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Human Research Loopholes: Alive and Well
Jan 01, 2016
In one of the darkest chapters in medical ethics, the United States government ran an experiment from the 1930s to the 1970s in which it withheld treatment and medical information from rural African-American men suffering from syphilis. The public uproar generated by the Tuskegee Syphilis Study eventually resulted in regulations restricting government-supported research testing on humans. These regulations are called the "Common Rule," and they are right now up for their first full update.
The Common Rule, also known as the "Federal Policy for the Protection of Human Subjects," is supposed to affirmatively protect us from the abuses of the future. However, the proposed regulation is lousy with loopholes, including ones that could exempt tracking online behavior and experiments related to intelligence activities.
File a comment on the "Federal Policy for the Protection of Human Subjects" through Regulations.gov.
What is the Common Rule
The Common Rule was created in 1991 as an outgrowth of the Belmont Report, a series of ethical and principles and guidelines created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address issues raised by the Tuskegee experiment. The Common Rule claims to strike a balance between the three goals identified in the Belmont Report: 1) respecting persons, 2) 'beneficence' (i.e.,maximizing the social value of science and research), and 3) justice.
This federal policy purportedly binds the Department of Health and Human Services (HHS) and numerous other agencies, including the CIA and Department of Homeland Security (per Executive Order 12333). But as we've seen, these agencies are adept at honing in on small loopholes, so the proposed language needs a serious edit if it is going to provide any real protection.
EFF filed a comment when HHS first proposed this update in 2011, and we are drafting a new comment laying out our biggest concerns to file by January 6, 2016.
The Biospecimen Consent Loophole
Perhaps the most glaring problem in the proposed rule is its weak update of the ethical practices around biospecimens or biological samples--such as blood, toenails, or DNA--taken from human beings. The proposed rule requires only "broad consent" before researchers can exempt secondary research (research done on leftover biospecimen after the initial purpose for the draw is complete) from review by independent ethics boards. This kind of 'consent' is almost no consent at all: it doesn't let human subjects know what the future biospecimen research entails, how it will affect them, or how the biospecimen or research data will be shared.
These specimens contain DNA that are more likely to be identifiable given the rise of genetic databases. While genomic-related research and technology is of great potential benefit, its rapid evolution also presents significant risk and uncertainty to privacy and social control, especially given the increasing use by law enforcement and government of genetic identification.
The "Public" Behavior Loophole
We are also concerned that the rule proposes an ethics-review exemption for all studies collecting "public behavior" as long as that information is "uninfluenced by the investigators" and properly anonymized.
In the first place, this places too much trust in the benefits of what currently qualifies as "anonymization." Traditional de-identification techniques are often no match for modern data analytics.
Second, the Common Rule cannot be considered a modern ethical standard if it potentially leaves sensitive Internet traffic beyond protection merely because it is not occurring in a single "private" physical place in one person's home. Knowing what we know about the impact of tracking who gathers where, and with whom they communicate--it is inexcusable to ignore the danger of creating language flexible enough to risk entirely exempting this subject matter from review.
The Intelligence Surveillance Activities Loophole
Lastly, HHS proposes absolute ethics-review exemptions for "intelligence surveillance activities." This would exempt actions "conducted to fulfill a department or agency's legal mandate to ensure the safety and protection of the United States, its people, and its national security interests." The government is professing to fence DHS and the CIA in through E.O. 12333, but they're actually building in a gaping breach for them to stroll right back out through.
Existing law under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule already includes a national security exception that permits doctors, hospitals, and any other "covered entity" to disclose individual health information "to authorized federal officials for the conduct of lawful intelligence, counter-intelligence, and other national security activities authorized by the National Security Act." But this is an exemption that needs to be patched over, not replicated.
Deadline Approaches
These loopholes discussed above are just a sample of many we hope to force HHS to reckon with when we file our comments by January 6, 2016. Please join us in respecting the memories of those abused by human subject research in the past by filing a comment of your own.
