Melissa Davey
The Guardian
Originally published February 5, 2019
A world-first study has called for the mass retraction of more than 400 scientific papers on organ transplantation, amid fears the organs were obtained unethically from Chinese prisoners.
The Australian-led study exposes a mass failure of English language medical journals to comply with international ethical standards in place to ensure organ donors provide consent for transplantation.
The study was published on Wednesday in the medical journal BMJ Open. Its author, the professor of clinical ethics Wendy Rogers, said journals, researchers and clinicians who used the research were complicit in “barbaric” methods of organ procurement.
“There’s no real pressure from research leaders on China to be more transparent,” Rogers, from Macquarie University in Sydney, said. “Everyone seems to say, ‘It’s not our job’. The world’s silence on this barbaric issue must stop.”
A report published in 2016 found a large discrepancy between official transplant figures from the Chinese government and the number of transplants reported by hospitals. While the government says 10,000 transplants occur each year, hospital data shows between 60,000 to 100,000 organs are transplanted each year. The report provides evidence that this gap is being made up by executed prisoners of conscience.
The info is here.
Showing posts with label Human Subject Protection. Show all posts
Showing posts with label Human Subject Protection. Show all posts
Tuesday, March 5, 2019
Thursday, February 28, 2019
‘Three Identical Strangers’: The high cost of experimentation without ethics
Barron H. Lerner
The Washington Post
Originally published January 27, 2019
Here is an excerpt:
Injunctions against unethical research go back at least to the mid-19th century, when the French scientist Claude Bernard admonished his fellow investigators never to do an experiment that might harm a single person, even if the result would be highly advantageous to science and the health of others. Yet despite Bernard’s admonition, the next century was replete with experiments that put orphans, prisoners, minorities and other vulnerable populations at risk for the sake of scientific discovery. Medical progress often came at too high a human cost, something the CNN documentary exposes.
Human experimentation surged during World War II as American scientists raced to find treatments for diseases encountered on the battlefield. This experimental enthusiasm continued into the Cold War years, as the United States competed with the Soviet Union for scientific knowledge. In both eras, a utilitarian mind-set trumped concerns about research subjects.
That the experiments continued after the war was especially ironic given the response to the atrocities committed by Nazi physicians in concentration camps. There, doctors performed horrific experiments designed to help German soldiers who faced extreme conditions on the battlefield. This research included deliberately freezing inmates, forcing them to ingest only seawater and amputating their limbs.
The info is here.
The Washington Post
Originally published January 27, 2019
Here is an excerpt:
Injunctions against unethical research go back at least to the mid-19th century, when the French scientist Claude Bernard admonished his fellow investigators never to do an experiment that might harm a single person, even if the result would be highly advantageous to science and the health of others. Yet despite Bernard’s admonition, the next century was replete with experiments that put orphans, prisoners, minorities and other vulnerable populations at risk for the sake of scientific discovery. Medical progress often came at too high a human cost, something the CNN documentary exposes.
Human experimentation surged during World War II as American scientists raced to find treatments for diseases encountered on the battlefield. This experimental enthusiasm continued into the Cold War years, as the United States competed with the Soviet Union for scientific knowledge. In both eras, a utilitarian mind-set trumped concerns about research subjects.
That the experiments continued after the war was especially ironic given the response to the atrocities committed by Nazi physicians in concentration camps. There, doctors performed horrific experiments designed to help German soldiers who faced extreme conditions on the battlefield. This research included deliberately freezing inmates, forcing them to ingest only seawater and amputating their limbs.
The info is here.
Tuesday, January 22, 2019
Proceedings Start Against ‘Sokal Squared’ Hoax Professor
Katherine Mangan
The Chronicle of Higher Education
Originally posted January 7, 2019
Here is an excerpt:
The Oregon university’s institutional review board concluded that Boghossian’s participation in the elaborate hoax had violated Portland State’s ethical guidelines, according to documents Boghossian posted online. The university is considering a further charge that he had falsified data, the documents indicate.
Last month Portland State’s vice president for research and graduate studies, Mark R. McLellan, ordered Boghossian to undergo training on human-subjects research as a condition for getting further studies approved. In addition, McLellan said he had referred the matter to the president and provost because Boghossian’s behavior "raises ethical issues of concern."
