Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label research ethics. Show all posts
Showing posts with label research ethics. Show all posts

Saturday, December 30, 2023

The ethics of doing human enhancement ethics

Rueda, J. (2023). 
Futures, 153, 103236.


Human enhancement is one of the leading research topics in contemporary applied ethics. Interestingly, the widespread attention to the ethical aspects of future enhancement applications has generated misgivings. Are researchers who spend their time investigating the ethics of futuristic human enhancement scenarios acting in an ethically suboptimal manner? Are the methods they use to analyze future technological developments appropriate? Are institutions wasting resources by funding such research? In this article, I address the ethics of doing human enhancement ethics focusing on two main concerns. The Methodological Problem refers to the question of how we should methodologically address the moral aspects of future enhancement applications. The Normative Problem refers to what is the normative justification for investigating and funding the research on the ethical aspects of future human enhancement. This article aims to give a satisfactory response to both meta-questions in order to ethically justify the inquiry into the ethical aspects of emerging enhancement technologies.


• Formulates second-order problems neglected in the literature on the ethics of future enhancement technologies.

• Discusses speculative ethics and anticipatory ethics methodologies for analyzing emerging enhancement innovations.

• Evaluates the main objections to engaging in research into the ethical aspects of future scenarios of human enhancement.

• Shows that methodological and normative meta-questions are key to advance the ethical debate on human enhancement.

Monday, August 7, 2023

Shake-up at top psychiatric institute following suicide in clinical trial

Brendan Borrell
Spectrum News
Originally posted 31 July 23

Here are two excerpts:

The audit and turnover in leadership comes after the halting of a series of clinical trials conducted by Columbia psychiatrist Bret Rutherford, which tested whether the drug levodopa — typically used to treat Parkinson’s disease — could improve mood and mobility in adults with depression.

During a double-blind study that began in 2019, a participant in the placebo group died by suicide. That study was suspended prior to completion, according to an update posted on ClinicalTrials.gov in 2022.

Two published reports based on Rutherford’s pilot studies have since been retracted, as Spectrum has previously reported. The National Institute of Mental Health has terminated Rutherford’s trials and did not renew funding of his research grant or K24 Midcareer Award.

Former members of Rutherford’s laboratory describe it as a high-pressure environment that often put publications ahead of study participants. “Research is important, but not more so than the lives of those who participate in it,” says Kaleigh O’Boyle, who served as clinical research coordinator there from 2018 to 2020.

Although Rutherford’s faculty page is still active, he is no longer listed in the directory at Columbia University, where he was associate professor, and the voicemail at his former number says he is no longer checking it. He did not respond to voicemails and text messages sent to his personal phone or to emails sent to his Columbia email address, and Cantor would not comment on his employment status.

The circumstances around the suicide remain unclear, and the institute has previously declined to comment on Rutherford’s retractions. Veenstra-VanderWeele confirmed that he is the new director but did not respond to further questions about the situation.


In January 2022, the study was temporarily suspended by the U.S. National Institute of Mental Health, following the suicide. It is unknown whether that participant had been taking any antidepressant medication prior to the study.

Four of Rutherford’s published studies were subsequently retracted or corrected for issues related to how participants taking antidepressants at enrollment were handled.

One retraction notice published in February indicates tapering could be challenging and that the researchers did not always stick to the protocol. One-third of the participants taking antidepressants were unable to successfully taper off of them.

Note: The article serves as a cautionary tale about the risks of clinical trials. While clinical trials can be a valuable way to test new drugs and treatments, they also carry risks. Participants in clinical trials may be exposed to experimental drugs that have not been fully tested, and they may experience side effects that are not well-understood.  Ethical researchers must follow guidelines and report accurate results.

Sunday, June 25, 2023

Harvard Business School Professor Francesca Gino Accused of Committing Data Fraud

Rahem D. Hamid
Crimson Staff Writer
Originally published 24 June 23

Here is an excerpt:

But in a post on June 17, Data Colada wrote that they found evidence of additional data fabrication in that study in a separate experiment that Gino was responsible for.

Harvard has also been internally investigating “a series of papers” for more than a year, according to the Chronicle of Higher Education. Data Colada wrote last week that the University’s internal report may be around 1,200 pages.

The professors added that Harvard has requested that three other papers co-authored by Gino — which Data Colada flagged — also be retracted and that the 2012 paper’s retraction be amended to include Gino’s fabrications.

