Sigal Samuel
vox.com
Originally posted March 9, 2019
A team of scientists in Spain is getting ready to experiment on prisoners. If the scientists get the necessary approvals, they plan to start a study this month that involves placing electrodes on inmates’ foreheads and sending a current into their brains. The electricity will target the prefrontal cortex, a brain region that plays a role in decision-making and social behavior. The idea is that stimulating more activity in that region may make the prisoners less aggressive.
This technique — transcranial direct current stimulation, or tDCS — is a form of neurointervention, meaning it acts directly on the brain. Using neurointerventions in the criminal justice system is highly controversial. In recent years, scientists and philosophers have been debating under what conditions (if any) it might be ethical.
The Spanish team is the first to use tDCS on prisoners. They’ve already done it in a pilot study, publishing their findings in Neuroscience in January, and they were all set to implement a follow-up study involving at least 12 convicted murderers and other inmates this month. On Wednesday, New Scientist broke news of the upcoming experiment, noting that it had approval from the Spanish government, prison officials, and a university ethics committee. The next day, the Interior Ministry changed course and put the study on hold.
Andrés Molero-Chamizo, a psychologist at the University of Huelva and the lead researcher behind the study, told me he’s trying to find out what led to the government’s unexpected decision. He said it makes sense to run such an experiment on inmates because “prisoners have a high level of aggressiveness.”
The info is here.
Showing posts with label IRB. Show all posts
Showing posts with label IRB. Show all posts
Sunday, April 7, 2019
Thursday, November 8, 2018
Do We Need To Teach Ethics And Empathy To Data Scientists?
Kalev Leetaru
One of the most frightening aspects of the modern web is the speed at which it has struck down decades of legislation and professional norms regarding personal privacy and the ethics of turning ordinary citizens into laboratory rats to be experimented on against their wills. In the space of just two decades the online world has weaponized personalization and data brokering, stripped away the last vestiges of privacy, centralized control over the world’s information and communications channels, changed the public’s understanding of the right over their digital selves and profoundly reshaped how the scholarly world views research ethics, informed consent and the right to opt out of being turned into a digital guinea pig.
It is the latter which in many ways has driven each of the former changes. Academia’s changing views towards IRB and ethical review has produced a new generation of programmers and data scientists who view research ethics as merely an outdated obsolete historical relic that was an obnoxious barrier preventing them from doing as they pleased to an unsuspecting public.
(cut)
Ironically, however, when asked whether she would consent to someone mass harvesting all of her own personal information from all of the sites she has willingly signed up for over the years, the answer was a resounding no. When asked how she reconciled the difference between her view that users of platforms willingly relinquish their right to privacy, while her own data should be strictly protected, she was unable to articulate a reason other than that those who create and study the platforms are members of the “societal elite” who must be granted an absolute right to privacy, while “ordinary” people can be mined and manipulated at will. Such an empathy gap is common in the technical world, in which people’s lives are dehumanized into spreadsheets of numbers that remove any trace of connection or empathy.
The info is here.
Forbes.com
Originally posted October 8, 2018
Here is an excerpt:
One of the most frightening aspects of the modern web is the speed at which it has struck down decades of legislation and professional norms regarding personal privacy and the ethics of turning ordinary citizens into laboratory rats to be experimented on against their wills. In the space of just two decades the online world has weaponized personalization and data brokering, stripped away the last vestiges of privacy, centralized control over the world’s information and communications channels, changed the public’s understanding of the right over their digital selves and profoundly reshaped how the scholarly world views research ethics, informed consent and the right to opt out of being turned into a digital guinea pig.
It is the latter which in many ways has driven each of the former changes. Academia’s changing views towards IRB and ethical review has produced a new generation of programmers and data scientists who view research ethics as merely an outdated obsolete historical relic that was an obnoxious barrier preventing them from doing as they pleased to an unsuspecting public.
(cut)
Ironically, however, when asked whether she would consent to someone mass harvesting all of her own personal information from all of the sites she has willingly signed up for over the years, the answer was a resounding no. When asked how she reconciled the difference between her view that users of platforms willingly relinquish their right to privacy, while her own data should be strictly protected, she was unable to articulate a reason other than that those who create and study the platforms are members of the “societal elite” who must be granted an absolute right to privacy, while “ordinary” people can be mined and manipulated at will. Such an empathy gap is common in the technical world, in which people’s lives are dehumanized into spreadsheets of numbers that remove any trace of connection or empathy.
