NEWS&ANALYSIS Off limits? Proposed E.U. rules would make it more difficult to use medical records for research.
Downloaded from www.sciencemag.org on March 10, 2015
patients’ privacy concerns and build public confidence in the system, which supporters say will be a boon for medical research. The European Commission unveiled its data protection proposal, which covers everything from online shopping to e-banking services, in 2012. It replaces a directive from 1995, a time when the Internet had just arrived. Most scientists said they could live with the commission’s draft proposal, which defined conditions under which health researchers can use patients’ data without their specific, explicit consent. The proposal acknowledged that consent is sometimes difficult to obtain. For instance, one U.K. study into the risk of leukemia for children living close to power lines used cancer registry data from 33,000 EUROPE patients; seeking individual consent from all of the kids’ families would have been impractical, scientists say. But in October 2013, the European Parliament’s civil liberties committee (LIBE) introduced several changes to narrow BRUSSELS—Neuroscientist Richard European Parliament, which is set to vote the exceptions. Research organizations are Frackowiak co-directs the Human Brain on the bill next month, to change it. More particularly upset about LIBE’s changes Project, a giant research endeavor that will than 40 European organizations involved in to Article 81 of the regulation, which now get €1 billion from the European Union in research have joined. They’re also targeting says that the obligation to get consent can the next 10 years. One part of the project tries national governments, which will negotiate be lifted only if the research serves a “high to link up hospital archives across Europe the plan later this year. “The European public interest” and “cannot possibly be to mine data from hundreds of thousands of Union is at risk of getting this dangerously carried out otherwise.” Even then, the data patients. The goal is to define diseases by bio- wrong,” the leaders of Science Europe, the must be anonymized—that is, stripped of logical and clinical patterns, anything that could betray and ultimately to build comthe patient’s identity— puter models of diseased or, if that’s impossible “Member States law may provide for exceptions to the brains and predict the effects for the study’s purpose, requirement of consent for research … that serves a of treatment. pseudonymized, so that high public interest, if that research cannot possibly But Frackowiak, who patients’ names are stored be carried out otherwise. The data in question shall be also serves as chair of the securely but not visible to medical sciences committee the researcher. anonymised, or if that is not possible for the research of Science Europe, an Consumer groups argue purposes, pseudonymised under the highest technical association of research that the changes strike a standards. …” funders, is worried that balance between legitimate such studies may become privacy concer ns and Article 81(2a) of the proposed E.U. Data Protection unworkable if the European public health needs. But Union approves a new bill research advocates say the Regulation, as amended by the LIBE committee aimed at better protecting amendment “is setting a citizens’ privacy and hardisproportionately high monizing the current patchwork of data Max Planck Society, the Institut Pasteur, and bar,” as Beth Thompson, a policy adviser protection rules across the continent. others said in an open letter in The Times last at the Wellcome Trust, puts it. Thompson As it stands, scientists say, the bill could month. argues that researchers sometimes need make it much harder—and in some cases Data protection is a hot topic across data, such as a postal code, age, or disease impossible—to use this kind of data without Europe, where Edward Snowden’s status, that could identify an individual. patients’ specific consent, as the Human revelations about U.S. snooping have caused For instance, a 63-year-old woman from Brain Project does. widespread indignation. Just last week, the a small town suffering from a rare disease The Wellcome Trust, a major health U.K. National Health Service announced it might be identifiable even if her name isn’t research charity in the United Kingdom, is will delay the creation of a national database used. “At the moment, it’s possible in the leading a campaign urging members of the of medical records for 6 months to address U.K. to use that kind of identifiable data
CREDIT: DAVEWHITNEY/ISTOCKPHOTO.COM
E.U. Privacy Protection Bill Would Hamper Research, Scientists Warn
www.sciencemag.org
SCIENCE
VOL 343
Published by AAAS
28 FEBRUARY 2014
959
NEWS&ANALYSIS
–TANIA RABESANDRATANA
960
AT M O S P H E R I C E V O L U T I O N
New Look at Ancient Mineral Could Scrap a Test for Early Oxygen Geologists trying to sniff out signs of oxygen in Earth’s early air have long struggled with a major obstacle: eons-old rocks that provide only a ragged, fragmentary record of the gas. Even so, some have for decades taken the presence of the mineral hematite in a so-called banded iron formation (BIF) in northwestern Australia as a sign that 2.5 billion years ago, Earth’s atmosphere had at least a trace of oxygen. The ruddy mineral was thought to record the moment when photosynthesis first pushed oxygen to levels high enough to fully oxidize iron. Now, a new study of that BIF, using the latest analytical techniques, suggests that this rock record has been misread. If true, oxygen actually may have appeared in the atmosphere
