Peter Yu, David Haussler and Jenny Reardon Discuss the Meeting of Biomedical Privacy and Genomic Openness
On January 22, 2014, the Science & Justice Working Group hosted the first in a series of ongoing conversations about the unresolved issues raised by the recent push to expand efforts to collect and aggregate biological samples and data. Jenny Reardon (Science & Justice Research Center Director and Associate Professor of Sociology) facilitated this conversation between Peter Yu (incoming President of the American Society of Clinical Oncology and Director of Cancer Research (ASCO) at the Palo Alto Medical Foundation) and David Haussler (Director of the UCSC Center for Biomolecular Sciences and Engineering). Peter Yu is a renowned medical oncologist and hematologist who has pioneered the advance of health information technology and its use to improve medical care. The American Society of Clinical Oncology is the world’s leading professional organization representing physicians who care for people with cancer, and has played a lead role in erasing the stigma around cancer through developing and sharing knowledge that promotes cancer prevention and treatment. In March of this year ASCO announced CancerLinQ, a major effort to collect data on hundreds of thousands of cancer patients to further advance cancer research and treatments. David Haussler is a pioneer in the field of bioinformatics whose group assembled and posted the first working draft of the human genome on the Internet, and is now innovating computer algorithms that will enable the use genomic data in the transformation of cancer care. In June of this year, Haussler and his colleagues announced a “Global Alliance” to foster the sharing of genomic and clinical data that CancerLinQ and other similar efforts require. Yu and Haussler will discuss the challenges and opportunities raised by efforts to harness big data approaches to biomedical research.
As both Yu and Haussler are keenly aware, aggregating patient tissues and data raises entangled ethical and technical concerns. Finding the proper balance between personal privacy, medical and scientific autonomy, and equitable public benefits is at the heart of multiple recent controversies, including the sequencing and subsequent publication of Henrietta Lacks’ genome and neonatal blood biobanking. These episodes make clear that the ability of informatic technologies to broaden and deepen the analysis of personal data raises issues that go to the heart of democratic governance. As a society, we have long associated personal control over our own bodies and privacy with full citizenship. Yet we also highly value transparency and knowledge sharing and view both as critical aspects of an open society, and as necessary components of scientific progress. Today, as aggregated biomedical data become both more useful and more risky, we confront a difficult conflict between the value of privacy and the value of openness.
In an age of widespread social media usage, it is an increasingly familiar task to balance these values in our daily lives. Yet Science & Justice Research Center Director Jenny Reardon recently experienced this tension between privacy and openness in a surprising new way when she had an appointment with a physician at UC San Francisco (UCSF) and was asked to sign a UCSF Terms of Service Form. That form told her that she “understood” that UCSF could use her tissues and/or medical data in research and that she had no property rights in these tissues/data. Despite being an expert in biomedicine, ethics and society, she found that she did not know what she was being told she “understood” in order that she might receive the medical services of UCSF. Reardon reflected on this experience in an article entitled “Should patients understand that they are research subjects?” that appeared on March 2, 2013 as the cover story for the San Francisco Chronicle’s Sunday Magazine Insight. This article circulated widely, and resulted in Yu contacting Reardon, establishing an ongoing conversation about the future of medical privacy, trust, and informatics.
At the heart of problem is a confusing mix of U.S. case law that denies ownership over one’s bodily tissues once they have left one’s body, medical privacy standards that require providers and researchers to inform you that they may use the tissues for research without directly requesting permission, and the speed at which medical advances are occurring. Given these conditions, it is more difficult than ever to know what one is agreeing to when one signs ubiquitous Terms of Service and informed consent forms.
The San Francisco Chronicle editorial board published an editorial along with Reardon’s articlethat suggested that the US Department of Health and Human Services revise its standards for medical consent. The editors proposed that the HHS standards foster full disclosure and clear communication with patients that more fully addressed questions of who will own and benefit from the collection and distribution of tissues and data. They also published a response from UCSF’s Elizabeth A. Boyd, associate vice chancellor for ethics and compliance, and Daniel Dohan, associate professor of health policy and social medicine. Boyd and Dohan argued that the success of personalized medicine rests on relationships of trust between physicians, researchers and patients. They noted that UCSF supports revising consent standards, and cite the recent creation of EngageUC, an initiative on the part of UC physicians and faculty to develop new comprehensive guidelines.
Within a few weeks of this discussion in the San Francisco Chronicle, The New York Timespublished an Op-Ed by Rebecca Skloot (author of bestselling book The Immortal Life of Henrietta Lacks) that called for the development of international standards to protect the privacy of genetic data. This call followed in the wake of the sequencing and publication of the HeLa cell line genome without the consent of the family of Henrietta Lacks, the African American woman whose cells were used to make the cell lines (again, without her consent). The New York Times followed with an article a few weeks later that discussed the concerns of Senator John D. Rockefeller IV, Chair of the Senate Commerce, Science and Transportation Committee, about patient privacy and the lack of transparency on who has access to patient health data. More recently the NIH’s chief Francis Collins personally worked with Lacks’ family to develop a protocol for accessing the HeLa genome data that aimed to balance researchers’ needs with the family’s desire for privacy.
This discomfort bubbling up on the national stage has led to calls to change the Common Rule (the set of laws that govern federally-funded biomedical research in the U.S.), which currently allows for collection of tissues and data from patients as long as anonymity is maintained. It has become clear that anonymity in an age of openness is at best an uncertain policy instrument. In addition to its technical limits, anonymity does not address the underlying concerns about who will be served by the mining of genomic and health data, and how concerns about privacy, property and justice can be addressed while fostering the creation of new knowledge needed to advance medical care. Both Yu and Haussler are leading efforts that seek to do a better job fostering innovative research while attending to these fundamental ethical and policy issues, knowing that we need to do both if we are to advance cancer research and care.
This conversation between Peter Yu and David Haussler, facilitated by Jenny Reardon, was the first of several dialogues planned by the Science & Justice Research Center that aim to help clarify these issues at stake in the evolving relationship between openness and privacy in the biomedical sciences.
Wednesday January 22, 2014 |4:00-6:00PM | Engineering 2, Room 599