22jul(jul 22)12:00 am24(jul 24)12:00 amInformed Consent in Genetic Research: Does it Mean the Same Thing to the Specimen Providers and Specimen Researchers? A Case Review: The Havasupai, An Indigenous Population – How Consent for Genetic Research on Diabetes Lead to Data Findings on the Migration of The Havasupai Ancestors and a $700,000 Settlement
Presented By: Catherine M. With, JD, LLM, LLM Legal Counsel, Armed Forces Institute of Pathology,Washington,DC,USA Abstract In the early 1990’s, members of the Native American Indian tribe,
Catherine M. With, JD, LLM, LLM
Legal Counsel, Armed Forces Institute of Pathology,Washington,DC,USA
In the early 1990’s, members of the Native American Indian tribe, Havasupai, who reside in the Grand Canyon in Arizona, gave blood samples to researchers at Arizona State University (ASU) with the understanding that the researchers would use the blood to study and determine why this indigenous population had such a high incidence of type 2 diabetes. By 2003, however, the Havasupai learned that the ASU researchers had, in addition to conducting a study related to diabetes, also conducted studies on other diseases and published papers based upon research with the Havasupai blood, on topics including schizophrenia, inbreeding, and the possibility that the Havasupai ancestors migrated from Asia through the Bering Straits, rather than originating in the Grand Canyon which is a main belief of the Havasupai. The Havasupai tribe was outraged by the additional use of the blood by the ASU researched and filed legal challenges to these additional studies that ASU conducted, contending that the Havasupai did not consent to these additional studies with the blood they have given the ASU researchers. In April 2010, after nearly 7 years of litigation in both State and Federal Courts, the Havasupai and the Board of Regents of ASU settled the case. ASU agreed to “remedy the wrong that was done” by returning all remaining blood samples to the Havasupai and paying $700,000 to 41 members of the tribe who had provided blood samples.
The Havasupai Indians’ main legal claim was for a violation of informed consent in the ASU research because they were told by the ASU researchers that their blood samples would be used for one purpose (diabetes studies) when in fact, they contend, it was used for other additional purposes for which they did not give consent. The ASU researchers contend that they did nothing improper in this regard. The Havasupai case clearly raises myriad issues and questions about the complex intersection of modern science and technology and the cultures and special interests of indigenous peoples.
This presentation will use the Havasupai Indian tribe case as a basis to discuss informed consent in terms of the issues related to genetic research on indigenous and vulnerable populations. It will present the different but related interests of those who provide the tissue specimens for genetic research — what is informed consent, confidentiality of information, control over the specimen, use of specimens for commercial purposes, use of the specimens to provide cures, fear of seeking future medical care if consent is violated, and unique concerns of a vulnerable and/or indigenous population; and those of the researchers who conduct the research on the tissue specimens provided – the necessity for access to research materials, potential chilling effect on research, feasibility of informed consent in genetic research, financial “rewards” for high quality research, research that may yield results beyond a “cure,” conduct of responsible and ethical research, and the limits of informed consent.
22 (Thursday) 12:00 am - 24 (Saturday) 12:00 am