President’s Bioethics Commission recommends self-regulation and government oversight.
As researchers predict that whole human genome sequencing may soon cost just $1,000, down from an estimation of $2.5 billion in 2000, observers caution that DNA sequencing may carry significant privacy risks.
To balance the need for privacy regulation and scientific research with a technology that has the potential to revolutionize medicine, the Presidential Commission for the Study of Bioethical Issues, an influential group of leaders in disciplines ranging from medicine to law, recently issued a new report recommending improved industry self-regulation and government oversight of DNA sequencing.
The Commission laid out a framework for industry self-regulation in order to address privacy issues including confidentiality, anonymity, and data security. These measures would include a clear determination of who can have access to genome data and for what purposes the data can be used.
The Commission also noted that persons who collect genome samples should develop a robust consent process and communicate both data access and permissible use policies to individuals who provide their DNA.
Further, the Commission recommended that persons in the possession of genome data, whether in research, clinical, or commercial settings, should establish professional ethical standards of confidentiality in their data use. To protect individuals, genome sequencing data should be wiped clean of information that could be used to determine an individual’s identity, such as Social Security numbers or home addresses.
While encouraging increased industry self-regulation, the report also suggested that the government should play a stronger role in ensuring adequate privacy protection.
The Commission report noted that current federal genetic privacy laws constitute only a patchwork and do not cover the whole spectrum of genome privacy issues. For example, although the Genetic Information Nondiscrimination Act prohibits employers and health insurers from discriminating based on genetic information, these protections do not cover discrimination elsewhere, such as in long-term care insurance or in athletic and educational settings.
The Commission called for federal and state governments to establish a “floor of privacy protections” that would prohibit genome sequencing without an individual’s consent. The report indicated that around fifty percent of states do not have laws that explicitly prevent a person from collecting another’s whole genome information secretly—such as from saliva on a discarded coffee cup, to use an example noted in the report—and analyzing it through a commercial vendor without consent. Such a privacy floor could standardize privacy protections in this and similar situations.
The Commission also found that federal law may treat the same data differently depending on the context, leading to inconsistencies in regulation and enforcement. For instance, the Health Insurance Portability and Accountability Act (HIPAA) would regulate the collection of a whole genome sequence for clinical care, whereas the Federal Policy for the Protection of Human Subjects would govern the same data collected for research purposes.
To ensure that informed consent forms are sufficiently robust, the Commission recommended that the Office for Human Research Protections or another federal agency develop “clear and consistent guidelines for informed consent forms.”
According to the report, new privacy regulations may benefit the genome sequencing industry, as current privacy concerns may be preventing scientific advances. Overcoming privacy concerns may motivate more individuals to donate their genes for research, thereby expanding the pool of genetic data. More available data could increase discovery and innovation as, for example, researchers would be able to correlate traits with genes more effectively.
The Commission crafted its report and accompanying recommendations while remaining mindful of what it previously identified as five ethical principles: “public beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation, and justice and fairness.”
To ensure both privacy and scientific progress, the Commission advised that industry self-regulation and government oversight should play different but complementary roles in ensuring data protection. It suggested that all public and private actors should design policies that ensure privacy while still enabling future research progress as well as clinical and commercial advances.
University of Pennsylvania President Dr. Amy Gutmann is the current Chair of the Bioethics Commission which issued the report. Professor Anita L. Allen, the Henry R. Silverman Professor of Law at Penn Law, is also a member of the Commission.
