The Havasupai Case
Carletta Tilousi, plaintiff and member of the Havasupai Tribe


RESEARCH WITHOUT PATIENT CONSENT

Can scientists do genetic research on your tissues without your consent? That's the essential question in a lawsuit pending before Judge Janet E. Barton of the Maricopa County Superior Court in Arizona. Members of the Havasupai Tribe allege that researchers from Arizona State University (ASU) and the University of Arizona (U of A) collected 400 blood samples from tribal members for diabetes research, but that those same samples were used for additional unauthorized research on schizophrenia, inbreeding, and population migration. The tribe asserts that research on schizophrenia and inbreeding sitgmatizes them and that they would not have authorized any migration research because it conflicts with their religious origin story.

The 650 members of the Havasupai Tribe are descendents of the Hohokam Indians, who migrated north from Mexico around 300 B.C. The Havasupai settled in an isolated and remote location in the Grand Canyon, which is still only accessible by horseback, foot, or helicopter. Such isolation is the reason that the Havasupai Tribe posses a restricted gene pool, in which certain genetic diseases are at higher incidence than in, say, a general urban population. In fact, the Havasupai have one of the highest incidences of type-2 diabetes anywhere in the world. In 1991, 55% of Havasupai women and 38% of Havasupai men were diabetic.

In 1989, two tribe members approached an ASU faculty member, asking for help to stem the tribe's high incidence of diabetes. They allege that researcher Therese Markow and a colleague originally presented their project to the tribal council as consisting of three elements: (1) "diabetes education," (2) "collecting and testing blood samples from individual members to identify diabetics or persons susceptible to diabetes," and (3) "genetic testing to identify an association between certain gene variants and diabetes among Havasupai people."

They allege that Markow did not inform them that she was in the process of, or had previously submitted, a grant application to study schizophrenia among the Havasupai. Nor were they subsequently told that Markow caused her assistant to surreptitiously examine their medical charts for schizophrenia after operating hours of the local health clinic. The complaint alleges that the defendants authored 15 publications dealing with schizophrenia, inbreeding, and theories about ancient human population migrations from Asia to North America - secondary uses of the samples to which the Havasupai would not have consented.

The faculty member who introduced Markow to the Havasupai complained to ASU officials that the research had strayed away from diabetes research. Given that ASU was about to launch an ambitious plan to accelerate genetic research, ASU desired to keep the conflict private and paid for an investigation conducted by attorney Stephan Hart. The investigation resulted in a nine-volume report. An article in Nature states that Hart's report provided "no firm findings of misconduct, but states that there are 'issues' on how the project was administered, the keeping of records, and whether the tribe realized the full extent of research that would be undertaken."

The complaint in the federal court case listed six causes of action: (1) breach of fiduciary duty and lack of informed consent (including not having appropriate procedures for vulnerable subjects such as children, people with mental illness, and people whose main language was the tribal language); (2) fraud and misrepresentation/fraudulent concealment; (3) intentional or negligent infliction of emotional distress; (4) conversion; (5) violation of civil rights; and (6) negligence, gross negligence and negligence per se.

On a motion to dismiss the case, the federal district court dismissed three of the six causes of action - lack of informed consent and breach of fiduciary duty claims as well as the fraud and misrepresentation/fraudulent concealment and conversion claims. The judge determined that the members of the tribe had consented to the research, even if the researchers had made fraudulent representations about the true nature of the studies to induce them to give consent. He also found that there was no fiduciary relationship between the parties, even if the members of the tribe trusted the researchers, because the researchers claimed to not accept the trust that had been placed in them.

The judge allowed the plaintiffs to continue their case with their claims for the infliction of emotional distress, violation of civil rights, and negligence. The plaintiffs then voluntarily dismissed their federal civil rights claim, stripping the federal court of jurisdiction to hear the case, and the court sent the case back to the Arizona state court.

Upon remand, two cases - one for the tribe itself, and one for individual members of the tribe - were consolidated into a single case against the Arizona Board of Regents (for ASU and U of A), Markow, and members of Markow's research team. The claims from the plaintiffs' Second Amended Complaint are currently pending in Maricopa County Superior Court. The plaintiffs claim four causes of action: (1) breach of confidential or fiduciary duty (including lack of informed consent); (2) fraud and misrepresentation/fraudulent concealment; (3) negligence, gross negligence, negligence per se; and (4) trespass (with respect to the blood samples and entry onto tribal lands).

In defense of Markow, Nature reports that research into interbreeding and migration patterns is "an accepted procedure" for researching the extent to which the studied population is isolated. According to Nature, information on the extent to which a studied population is isolated is "important" for the genetic investigation of a disease. However, most research to identify human disease genes has proceeded without inbreeding studies, and Nature fails to explain how schizophrenia is linked to diabetes research. Moreover, even if such studies were standard procedure, the Havasupai argue that they should have been told of these "accepted procedures" before they were asked whether they were willing to consent to the research.

On the website about her lab, Markow (now a Regents Professor of Ecology and Evolutionary Biology at the U of A) reports that her work uses Drosophila to research speciation, mating system evolution, ecology and population biology, and biological stoichiometry. There is no mention of research on human subjects, despite the fact that she has published articles about the Havasupai, including an article on inbreeding.

Perhaps her fruit flies didn't care which studies she undertook, but her human research subjects certainly did. The pending lawsuit will determine whether certain acceptable practices for animal research require a higher level of ethics when applied to the human realm.


Related Articles

Paul Rubin, "Indian Givers," Phoenix New Times, May 27, 2004.

Rex Dalton, "When Two Tribes Go to War," 430 Nature 500, 500-02, July 29, 2004.

Nature (editorial), "Tribal Culture Versus Genetics," 430 Nature, 489, July 29, 2004.

Order in Tilousi v. Arizona State University, No. 04-CV-1290 (D. Ariz. March 3, 2005)


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