Last week, Bazerman told the Chronicle of Higher Education that he was informed by Harvard that the experiments he co-authored contained additional fraudulent data.

Bazerman called the evidence presented to him by the University “compelling,” but he denied to the Chronicle that he was at all involved with the data manipulation.

According to Data Colada, Gino was “the only author involved in the data collection and analysis” of the experiment in question.

“To the best of our knowledge, none of Gino’s co-authors carried out or assisted with the data collection for the studies in question,” the professors wrote.

In their second post on Tuesday, the investigators wrote that a 2015 study co-authored by Gino also contains manipulations to prove the paper’s hypothesis.

Observations in the paper, the three wrote, “were altered to produce the desired effect.”

“And if these observations were altered, then it is reasonable to suspect that other observations were altered as well,” they added.

Science is a part of a healthy society:
  • Scientific research relies on the integrity of the researchers. When researchers fabricate or falsify data, they undermine the trust that is necessary for scientific progress.
  • Data fraud can have serious consequences. It can lead to the publication of false or misleading findings, which can have a negative impact on public policy, business decisions, and other areas.

Friday, February 24, 2023

What Do We Owe Lab Animals?

Brandon Keim
The New York Times
Originally published 24 Jan 23

Here is an excerpt:

Scientists often point to the so-called Three Rs, a set of principles first articulated in 1959 by William Russell, a sociologist, and Rex Burch, a microbiologist, to guide experimental research on animals. Researchers are encouraged to replace animals when alternatives are available, reduce the number of animals used and refine their use so as to minimize the infliction of pain and suffering.

These are unquestionably noble aims, ethicists note, but may seem insufficient when compared with the benefits derived from animals. Covid vaccines, for example, which were tested on mice and monkeys, and developed so quickly thanks to decades of animal-based work on mRNA vaccine technology, saved an estimated 20 million lives in their first year of use and earned tens of billions of dollars in revenues.

In light of that dynamic — which applies not only to Covid vaccines, but to many other human lifesaving, fortune-generating therapeutics — some wonder if a fourth R might be warranted: repayment.

Inklings of the idea of repayment can already be found in the research community, most visibly in laboratories that make arrangements for animals — primarily monkeys and other nonhuman primates — to be retired to sanctuaries. In the case of dogs and companion species, including rats, they are sometimes adopted as pets.

“It’s kind of karma,” said Laura Conour, the executive director of Laboratory Animal Resources at Princeton University, which has a retirement arrangement with the Peaceable Primate Sanctuary. “I feel like it balances it out a little bit.” The school has also adopted out guinea pigs, anole lizards and sugar gliders as pets to private citizens, and tries to help with their veterinary care.

Adoption is not an option for animals destined to be killed, however, which raises the question of how the debt can be repaid. Lesley Sharp, a medical anthropologist at Barnard College and author of “Animal Ethos: The Morality of Human-Animal Encounters in Experimental Lab Science,” noted that research labs sometimes create memorials for animals: commemorative plaques, bulletin boards with pictures and poems and informal gatherings in remembrance.

“There is this burden the animal has to carry for humans in the context of science,” Dr. Sharp said. “They require, I think, respect, and to be recognized and honored and mourned.”

She acknowledged that honoring sacrificed animals was not quite the same as giving something back to them. To imagine what that might entail, Dr. Sharp pointed to the practice of donating one’s organs after death. Transplant recipients often want to give something in return, “but the donor is dead,” Dr. Sharp said. “Then you need somebody who is a sort of proxy for them, and that proxy is the close surviving kin.”

If someone receives a cornea or a heart from a pig — or funding to study those procedures — then they might pay for the care of another pig at a farmed animal sanctuary, Dr. Sharp proposed: “You’re going to have animals who stand in for the whole.”

Wednesday, July 27, 2022

Blots on a Field? (A modern story of unethical research related to Alzheimer's)

Charles Pillar
Science Magazine
Originally posted 21 JUL 22

Here is an excerpt:

A 6-month investigation by Science provided strong support for Schrag’s suspicions and raised questions about Lesné’s research. A leading independent image analyst and several top Alzheimer’s researchers—including George Perry of the University of Texas, San Antonio, and John Forsayeth of the University of California, San Francisco (UCSF)—reviewed most of Schrag’s findings at Science’s request. They concurred with his overall conclusions, which cast doubt on hundreds of images, including more than 70 in Lesné’s papers. Some look like “shockingly blatant” examples of image tampering, says Donna Wilcock, an Alzheimer’s expert at the University of Kentucky.