Boghossian and his supporters have gone on the offensive with an online press kit that links to emails from Portland State administrators. It also includes a video filmed by a documentary filmmaker that shows Boghossian reading an email that asks him to appear before the institutional review board in October. In the video, Boghossian discusses the implications of potentially being found responsible for professional misconduct. He’s speaking with his co-authors, Helen Pluckrose, a self-described "exile from the humanities" who studies medieval religious writings about women, and James A. Lindsay, an author and mathematician.
The info is here.
The Chronicle of Higher Education
Originally posted January 7, 2019
Here is an excerpt:
The Oregon university’s institutional review board concluded that Boghossian’s participation in the elaborate hoax had violated Portland State’s ethical guidelines, according to documents Boghossian posted online. The university is considering a further charge that he had falsified data, the documents indicate.
Last month Portland State’s vice president for research and graduate studies, Mark R. McLellan, ordered Boghossian to undergo training on human-subjects research as a condition for getting further studies approved. In addition, McLellan said he had referred the matter to the president and provost because Boghossian’s behavior "raises ethical issues of concern."
Boghossian and his supporters have gone on the offensive with an online press kit that links to emails from Portland State administrators. It also includes a video filmed by a documentary filmmaker that shows Boghossian reading an email that asks him to appear before the institutional review board in October. In the video, Boghossian discusses the implications of potentially being found responsible for professional misconduct. He’s speaking with his co-authors, Helen Pluckrose, a self-described "exile from the humanities" who studies medieval religious writings about women, and James A. Lindsay, an author and mathematician.
The info is here.
Tuesday, August 21, 2018
Ethical Concerns Raised by Illicit Human Experiments
David Tereshchuk
Religion and Ethics - PBS.org
Originally posted July 16, 2018
Institutional regulation in science – including medical science – is undergoing one of its periodic assaults by proponents of greater freedom in research. These proponents argue (most of them in entirely good faith, I should stress) that experimentation is often needlessly hampered by too much official control. Formal constraints, they say, can cramp the kind of spontaneous improvisation that leads to unexpected, sometime spectacular, breakthroughs.
As reported by Marisa Taylor of Kaiser Health News, it has been revealed that the federal Food and Drug Administration (who won’t officially confirm this) is pursuing criminal inquiries into an egregious case of medical experimentation – conducted illicitly in off-shore locations and in hotel rooms on American soil.
The procedures under investigation were self-styled drug ‘trials’ – apparently a last-ditch effort by a university professor of microbiology, William Halford who – knowing he was dying from an incurable cancer – evidently threw both professional caution and ethics to the winds. He embarked hell-bent on a test-program for a herpes vaccine he’d invented, but for which he hadn’t gained FDA approval – a program that involved injecting it into human subjects.
The information is here.
Religion and Ethics - PBS.org
Originally posted July 16, 2018
Institutional regulation in science – including medical science – is undergoing one of its periodic assaults by proponents of greater freedom in research. These proponents argue (most of them in entirely good faith, I should stress) that experimentation is often needlessly hampered by too much official control. Formal constraints, they say, can cramp the kind of spontaneous improvisation that leads to unexpected, sometime spectacular, breakthroughs.
As reported by Marisa Taylor of Kaiser Health News, it has been revealed that the federal Food and Drug Administration (who won’t officially confirm this) is pursuing criminal inquiries into an egregious case of medical experimentation – conducted illicitly in off-shore locations and in hotel rooms on American soil.
The procedures under investigation were self-styled drug ‘trials’ – apparently a last-ditch effort by a university professor of microbiology, William Halford who – knowing he was dying from an incurable cancer – evidently threw both professional caution and ethics to the winds. He embarked hell-bent on a test-program for a herpes vaccine he’d invented, but for which he hadn’t gained FDA approval – a program that involved injecting it into human subjects.
The information is here.