modern optical microscopes, as well as with a scanning electron microscope equipped with an x-ray spectrometer for elemental analysis. That let the researchers see where each microscopic mineral in the rock formed and get a sense of the order of their creation. Knowing the conditions under which each mineral could form, the researchers could tell a tale about conditions in the ocean beneath which the BIF was first laid down—a time when oxygen gas may have been making its first, tentative appearance on Earth. Their more detailed look at the rocks focused on hematite, which consists of iron combined with as much oxygen as iron’s bonds can hold. Because the Dales Gorge BIF has plenty of oxygen-rich hematite, earlier researchers concluded that oxygen gas from the atmosphere must have already been dissolved in the ocean and in the underlying sediments 2.5 billion years ago, when the makings of this BIF first settled to the ocean bottom. But the Australian researchers see signs that the BIF’s hematite was a Johnny-come-lately. Other ironrich minerals—ones that, unlike Late oxygen. Thin layers of oxygen-rich hematite formed long hematite, form in the absence of after this sediment was deposited. oxygen gas—were there in the original seafloor sediments, the hundreds of millions of years later than this group argues. But they conclude that this BIF suggested. Geologists say the study raises iron was probably not oxidized, producing serious questions about a supposedly reliable the hematite, until about 300 million years test. “People are recognizing that we have to later, after tectonic forces crumpled the sea be more careful,” says geochemist Timothy floor into mountains and drove oxygen-laden Lyons of the University of California, water down into the rock. Given that western Riverside. “We need to increasingly focus on Australia hosts the archetypal examples of doing just what [these authors] did, a more BIFs in that early time, Rasmussen says, the careful characterization of samples.” Dales Gorge formation “probably records In a paper in the Geological Society fundamental processes that also affected of America Bulletin published online on other BIFs at some time in their history.” 3 February, geologists Birger Rasmussen, Others are not ready to go quite that far. Bryan Krapež, and Daniela Meier of Curtin BIF geologist Bruce Simonson of Oberlin University, Bentley, Australia, reanalyze the College in Ohio praises the team’s “careful mineral makeup of the Dales Gorge BIF, study and reasonable conclusions” but adds an ancient ocean bottom now in western that “it would be premature to extrapolate Australia. Their original intent was to their conclusions to all BIFs everywhere.” explain how run-of-the-mill BIFs like Dales Even so, both he and Lyons see the new work Gorge turn into the iron-rich ores so heavily as a warning shot. “Big stories [of oxygen’s mined worldwide. history] have been told by small amounts of The team took 400 translucent slivers data,” Lyons says. Lately, “by being more of Dales Gorge rock from four deep-drill careful, we’re seeing a more nuanced, more cores and studied them with several kinds of coherent picture.” –RICHARD A. KERR
28 FEBRUARY 2014
VOL 343
SCIENCE
Published by AAAS
www.sciencemag.org
CREDIT: B. RASMUSSEN ET AL., GEOLOGICAL SOCIETY OF AMERICA BULLETIN 8 (3 FEBRUARY 2014)
without consent,” Thompson says. “We’re not saying it should be easy, but it should be an option.” Researchers in some other countries are less concerned. France, for example, already has one of the strictest data protection legislations in Europe, says Charles Persoz, head of the public health unit at France’s national health research institute INSERM in Paris. Tougher E.U.-wide data rules would make procedures more burdensome, but would not restrict the work of researchers in France as much as they would in the United Kingdom, he says. But Persoz does worry that the bill’s failure to define a “high public interest” could end up imperiling research even in France. “The absence of definition could have dreadful consequences,” he warns. If, for instance, a register of gynecological cancers in a French region isn’t deemed to be of high public interest, tapping the data would become illegal because patients don’t give explicit consent to have their information entered. Jan Philipp Albrecht, a Green member of the European Parliament and the lead author of LIBE’s opinion on the bill, says researchers shouldn’t worry too much. The two criteria laid out in the amended Article 81 are necessary and reasonable safeguards, he says, adding that public health research generally qualifies as a “high public interest” endeavor. (Some private research may not, he says.) But Albrecht says that researchers can still weigh into the debate and suggest better wording if they think it’s necessary. Patients generally support the use of medical data for health research, says Cicely Marston of the London School of Hygiene & Tropical Medicine, who studies patient views on the use of electronic health records in the United Kingdom. But unlike researchers, they may not be aware of all the safeguards currently in place, and they want to know how and for what their data are used. Better informed patients may be more willing to share their information, Marston says. In the end, there will always be some risk of privacy breaches, Frackowiak says—but he believes that risk is minor, and worth taking given the huge potential health benefits of population-based studies. European countries have developed a strong system of ethical panels to review every study, Frackowiak says, and in his experience most patients trust scientists with their data to advance medical knowledge. “There’s a big infrastructure in place, that thus far hasn’t created any scandal at all,” he says.