The authors “appeared to have composed figures by piecing together parts of photos from different experiments,” says Elisabeth Bik, a molecular biologist and well-known forensic image consultant. “The obtained experimental results might not have been the desired results, and that data might have been changed to … better fit a hypothesis.”

Early this year, Schrag raised his doubts with NIH and journals including Nature; two, including Nature last week, have published expressions of concern about papers by Lesné. Schrag’s work, done independently of Vanderbilt and its medical center, implies millions of federal dollars may have been misspent on the research—and much more on related efforts. Some Alzheimer’s experts now suspect Lesné’s studies have misdirected Alzheimer’s research for 16 years.

“The immediate, obvious damage is wasted NIH funding and wasted thinking in the field because people are using these results as a starting point for their own experiments,” says Stanford University neuroscientist Thomas Südhof, a Nobel laureate and expert on Alzheimer’s and related conditions.

Lesné did not respond to requests for comment. A UMN spokesperson says the university is reviewing complaints about his work.

To Schrag, the two disputed threads of Aβ research raise far-reaching questions about scientific integrity in the struggle to understand and cure Alzheimer’s. Some adherents of the amyloid hypothesis are too uncritical of work that seems to support it, he says. “Even if misconduct is rare, false ideas inserted into key nodes in our body of scientific knowledge can warp our understanding.”


The paper provided an “important boost” to the amyloid and toxic oligomer hypotheses when they faced rising doubts, Südhof says. “Proponents loved it, because it seemed to be an independent validation of what they have been proposing for a long time.”

“That was a really big finding that kind of turned the field on its head,” partly because of Ashe’s impeccable imprimatur, Wilcock says. “It drove a lot of other investigators to … go looking for these [heavier] oligomer species.”

As Ashe’s star burned more brightly, Lesné’s rose. He joined UMN with his own NIH-funded lab in 2009. Aβ*56 remained a primary research focus. Megan Larson, who worked as a junior scientist for Lesné and is now a product manager at Bio-Techne, a biosciences supply company, calls him passionate, hardworking, and charismatic. She and others in the lab often ran experiments and produced Western blots, Larson says, but in their papers together, Lesné prepared all the images for publication.

Sunday, February 13, 2022

Hit by the Virtual Trolley: When is Experimental Ethics Unethical?

Rueda, J. (2022).


The  trolley  problem  is  one  of  the  liveliest  research  frameworks  in experimental  ethics. In  the last  decade, social  neuroscience  and experimental  moral psychology  have  gone  beyond  the  studies  with  mere text-based  hypothetical  moral dilemmas. In this article, I present the rationale behind testing the actual behaviour in more realistic scenarios  through Virtual Reality and summarize the body of evidence raised by the experiments with virtual trolley scenarios. Then, I approach the argument of Ramirez and LaBarge (2020), who claim that the virtual simulation of the Footbridge version  of  the  trolley  dilemma  is  an  unethical  research  practice,  and  I  raise  some objections to it. Finally, I provide some reflections about the means and ends of trolley-like scenarios and other sacrificial dilemmas in experimental ethics.


From Rethinking the Means and Ends of Trolleyology

The first response states that these studies have no normative relevance at all. A traditional objection to the trolley dilemma pointed to the artificiality of the scenario and its normative uselessness in translating to real contemporary problems (see, for instance, Midgley, cited in Edmonds, 2014, p. 100-101). We have already seen that this is not true. Indeed, the existence of real dilemmas that share structural similarities with hypothetical trolley scenarios makes it  practically useful to test our intuitions on them (Edmonds, 2014). Besides that, a more sophisticated objection claims that intuitive responses to the trolley problem have no ethical value because intuitions are quite unreliable. Cognitive science has frequently shown how fallible, illogical, biased, and irrational many of our intuitive preferences can be. In fact, moral intuitions in text-based trolley dilemmas are subject to morally irrelevant factors such as order (Liao et al., 2012), frame (Cao et al., 2017), or mood (Pastötter et al., 2013). However, the fact that there are wrong or biased intuitions  does  not  mean  that  intuitions  do not  have any  epistemic or  moral  value. Dismissing intuitions because they are subject to implicit psychological factors in favour of armchair ethical theorizing is inconsistent. Empirical evidence should play a role in normative theorizing on trolley dilemmas as long as ethical theorizing is also subject to implicit  psychological  factors—and  which  experimental  research  can  help  to  make explicit (Kahane, 2013).  

