claims Native Americans migrated to the Americas from Siberia), according to the university's 152-page report.

In a multi-million dollar lawsuit they have filed against the university, tribal members involved in the diabetes project and the Havasupai Tribe argue that ASU researchers had "intentionally deceived" them during the research project.

Researchers contest some of the Havasupai claims. However, they also blame each other for not fully disclosing the true nature of their medical research, for "lying" to tribal members, and for distributing genetic samples to other researchers, according to the report.

Preventing Exploitation

This scandal exposed once again the need for tribal governments and Native American communities to get involved in regulating research on human subjects. In response to this need, tribal colleges and universities (TCUs) are slowly but increasingly adopting procedures to make themselves gatekeepers for research conducted at their schools and among their affiliated American Indian communities.

They want to prevent exploitation of Indian people, train their own students in research, and encourage the medical research field to meet the health needs of the Indian community.

By establishing Institutional Review Boards (IRBs), growing numbers of tribal colleges and universities are able to closely review and monitor the procedures and ethics of researchers in their communities. In addition, TCUs hope that the students can take the idea home to their own tribal governments. Tribes that desperately need health research can adopt laws for protecting individuals and their communities from harmful and deceptive research.

Dr. William L. Freeman of Northwest Indian College (NWIC) in Bellingham, WA, is perhaps the foremost expert in the country on creating safeguards for human studies at universities, research institutions, and tribal colleges and universities.

He chaired the Indian Health Service (IHS) Headquarters IRB for 11 years and currently leads the Northwest Indian College IRB, as well as being the tribal college's head of Tribal Community Health Programs. He speaks at national research conferences and fields a steady stream of questions from tribal college administrators about the process of creating an IRB at their schools.

Congress in 1974 passed the National Research Act, which introduced the requirement for IRBs, according to Freeman. Congress recognized the need to protect research subjects from negligent practices, such as infecting unknowing people with syphilis, as was done in the infamous Tuskegee experiment in the 1930s.

In the case of the Havasupai and ASU, however, the IRB safeguards failed. The ASU incident outraged Freeman. The university's IRB regulations should have been adequate to protect study participants, he says, but researchers did not meet the basic standards.

Historically, outsiders often have disregarded the needs and concerns of tribal people, he says. Increasingly, tribal colleges are becoming involved in conducting, directing, and influencing medical and behavioral research at their schools. "IRBs are opportunities for tribal colleges and universities to do things right in research," Freeman says.

At mainstream universities where faculty or staff receives federal funding to collect everything from oral histories to blood samples, both an Institutional Review Board (IRB) and Federal Wide Assurance (FWA) have been established. For example, anthropologists must fulfill IRB requirements if they want to collect oral histories from individuals or "observe" the behavior of groups.

On those campuses, an IRB committee reviews applications for such research and either approves or rejects them. The committee evaluates criteria such as the length of the study, safety procedures, and the wording of the participant consent form.

In order for researchers to receive their grants, they must get IRB approval first from their own institution. Then, that official approval is sent back to the funding agency, and the grant under scrutiny is released to the researcher.

A research conference at Haskell Indian Nations University (Lawrence, KS) in the spring of 2002 sparked the nascent but growing movement among American Indian college administrators to adopt federal procedures and rules for approving research projects.

"There's a heightened awareness and enthusiasm among tribal colleges," according to Freda Tapedo Gipp (Apache Tribe of Oklahoma) of the Haskell Office of Institutional Research and Sponsored Programs. She says many are asking her how to start an IRB or make an existing one better. As more schools apply for grants for critical programs like diabetes prevention, they are discovering that many federal agencies require that a college has its own IRB.

Research and Tribal Colleges

Scientific research and American Indian communities share a long, conflicted relationship, and abuses continue, Tapedo Gipp says. Her concerns about American Indians and researchers resonate clearly throughout Indian Country.

"Indian people are one of the most researched groups in the nation," says Dr. Susan Faircloth (Coharie), one of the organizers of the 2002 Haskell conference called "Research Review in Indian Country, Setting Our Future Agenda" and currently assistant professor in educational leadership and special education at Pennsylvania State University. "(We) are a highly vulnerable population because so much bad research has been done," she says.

An IRB is one mechanism for protecting Indian people. While the process may have been part of normal operations at many universities for decades, tribal colleges -- for the most part -- are only beginning to experience its benefits.

