Broad Consent Comes Up Short in Arizona: Research Ethics in the News

Members of the Havasupai tribe, a small tribe from the Grand Canyon, were angered to discover that their blood samples were being used for research studies beyond the original scope or perceived intent of the project. In other words, the tribe thought it had consented to diabetes research, but found that researchers were also studying schizophrenia and the tribe’s ethnic origins. Over 200 members of the tribe completed a consent form that included an indication that the blood samples could be used to “study the causes of behavioral/medical disorders.” (See: Amy Harmon. Indian wins fight to limit research of its DNA. The New York Times. April 21, 2010. ) Such a clause is certainly broad enough to include research on schizophrenia; research on genetic origins seems less appropriate.

The dust has settled a bit since the Arizona State University Board of Regents agreed to a legal settlement with the Havasupai tribe. (For an overview of the legal issues, see Katherine Drabiak-Syed’s “Havasupai Tribe and Arizona State University Settlement Agreement: ASU to Return the Blood Samples” at PredictER News.) In hindsight, ASU probably wishes it had implemented a more robust outreach and collaboration effort with the tribe. Including Havasupai representatives on a communications team or community advisory board might have helped. Perhaps the tribe would have cautioned the university against culturally sensitive research, including studies on mental illness and genetic origins. Perhaps the tribe would have agreed to research on topics in addition to diabetes.

In any case, it is probable that ongoing Havasupai participation in the governance of the genetic research on their samples would have preserved the tribe’s trust in the research process. As it turns out, research without community trust can be very expensive. After spending $1.7 million in legal fees on the case, the Board of Regents agreed to settle the dispute by paying $700,000 to the tribe for their troubles. ASU also agreed to return the blood samples and, as Harmon reports, to “provide other forms of assistance.” In the long run, the loss of trust may be the most damaging outcome of this dispute between ASU and the Havasupai tribe. Arizona is the home of 22 tribes and ASU is proud of its partnerships with American Indiana Tribes. Following the dispute with the Havasupai, other tribes may be wary of future research projects. Given that the dispute was reported widely, the loss of tribal trust in researchers may impact the progress of research in other states as well. In fact, Rob Capriccioso of Indian Country Today reported that tribal officials “nationwide” had already condemned the conduct of the principle investigator. With this in mind, Rob Rosette, a lawyer for the Havasupai tribe, comments on the future impact of the settlement:  “A precedent was set. Researchers will now know that if they do this kind of research without informed consent, they are going to get in big trouble for it, costing themselves time and money. Exploiting these people was just not worth it.”

Related:

Rex Dalton. Native American Research Lawsuit Settled. The Great Beyond [Nature blog]. April 22, 2010.
Michael Kiefer. Havasupai Tribe ends regents lawsuit with burial. The Arizona Republic. April 22, 2010.
The Havasupai Case: Research Without Patient Consent. Who Owns Your Body? [2007]

Other Research Ethics News

Derek Parker. His little piggies may save lives: Paul Tan. The Australian. May 1, 2010.

Kounteya Sinha. ‘Cervical cancer vaccine trial guidelines not followed’. The Times of India. April 29, 2010.

Rob Stein. 13 additional stem cell lines eligible for federal funding, NIH says. The Washington Post. April 28, 2010.

Nancy Walton. The Thalidomide tragedy: reminding us why research ethics oversight is here to stay. The Research Ethics Blog. April 27, 2010.

Clinical trials hindered by red tape: MDs. CBC News. April 26, 2010.

Evan Binns. St. Louis doctors get $2.5 million from Pfizer, Lilly, Glaxo, Merck. St. Louis Business Journal. April 23, 2010.

AP. Doctor Groups Set New Policy to Curb Industry Sway. The New York Times. April 21, 2010.

Katherine Hobson. Medical Groups Sign on to Tough Ethics Rules. WSJ Health Blog. April 21, 2010.

Wagdy Sawahel. New centre to document bioethics in the Arab world. SciDevNet. April 9, 2010.

Amy Davis. PRIM&R joins the University of Pittsburgh in “Building Trust Between Minorities and Researchers”. Ampersand. April 6, 2010.

— J.O.

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