The second option states that what should be done as public policy on sacrificial dilemmas is what the majority of people say or do in those situations. In other words, the descriptive results of the experiments show us how we should act at the normative level. Consider the following example from the debate of self-driving vehicles: “We thus argue that any implementation of an ethical decision-making system for a specific context should be based on human decisions made in the same context” (Sütfeld et al., 2017). So, as most people act in a utilitarian way in VR simulations of traffic dilemmas, autonomous cars should act similarly in analogous situations (Sütfeld et al. 2017).

Saturday, September 18, 2021

Fraudulent data raise questions about superstar honesty researcher

Cathleen O'Grady
Originally posted 24 Aug 21

Here is an excerpt:

Some time later, a group of anonymous researchers downloaded those data, according to last week’s post on Data Colada. A simple look at the participants’ mileage distribution revealed something very suspicious. Other data sets of people’s driving distances show a bell curve, with some people driving a lot, a few very little, and most somewhere in the middle. In the 2012 study, there was an unusually equal spread: Roughly the same number of people drove every distance between 0 and 50,000 miles. “I was flabbergasted,” says the researcher who made the discovery. (They spoke to Science on condition of anonymity because of fears for their career.)

Worrying that PNAS would not investigate the issue thoroughly, the whistleblower contacted the Data Colada bloggers instead, who conducted a follow-up review that convinced them the field study results were statistically impossible.

For example, a set of odometer readings provided by customers when they first signed up for insurance, apparently real, was duplicated to suggest the study had twice as many participants, with random numbers between one and 1000 added to the original mileages to disguise the deceit. In the spreadsheet, the original figures appeared in the font Calibri, but each had a close twin in another font, Cambria, with the same number of cars listed on the policy, and odometer readings within 1000 miles of the original. In 1 million simulated versions of the experiment, the same kind of similarity appeared not a single time, Simmons, Nelson, and Simonsohn found. “These data are not just excessively similar,” they write. “They are impossibly similar.”

Ariely calls the analysis “damning” and “clear beyond doubt.” He says he has requested a retraction, as have his co-authors, separately. “We are aware of the situation and are in communication with the authors,” PNAS Editorial Ethics Manager Yael Fitzpatrick said in a statement to Science.

Three of the authors say they were only involved in the two lab studies reported in the paper; a fourth, Boston University behavioral economist Nina Mazar, forwarded the Data Colada investigators a 16 February 2011 email from Ariely with an attached Excel file that contains the problems identified in the blog post. Its metadata suggest Ariely had created the file 3 days earlier.

Ariely tells Science he made a mistake in not checking the data he received from the insurance company, and that he no longer has the company’s original file. He says Duke’s integrity office told him the university’s IT department does not have email records from that long ago. His contacts at the insurance company no longer work there, Ariely adds, but he is seeking someone at the company who could find archived emails or files that could clear his name. His publication of the full data set last year showed he was unaware of any problems with it, he says: “I’m not an idiot. This is a very easy fraud to catch.”

Wednesday, May 5, 2021

Top German psychologist found to have fabricated data—University Investigation Finds Anxiety Expert Pressured Whistleblowers

Hristio Boytchev
Science  09 Apr 2021:
Vol. 372, Issue 6538, pp. 117-118
DOI: 10.1126/science.372.6538.117

Here is an excerpt:

Wittchen was one of the top epidemiologists of psychiatry, and TU Dresden “has benefited greatly from him,” says Jürgen Margraf, a psychologist at Ruhr University, Bochum, who has collaborated with Wittchen. “If the commission’s findings turn out to be true, they are very disturbing for the entire field, and that would also have an impact on TU Dresden.” Thomas Pollmächer, director of the mental health center at Ingolstadt Hospital, says the allegations are “startling.” He worries about other possible irregularities in Wittchen’s extensive publication record. “Some time bombs may be ticking,” he says.

