A leave of absence and silence in the Kuklo case

Recently in the New York Times, it was reported that Dr. Timothy Kuklo, the Washington University School of Medicine surgeon accused of falsifying data, has taken a leave of absence in order to, as the University states, "focus on responding to queries about his research and consulting".

Here is a link to the story: Former Army Doctor Accused of Research Fraud Takes Leave from University

Dr. Kuklo, an associate professor of orthopedic surgery, will not perform operations, conduct research or teach students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo “can focus on responding to queries about his research and consulting.”
Ms. Westerhouse declined to say whether the leave, which began Thursday, was paid or unpaid. She said she did not know its duration or whether Dr. Kuklo requested it or it was imposed on him. The university has declined to say whether it was investigating Dr. Kuklo.
“We know this is a major situation,” Ms. Westerhouse said.

Kuklo's apparent wrongdoings came to light last week when it was revealed that he had falsified data and had forged other physicians' signatures on an article published in the British Journal of Bone and Joint Surgery— which has now been retracted. From a period of about 2000 -2006, Kuklo, an orthopedic surgeon, was a physician with the US army at the Walter Reed Army Medical Center and was working with Medtronic (the largest manufacturer of medical devices in the USA) investigating the efficacy of "Infuse", a bioengineered product given to promote bone-growth after severe bone-shattering leg injuries sustained by American soldiers injured in the Iraq war. In his published research, Kuklo presented "Infuse" in a more favourable light than the data supports, according to the Army, who first brought the issue into the public eye a few weeks ago, and contacted the journal in which Kuklo published, along with the University and Medtronic. As Kuklo is now retired from the military, the Army are not investigating the matter further.

So far, no one involved has said very much. Kuklo has not spoken publicly about his involvement with Medtronic nor about the claims of falsifying data and forging signatures. Representatives from Medtronic have not spoken publicly either — except to say that they "had no involvement with the disputed research". That's a strange statement, given that Kuklo was researching their product and they were not only funding the work but also providing thousands of dollars for Kuklo to travel extensively during the time he worked with the company, according to a related story on the Center for Public Integrity's blog, The Paper Trail.

Here's a link to the Centre for Public Integrity story: Accountability: Kuklo, Target of Army Probe, A Top Recipient of Medtronic Travel.

Between 2001 and 2006, Medtronic paid for at least 15 trips taken by Dr. Kuklo, worth more than $13,000, according to travel disclosure records obtained from the Office of Government Ethics. Kuklo, now an associate professor at Washington University medical school in St. Louis, took more than 20 privately-funded trips.
“There’s no lack of creativity in how the industry tries to influence studies,” said Shahram Ahari, a medical ethicist and former drug sales representative. “This is what marketing is about, you take people with that position of respect and credibility, and every once in a while they spin one out that helps the marketing, and it’s hard to distinguish the marketing from the science.”

So far, this story is pretty murky, and no doubt will only get murkier as new details emerge and perhaps, the key players offer some kind of public statements about what went on. At this point however, it is clear that this is yet another story demonstrating the kinds of blatant conflicts of interest and complexities in the relationships that exist between researchers and industry. It's also clear that there is blame to be laid here but so far, most involved are either denying wrongdoing or providing no clear statements of explanation. The four physicians whose signatures Kuklo forged haven't made public statements, the Army is washing its hands of the ordeal, Kuklo is silent and Medtronic denies being involved in research on their own product. At the end of the day, in this flurry of denial of involvement and wrongdoing, it remains a fact that the only ones who were involved were the participants: severely injured American soldiers returning from the Iraq war. Someone here owes them an explanation.

Animal Testing, and Alternatives, as Precursors to Human Trials

This blog is normally about ethical issues in research on human subjects; we don't normally deal with issues related to the use of animals in research. But this story from The Economist demonstrates an important connection between the two: "Catheter and mouse: Sharing information on failed animal experiments would help both scientists and rats"

IN AN ideal world, people would not test medicines on animals. Such experiments are stressful and sometimes painful for animals, and expensive and time-consuming for people. Yet there are vast gaps in medical knowledge which animal experimentation can help close. People have power over animals, so they use animals to help their own species.

