The Burrill Report

As the rapidly falling cost of whole genome sequencing moves it toward broader clinical applications, a report from a presidential commission warns that new privacy protections must be put into place to ensure its medical promise is realized.

The Presidential Commission for the Study of Bioethical Issues says that in order to realize the benefits of whole genome sequencing, widespread public participation and a willingness among individuals to share genomic data and relevant medical information is necessary. In order for this to happen, though, there must also be confidence among the public that there are adequate privacy protections. To that end, the commission in its report offered a dozen recommendations relating to such issues as informed consent, data security, accountability, and the exchange of information.

The dilemma, says the committee, is that while society as a whole will benefit from the information gleaned from whole genome sequencing, it is individuals who stand to bear the risk of misuse of their information even though most people will not enjoy direct benefit.

“The Commission’s goal was to find the most feasible ways of reconciling the enormous medical potential of whole genome sequencing with the pressing privacy and data access issues raised by the rapid emergence of low-cost whole genome sequencing,” says Commission Chair Amy Gutmann. “The life-saving potential of genome sequencing depends on gathering genetic information from many thousands (perhaps millions) of individuals, most of whom will not directly benefit from the research.”

Gutmann says people who are willing to share intimate information about themselves to advance medical progress should have confidence that private medical information, such as their risk for developing a specific disease, will be protected as confidential. In the absence of that, she says, individuals will be less likely to supply data that could lead to life-saving treatments for genetic diseases.

With variation in protections from state to state, the commission called for the establishment of a “consistent floor of protections covering whole genome sequence data regardless of how they were obtained.” That means whether someone willingly provided a sample to researchers or medical professionals, or simply left saliva behind on an abandoned cup of coffee. The policies, says the commission, should include prohibitions against unauthorized whole genome sequencing without the consent of the individual from whom the sample came.

“Your genome sequenced at your doctor’s office would be the same as your genome sequenced during research. However, the sequence information collected in a doctor’s office is protected by the Health Insurance Portability and Accountability Act (HIPAA) and the sequence information collected during research is protected by what’s known as the Common Rule,” Gutmann says. “Moreover, in many states in the U.S. someone could legally pick up your discarded coffee cup and send a sample of your saliva out for sequencing to see if you show a predisposition for certain diseases. The exact same data – arguably your most personal data – are treated differently depending on who took your sample to sequence your genome.”


October 12, 2012
http://www.burrillreport.com/article-commission_calls_for_genome_privacy_protections.html