Technology: The ethical and legal challenges of large-scale human genome sequencing

The progression of genetic technology has spawned security, privacy and ownership concerns

The Presidential Commission for the Study of Bioethical Issues recently issued a request for public comment on a variety of issues raised by large-scale human genome sequencing, and just last week The New York Times ran an article on Washington University’s effort to save the life of Dr. Lukas Wartman, who was diagnosed with leukemia, by fully sequencing the genes of his cancer cells and his healthy cells for comparison. After finding that Dr. Wartman had a normal gene that worked in overdrive, spurring growth of his cancer, researchers were able to identify and use a new drug—which had been tested and approved only for advanced kidney cancer—to shut down his malfunctioning gene. Researchers say that Dr. Wartman’s case is an illustration of the importance of genes in driving a cancer, as opposed to the organ or tissues where the cancer originates.

Whole genome sequencing, along with greatly improved DNA sequencing techniques, has the potential to improve our understanding of the pathogenesis of disease and enhance drug design. Many predict that within a decade or so whole genome sequencing will be widely available at a price of $1,000 or less and perhaps paid for by insurance. Industry and venture capitalists are increasingly interested in initiatives to identify specific disease-causing genes and to test drugs that target those genes.

Laws that explicitly establish individuals’ ownership rights in their tissue in order to guard against these concerns, however, have important implications for research involving large-scale human genome sequencing. Some fear that such laws could have a chilling effect on the development of biorepositories for research purposes, due to fear of private claims for violation of individuals’ property rights in their DNA samples. Some worry that procedures for transfer of an individual’s property right in his samples to a research entity will run afoul of legal and ethical concerns about selling human tissue. And some hypothesize that individuals will have a greater ability to place limitations on the research use of their samples.

Rapid technological advances complicate not only tissue sample ownership but also the use of genetic information obtained via genome sequencing performed with consent of the tissue donor. In order to protect autonomy and privacy interests, it is critical to obtain fully informed consent from the tissue donor for whole or partial genome sequencing, subsequent testing and use and disclosure of test results. The informed consent discussion must address:  

Contributing Author

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Robyn Shapiro

Robyn Shapiro is a partner in the Health Care Practice and co-chair of the Life Sciences group at Drinker Biddle & Reath. Her practice focuses...

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