The Facebook Emotions Study

•July 24, 2014 • 1 Comment

Over at my Business Ethics Blog, I just posted my thoughts on the recent controversy over the Facebook / Cornell study. I look at the question not of the ethics of the Cornell researchers, but of Facebook as a corporation I basically argue that:

a) the risks involved were trivial;
b) the commercial context matters, and permits certain kinds of experimentation;
c) the study was, from Facebook’s point of view, closer to ‘program evaluation,’ (i.e., closer to a kind of study that is normally exempt from research regulations anyway).

You can read the whole thing, here: Facebook’s Study Did No Wrong.

Here also is the view of 33 bioethicists, published in Nature, saying that while prior ethical review would have been a good idea, the study was not fundamentally unethical:
Misjudgements will drive social trials underground.

Research ethics scandals in Canada, you ask? Sadly, yes.

•July 23, 2013 • Leave a Comment

There are certainly plenty of people who think that research ethics scandals happen everywhere else, but not in Canada. Well, it seems that a recent report by food historian Ian Mosby at the University of Guelph has uncovered that, yes, in fact research ethics scandals can, do and have happened in Canada.

Mosby’s report, published in Histoire Sociale/Social History, provides “a narrative record of a largely unexamined episode of exploitation and neglect by the Canadian government” and describes ten years of nutritional experiments conducted on 1300 Aboriginal adults and children, including those in residential schools. These funded studies were done without community or individual consent, without an assessment of potential benefits and risks, without any consideration of the extreme vulnerability of the persons and without any clear humanitarian or altruistic aims or realization of benefits to any people involved while exposing them to real harms. That’s just the beginning of the problems.

The details of the report are horrific.

What is most shocking about this is that these researchers were in communities in which they already knew there were significantly higher general and infant mortality rates (compared to anywhere else at that time in Canada), high rates of malnutrition and hunger along with high rates of TB and other diseases, and yet when they arrived — and these documented facts were clearly confirmed by what they observed ‐ they saw this as a clear opportunity and a kind of living laboratory, rather than a humanitarian tragedy that required their intervention.

Many people, upon first hearing of these experiments, will wonder why the principles of research ethics were not followed here or why the obvious potential and actual ethical problems involved were not addressed in any way. Well, those who are familiar with research ethics know that, during the time these experiments were being conducted in Canada, the Doctor’s Trials were taking place in Nuremberg, Germany after the Second World War (1946-1947). Out of that trial came the Nuremberg Code which outlined ten principles of ethically sound research, including the requirement that research subjects must provide voluntary consent. This challenged the paternalistic approach to research that, in some cases, assigned little to no inherent value to persons who were simply research subjects and nothing more. But what’s important to realize is that it really isn’t the case that as soon as the Nuremberg Code was established, everything instantly got better for research subjects and researchers stopped exploiting persons. That didn’t happen and in many cases, research that was ethically problematic continued, despite the Nuremberg principles. It has taken many years for these principles to become the norm – to become realized, formalized, institutionalized and embedded in the culture of research. Consider the Tuskegee Syphilis Study which was not stopped until 1972 and only then after about 6 years of active lobbying by a persistent whistleblower.

According to the Toronto Star:

These experiments aren’t surprising to Justice Murray Sinclair, chair of the Truth and Reconciliation Commission. The commission became aware of the experiments during their collection of documents relating to the treatment and abuse of native children at residential schools across Canada from the 1870s to the 1990s.
It’s a disturbing piece of research, he said, and the experiments are entrenched with the racism of the time.
“This discovery, it’s indicative of the attitude toward aboriginals,” Sinclair said. “They thought aboriginals shouldn’t be consulted and their consent shouldn’t be asked for. They looked at it as a right to do what they wanted then.”

Here are some links to the media coverage of the release of the report:

Hungry Canadian aboriginal children were used in government experiments during 1940s, researcher says

Canadian government withheld food from hungry aboriginal kids in 1940s nutritional experiments, researcher finds

Past abuses linger over First Nations education debate

When Canada used hunger to clear the West

Here, as well, is a link to Chapter 9 of the Canadian TriCouncil Policy Statement on Research involving the First Nations, Inuit and Métis peoples of Canada.