The info is here.
Tuesday, May 29, 2018
Ethics debate as pig brains kept alive without a body
Pallab Ghosh
BBC.com
Originally published April 27, 2018
Researchers at Yale University have restored circulation to the brains of decapitated pigs, and kept the organs alive for several hours.
Their aim is to develop a way of studying intact human brains in the lab for medical research.
Although there is no evidence that the animals were aware, there is concern that some degree of consciousness might have remained.
Details of the study were presented at a brain science ethics meeting held at the National Institutes of Health (NIH) in Bethesda in Maryland on 28 March.
The work, by Prof Nenad Sestan of Yale University, was discussed as part of an NIH investigation of ethical issues arising from neuroscience research in the US.
Prof Sestan explained that he and his team experimented on more than 100 pig brains.
The information is here.
BBC.com
Originally published April 27, 2018
Researchers at Yale University have restored circulation to the brains of decapitated pigs, and kept the organs alive for several hours.
Their aim is to develop a way of studying intact human brains in the lab for medical research.
Although there is no evidence that the animals were aware, there is concern that some degree of consciousness might have remained.
Details of the study were presented at a brain science ethics meeting held at the National Institutes of Health (NIH) in Bethesda in Maryland on 28 March.
The work, by Prof Nenad Sestan of Yale University, was discussed as part of an NIH investigation of ethical issues arising from neuroscience research in the US.
Prof Sestan explained that he and his team experimented on more than 100 pig brains.
The information is here.
Friday, April 21, 2017
Facebook plans ethics board to monitor its brain-computer interface work
Josh Constine
Tech Crunch
Originally posted April 19, 2017
Facebook will assemble an independent Ethical, Legal and Social Implications (ELSI) panel to oversee its development of a direct brain-to-computer typing interface it previewed today at its F8 conference. Facebook’s R&D department Building 8’s head Regina Dugan tells TechCrunch, “It’s early days . . . we’re in the process of forming it right now.”
Meanwhile, much of the work on the brain interface is being conducted by Facebook’s university research partners like UC Berkeley and Johns Hopkins. Facebook’s technical lead on the project, Mark Chevillet, says, “They’re all held to the same standards as the NIH or other government bodies funding their work, so they already are working with institutional review boards at these universities that are ensuring that those standards are met.” Institutional review boards ensure test subjects aren’t being abused and research is being done as safely as possible.
The article is here.
Tech Crunch
Originally posted April 19, 2017
Facebook will assemble an independent Ethical, Legal and Social Implications (ELSI) panel to oversee its development of a direct brain-to-computer typing interface it previewed today at its F8 conference. Facebook’s R&D department Building 8’s head Regina Dugan tells TechCrunch, “It’s early days . . . we’re in the process of forming it right now.”
Meanwhile, much of the work on the brain interface is being conducted by Facebook’s university research partners like UC Berkeley and Johns Hopkins. Facebook’s technical lead on the project, Mark Chevillet, says, “They’re all held to the same standards as the NIH or other government bodies funding their work, so they already are working with institutional review boards at these universities that are ensuring that those standards are met.” Institutional review boards ensure test subjects aren’t being abused and research is being done as safely as possible.
The article is here.
Wednesday, July 20, 2016
Fear and Loathing in Bioethics
Carl Elliott
Narrative Inquiry in Bioethics
Volume 6.1 (2016) 43–46
Abstract
As bioethicists have become medical insiders, they have had to struggle with a conflict between what their superiors expect of them and the demands of their conscience. Often they simply resign themselves to the conflict and work quietly within the system. But the machinery of the medical–industrial complex grinds up conscientious people because those people can see no remedies for injustice apart from the bureaucratic procedures prescribed by the machine itself. The answer to injustice is not a memorandum of understanding or a new strategic plan, but rather public resistance and solidarity.
The article is here.
Narrative Inquiry in Bioethics
Volume 6.1 (2016) 43–46
Abstract
As bioethicists have become medical insiders, they have had to struggle with a conflict between what their superiors expect of them and the demands of their conscience. Often they simply resign themselves to the conflict and work quietly within the system. But the machinery of the medical–industrial complex grinds up conscientious people because those people can see no remedies for injustice apart from the bureaucratic procedures prescribed by the machine itself. The answer to injustice is not a memorandum of understanding or a new strategic plan, but rather public resistance and solidarity.
The article is here.