An Urgent Message From Our Co-Founder
Dear Common Dreams reader, It’s been nearly 30 years since I co-founded Common Dreams with my late wife, Lina Newhouser. We had the radical notion that journalism should serve the public good, not corporate profits. It was clear to us from the outset what it would take to build such a project. No paid advertisements. No corporate sponsors. No millionaire publisher telling us what to think or do. Many people said we wouldn't last a year, but we proved those doubters wrong. Together with a tremendous team of journalists and dedicated staff, we built an independent media outlet free from the constraints of profits and corporate control. Our mission has always been simple: To inform. To inspire. To ignite change for the common good. Building Common Dreams was not easy. Our survival was never guaranteed. When you take on the most powerful forces—Wall Street greed, fossil fuel industry destruction, Big Tech lobbyists, and uber-rich oligarchs who have spent billions upon billions rigging the economy and democracy in their favor—the only bulwark you have is supporters who believe in your work. But here’s the urgent message from me today. It's never been this bad out there. And it's never been this hard to keep us going. At the very moment Common Dreams is most needed, the threats we face are intensifying. We need your support now more than ever. We don't accept corporate advertising and never will. We don't have a paywall because we don't think people should be blocked from critical news based on their ability to pay. Everything we do is funded by the donations of readers like you. When everyone does the little they can afford, we are strong. But if that support retreats or dries up, so do we. Will you donate now to make sure Common Dreams not only survives but thrives? —Craig Brown, Co-founder |
This work is licensed under a Creative Commons Attribution-Share Alike 3.0 License.
Lee Tien
Lee Tien is a Senior Staff Attorney with the Electronic Frontier Foundation, specializing in free speech law, including intersections with intellectual property law and privacy law.
Yonatan Moskowitz
Yonatan Moskowitz is a legal intern with EFF.
In one of the darkest chapters in medical ethics, the United States government ran an experiment from the 1930s to the 1970s in which it withheld treatment and medical information from rural African-American men suffering from syphilis. The public uproar generated by the Tuskegee Syphilis Study eventually resulted in regulations restricting government-supported research testing on humans. These regulations are called the "Common Rule," and they are right now up for their first full update.
The Common Rule, also known as the "Federal Policy for the Protection of Human Subjects," is supposed to affirmatively protect us from the abuses of the future. However, the proposed regulation is lousy with loopholes, including ones that could exempt tracking online behavior and experiments related to intelligence activities.
File a comment on the "Federal Policy for the Protection of Human Subjects" through Regulations.gov.
What is the Common Rule
The Common Rule was created in 1991 as an outgrowth of the Belmont Report, a series of ethical and principles and guidelines created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address issues raised by the Tuskegee experiment. The Common Rule claims to strike a balance between the three goals identified in the Belmont Report: 1) respecting persons, 2) 'beneficence' (i.e.,maximizing the social value of science and research), and 3) justice.
This federal policy purportedly binds the Department of Health and Human Services (HHS) and numerous other agencies, including the CIA and Department of Homeland Security (per Executive Order 12333). But as we've seen, these agencies are adept at honing in on small loopholes, so the proposed language needs a serious edit if it is going to provide any real protection.
EFF filed a comment when HHS first proposed this update in 2011, and we are drafting a new comment laying out our biggest concerns to file by January 6, 2016.
The Biospecimen Consent Loophole
Perhaps the most glaring problem in the proposed rule is its weak update of the ethical practices around biospecimens or biological samples--such as blood, toenails, or DNA--taken from human beings. The proposed rule requires only "broad consent" before researchers can exempt secondary research (research done on leftover biospecimen after the initial purpose for the draw is complete) from review by independent ethics boards. This kind of 'consent' is almost no consent at all: it doesn't let human subjects know what the future biospecimen research entails, how it will affect them, or how the biospecimen or research data will be shared.
These specimens contain DNA that are more likely to be identifiable given the rise of genetic databases. While genomic-related research and technology is of great potential benefit, its rapid evolution also presents significant risk and uncertainty to privacy and social control, especially given the increasing use by law enforcement and government of genetic identification.
The "Public" Behavior Loophole
We are also concerned that the rule proposes an ethics-review exemption for all studies collecting "public behavior" as long as that information is "uninfluenced by the investigators" and properly anonymized.
In the first place, this places too much trust in the benefits of what currently qualifies as "anonymization." Traditional de-identification techniques are often no match for modern data analytics.
Second, the Common Rule cannot be considered a modern ethical standard if it potentially leaves sensitive Internet traffic beyond protection merely because it is not occurring in a single "private" physical place in one person's home. Knowing what we know about the impact of tracking who gathers where, and with whom they communicate--it is inexcusable to ignore the danger of creating language flexible enough to risk entirely exempting this subject matter from review.
The Intelligence Surveillance Activities Loophole
Lastly, HHS proposes absolute ethics-review exemptions for "intelligence surveillance activities." This would exempt actions "conducted to fulfill a department or agency's legal mandate to ensure the safety and protection of the United States, its people, and its national security interests." The government is professing to fence DHS and the CIA in through E.O. 12333, but they're actually building in a gaping breach for them to stroll right back out through.
