With DNA sequencing speeding into clinical practice, researchers and policy-makers must find ways to protect individuals’ genomic data while still being able to share information, according to the US President’s Commission on Bioethics. The group today released a report containing a series of recommendations about whole-genome sequencing and privacy.
The report also called on policy-makers to cooperate to create a “floor” of privacy protections that apply regardless of how a sample was obtained for sequencing. In particular, no one should be sequenced without their knowledge.
Privacy protections are important not just for respecting individuals but for advancing science, said commission chair Amy Gutmann. “In order to make full use of whole genome sequencing, we’re going to need to figure out how to protect people’s privacy and avoid the harm that could come of misuse of this data.” Figuring out how to use genetic information to treat complex diseases such as cancer or Alzheimer’s will require information from at least thousands of individuals, she said, and people cannot be expected to share data without protection and assurances. “Confusion and uncertainty tend to erode trust, and trust is the key to amassing the large number of genomic data sets needed to make powerful life-saving discoveries.”
Existing legislation is insufficient, said Gutmann. The Health Insurance and Portability and Accountability Act (HIPAA) does not apply to participants in clinical research, for example, and the Genetic Information Nondiscrimination Act (GINA) prohibits data from being shared with employers and health insurers, but not other entities.
Whole-genome data are particularly sensitive because their information extends beyond an individual, said Gutmann. “It’s not just you. It’s your family.”
The commission also called for lawmakers to establish consistent protections governing how data can be collected, shared and stored. “Your genome sequenced at your doctor’s office would be the same as your genome sequenced during research,” Gutmann said, but data are protected differently. Protection also differs by geography. For example, about half of US states do not protect individuals from having their DNA collected and sequenced surreptitiously.
The report also called for a federal agency to establish guidelines for informed consent. The consent process should cover issues such as planned and potential use of the data, whether participants would have control over future use of the data, what results might be returned to participants and potential risks.
People should also be told that sequencing can reveal unsought and troubling information, and funders of whole-genome sequencing studies should also support studies about when and how to tell people about such ‘incidental findings’. For example, individuals may learn that they are likely to get a serious, untreatable disease or that their father is not who they thought. Case studies in the report describe how woman declined to inform doctors of a disease gene for fear of losing her insurance or paying higher premiums. A man who learned he would become blind said anticipating losing his vision was worse than the actual loss.
Amy McGuire, director of the center for medical ethics and health policy at Baylor College of Medicine in Houston, Texas, says that the report does a good job of summarizing the debate about balancing the need to protect individuals with the public benefit of making more data available. However, many of the recommendations cover appropriate access to genetic information rather than possible consequences of using it inappropriately, she says. “You can protect against it being out there or against people using it in ways that they shouldn’t be using it. I would have liked to see the latter more addressed.”
The full 150-page report, ‘Privacy and progress in the era of whole genome sequencing’, is available at www.bioethics.gov.