It’s my genome: should researchers be obliged to return genetic data to research participants?
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Daniel MacArthur, Wellcome Trust Sanger Institute and Genetic Future.
Alice signed up as a “healthy control” for a research project into the genetics of type 2 diabetes. During the project, researchers identified a variation in Alice’s BRCA1 gene that is known to be associated with a high risk of breast cancer. Alice is unaware that she carries this variant, and if she was told about it she would be able to take steps to minimise her risk of cancer.
It is clearly in Alice’s best interests to be given the option to be informed about this discovery – and yet in most research studies she would have no such opportunity. Instead, Alice is likely to have signed an informed consent form advising her that she will not receive any findings from the research study, and that indeed she has no automatic right to access any of the data generated from her DNA during the project.
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Why Are We Missing What Is Important In Personalized Medicine?
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Steven Murphy, Helix Health of CT.
A 33 year old man with anxiety comes to the office. He says he has some worsening of his anxiety. It causes chest pressure. I saw his brother last week for a physical. He told me his father had a heart attack at 50.
The TIMI score for risk puts him at a 0.8% all cause 30 day mortality risk. No big deal right? His Reynolds Risk? 2%. Do I send him for a genetic test? No. I send him for a stress test. Why? Family History.
There are more people with Family History, than with faulty SNPs.
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Privacy & Ownership of an Individual’s Personal Genetic Information
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jennifer Sweeney, Knome, Inc.
As personal genetic information becomes increasingly accessible and affordable, the ownership and privacy of such data will emerge as a central issue in genomics. Is personal genetic information, stored within a centralized database where a third-party gatekeeper determines who has access, really still private? Who owns such data? Should the individual have control over how, when and where their information is used? In such cases, it certainly seems the individual may have forfeited ownership and rights to control access to their own data.
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Finding The Proper Place for Genetics in Insurance
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Mark Henderson, Science Editor for The Times and author of 50 Genetics Ideas You Really Need to Know.
It is a mark of the quality of the science fiction movie Gattaca that, 12 years after its release, so many ethical issues surrounding genetics are still seen through its prism. In Andrew Niccol’s dystopian vision, DNA divides society into “valids” and “invalids”, some of whom are decidedly more equal than others.
Concerns about such genetic discrimination are relevant to many ELSI discussions, but rarely more so than when the subject is insurance. The great fear is that genetic data could create an uninsurable underclass, denied mortgages and life and health cover because of genomic flaws beyond their control.
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Personalized Genomic Medicine and Health Care Justice
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Michelle L. McGowan Ph.D., Case Western Reserve University Department of Bioethics.
The most significant challenge to the promise of personalized genomic medicine hinges on the realization of health care justice. From a social justice perspective, meeting the basic health care needs of the population – locally and globally – is an urgent objective that dwarfs the goal of a genomic approach to medicine.
The challenge to proponents of personalized genomic medicine is to find a way to frame their aspirations and actions in a way that simultaneously moves towards realizing personalized medicine and global health care justice. However, the terminology and current direction of personalized medicine has the potential to hinder this effort.
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Education, Not Regulation, Will Benefit Consumers of Recreational Genetics
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Blaine Bettinger, Bond, Schoeneck & King and publisher of The Genetic Genealogist.
Genetic ancestry testing, the use of DNA to explore an individual’s recent or ancient genetic contributors, has been available to customers for almost a decade but has recently been a topic of much debate among bioethicists. The concerns often center around topics such as privacy, definitions of race, and emotional or psychological effects of test results, among others. These concerns, together with continuing advances in personalized genomics that have the potential to make our DNA an important part of how we shape our identity and interact with society, lead to the question of whether recreational genetics should be regulated in order to prevent any potential harms to consumers. Or, as some argue, will regulations hinder the field without providing any real benefit?
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The Direct to Consumer Disconnect: Why the genomics community is going to have trouble talking to patients and doctors alike
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Matthew Herper, Forbes.
We can sequence DNA cheaper and faster, and even deal with all the data.
But if genomics is really going to impact medicine, we’re going to have to start bridging the gap between the companies and scientists doing this early work and the traditional medical establishment. The genoscenti like to talk about how everyone should have access to his own DNA. Your genes are a part of you, they say. How could they belong to anyone else?
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Medical vs. “Recreational” Genomics: Drawing a Line in the Sand
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Allie Janson, University Health Network/Mount Sinai Hospital’s Fred A. Litwin Family Centre in Genetic Medicine and DNA Exchange.
To me, one of the most interesting aspects of genomics is the potential for it to be both medical and recreational in nature. Direct-to-consumer companies have picked up on the recreational aspect of genomics and run with it—successfully marketing their service as a fun and interesting glimpse “inside oneself.” Understandably, the medical community has been, and will be, slower and more cautious about incorporating weak gene variant-disease associations into medical care. However, as the 1000$ genome comes barrelling towards hospital doors, physicians may no longer have a choice. Patients will present with a symptom and a genome print-out in hand, and demand answers.
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We need to work together to expand access to genetic testing
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jonathan T. Lord, Navigenics, Inc.
At Navigenics, we know that the future of health care rests in preventing disease, not just treating it. And we know that personalized genomics will play a big part in transforming medicine from a “sick care” system to a true health care system, allowing doctors to tailor prevention plans and treatments to meet patients’ needs.
But in order to expand access to personalized genetic testing, we must first address the most pressing question – where and how to start?
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The Hidden Legal Barriers to Scientific Research
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Thinh H. Nguyen, Creative Commons Counsel for Science Commons.
When thinking about the legal issues associated with genomics, many people, particularly lawyers, tend to focus on patent issues. While there are legitimate concerns about patents, there is a growing body of sociological research to suggest that in the vast majority of cases, bench science is not impeded by fear of patent lawsuits, but rather by far more mundane legal and cultural barriers.
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