Ethical Design for Cluster Randomized Trials

•November 22, 2012 • Leave a Comment

A team led by our friend and colleague Charles Weijer at the University of Western Ontario has just issued guideliens for what are known as “cluster randomized trials” (CRTs).

See the story here:
Western-led team delivers world-first ethics guidelines.

CRTs are clinical trials in which randomization occurs across groups of participants, or across institutions, rather than across individual participants. In other words, each participant is not randomized into one arm of the trial or another. Rather, randomization is done at the higher level — an entire institution’s patient, population is treated as a unit for purposes of randomization. This raises a number of interesting ethical issues. These new guidelines will surely help advance our understanding, as well as highlighting an important range of issues for those of us not previously aware of them.

Clinical Trials in Russia

•November 12, 2012 • Leave a Comment

Generally, when westerners think of people in foreign lands participating as human subjects in clinical trials, we think of the developing world. That image is somewhat incomplete.

This was from September, but well worth a look at this NYT piece if you missed it:
Russians Eagerly Participate in Medical Experiments, Despite Risks

As a test subject in a Russian clinical trial for an experimental weight loss drug, Galina I. Malinina had to inject herself in the stomach daily. … she threw up every day for two weeks, yet stuck to the regimen, something valued by companies, as dropouts are expensive.
“It’s wonderful,” she said of the test substance, a weight loss serum under development by the Danish biotechnology giant Novo Nordisk. In addition to losing 22 pounds in a year, she said, “I became more lively; I walk easier and I have energy.”

Why go through this? For the same reason that people sign up for clinical trials in India or rural China.

Patients, as was the case with Ms. Malinina, are eager to join trials because often it is the only way to receive modern medical care.

Is this predatory? Are drug companies testing drugs on poor Russians in order to sell drugs to wealthy Americans, Canadians, and Brits? The answer is not so simple. The Russian government, apparently, is pretty excited to provide incentives for drug companies to conduct trials there:

…under a law passed in 2010, ostensibly on health grounds, foreign drug companies must test medicine on Russians for it to be marketed in Russia.

Interpreting Canada’s TCPS2

•January 17, 2012 • Leave a Comment

Canada’s Interagency Advisory Panel on Research Ethics has begun putting online its interpretations of the second iteration of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (a.k.a. “TCPS2”).

“The Interagency Advisory Panel on Research Ethics (the Panel) is pleased to share a growing collection of its responses to written requests for interpretation….”

The website also explains the role of the Panel in interpreting the TCPS2, as well as featuring a nifty feedback function attached to each interpretive note.

Cracking Down on Research Misconduct at a Chinese University

•January 14, 2012 • Leave a Comment

Here’s an interesting bit on one Chinese university’s efforts to crack down on research misconduct:

From Nature: Research ethics: Zero tolerance — A university cracks down on misconduct in China.

Most readers of this blog will know that research misconduct doesn’t fall under the heading of Research Ethics, as that term is normally applied to the work of Research Ethics Boards and Institutional Review Boards. But neither are the issues entirely separate.

Here’s a paragraph I found particularly interesting, about the causes of misconduct:

Cao and other experts on misconduct point to specific contributing factors. China’s research system has developed very rapidly, and universities are scrambling to train the influx of students, scientists and administrators. “As a large, newly developed system of research, China does not have the control of its research programmes that is found in the West,” says Nicholas Steneck, who studies research integrity at the University of Michigan in Ann Arbor. Some researchers are simply oblivious to the rules, says Zhong Haining, a neuroscientist who trained at Tsinghua University and is now starting a lab at Oregon Health and Science University in Portland. “The official guideline for scientific misconduct may (or may not) exist, but it’s not very well publicized, at least not emphasized so much in training,” he says.

I wonder if the causes of misconduct are so different in other places?

Research Fraud Case Raises Concerns Over Ethics of Psychology Research

•November 15, 2011 • 1 Comment

It’s a big story in research ethics and it has been reported in major newspapers all over the world. There’s even a Wikipedia page already about this case. The story centres on a fraud case against Diederik Stapel, a well-known psychologist and widely-published researcher at Tilburg University. It is claimed that Dr. Stapel drew inaccurate and false conclusions from analysis of collected data and also that he also falsified and “made up” entire experiments, which were written up and published in a variety of high profile journals, including Science and The Journal of Personality and Social Psychology, a publication of the American Psychological Association. Over his career, Dr. Stapel has published more than 150 papers which each, as the New York Times story about this case notes, are designed to “make a splash in the media” through provocative titles and topics. Not only have his own published papers been found suspect, many of the PhD theses he supervised have been found to be “tainted” according to a Science on-line magazine story.

