Controversies concerning the meaning of informed consent in connection with the use of genetic materials from human subjects are not new. Recent legal disputes are, however, bringing the matter to the forefront once again and raising important questions about whether researchers should be allowed to use genetic material collected for one purpose for a subsequent unrelated purpose and, if so, under what parameters.
Two controversies, while seemingly very different—one involving the routine collection of dried blood spot samples from newborns (NBS) and one involving genetic research on a large group of Native Americans—raise similar issues and questions.
Earlier this year, a dispute between members of the Havasupai tribe and Arizona State University (ASU) made headlines when the university and the tribe agreed to settle a dispute over the university’s use of genetic materials collected from a number of tribe members. The dispute arose after many Havasupai agreed to provide researchers from ASU with blood samples so that the researchers might be able to better understand the tribe’s devastatingly high rate of diabetes.
Subsequently, it was discovered that the researchers had used the samples for unrelated research, including research into rates of schizophrenia (a disorder the tribe reportedly considers to be stigmatizing) and research that tracked the tribe’s genetic origins to Asia, a finding that contradicts their traditional stories and heritage. Not too surprisingly, this news was upsetting to the tribe, which subsequently issued a “banishment” order to prevent ASU employees from setting foot on their land and also filed a multimillion dollar lawsuit against the university.
At issue in this matter was whether the participants gave effective informed consent to the subsequent research. While they reportedly signed a consent stating that their blood could be used to study “the causes of behavioral/medical disorder,” there were questions about the ability of the participants to understand the consent and many participants claimed that it was their belief that their samples would be used solely for diabetes research. Litigated for over six years, the dispute was recently settled in exchange for a payment of $700,000, an agreement to return the blood samples to the participants, and the provision of certain assistance to the Havasupai people.