Saturday, June 11, 2016
Scientists Are Just as Confused About the Ethics of Big-Data Research as You
Sarah Zhang
Wired Magazine
Originally published May 20, 2016
Here is an excerpt:
Shockingly, though, the researchers behind both of those big data blowups never anticipated public outrage. (The OkCupid research does not seem to have gone through any kind of ethical review process, and a Cornell ethics review board approved the Facebook experiment.) And that shows just how untested the ethics of this new field of research is. Unlike medical research, which has been shaped by decades of clinical trials, the risks—and rewards—of analyzing big, semi-public databases are just beginning to become clear.
And the patchwork of review boards responsible for overseeing those risks are only slowly inching into the 21st century. Under the Common Rule in the US, federally funded research has to go through ethical review. Rather than one unified system though, every single university has its own institutional review board, or IRB. Most IRB members are researchers at the university, most often in the biomedical sciences. Few are professional ethicists.
The article is here.
Wired Magazine
Originally published May 20, 2016
Here is an excerpt:
Shockingly, though, the researchers behind both of those big data blowups never anticipated public outrage. (The OkCupid research does not seem to have gone through any kind of ethical review process, and a Cornell ethics review board approved the Facebook experiment.) And that shows just how untested the ethics of this new field of research is. Unlike medical research, which has been shaped by decades of clinical trials, the risks—and rewards—of analyzing big, semi-public databases are just beginning to become clear.
And the patchwork of review boards responsible for overseeing those risks are only slowly inching into the 21st century. Under the Common Rule in the US, federally funded research has to go through ethical review. Rather than one unified system though, every single university has its own institutional review board, or IRB. Most IRB members are researchers at the university, most often in the biomedical sciences. Few are professional ethicists.
The article is here.
Sunday, May 29, 2016
The job of ‘ethics committees’ should be ethically informed code consistency review
Søren Holm
J Med Ethics doi:10.1136/medethics-2015-103343
Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only. They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed.
The first flawed argument is the argument related to the separation of powers. Moore and Donnelly proceed from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement.
The response article is here.
J Med Ethics doi:10.1136/medethics-2015-103343
Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only. They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed.
The first flawed argument is the argument related to the separation of powers. Moore and Donnelly proceed from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement.
The response article is here.
Saturday, May 28, 2016
The job of ‘ethics committees’
Andrew Moore and Andrew Donnelly
J Med Ethics doi:10.1136/medethics-2015-102688
Abstract
What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions.
The article is here.
J Med Ethics doi:10.1136/medethics-2015-102688
Abstract
What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions.
The article is here.
Friday, December 11, 2015
A Controversial Rewrite For Rules To Protect Humans In Experiments
By Rob Stein
NPR Morning Edition
Originally posted November 25, 2015
Throughout history, atrocities have been committed in the name of medical research.
Nazi doctors experimented on concentration camp prisoners. American doctors let poor black men with syphilis go untreated in the Tuskegee study. The list goes on.
To protect people participating in medical research, the federal government decades ago put in place strict rules on the conduct of human experiments.
Now the Department of Health and Human Services is proposing a major revision of these regulations, known collectively as the Common Rule. It's the first change proposed in nearly a quarter-century.
"We're in a very, very different world than when these regulations were first written," says Dr. Jerry Menikoff, who heads the HHS Office of Human Research Protections. "The goal is to modernize the rules to make sure terrible things don't happen."
The article and audio file are here.
NPR Morning Edition
Originally posted November 25, 2015
Throughout history, atrocities have been committed in the name of medical research.
Nazi doctors experimented on concentration camp prisoners. American doctors let poor black men with syphilis go untreated in the Tuskegee study. The list goes on.
To protect people participating in medical research, the federal government decades ago put in place strict rules on the conduct of human experiments.
Now the Department of Health and Human Services is proposing a major revision of these regulations, known collectively as the Common Rule. It's the first change proposed in nearly a quarter-century.
"We're in a very, very different world than when these regulations were first written," says Dr. Jerry Menikoff, who heads the HHS Office of Human Research Protections. "The goal is to modernize the rules to make sure terrible things don't happen."
The article and audio file are here.
Thursday, August 27, 2015
Steven Pinker is right about biotech and wrong about bioethics
Bill Gardner
The Incidental Economist
Originally published August 7, 2015
Here is an excerpt:
First, even by newspaper op-ed standards this is lazily argued. Pinker attributes a host of opinions to bioethicists without quoting any bioethicist. He does not cite any cases to document that bioethicists’ concerns about long term consequences have impeded research and caused harms. There likely are such cases, but he writes as if they are common. I served for years on the University of Pittsburgh IRB. For better or worse, the long term risks of biomedical research were never even discussed.