The study in question was a €2.4 million survey of staffing levels and quality at nearly 100 German psychiatric facilities. Working for TU Dresden’s Association for Knowledge and Technology Transfer (GWT), Wittchen was the principal investigator of the effort, which aimed to examine workloads at the clinics and inform government regulations.

But in February 2019, German media reported allegations, stemming from whistle-blowers close to the survey project, that study data had been fabricated. The university launched a formal investigation, led by law professor Hans-Heinrich Trute.

After 2 years of work, the commission, in its final report, has found that only 73 of 93 psychiatric clinics were actually surveyed. For the others, the report says, Wittchen instructed researchers to copy data from one clinic and apply them to another.

 “The violations were intentional, not negligent,” the report says. “Wittchen wanted to appear more successful than he was.”

Wittchen told Science he would not answer detailed questions “because they are the issue of legal proceedings.” But he denies any wrongdoing and says the study in question was “scientifically correct.”

The investigation report also shows how Wittchen sought to avoid repercussions. 

In April 2019, he sent an email to Hans Müller-Steinhagen, president of TU Dresden at the time, warning him to “stay out of the project” and stop the investigation, because otherwise there would be a “national political earthquake.” 

Tuesday, January 26, 2021

Publish or Be Ethical? 2 Studies of Publishing Pressure & Scientific Misconduct in Research

Paruzel-Czachura M, Baran L, & Spendel Z. 
Research Ethics. December 2020. 


The paper reports two studies exploring the relationship between scholars’ self-reported publication pressure and their self-reported scientific misconduct in research. In Study 1 the participants (N = 423) were scholars representing various disciplines from one big university in Poland. In Study 2 the participants (N = 31) were exclusively members of the management, such as dean, director, etc. from the same university. In Study 1 the most common reported form of scientific misconduct was honorary authorship. The majority of researchers (71%) reported that they had not violated ethical standards in the past; 3% admitted to scientific misconduct; 51% reported being were aware of colleagues’ scientific misconduct. A small positive correlation between perceived publication pressure and intention to engage in scientific misconduct in the future was found. In Study 2 more than half of the management (52%) reported being aware of researchers’ dishonest practices, the most frequent one of these being honorary authorship. As many as 71% of the participants report observing publication pressure in their subordinates. The primary conclusions are: (1) most scholars are convinced of their morality and predict that they will behave morally in the future; (2) scientific misconduct, particularly minor offenses such as honorary authorship, is frequently observed both by researchers (particularly in their colleagues) and by their managers; (3) researchers experiencing publication pressure report a willingness to engage in scientific misconduct in the future.


Our findings suggest that the notion of “publish or be ethical?” may constitute a real dilemma for the researchers. Although only 3% of our sample admitted to having engaged in scientific misconduct, 71% reported that they definitely had not violated ethical standards in the past. Furthermore, more than a half (51%) reported seeing scientific misconduct among their colleagues. We did not find a correlation between unsatisfactory work conditions and scientific misconduct, but we did find evidence to support the theory that perceived pressure to collect points is correlated with willingness to exceed ethical standards in the future.

Friday, November 29, 2019

This Researcher Exploited Prisoners, Children, and the Elderly. Why Does Penn Honor Him?

Image result for albert kligman
Albert Kligman
Alexander Kafka
The Chronicle of Higher Education
Originally published Nov 8, 2019

Here is an excerpt:

What the university sites don’t mention is how Retin-A and Renova, an anti-wrinkle variation of the retinoic acid compound, were derived from substances first experimentally applied by Kligman’s research team to the skin of inmates at Holmesburg Prison, then a large facility in Philadelphia.

From the 1950s into the 1970s, the prison served as Kligman’s “Kmart of human experimentation,” in the words of Allen M. Hornblum, an author who exhaustively documented the Penn researcher’s projects at Holmesburg in his books Acres of Skin (1998) and Sentenced to Science: One Black Man’s Story of Imprisonment in America (2007).

Colleges are questioning the morality of accepting research funds from Jeffrey Epstein, who was accused of sexually molesting young girls, and the Sacklers, makers of OxyContin.

They are searching their souls over institutional ties to slavery and Jim Crow-era exploitation.

Hornblum and others have asked for decades whether Penn should be honoring Kligman, and Hornblum and Yusef Anthony, the former inmate whose story Hornblum tells in Sentenced to Science, will ask again in a lecture at Princeton next month. The current ethical climate amplifies their question.