Downloaded from www.sciencemag.org on March 10, 2015
patients’ privacy concerns and build public confidence in the system, which supporters say will be a boon for medical research. The European Commission unveiled its data protection proposal, which covers everything from online shopping to e-banking services, in 2012. It replaces a directive from 1995, a time when the Internet had just arrived. Most scientists said they could live with the commission’s draft proposal, which defined conditions under which health researchers can use patients’ data without their specific, explicit consent. The proposal acknowledged that consent is sometimes difficult to obtain. For instance, one U.K. study into the risk of leukemia for children living close to power lines used cancer registry data from 33,000 EUROPE patients; seeking individual consent from all of the kids’ families would have been impractical, scientists say. But in October 2013, the European Parliament’s civil liberties committee (LIBE) introduced several changes to narrow BRUSSELS—Neuroscientist Richard European Parliament, which is set to vote the exceptions. Research organizations are Frackowiak co-directs the Human Brain on the bill next month, to change it. More particularly upset about LIBE’s changes Project, a giant research endeavor that will than 40 European organizations involved in to Article 81 of the regulation, which now get €1 billion from the European Union in research have joined. They’re also targeting says that the obligation to get consent can the next 10 years. One part of the project tries national governments, which will negotiate be lifted only if the research serves a “high to link up hospital archives across Europe the plan later this year. “The European public interest” and “cannot possibly be to mine data from hundreds of thousands of Union is at risk of getting this dangerously carried out otherwise.” Even then, the data patients. The goal is to define diseases by bio- wrong,” the leaders of Science Europe, the must be anonymized—that is, stripped of logical and clinical patterns, anything that could betray and ultimately to build comthe patient’s identity— puter models of diseased or, if that’s impossible “Member States law may provide for exceptions to the brains and predict the effects for the study’s purpose, requirement of consent for research … that serves a of treatment. pseudonymized, so that high public interest, if that research cannot possibly But Frackowiak, who patients’ names are stored be carried out otherwise. The data in question shall be also serves as chair of the securely but not visible to medical sciences committee the researcher. anonymised, or if that is not possible for the research of Science Europe, an Consumer groups argue purposes, pseudonymised under the highest technical association of research that the changes strike a standards. …” funders, is worried that balance between legitimate such studies may become privacy concer ns and Article 81(2a) of the proposed E.U. Data Protection unworkable if the European public health needs. But Union approves a new bill research advocates say the Regulation, as amended by the LIBE committee aimed at better protecting amendment “is setting a citizens’ privacy and hardisproportionately high monizing the current patchwork of data Max Planck Society, the Institut Pasteur, and bar,” as Beth Thompson, a policy adviser protection rules across the continent. others said in an open letter in The Times last at the Wellcome Trust, puts it. Thompson As it stands, scientists say, the bill could month. argues that researchers sometimes need make it much harder—and in some cases Data protection is a hot topic across data, such as a postal code, age, or disease impossible—to use this kind of data without Europe, where Edward Snowden’s status, that could identify an individual. patients’ specific consent, as the Human revelations about U.S. snooping have caused For instance, a 63-year-old woman from Brain Project does. widespread indignation. Just last week, the a small town suffering from a rare disease The Wellcome Trust, a major health U.K. National Health Service announced it might be identifiable even if her name isn’t research charity in the United Kingdom, is will delay the creation of a national database used. “At the moment, it’s possible in the leading a campaign urging members of the of medical records for 6 months to address U.K. to use that kind of identifiable data
CREDIT: DAVEWHITNEY/ISTOCKPHOTO.COM
E.U. Privacy Protection Bill Would Hamper Research, Scientists Warn
www.sciencemag.org
SCIENCE
VOL 343
Published by AAAS
28 FEBRUARY 2014
959
NEWS&ANALYSIS
–TANIA RABESANDRATANA
960
AT M O S P H E R I C E V O L U T I O N
New Look at Ancient Mineral Could Scrap a Test for Early Oxygen Geologists trying to sniff out signs of oxygen in Earth’s early air have long struggled with a major obstacle: eons-old rocks that provide only a ragged, fragmentary record of the gas. Even so, some have for decades taken the presence of the mineral hematite in a so-called banded iron formation (BIF) in northwestern Australia as a sign that 2.5 billion years ago, Earth’s atmosphere had at least a trace of oxygen. The ruddy mineral was thought to record the moment when photosynthesis first pushed oxygen to levels high enough to fully oxidize iron. Now, a new study of that BIF, using the latest analytical techniques, suggests that this rock record has been misread. If true, oxygen actually may have appeared in the atmosphere