Here’s one account of the case, from one of my favourite science writers, Benedict Carey of the New York Times: Fraud Case Seen as a Red Flag for Psychology Research

There isn’t a lot to say about this case that differentiates it from others out there about fraudulent conduct in science – there are plenty of stories about research fraud out there (far too many) describing claims of falsification of data, skewing of data, or misrepresentations of data, even “making up entire experiments”. But two things stood out for me the more I read about this case.

First, the claims of fraud extend beyond Stapel’s own work and publications. It’s not unusual to read stories about fraud that may imply that colleagues or lab assistants turned a blind eye, or wondered about the veracity of findings or the ‘incredible luck’ of colleagues with seemingly perfect data. But this case extends well beyond inattentive, ignorant or silent colleagues. In this case, Stapel, as a supervisor, included his own students in his fraud and has quite possibly ruined their careers and their prospects. The Tilburg University commission investigating Stapel’s misconduct has recommended that criminal charges may be appropriate based not only on the misuse of research funds, but also on harm done to these students. While many might ask, “Why would he also ruin the careers of students?” it would appear that the fraud was so extensive that he not only had no raw data to provide to students for secondary analyses or to inform their work, but that he really may not have ever conducted a well-run psychological study himself, in order to be able to guide someone else through the process. This “trickle-down” effect of research fraud is typically not addressed at all in stories like this even though it is clear that a key role of a senior scientist is almost always the mentorship of young scientists and researchers. The negative effects of scientific misconduct on those who are junior, who are entering the field with good intentions, thoughtfulness and enthusiasm is a serious potential fallout and one that should be treated just as seriously as the fraud or misconduct.

The second part of this story that interested me most was what Carey, writing in the New York Times, had to say. According to him, this case isn’t the straw that “broke the camel’s back”, rather it’s evidence that the camel’s back has already and most certainly been broken. Benedict Carey is a New York Times science and medicine writer since 2004. I’ve read plenty of Carey’s writing and he’s a smart journalist who writes thoughtfully and articulately about all kinds of topics in the science and medical research world. What Carey notes and the Science magazine story confirms is that one reason why Stapel was able to do this so easily is that he never showed anyone his raw data, nor was he ever required to do so. Incredulously, students who wrote their thesis with Stapel as a supervisor were not allowed to view raw data or data sets that were being used for their own papers. Some never even were allowed to conduct an experiment at all. The findings Stapel cited in many of this own studies his colleagues felt were “too good to be true” and their failure to be able to replicate these results were felt to be due to their own shortcomings. “Cutting corners” with data, “statistical sloppiness, falsifying data” and “reporting unexpected findings as predicted” are claims that Carey notes are prevalent in a discipline in which raw data are rarely shared in order to back up results or requested by reviewers to verify findings and conclusions. What I’ve found is that researchers in the area of psychology tend to keep datasets for long periods of time — longer than any other human-research discipline I’ve encountered. I find it interesting that no one, at any time, requested to see an anonymized dataset or something to back up the (often) controversial claims of Stapel. In ethics review processes, we often think about what we call “the life of the data”. We are concerned with what happens to datasets after collection and analysis are complete, details about how data are stored, and who might be able to access data in the future. From what I’ve read in research protocols about data management, researchers are not always thinking about the data as the very fundamental proof that can back up any claim they wish to make and publish. I often read graduate student research protocols, from a variety of disciplines, in which they state that the raw data will be destroyed as soon as the research or thesis is published. I always tell them that’s unwise — and that data should be stored for a reasonable amount of time after publication or dissemination of findings. It’s amazing, to me, that this is very often the first time (during the ethics review process) that anyone has talked to many new researchers about the idea that the data are there (and must be there!) as the fundamental link between a hypothesis and the claims made by a researcher.

It will be interesting to see if there is any further fall-out from this story. I’ll continue to follow the story and update it.

The University of Tilburg established a commission to investigate Stapel’s work and the claims made about fraudulent scientific conduct. As of two weeks ago, it is now available in English here.


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