Report urges programs to develop consumer confidence in government research
In an age when government demands nude X-ray images for someone to be an airplane passenger and is planning to have the IRS watch what kind of health coverage one has, is there any area of life that actually is private?
Well, maybe DNA, at least until the feds launch their programs to convince consumers to trust government agents with their most personal data, that which can reveal not only present characteristics but possible future outcomes for that person and his or her family.
The U.S. government now has released a report called “Privacy and Progress in Whole Genome Sequencing,” that comes from the Presidential Commission for the Study of Bioethical Issues.
Its 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.”
The chairman, Amy Gutmann, said without the cooperation of millions of Americans the research will falter, perhaps fail.
“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,” she said.
“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, for example, about any discovered genetic variations that link to increased likelihood of certain diseases, such as Alzheimer’s, diabetes, heart disease and schizophrenia.”
She warned that without assurances in place, “individuals are less likely to voluntarily supply the data that have the potential to benefit us all with life-saving treatments for genetic diseases.”
The commission’s report found that current procedures vary. On one end of the scale would be secure methods of protecting such private information – and on the other end?
“In many states someone could legally pick up a discarded coffee cup and send a saliva sample to a commercial sequencing entity in an attempt to discover an individual’s predisposition to neurodegenerative disease. The information might then be misused, for example, by a contentious spouse as evidence of unfitness to parent in a custody case. Or, the information might be publicized by a malicious stranger or acquaintance without the individual’s knowledge or consent in a social networking space, which could adversely affect that individual’s chance of finding a spouse, achieving standing in a community, or pursuing a desired career path,” the report said.
That cooperation will be needed from many is not the question.
“Realizing the promise of whole genome sequencing requires widespread public participation and individual willingness to share genomic data and relevant medical information,” said commission vice chair James W. Wagner. “In other words, scientists and clinicians must have access to data from large numbers of people who are willing to share their private information.
“This, in turn,” he said, “requires public trust that any whole genome sequence data shared by individuals with clinicians and researchers will be adequately protected.”
A primary goal, then, would be for procedures to be established so that all genomic data is protected, and that would include a ban on whole genome sequencing without the consent of the person.
“Your genome sequenced at your doctor’s office would be the same as your genome sequenced during research,” Gutmann suggested. “However, the sequence information collected in a doctor’s office is protected by the Health Insurance Portability and Accountability Act … and the sequence information collected during research is protected by what’s known as the Common Rule… These are just a few discrepancies in public policy that can create confusion and uncertainty.”
She continued, “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.”
The medical experts putting the report together said, “Currently, the majority of the benefits anticipated from whole genome sequencing research will accrue to society, while associated risks fall to the individuals sharing their data.”
Among the recommendations:
- All those involved in genomic research, from those who fund it to server companies that offer computing availability, “should maintain or establish clear policies defining acceptable access to and permissible uses of whole genome sequence data.”
- There should be a “consistent floor of privacy protections … regardless of how they were obtained.”
- “Professional ethical standards” related to privacy and confidentiality would have to be observed by every researcher, manager, operation of any database and others. Penalties would apply for failure.
- Access by “law enforcement or defense and security” to biospecimens should be allowed “only in exceptional circumstances.”
- “Robust and workable consent processes” should be developed so participants fully understand who has access to their information and for what purpose.
- A clear procedure for revealing to patients “incidental findings” must be established. Those could involve markers that could indicate a proclivity for development of a specific disease, such as cancer.
“Respect for persons implies not only respecting individual privacy, but also respecting research participants as autonomous persons who might choose to share their own data. Public beneficence is advanced by giving researchers access to plentiful data from which they can work to advance health care. Regulatory parsimony recommends only as much oversight as is truly necessary and effective in ensuring an adequate degree of privacy, justice and fairness, and security and safety while pursuing the public benefits of whole genome sequencing. Therefore, existing privacy protections and those being contemplated should be parsimonious and not impose high barriers to data sharing,” the report said.
“Clinicians and researchers must also act responsibly to earn public trust for the research enterprise,” the report said.
WND previously has reported on disputes over DNA data, including a case in Minnesota where the state was warehousing the DNA of all newborns.
Ultimately, the state Supreme Court gave privacy advocates a huge victory over their state government, deciding state law does not allow Minnesota’s health agencies to take, keep and use the blood spots that include DNA data for each child without restriction.
The state had argued that officials were entitled to the information and could use it for outside studies as they chose.
The case had been brought by nine families with 25 children. The Citizen’s Council for Health Freedom, which monitored the case’s progress since it was launched, had expressed concern about the possible eugenics influences that could result from inappropriate use of DNA data.
President Twila Brase said at the time last year, “We are cheered by this good news. When our organization discovered the state health department’s baby DNA warehouse in 2003 and the use of newborn DNA for genetic research without parent consent, we determined to do all that we could to stop this practice. No state law expressly permits these activities.”
She said, “We are pleased that these nine families were willing to sue the state of Minnesota. Their action and this decision now secures the genetic privacy rights and informed written consent rights of all Minnesota parents and newborn citizens.”
The ItsMyDNA.org website posts information for consumers, especially parents of newborns, to show what their own state does regarding the acquisition, maintenance and use of babies’ DNA.
She said there are 18 states that keep such information from 10 years to indefinitely.
“We know at the federal level, researchers want the states to become the steward of these blood spots,” she warned. “We’re saying that this DNA is the property of the children and the state doesn’t have a right to claim ownership.”
She continued, “We are not government subjects of research by virtue of being born, and our DNA is not government property.”
In a previous report, Brase warned that the accumulation of DNA data on entire generations of the population could result in unwelcome actions.
“Suppose … expanded screening of an infant reveals not a fatal and incurable disease but instead a host of genetic variants, each of which merely confers elevated risk for some condition or other,” her report said. “Who is to say at what point an uncovered defect becomes serious enough to warrant preventing the birth of other children who might carry it? At what point have we crossed the line from legitimate family planning to capricious and morally dubious eugenics?”
WND reported earlier when Brase’s report said the concept of “identifying” those who would be “unsuitable” for reproduction is enough reason for parents to be alarmed.
Her report said most parents “have no idea that government is doing the testing or retaining the data and DNA.”
“It is not hard to imagine the day when any discovered but nonsymptomatic condition could become a ‘pre-existing condition’ for which private insurers would not pay. The eugenic implications are obvious. Thus, the growing collection of genetic test results and newborn DNA could easily enable a eugenics agenda on the part of government agencies and private industry,” the report said.
WND also reported when the state of Texas forwarded the DNA from hundreds of newborn babies to a military database without parental permission or knowledge.
The Texas Tribune, an online publication founded by a former editor of the Texas Monthly and a longtime owner of the Texas Weekly, had published a story about the Department of State Health Services in Texas giving some 800 DNA samples to the Armed Forces Institute of Pathology’s DNA Identification Laboratory.
The actions were uncovered as part of the publication’s review of nine years’ worth of e-mails over the collection of babies’ DNA, which recently was targeted by a lawsuit.
WND reported late last year that the dispute was settled out of court, providing a victory for genetic privacy.
According to the Tribune report, Texas officials routinely collected blood spots to screen for health issues. Then around 2002, officials started storing the blood spots on cards at Texas A&M University.
But officials never obtained parental permission and found themselves targeted by a lawsuit over their actions.
The Tribune reported that in addition to storing the blood spots, the state gave 800 samples – from which it removed identifying labels such as names and dates – to the military operation.
Brase said at the time there remain concerns, “This is the government. This is what people forget. This is the government planning to create a DNA warehouse of citizens.”
Would you trust the federal government with your DNA?