modern optical microscopes, as well as with a scanning electron microscope equipped with an x-ray spectrometer for elemental analysis. That let the researchers see where each microscopic mineral in the rock formed and get a sense of the order of their creation. Knowing the conditions under which each mineral could form, the researchers could tell a tale about conditions in the ocean beneath which the BIF was first laid down—a time when oxygen gas may have been making its first, tentative appearance on Earth. Their more detailed look at the rocks focused on hematite, which consists of iron combined with as much oxygen as iron’s bonds can hold. Because the Dales Gorge BIF has plenty of oxygen-rich hematite, earlier researchers concluded that oxygen gas from the atmosphere must have already been dissolved in the ocean and in the underlying sediments 2.5 billion years ago, when the makings of this BIF first settled to the ocean bottom. But the Australian researchers see signs that the BIF’s hematite was a Johnny-come-lately. Other ironrich minerals—ones that, unlike Late oxygen. Thin layers of oxygen-rich hematite formed long hematite, form in the absence of after this sediment was deposited. oxygen gas—were there in the original seafloor sediments, the hundreds of millions of years later than this group argues. But they conclude that this BIF suggested. Geologists say the study raises iron was probably not oxidized, producing serious questions about a supposedly reliable the hematite, until about 300 million years test. “People are recognizing that we have to later, after tectonic forces crumpled the sea be more careful,” says geochemist Timothy floor into mountains and drove oxygen-laden Lyons of the University of California, water down into the rock. Given that western Riverside. “We need to increasingly focus on Australia hosts the archetypal examples of doing just what [these authors] did, a more BIFs in that early time, Rasmussen says, the careful characterization of samples.” Dales Gorge formation “probably records In a paper in the Geological Society fundamental processes that also affected of America Bulletin published online on other BIFs at some time in their history.” 3 February, geologists Birger Rasmussen, Others are not ready to go quite that far. Bryan Krapež, and Daniela Meier of Curtin BIF geologist Bruce Simonson of Oberlin University, Bentley, Australia, reanalyze the College in Ohio praises the team’s “careful mineral makeup of the Dales Gorge BIF, study and reasonable conclusions” but adds an ancient ocean bottom now in western that “it would be premature to extrapolate Australia. Their original intent was to their conclusions to all BIFs everywhere.” explain how run-of-the-mill BIFs like Dales Even so, both he and Lyons see the new work Gorge turn into the iron-rich ores so heavily as a warning shot. “Big stories [of oxygen’s mined worldwide. history] have been told by small amounts of The team took 400 translucent slivers data,” Lyons says. Lately, “by being more of Dales Gorge rock from four deep-drill careful, we’re seeing a more nuanced, more cores and studied them with several kinds of coherent picture.” –RICHARD A. KERR
28 FEBRUARY 2014
VOL 343
SCIENCE
Published by AAAS
www.sciencemag.org
CREDIT: B. RASMUSSEN ET AL., GEOLOGICAL SOCIETY OF AMERICA BULLETIN 8 (3 FEBRUARY 2014)
without consent,” Thompson says. “We’re not saying it should be easy, but it should be an option.” Researchers in some other countries are less concerned. France, for example, already has one of the strictest data protection legislations in Europe, says Charles Persoz, head of the public health unit at France’s national health research institute INSERM in Paris. Tougher E.U.-wide data rules would make procedures more burdensome, but would not restrict the work of researchers in France as much as they would in the United Kingdom, he says. But Persoz does worry that the bill’s failure to define a “high public interest” could end up imperiling research even in France. “The absence of definition could have dreadful consequences,” he warns. If, for instance, a register of gynecological cancers in a French region isn’t deemed to be of high public interest, tapping the data would become illegal because patients don’t give explicit consent to have their information entered. Jan Philipp Albrecht, a Green member of the European Parliament and the lead author of LIBE’s opinion on the bill, says researchers shouldn’t worry too much. The two criteria laid out in the amended Article 81 are necessary and reasonable safeguards, he says, adding that public health research generally qualifies as a “high public interest” endeavor. (Some private research may not, he says.) But Albrecht says that researchers can still weigh into the debate and suggest better wording if they think it’s necessary. Patients generally support the use of medical data for health research, says Cicely Marston of the London School of Hygiene & Tropical Medicine, who studies patient views on the use of electronic health records in the United Kingdom. But unlike researchers, they may not be aware of all the safeguards currently in place, and they want to know how and for what their data are used. Better informed patients may be more willing to share their information, Marston says. In the end, there will always be some risk of privacy breaches, Frackowiak says—but he believes that risk is minor, and worth taking given the huge potential health benefits of population-based studies. European countries have developed a strong system of ethical panels to review every study, Frackowiak says, and in his experience most patients trust scientists with their data to advance medical knowledge. “There’s a big infrastructure in place, that thus far hasn’t created any scandal at all,” he says.