In a survey two years ago Faircloth found only 9 of the 35 tribal colleges had IRBs: Diné College, College of Menominee Nation, Nebraska Indian Community College, Sinte Gleska University, Northwest Indian College, Fort Peck Community College, Little Priest Tribal College, Sitting Bull College, and Haskell Indian Nations University. Interest among tribal colleges, however, seems to be growing, based on the number of colleges contacting Freeman recently.

To create the IRB at Haskell, Tapedo Gipp and Haskell President Dr. Karen Swisher (Hunkpapa Lakota) took Freeman's advice to do research on the World Wide Web and looked at the University of Kansas's IRB as their model. They went a step further and convinced the head of the University of Kansas's IRB Office, David Hann, to become a member of their IRB.

"Why re-invent the wheel? But we do have to take into consideration different aspects than other institutions," Tapedo Gipp says. For example, Haskell students often do research for their degrees on their home reservations where other protocol, such as respect for elders and the sanctity of oral history, may come into play.

Although it is only one year old, Haskell's IRB office has seen a lot of action. It has reviewed 13 applications for research on the Haskell campus, according to IRB Director Lou Edith Hara (Ponca Tribe of Oklahoma).

Often, Hara says, researchers from other institutions fail to include Haskell at the beginning and show up on campus unaware that at Haskell, a new level of approval awaits them. "They (outside researchers) have to get clearance if they are on our campus soliciting our students and faculty."

	Dr. William L. Freeman: "An IRB that's Indian-focused would help ensure that harm is done neither to individuals nor to the community." Photo by Jon Brunk
	Lou Edith Hara: "They (outside researchers) have to get clearance if they are on our campus soliciting our students and faculty." Photo by Lori Tapahonso
	Freda Tapedo Gipp: "There's a heightened awareness and enthusiasm among tribal colleges." Photo by Lori Tapahonso

The proposals and IRB forms that come through the Haskell IRB office are predominantly for funding purposes. The committee's responsibility is primarily safeguarding the research subjects from harm, she says.

Tapedo Gipp encourages tribal administrators not to be intimidated. "It's not a difficult process," she says. She emphasized the importance of training for committee members, however.

Freeman advises tribal administrators not to view the regulations as strict guidelines but as a flexible set of rules that can be shaped to fit the needs of the tribal student population and surrounding communities the college serves. For example, IRBs can safeguard the community mores for religious or social customs.

At Haskell, Tapedo Gipp and Hara say their IRB office will continue to grow and evolve. Sometimes they find it difficult to convey the reasons for their own passion and dedication to this work, but Tapedo Gipp is determined to convince students to think critically about research in their communities. "I think it will serve Indian Country and prevent some of the atrocities."

In light of the research scandal at Havasupai, Freeman says that the need for TCUs to review research is paramount. "An IRB that's Indian-focused would help ensure that to the extent possible, harm is done neither to individuals nor to the community," he says.

Juanan A. Avila Hernandez (Yoeme/Yoi) is an award-winning journalist and a Ph.D. candidate in history at the University of California-Davis.

How to Build an IRB

The best guide for tribal colleges and universities seeking to form an Institutional Review Board (IRB) is Dr. William Freeman's four-page guide, "Starting an IRB." It provides the essential government websites and basic IRB definitions. It also includes key suggestions for tribal college and university (TCU) presidents - who usually spearhead the IRB application- about selecting IRB board members and assuring their training.

The first step, according to Freeman, is to visit the Office for Human Research Protection (OHRP) website at the U.S. Department of Health and Human Services . Freeman's guide includes an attached IRB registration form and "helpful hints" tailored to TCUs to complete the IRB and the Federal Wide Assurance registration forms.

One essential step to setting up a tribal college IRB is selecting and appointing IRB board members. To operate, an IRB must have at least five members including both men and women; at least one member must be trained in a science such as a physician, social worker, or chemist; and one member must be a "non-scientist" - often referred to as the "community member" -- such as a member of a tribe, lawyer, or even a pastor.

Lastly, one IRB board member must come from off campus. For example, one of Haskell's IRB board members is the head of the University of Kansas's IRB. Both the scientist and community member must be present when votes are made on research proposals.

Training and education for members can be completed on the OHRP website or through videos from the agency. Freeman suggests that TCU presidents and IRB chairpersons take the training early in the registration process. Finally, he suggests discussions between IRB board members and an experienced IRB member to become familiar with the OHRP rules.