Last week, the Havasupai, a tiny American Indian tribe living deep in the Grand Canyon, won a legal settlement of $700,000 in a landmark case that enforced the tribe's right to control what scientific research was being done on its DNA.  In addition to the $700,000 payment to be divided among 41 plaintiffs, the agreement stipulated that the blood samples that were used for the research will be returned to the tribe. The settlement also has provisions for the establishment of a new health clinic and high school in the village. 

This marks the end of a case that began in 2003 and sets an important precedent. Current law does not support the right of an individual to ownership of his own DNA.   This case does not change that, but highlights the definition of informed consent and brings up questions regarding the ethical issues involved in genetic research, in particular with special or vulnerable populations.  A person gives informed consent only when he or she has a clear appreciation and understanding of the facts, implications and future consequences of an action.  When this involves participation in a research study, this refers to a written agreement to voluntarily participate after having been advised of the purpose of the study, the type of the information being collected, and how information will be used.

According to legal commentators quoted in The New York Times, this settlement "implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used." 

The research, conducted in the 1990s at Arizona State University, was originally intended to look for genetic markers of diabetes, which occurs at extremely high rates in American Indians.  Genetic associations have previously been shown in another Arizona tribe, the Pima Indians, but were not found among the Havasupai.  When researchers at Arizona State requested blood samples from Havasupai volunteers beginning in 1990, more than 100 members of the 600 member tribe signed a consent form to allow use of their blood samples for medical research.  However, tribal members reportedly only believed it would be used to research diabetes.  Later, they found out that the same samples had been used for an additional 24 other published studies, without their knowledge or permission.  Those areas of research ranged far beyond diabetes and included such potentially controversial topics as schizophrenia, inbreeding, and the geographic origins of their population.  The first two subjects carry great stigma among this tribe.  The question of where the tribe originated is controversial both in how it conflicts with tribal legend and in concerns over its potential effect on land rights.

Dr. Therese Markow, the geneticist who headed these studies, was quoted in The New York Times article stating, "The consent form was purposely simple given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors." 

This case highlights ethical questions that are increasingly being raised in the era of genetic research.  From an historical and anthropological perspective, this topic is especially significant because it recalls the long history of governmental exploitation of American Indian tribes, including broken treaties, relocation programs, and forced acculturation. Commenting in an article published in 2001 based upon similar issues raised on research into a Canadian tribe, the Nuu-chah-nulth of Vancouver Island, Judy Gobert, the dean of math and sciences at Salish Kootenai College on Montana's Flathead Indian Reservation, raised the question of the benefit of this research to the people being studied: "They don't want to help us preserve the culture or language we evolved in.  They just want our DNA."  Further, Clifton Poodry, director of the Division of Minority Opportunities in Research at the National Institute of General Medical Sciences, and himself a member of the Seneca Nation, stated, "Native Americans will give informed consent to have their samples analyzed for a specific study.  But they object to having those samples amplified and reproduced for future studies of which they have no knowledge."

From a scientific and research perspective, these ethical concerns raise questions on the ability to continue genomic research.  American Indians are often studied because of the genetic homogeneity of their population and also because they are a convenient sample, being clustered in limited geographic areas (reservations).  The possibility of finding a genetic basis for diseases such as Type 2 diabetes is higher in such a population.  However, it is the nature of scientific discovery that new research questions are raised as projects progress, raising the issue of whether subjects would need to be re-consented before each new phase of the study.

Last week's settlement, approved by the Arizona Board of Regents, highlights ethical questions on the definition of what constitutes informed consent.  These issues will need to be examined more closely in the special case of DNA research.  The difficulty for researchers is how to consent study subjects when the questions may not all yet be known.

___________________________________________________ 

Sources:

"Indian Tribe Wins Fight to Limit Research of Its DNA," The New York Times.

"Lawsuits settled over Arizona tribe blood samples," AP. 

Schmidt, C.  (May 2001).  Indi-gene-ous Conflicts, Environmental Health Perspectives, Vol. 109, No. 5.