Yet the notion that animal suffering is pitted against human welfare—animal pain against human gain—is too stark. After all, it is in scientists’ interests to treat animals well. If laboratory animals are properly looked after, differences in experimental results are more likely to be down to the science than to the guinea-pigs’ health. Sometimes, numbing animals’ pain makes sense, too. Research has shown that giving pain-relieving drugs to animals that are undergoing experimental surgery may enhance the results, by making the animal’s experience more like a person’s. And some changes in the regulation of scientific research, proposed by the European Commission on May 5th, should further reduce animal suffering and at the same time produce better science....

The story also notes the (indirect) connection to human research. Regulations typically require that new drugs be tested on animals before being tested on humans. Finding alternatives to animal experimentation is desirable, but it also requires that different countries reach agreement on what kinds of alternatives really can make up a satisfactory part of the drug approval process.

Sadly, international agreements on the sale of medical treatments limit the use of alternatives. On April 27th America, Canada, Europe and Japan promised to co-operate on validating alternatives to animal testing. The EU law is another step forward....

The article also has some good things to say about the value of sharing data such that experiments aren't needlessly duplicated — something that is clearly of interest in the realm of human subjects research, too.

Research on torture: Should we put limits on what topics researchers can study?

Recently, in a blog entry on The Monkey Cage, Joshua Tucker (a professor of politics at NYU) posed a difficult question: Should social scientists be conducting research on torture? I've simplified the question somewhat here for the purpose of being as clear as possible while also recognizing that this is a complex and sensitive issue.

Here is a link to the original blog entry: Torture, Social Science, and Ethical Responsibility

Do we need some sort of social science code of ethics that sets certain research topics off limits? (e.g., something equivalent to doctors refusing to work on projects about devising more effective/painful instruments of torture.) Or is that an automatic affront to intellectual freedom?

Tucker discusses whether social scientists who study torture should only publish results if they provide support for the argument against the use of torture in any context. He notes that he would support the publication of good empirical findings that would "come out in one particular direction", i.e. against torture, but that publishing results in the other direction might be problematic.

Tucker's question about the notion of having a "social science code of ethics" which would set certain research topics off limits is a thorny one. First, it would be more than challenging to find an agreed-upon list of what kinds of topics should — and shouldn't — be studied. If you look back to a previous blog entry entitled "Oral Sex (Yes, Oral Sex) and Academic Freedom",we talked about how certain politicians in Georgia wanted to stop academic research into sexual behaviours (such as oral sex and male prostitution). Depending on your beliefs about any of a number of controversial societal issues as well as your views on the importance of furthering scientific knowledge, you might be for or against certain kinds and topics of research. But in a diverse society, could we all agree on what topics should be off limits for researchers? Obviously not. Tucker notes that banning research on particular problematic topics might well be "an affront to intellectual freedom" and I agree with that statement. But the concern about banning research on particular problematic topics isn't just about intellectual freedom. It's also, arguably, about what we might miss out on learning if we disallow research on topics that are considered to be controversial or even unethical.

When we're talking about unethical research, we're usually talking about classic teaching cases in research ethics such as Stanley Milgram's Obedience to Authority and Philip Zimbardo's Stanford Prison Study. Both these projects, in different ways, involved the deceptive and blatantly unethical treatment of human subjects. However, even the harshest critic of both these studies has to acknowledge — perhaps begrudgingly — that we learned more from these two studies than simply how to better treat human participants. From Milgram's work, we have learned more not only about the social phenomenon of extreme obedience to authority but also about compliance and conformity more generally. Zimbardo's work has informed inquests into the treatment of prisoners at Abu Ghraib and has provided valuable insight into the reasons why cults are so effective. Both studies have helped psychologists and other behavioural scientists as they work to answer the question of "why good people do bad things".

There's a difference between unethical research and research on topics we consider to be "unethical" — like torture or discrimination or violent crime, to cite some examples. These topics have much to teach us about human nature — even the negative aspects. Both Milgram and Zimbardo's projects were considered to be "unethical", not because of the topics the researchers explored, but because of the way in which they were conducted. Reflection on these and other cases of unethical research has resulted in a focus on the way in which research is conducted: guidelines for the ethical conduct of research, the review, approval and oversight of research by ethics review boards and discipline-specific codes of conduct for ethically sound research, e.g. the requirement for debriefing in most psychology human-subject research. So, we can — and should — address issues of process in research in an attempt to ensure that research is conducted in an ethical manner. However, should we put limits on the kinds of topics social science researchers should be exploring? I think not.

The Merck-Elsevier Scandal & Research Integrity

You've probably heard about this story by now: the academic publisher, Elsevier, published a fake journal on behalf of Merck in Australia. Outrage has rightly been widespread.