The university’s president, Amy Gutmann, and a Penn colleague, the bioethicist Jonathan D. Moreno, recently published a book on bioethics and health care. “They are advising the world on all of these different issues,” Hornblum says, “but they don’t know what’s going on on their own campus? They don’t know it’s wrong?”

Penn says it “regrets the manner in which this research was conducted” and emphasizes the university’s commitment to research ethics. But it has given no indication that it plans to take any action regarding the lectureship or the university’s portrayal of Kligman.

Kligman, who died in 2010, defended his work by saying that experiments on prisoners were common at the time, and he was right. But, Hornblum says, the scale and duration of the Holmesburg experiments stood out even then.

The info is here.

Saturday, November 23, 2019

Is this “one of the worst scientific scandals of all time”?

Hans Eysenck
Stephen Fleischfresser
Originally posted 21 October 2019

Here is an excerpt:

Another study on the efficacy of psychotherapy in preventing cancer showed 100% of treated subjects did not die of cancer in the following 13 years, compared to 32% of an untreated control group.

Perhaps most alarming results were connected to Eysenck and Grossath-Maticek’s notion of ‘bibliotherapy’ which consisted of, as Eysenck put it, “a written pamphlet outlining the principles of behaviour therapy as applied to better, more autonomous living, and avoidance of stress.”

This was coupled with five hours of discussion, aimed both at reorienting a patient’s personality away from the cancer-prone and toward a healthier disposition. The results of this study, according to Pelosi, were that “128 of the 600 (21%) controls died of cancer over 13 years compared with 27 of 600 (4.5%) treated subjects.

"Such results are otherwise unheard of in the entire history of medical science.” There were similarly spectacular results concerning various forms of heart disease too.

These decidedly improbable findings led to a blizzard of critical scrutiny through the 90s: Eysenck and Grossath-Maticek’s work was attacked for its methodology, statistical treatment and ethics.

One researcher who attempted a sympathetic review of the work, in cooperation with the pair, found, says Pelosi, “unequivocal evidence of manipulation of data sheets,” from the Heidelberg cohort, as well as numerous patient questionnaires with identical responses.

An attempt at replicating some of their results concerning heart disease provided cold comfort, indicating that the personality type association with coronary illness was non-existent for all but one of the types.

A slightly modified replication of Eysenck and Grossath-Maticek’s research on personality and cancer faired no better, with the author, Manfred Amelang, writing “I know of no other area of research in which the change from an interview to a carefully constructed questionnaire measuring the same construct leads to a change from near-perfect prediction to near-zero prediction.”

The info is here.

Friday, May 17, 2019

Scientific Misconduct in Psychology: A Systematic Review of Prevalence Estimates and New Empirical Data

Johannes Stricker & Armin Günther
Zeitschrift fur Psychologie
Published online: March 29, 2019


Spectacular cases of scientific misconduct have contributed to concerns about the validity of published results in psychology. In our systematic review, we identified 16 studies reporting prevalence estimates of scientific misconduct and questionable research practices (QRPs) in psychological research. Estimates from these studies varied due to differences in methods and scope. Unlike other disciplines, there was no reliable lower bound prevalence estimate of scientific misconduct based on identified cases available for psychology. Thus, we conducted an additional empirical investigation on the basis of retractions in the database PsycINFO. Our analyses showed that 0.82 per 10,000 journal articles in psychology were retracted due to scientific misconduct. Between the late 1990s and 2012, there was a steep increase. Articles retracted due to scientific misconduct were identified in 20 out of 22 PsycINFO subfields. These results show that measures aiming to reduce scientific misconduct should be promoted equally across all psychological subfields.

The research is here.

Tuesday, May 7, 2019

Are Placebo-Controlled, Relapse Prevention Trials in Schizophrenia Research Still Necessary or Ethical?

Ryan E. Lawrence, Paul S. Appelbaum, Jeffrey A. Lieberman
JAMA Psychiatry. Published online April 10, 2019.

Randomized, placebo-controlled trials have been the gold standard for evaluating the safety and efficacy of new psychotropic drugs for more than half a century. Although the US Food and Drug Administration (FDA) does not require placebo-controlled trial data to approve new drugs or marketing indications, they have become the industry standard for psychotropic drug development.