Worse, Pinker brackets “dignity” and “social justice”* in sneer quotes, as if it were self-evident that affronts to these values do not fall into the class of “identifiable harms” and as if these concerns can be dismissed without any actual argument. The only normative framework that has weight, by his lights, are the mortality and morbidity of disease. Of course mortality and morbidity are exceptionally important. But if that is the only framework that matters to Pinker he is in a very small minority.
The entire critique is here.
The Incidental Economist
Originally published August 7, 2015
Here is an excerpt:
First, even by newspaper op-ed standards this is lazily argued. Pinker attributes a host of opinions to bioethicists without quoting any bioethicist. He does not cite any cases to document that bioethicists’ concerns about long term consequences have impeded research and caused harms. There likely are such cases, but he writes as if they are common. I served for years on the University of Pittsburgh IRB. For better or worse, the long term risks of biomedical research were never even discussed.
Worse, Pinker brackets “dignity” and “social justice”* in sneer quotes, as if it were self-evident that affronts to these values do not fall into the class of “identifiable harms” and as if these concerns can be dismissed without any actual argument. The only normative framework that has weight, by his lights, are the mortality and morbidity of disease. Of course mortality and morbidity are exceptionally important. But if that is the only framework that matters to Pinker he is in a very small minority.
The entire critique is here.
Wednesday, August 12, 2015
Conflicts of Interest on Institutional Review Boards Remain Problematic
By Ed Silverman
The Wall Street Journal
Originally posted July 14, 2015
Here is an excerpt:
Well, a new study in JAMA Internal Medicine finds there is “significant progress” among IRB members in reporting and managing conflicts of interest when compared with the results of a similar study conducted in 2005. Still, the study authors, who queried 493 IRB members at 100 medical schools and 15 hospitals that received the most funding from NIH in 2012, say that problems remain.
First, though, here is the good news: There was a drop in the percentage of IRB members with conflicts – 30.4% last year compared with 39% in 2005, although this was not deemed to be a significant change. And those who were willing to report a conflict jumped to 80% from 55%. And 68% of IRB members with a conflict said they would leave the room when a protocol was discussed, compared with 38% in 2005.
The entire story is here.
The Wall Street Journal
Originally posted July 14, 2015
Here is an excerpt:
Well, a new study in JAMA Internal Medicine finds there is “significant progress” among IRB members in reporting and managing conflicts of interest when compared with the results of a similar study conducted in 2005. Still, the study authors, who queried 493 IRB members at 100 medical schools and 15 hospitals that received the most funding from NIH in 2012, say that problems remain.
First, though, here is the good news: There was a drop in the percentage of IRB members with conflicts – 30.4% last year compared with 39% in 2005, although this was not deemed to be a significant change. And those who were willing to report a conflict jumped to 80% from 55%. And 68% of IRB members with a conflict said they would leave the room when a protocol was discussed, compared with 38% in 2005.
The entire story is here.
Tuesday, March 24, 2015
UMN research review finds inadequate protections
By Josh Verges
twincities.com
Originally posted February 27m 2015
A decade after a psychiatric patient's suicide, the University of Minnesota still fails on several fronts to protect vulnerable human research subjects.
That's the finding of an external review ordered by President Eric Kaler last year and made public Friday. It raises serious questions about the authorization of and oversight for U research, especially in the Department of Psychiatry.
Questions about recruitment, consent and treatment have persisted since a 2008 Pioneer Press series concerning the 2004 death of Dan Markingson, an antipsychotic drug research subject.
The entire article is here.
twincities.com
Originally posted February 27m 2015
A decade after a psychiatric patient's suicide, the University of Minnesota still fails on several fronts to protect vulnerable human research subjects.
That's the finding of an external review ordered by President Eric Kaler last year and made public Friday. It raises serious questions about the authorization of and oversight for U research, especially in the Department of Psychiatry.
Questions about recruitment, consent and treatment have persisted since a 2008 Pioneer Press series concerning the 2004 death of Dan Markingson, an antipsychotic drug research subject.
The entire article is here.