Saturday, May 12, 2018
Bystander risk, social value, and ethics of human research
S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch, and others
Science 13 Apr 2018 : 158-159
Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated when risks are substantial but not offset by direct benefit to participants, and the benefit to society (“social value”) is context-dependent? We encountered these issues while serving on a multidisciplinary, independent expert panel charged with addressing whether human challenge trials (HCTs) in which healthy volunteers would be deliberately infected with Zika virus could be ethically justified (1). Based on our experience on that panel, which concluded that there was insufficient value to justify a Zika HCT at the time of our report, we propose a new review mechanism to preemptively address issues of bystander risk and contingent social value.
(cut)
Some may object that generalizing and institutionalizing this approach could slow valuable research by adding an additional layer for review. However, embedding this process within funding agencies could preempt ethical problems that might otherwise stymie research. Concerns that CERCs might suffer from “mission creep” could be countered by establishing clear charters and triggers for deploying CERCs. Unlike IRBs, their opinions should be publicly available to provide precedent for future research programs or for IRBs evaluating particular protocols at a later date.
The information is here.
Science 13 Apr 2018 : 158-159
Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated when risks are substantial but not offset by direct benefit to participants, and the benefit to society (“social value”) is context-dependent? We encountered these issues while serving on a multidisciplinary, independent expert panel charged with addressing whether human challenge trials (HCTs) in which healthy volunteers would be deliberately infected with Zika virus could be ethically justified (1). Based on our experience on that panel, which concluded that there was insufficient value to justify a Zika HCT at the time of our report, we propose a new review mechanism to preemptively address issues of bystander risk and contingent social value.
(cut)
Some may object that generalizing and institutionalizing this approach could slow valuable research by adding an additional layer for review. However, embedding this process within funding agencies could preempt ethical problems that might otherwise stymie research. Concerns that CERCs might suffer from “mission creep” could be countered by establishing clear charters and triggers for deploying CERCs. Unlike IRBs, their opinions should be publicly available to provide precedent for future research programs or for IRBs evaluating particular protocols at a later date.
The information is here.
Thursday, February 22, 2018
NIH adopts new rules on human research, worrying behavioral scientists
William Wan
The Washington Post
Originally posted January 24, 2018
Last year, the National Institutes of Health announced plans to tighten its rules for all research involving humans — including new requirements for scientists studying human behavior — and touched off a panic.
Some of the country’s biggest scientific associations, including the American Psychological Association and Federation of Associations in Behavioral and Brain Sciences, penned impassioned letters over the summer warning that the new policies could slow scientific progress, increase red tape and present obstacles for researchers working in smaller labs with less financial and administrative resources to deal with the added requirements. More than 3,500 scientists signed an open letter to NIH director Francis Collins.
The new rules are scheduled to take effect Thursday. They will have a big impact on how research is conducted, especially in fields like psychology and neuroscience. NIH distributes more than $32 billion each year, making it the largest public funder of biomedical and health research in the world, and the rules apply to any NIH-supported work that studies human subjects and is evaluating the effects of interventions on health or behavior.
The article is here.
The Washington Post
Originally posted January 24, 2018
Last year, the National Institutes of Health announced plans to tighten its rules for all research involving humans — including new requirements for scientists studying human behavior — and touched off a panic.
Some of the country’s biggest scientific associations, including the American Psychological Association and Federation of Associations in Behavioral and Brain Sciences, penned impassioned letters over the summer warning that the new policies could slow scientific progress, increase red tape and present obstacles for researchers working in smaller labs with less financial and administrative resources to deal with the added requirements. More than 3,500 scientists signed an open letter to NIH director Francis Collins.
The new rules are scheduled to take effect Thursday. They will have a big impact on how research is conducted, especially in fields like psychology and neuroscience. NIH distributes more than $32 billion each year, making it the largest public funder of biomedical and health research in the world, and the rules apply to any NIH-supported work that studies human subjects and is evaluating the effects of interventions on health or behavior.
The article is here.
Wednesday, February 21, 2018
The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward
Alison Bateman-House and Christopher T. Robertson
JAMA Intern Med. Published online January 22, 2018.
In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is not going to live more than four weeks [anyway.]” Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box). As of December 2017, the US House of Representatives was considering the bill.
The article is here.
JAMA Intern Med. Published online January 22, 2018.
In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is not going to live more than four weeks [anyway.]” Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box). As of December 2017, the US House of Representatives was considering the bill.
The article is here.
Subscribe to:
Posts (Atom)