Johns Hopkins University Sued for $1bn Over Guatemalan Study

•April 6, 2015 • Leave a Comment

This story is pretty much a ‘perfect storm’ of research ethics problems: international research, on vulnerable populations (orphans, prisoners and mental health patients), lack of consent, and questionable institutional responsibility for the actions of now-dead researchers.

From The Guardian: Guatemalans deliberately infected with STDs sue Johns Hopkins University for $1bn

…Nearly 800 plaintiffs have launched a billion-dollar lawsuit against Johns Hopkins University over its alleged role in the deliberate infection of hundreds of vulnerable Guatemalans with sexually transmitted diseases, including syphilis and gonorrhoea, during a medical experiment programme in the 1940s and 1950s….

A call for “new rules” for Internet-based research

•September 16, 2014 • Leave a Comment

information-literacy-researching-online-500x312The John Hopkins Berman Institute of Bioethics put out a press release today, announcing the pre-release of an article in the Proceedings of the National Academy of Science: In Wake of Uproar Over Facebook’s Emotional Manipulation Study, Bioethics Scholars Say New Rules Are a “Moral Imperative”

It’s not actually news, many would agree, but good to know someone in bioethics has said this in print and that it seems others are paying attention. Many ethics review board members have been grappling with concerns as well as exciting new frontiers in the area of Internet-based research for a few years now. I have about six different versions of a presentation on the ethical considerations of Internet-based research, the oldest one dating from 2008. Those in research ethics have been talking about this for a few years now. It wasn’t until the Facebook Cornell “emotion contagion” study, it seems, that other people in bioethics started paying attention and asking the questions. What does it mean to be a participant? Should a virtual participant be treated similarly to a face-to-face participant? When and how should an informed consent process take place? Should the ethical standards we apply to face-to-face research apply in a virtual context? If so, how does that work?

The authors of the paper have chosen to focus, or at least begin the discussion of ethics in online research with the idea of the “large-scale social computing research” studies, citing growing public interest and concern. They also ask a number of the questions I’ve posed above to begin to guide their discussions and exploration into this topic.

The press release highlights a number of the recommendations from the paper (which is still embargoed, so not yet available in full text, to me).

They recommend that there needs to be inclusion of clear language in guidelines about what types of online research should be categorized as research involving human participants – and thus subject to a process of ethics review and oversight. Additionally, the way that we traditionally approach informed consent needs to be reconsidered in light of and in response to the challenges of online participation. Traditional approaches to and templates for informed consent simply don’t work in a virtual environment.

The authors here identify research ethics concerns that are not unique to internet-based research and that, in part, really don’t address the lack of smart, relevant guidelines in this area. They recommend that journals should act as a final and independent evaluator in deciding if a research project has been carried out with ethical soundness. That’s a great aspiration – for sure – but it’s important to remember that if we do claim that this should happen, most editorial boards and/or editors are now going to have to not only be well versed in research ethics, but also on the application of research ethics guidelines to internet-based research, which comes in many forms and types. And this of course then applies to reviewers. The burden of ensuring that internet-based research is carried out with ethical soundness lies with the researchers and ethics review boards. This then suggests that there not only be clear, relevant and explicit guidelines, but that there are also plenty of opportunities for conversations between researchers who are involved in internet-based research and ethics review boards.

They also identify that public-private collaboration is often a key part of Internet-based research initiatives and the collection of vast amounts of information and that these kinds of collaborations should not be viewed in a kind of knee-jerk negative way, but that this should provide opportunity and incentive for researchers. Finally, they state that geography and politics has an impact upon online interaction and that there is a lack of clarity regarding jurisdictional and relevant legal precedents. This lack of clarity may well provide a barrier to researchers getting approval for all kinds of projects, not just those carried out in an online environment, although it is fair to acknowledge that the online element may provide additional sources of confusion.

From these recommendations stated thus far, I think it’s also important to also consider a couple of other things, going forward:

First, it’s not just about “big data” and large-scale research. We need to think carefully in research ethics about how we consider internet-based research within our much more traditional paradigm for ethics review – which assumes a kind of relationship between participant and researcher that more often than not, does not occur in many types of internet-based research. So while it’s definitely a good starting point to consider the questions we need to ask within the context of large-scale research, we also must acknowledge the fact that many ethics review boards are reading much smaller scale proposals involving Internet-based research and are seriously grappling with how to apply traditional guidelines to funky new research studies in an online environment.

We also need to remember the fact that research in an online environment is just as diverse in terms of methods and aims as research in the F2F world context. Creating one-size-fits-all ‘Internet research guidelines’ based on large-scale research studies will not be adequate to reflect the varying kinds of research activity that goes on, in an online environment. Many research ethics guidelines are dynamic and have evolved over the years to better reflect new, emerging and innovative methods and methodologies. We’ve learned from this that a “one-size-fits-all” approach to ethics review doesn’t work – and I can confidently say that it very likely won’t work in the development of guidelines for Internet-based research – so let’s make sure we approach this exercise with that in mind.

Second, we need to consider that not only do we need to think about and develop guidelines for internet-based research, but we also should acknowledge that in many cases, children, adolescents and youth will be approached to take part in research in a online environment, rather than through more traditional F2F means. It is, of course, one interesting and compelling way to recruit and attract participants who are more likely to be digital natives, and who may be far more comfortable, as a cohort, with the notion of a fully integrated digital self. Many ethics review boards already treat research proposals involving children and youth quite differently, appropriately, and I’m not suggesting that should change. But we may find that what many ethics review board members are uncomfortable with in internet-based research, some young participants are perfectly acclimatized to, without worry or concern. This leads me to my third point here – it’s not just about the guidelines. And it shouldn’t be. It’s also about building capacity in the world of research ethics in the area of internet-based research. It means thinking about who sits around the table as members of an ethics review board and the more urgent imperative to ensure that someone with knowledge of this area is included in the membership of boards. In Canada, we have a membership and composition requirements that include an imperative to ensure that the membership includes those with expertise in ethics and in the areas of relevant law. On ethics review boards I’ve been on, we’ve already been thinking about other kinds of representation that there needs to be around the table. One such consideration might be to have someone with expertise in the methods, variations and ethics of Internet-based research.

It will be interesting to read the full article, and to see what happens in terms of next steps. I think many people who are active in the area of research ethics at all kinds of institutions with a wide variety of expertise in this area are already well beyond thinking that this conversation needs to begin, and hopefully a diverse representation of people with this expertise and experience will be invited to the table.

Facebook and ‘Being Experimented Upon’

•August 21, 2014 • Leave a Comment

Following on my recent blog posting about the Facebook emotion-manipulation study, here’s a useful piece from The Atlantic: How Much Should You Know About How Facebook Works?

The piece focuses on the ubiquity of constantly-tweaked algorithms in online services such as Google and Facebook. The algorithms such companies use today are quite different from the ones they used 5 years ago, in part because the companies are constantly experimenting and using the results of those experiments to adjust the “math” behind your Facebook newsfeed and your Google search results.

Cornell professor Jeff Hancock, one of the authors of the infamous study, is quoted as asking: “If you think about Google search and you say, ‘I don’t want to be experimented on,’ then the question is, well, what does that mean?

Good question!

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 • 1 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.