Laws to keep genetic information private are not strong enough — a situation that could hinder progress in important research, according to a new high-level study Thursday on medical ethics.
As human genome sequencing becomes more and more affordable, researchers are finding new and important ways to use the data for research and at the clinical level.
This has the potential to lead to even more major advances in medicine and science, the Presidential Commission for the Study of Bioethical Issues said in its report.
But these advances depend on having available vast amounts of genetic information, coming from tens of thousands, or even millions of people, most of whom would not benefit directly from the research, emphasized commission chair Amy Gutmann.
And therein lies the potential for ethical dilemmas, the authors wrote, making a dozen recommendations on reinforcing regulations to protect the confidentiality of an individual’s genetic information.
“Those who are willing to share some of the most intimate information about themselves for the sake of medical progress should be assured appropriate confidentiality,” Gutmann said.
“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,” she added.
For instance, a person’s genome may reveal a predisposition for diseases like Alzheimer’s, diabetes, schizophrenia or heart problems. That information could be used in a negative way by employers or health insurance companies.
Without assurances that would not happen, many people may feel wary of volunteering for genome sequencing, the authors wrote.
And while genomic data are kept confidential in some situations, in others the rules are less clear.
“The exact same data — arguably your most personal data — are treated differently depending on who took your sample to sequence your genome,” Guttmann said.
Done at a doctor’s office, the genetic information is protected under medical privacy laws. Not so, if the same procedure is done in the context of a research study, the commission emphasized.
“Moreover, in many states in the US, 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,” Guttmann said.
The commission recommended federal and state governments develop a process for ensuring a minimum level of protections for genome sequence data that would be consistent across the country and would apply no matter how the data were gathered.
The panel said this must be achieved while also keeping an eye to promoting data access and sharing.