Monday, March 23, 2015
The Best-Selling, Billion-Dollar Pills Tested on Homeless People
How the destitute and the mentally ill are being used as human lab rats
by Carl Elliott
Matter
Originally posted on July 27, 2014
Here are two excerpts:
If you’re looking for poor people who have been paid to test experimental drugs, Philadelphia is a good place to start. The city is home to five medical schools, and pharmaceutical and drug-testing companies line a corridor that stretches northeast into New Jersey. It also has one of the most visible homeless populations in the country. In Philly, homeless people seem to be everywhere: sleeping in Love Park, slumped on benches in Suburban Station, or gathered along the Benjamin Franklin Parkway, waiting for the free meals that a local church gives out on Saturdays.
(cut)
Not long ago, such offers would have been considered unethical. Paying any volunteer was seen as problematic, even more so if the subjects were poor, uninsured, and compromised by illness. Payment, it was argued, might tempt vulnerable subjects to risk their health. As trials have moved into the private sector, this ethical calculus has changed. First came a hike in the sums that volunteers could be paid: Many clinical trial sites now offer over $6,000 for an inpatient drug study. Eligibility requirements have changed, too. For years, trial sites paid only healthy volunteers, mainly to test new drugs for safety. These days people with asthma, diabetes, kidney disease, liver disease, and other conditions can be paid take part in trials.
The entire article is here.
by Carl Elliott
Matter
Originally posted on July 27, 2014
Here are two excerpts:
If you’re looking for poor people who have been paid to test experimental drugs, Philadelphia is a good place to start. The city is home to five medical schools, and pharmaceutical and drug-testing companies line a corridor that stretches northeast into New Jersey. It also has one of the most visible homeless populations in the country. In Philly, homeless people seem to be everywhere: sleeping in Love Park, slumped on benches in Suburban Station, or gathered along the Benjamin Franklin Parkway, waiting for the free meals that a local church gives out on Saturdays.
(cut)
Not long ago, such offers would have been considered unethical. Paying any volunteer was seen as problematic, even more so if the subjects were poor, uninsured, and compromised by illness. Payment, it was argued, might tempt vulnerable subjects to risk their health. As trials have moved into the private sector, this ethical calculus has changed. First came a hike in the sums that volunteers could be paid: Many clinical trial sites now offer over $6,000 for an inpatient drug study. Eligibility requirements have changed, too. For years, trial sites paid only healthy volunteers, mainly to test new drugs for safety. These days people with asthma, diabetes, kidney disease, liver disease, and other conditions can be paid take part in trials.
The entire article is here.
Tuesday, January 27, 2015
Social Media Ethics
Religion and Ethics Newsweekly
Originally published January 9, 2015
Some social media companies—including Facebook—have run experiments to learn what influences user behavior. Many of these experiments have troubled both social media users and privacy advocates, who worry that this research and use of personal information is unethical.
Originally published January 9, 2015
Some social media companies—including Facebook—have run experiments to learn what influences user behavior. Many of these experiments have troubled both social media users and privacy advocates, who worry that this research and use of personal information is unethical.
Monday, December 29, 2014
Collaborating across cultures
Working with scientists from the Arab world improved my worldview, my career and my life. I urge you to collaborate with researchers from other cultures, too.
By Thomas Eissenberg, PhD
Monitor on Psychology
December 2014, Vol 45, No. 11
Print version: page 60
Working with scientists from the Arab world improved my worldview, my career and my life. I urge you to collaborate with researchers from other cultures, too.
One reason to collaborate across cultures is that many global problems — environmental degradation, disease, conflict and inequity — cannot be addressed comprehensively without global partnerships.
Yet crafting empirically based solutions with colleagues around the world involves ethical issues that extend beyond those typically considered by an Institutional Review Board (IRB). That is, rewarding and successful cross-cultural collaboration demands that partners re-dedicate themselves to basic ethical principles that involve interactions with research participants and also interactions among researchers themselves.
The entire article is here.
By Thomas Eissenberg, PhD
Monitor on Psychology
December 2014, Vol 45, No. 11
Print version: page 60
Working with scientists from the Arab world improved my worldview, my career and my life. I urge you to collaborate with researchers from other cultures, too.
One reason to collaborate across cultures is that many global problems — environmental degradation, disease, conflict and inequity — cannot be addressed comprehensively without global partnerships.
Yet crafting empirically based solutions with colleagues around the world involves ethical issues that extend beyond those typically considered by an Institutional Review Board (IRB). That is, rewarding and successful cross-cultural collaboration demands that partners re-dedicate themselves to basic ethical principles that involve interactions with research participants and also interactions among researchers themselves.
The entire article is here.
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