Twelve years ago, members of the Havasupai Tribe entered into a legal battle with Arizona State University, over the ways in which school researchers were using blood samples from tribe members without proper informed consent. The case halted the research and the university returned the blood to the tribe, along with financial compensation. The scuffle became a landmark case in bioethics.
Deborah Zoe Laufer’s play, “Informed Consent,” running through September 13 at The Duke on 42nd Street theater in New York City, dramatizes the important case. Though not meant to be an exact retelling of the story, the play provides a springboard for discussion about the importance of informed consent in scientific research.
The script follows the journey of a scientist who, motivated by the desire to understand the gene for early onset Alzheimer’s that runs in her family, seeks out an isolated Native American tribe living in the Grand Canyon. The tribe presents an ideally uncorrupted gene pool for her research.
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The scientist initially struggles to convince tribe members to provide samples of blood, which they consider sacred, for her studies. They eventually agree, in hope that the research will reveal genetic clues to the devastating rates of diabetes destroying their own family and friends. The individuals sign a broad consent form that the scientist has deliberately written in simple language.
The tribe later learns that the researcher used the blood to study ailments that it was unaware of, including mental illness and the tribe’s geographic origins. Feeling angered and betrayed, the tribe sues the university and demands that it return the blood.
“What I didn’t realize when I started writing was that this was a landmark case that changed how informed consent is addressed now,” Laufer says. While conducting research for the play, Laufer spent time in the Grand Canyon with the Havasupai people. “[It] gave me a chance to see how personally devastating the court case was to the tribe.”
The Havasupai case and earlier studies such the Tuskegee syphilis study and the Stanford prison experiment highlight the serious harm that can be done when participants do not fully understand the study they are signing up for. Many years have passed since those events, yet the struggle to define proper informed consent remains an issue today, and one that is growing because researchers are collecting biological material at a larger scale than ever before. Biobanks are now maintained at research centers all around the world, where investigators gather samples from patients and the general population. Some samples are kept for decades, making it impossible to know exactly what they will be used for in the future. The recently proposed Ebola biobank may hold up to 100,000 biological samples.
“Huge biobanks are fantastic for research, but there are very real concerns about protecting people’s confidentiality,” says Tia Powell, a psychiatrist and bioethicist at the Albert Einstein College of Medicine, who will be doing a talkback with the audience after an upcoming performance of the play. According to Powell, some centers are trying to address these issues by creating “active community panels” where researchers can discuss privacy concerns, as well as what studies scientists should be allowed to conduct with the public.
Privacy issues have also grown in recent years because of new services such as direct-to-consumer genetic testing kits like 23andMe. Lack of rules and regulation about how researchers – or other interested parties – will use the large amounts of information they are accumulating poses an even greater issue.
As genetic testing becomes more common and extensive biological data are collected around the world, it is becoming increasingly important that people are aware of exactly how this information can be used and who will be using it. “I think there is something very powerful about DNA,” Powell says. “I believe people are correct in feeling that there is something special that deserves protection in the blueprint that identifies you as a unique entity in the world.”