Placebos are controversial. The FDA guidelines state “when a new treatment is tested for a condition for which no effective treatment is known, there is usually no ethical problem with a study comparing the new treatment to placebo.”1 However, “in cases where an available treatment is known to prevent serious harm, such as death or irreversible morbidity, it is generally inappropriate to use a placebo control”. When new antipsychotics are developed for schizophrenia, it can be debated which guideline applies.

From the Conclusion:

We believe the time has come to cease the use of placebo in relapse prevention studies and encourage the use of active comparators that would protect patients from relapse and provide information on the comparative effectiveness of the drugs studied. We recommend that pharmaceutical companies not seek maintenance labeling if it would require placebo-controlled, relapse prevention trials. However, for putative antipsychotics with a novel mechanism of action, placebo-controlled, relapse prevention trials may still be justifiable.

The info is here.

Wednesday, May 1, 2019

Chinese scientists create super monkeys by injecting brains with human DNA

Harriet Brewis
Originally published April 13, 2019

Chinese scientists have created super-intelligent monkeys by injecting them with human DNA.

Researchers transferred a gene linked to brain development, called MCPH1, into rhesus monkey embryos.

Once they were born, the monkeys were found to have better memories, reaction times and processing abilities than their untouched peers.

"This was the first attempt to understand the evolution of human cognition using a transgenic monkey model," said Bing Su, a geneticist at Kunming Institute of Zoology in China.

The research was conducted by Dr Su’s team at the Kunming Institute of Zoology, in collaboration with the Chinese Academy of Sciences and University of North Carolina in the US.

“Our findings demonstrated that nonhuman primates (excluding ape species) have the potential to provide important – and potentially unique – insights into basic questions of what actually makes human unique,” the authors wrote in the study.

The info is here.

Tuesday, March 5, 2019

Call for retraction of 400 scientific papers amid fears organs came from Chinese prisoners

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.

Monday, January 28, 2019

Second woman carrying gene-edited baby, Chinese authorities confirm

Zhou Xiaoqin, left, loads Cas9 protein and PCSK9 sgRNA molecules into a fine glass pipette as Qin Jinzhou watches at a laboratory in Shenzhen in southern ChinaAgence France-Presse
Originally posted January 21, 2019

A second woman became pregnant during the experiment to create the world’s first genetically edited babies, Chinese authorities have confirmed, as the researcher behind the claim faces a police investigation.

He Jiankui shocked the scientific community last year after announcing he had successfully altered the genes of twin girls born in November to prevent them contracting HIV.

He had told a human genome forum in Hong Kong there had been “another potential pregnancy” involving a second couple.

A provincial government investigation has since confirmed the existence of the second mother and that the woman was still pregnant, the official Xinhua news agency reported.

The expectant mother and the twin girls from the first pregnancy will be put under medical observation, an investigator told Xinhua.

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.

Thursday, November 8, 2018

Do We Need To Teach Ethics And Empathy To Data Scientists?

Kalev Leetaru
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.


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, October 9, 2018

Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals

Charles Ornstein and Katie Thomas
The New York Times
Originally published September 8, 2018

One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet.

The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations, has had a stake in start-ups testing cancer therapies, and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

According to an analysis by The New York Times and ProPublica, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.

The info is here.

Saturday, September 15, 2018

Social Science One And How Top Journals View The Ethics Of Facebook Data Research

Kalev Leetaru
Originally posted on August 13, 2018

Here is an excerpt:

At the same time, Social Science One’s decision to leave all ethical questions TBD and to eliminate the right to informed consent or the ability to opt out of research fundamentally redefines what it means to conduct research in the digital era, normalizing the removal of these once sacred ethical tenets. Given the refusal of one of its committee members to provide replication data for his own study and the statement by another committee member that “I have articulated the argument that ToS are not, and should not be considered, ironclad rules binding the activities of academic researchers. … I don't think researchers should reasonably be expected to adhere to such conditions, especially at a time when officially sanctioned options for collecting social media data are disappearing left and right,” the result is an ethically murky landscape in which it is unclear just where Social Science One draws the line at what it will or will not permit.

Given Facebook’s new focus on “privacy first” I asked the company whether it would commit to offering its two billion users a new profile setting allowing them to opt out of having their data made available to academic researchers such as Social Science One. As it has repeatedly done in the past, the company declined to comment.

The info is here.