Existing law under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule already includes a national security exception that permits doctors, hospitals, and any other "covered entity" to disclose individual health information "to authorized federal officials for the conduct of lawful intelligence, counter-intelligence, and other national security activities authorized by the National Security Act." But this is an exemption that needs to be patched over, not replicated.
Deadline Approaches
These loopholes discussed above are just a sample of many we hope to force HHS to reckon with when we file our comments by January 6, 2016. Please join us in respecting the memories of those abused by human subject research in the past by filing a comment of your own.
Lee Tien
Lee Tien is a Senior Staff Attorney with the Electronic Frontier Foundation, specializing in free speech law, including intersections with intellectual property law and privacy law.
Yonatan Moskowitz
Yonatan Moskowitz is a legal intern with EFF.
In one of the darkest chapters in medical ethics, the United States government ran an experiment from the 1930s to the 1970s in which it withheld treatment and medical information from rural African-American men suffering from syphilis. The public uproar generated by the Tuskegee Syphilis Study eventually resulted in regulations restricting government-supported research testing on humans. These regulations are called the "Common Rule," and they are right now up for their first full update.
The Common Rule, also known as the "Federal Policy for the Protection of Human Subjects," is supposed to affirmatively protect us from the abuses of the future. However, the proposed regulation is lousy with loopholes, including ones that could exempt tracking online behavior and experiments related to intelligence activities.
File a comment on the "Federal Policy for the Protection of Human Subjects" through Regulations.gov.
What is the Common Rule
The Common Rule was created in 1991 as an outgrowth of the Belmont Report, a series of ethical and principles and guidelines created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address issues raised by the Tuskegee experiment. The Common Rule claims to strike a balance between the three goals identified in the Belmont Report: 1) respecting persons, 2) 'beneficence' (i.e.,maximizing the social value of science and research), and 3) justice.
This federal policy purportedly binds the Department of Health and Human Services (HHS) and numerous other agencies, including the CIA and Department of Homeland Security (per Executive Order 12333). But as we've seen, these agencies are adept at honing in on small loopholes, so the proposed language needs a serious edit if it is going to provide any real protection.
EFF filed a comment when HHS first proposed this update in 2011, and we are drafting a new comment laying out our biggest concerns to file by January 6, 2016.
The Biospecimen Consent Loophole
Perhaps the most glaring problem in the proposed rule is its weak update of the ethical practices around biospecimens or biological samples--such as blood, toenails, or DNA--taken from human beings. The proposed rule requires only "broad consent" before researchers can exempt secondary research (research done on leftover biospecimen after the initial purpose for the draw is complete) from review by independent ethics boards. This kind of 'consent' is almost no consent at all: it doesn't let human subjects know what the future biospecimen research entails, how it will affect them, or how the biospecimen or research data will be shared.
These specimens contain DNA that are more likely to be identifiable given the rise of genetic databases. While genomic-related research and technology is of great potential benefit, its rapid evolution also presents significant risk and uncertainty to privacy and social control, especially given the increasing use by law enforcement and government of genetic identification.
The "Public" Behavior Loophole
We are also concerned that the rule proposes an ethics-review exemption for all studies collecting "public behavior" as long as that information is "uninfluenced by the investigators" and properly anonymized.
In the first place, this places too much trust in the benefits of what currently qualifies as "anonymization." Traditional de-identification techniques are often no match for modern data analytics.
Second, the Common Rule cannot be considered a modern ethical standard if it potentially leaves sensitive Internet traffic beyond protection merely because it is not occurring in a single "private" physical place in one person's home. Knowing what we know about the impact of tracking who gathers where, and with whom they communicate--it is inexcusable to ignore the danger of creating language flexible enough to risk entirely exempting this subject matter from review.
The Intelligence Surveillance Activities Loophole
Lastly, HHS proposes absolute ethics-review exemptions for "intelligence surveillance activities." This would exempt actions "conducted to fulfill a department or agency's legal mandate to ensure the safety and protection of the United States, its people, and its national security interests." The government is professing to fence DHS and the CIA in through E.O. 12333, but they're actually building in a gaping breach for them to stroll right back out through.
Existing law under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule already includes a national security exception that permits doctors, hospitals, and any other "covered entity" to disclose individual health information "to authorized federal officials for the conduct of lawful intelligence, counter-intelligence, and other national security activities authorized by the National Security Act." But this is an exemption that needs to be patched over, not replicated.
Deadline Approaches
These loopholes discussed above are just a sample of many we hope to force HHS to reckon with when we file our comments by January 6, 2016. Please join us in respecting the memories of those abused by human subject research in the past by filing a comment of your own.
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