I blogged about this over at the Business Ethics Blog, under the title Drug Companies Make Other Companies Do Stupid, Unethical Things

A couple of times recently I've read about pharma executives wondering out loud why their companies get such a bad rap — you know, what with all the good work they do, saving lives and all. The short answer is: we'd give you more credit if you would just stop distracting us by doing blatantly unethical things....

My focus in that blog entry was of course on bad corporate ethics. But as lots of other people have pointed out, this story also has bad implications for research integrity.

First, it's straightforwardly dishonest, and amounts to warping the research-based evidence about pharmaceuticals (in particular, ones made by Merck, one of the world's biggest pharma companies).

Second, as the Respectful Insolence blog pointed out, this incident also makes the entire effort at keeping healthcare rooted in ethics look bad. Why would anyone want to be associated with research-based healthcare if this is the sort of behaviour that typifies the field? Of course, that's based on a ridiculously-hasty generalization. But still, Merck and Elsevier need to understand the damage they've done.

Outsourcing Clinical Research: Alternative Ethical Paradigms

This past Saturday afternoon I was part of a panel discussion at the Annual Meeting of CAREB (the Canadian Association of Research Ethics Boards) in Vancouver.

The hopefully-provocative title of my talk was "Outsourcing Research to Developing Countries: Exploitation or International Trade?" The main goal of the talk was to point out, to an audience with background mostly in bioethics, that not all ethical reflection goes on from a bioethics point of view. That wouldn't be news to everyone, but to some it would.

I pointed out that bioethics and business ethics are kindred disciplines that have different histories and that focus on different problems. I suggested that a single ethical issue could look quite different when examined from a business ethics point of view as opposed to a bioethics point of view. I further suggested that neither 'lens' can really claim to "trump" the other, in general. But it's useful for people working from one perspective to understand that things might look different to people working from the other.

Then I pointed out that commercial pharmaceutical research lies at the intersection: it's of interest both to people who study bioethics, and to people who study business ethics:

To illustrate my point, I talked a bit about the outsourcing of clinical trials to developing nations. I suggested that the 3 key worries with regard to outsourcing (as outlined in this NEJM article) are:

• Oversight, rigour, safety;
  
• Exploitation of research subjects; and
  
• International Justice.
  

I then sketched briefly how each of those issues might look from a business ethics point of view, one aimed at getting pharmaceutical companies to find the right way to balance their legitimate desire to make a profit against both the economic development interests of developing nations and the employment interests and human rights of potential research subjects.

I finished by suggesting that while the bioethics lens — the lens that focuses on the protection of human subjects and the integrity of the research enterprise — must absolutely be the primary lens through which ethics boards look at outsourcing, it's still useful for ethics boards to understand the alternative ethical framings that might be applied by other people looking at the same issue.

Research or creative practice? The ethics of innovative research using new technologies

In a recent issue of The Chronicle of Higher Education, two creative research projects, both being carried out by academics, are highlighted. I found these particularly interesting as the cases demonstrate the challenges that many ethics review boards are facing as they try to differentiate between research and creative practices, especially with the increased use of new media in projects.

Here's the story (The Chronicle requires a paid subscription to read articles but it also offers short term free on-line access via this link): Two Professors Rock Out Online to Study Fame — and Us

In the first of the two studies highlighted in the article, Nick Trujillo, a professor of communication studies at California State University at Sacramento, has created what he classifies as a new kind of ethnography in which he has created a false persona, "Gory Bateson", an aging rock star, with his own band, rock videos, Web site and group of followers — mostly fellow colleagues who are "in" on the project. According to the article, the goal of Trujillo's study is to use his methods of performance art to explore important social issues, although it's not clear what social issues are being explored here. Trujillo, as Bateson, has posted his own videos on YouTube and then has taken the step of sending out mass emails to student computer clubs at universities to try to get as many viewers as possible.

The project fits into an academic practice called performance studies, in which fiction or music or dance is created to critically explore social issues. By jointly writing the stories of an aging rocker and his groupies, these scholars say they are revealing shared cultural memories and social stereotypes.

What's unusual about this academic project is how big a stage Mr. Trujillo wants his fictional character to perform on. In my talks with the professor-turned-fake-rocker, he mentioned that he hopes for at least a million hits on his videos, and for someone like Eric Clapton to start riffing on his fictional story, pretending that he once jammed with the Ethnogs back in the day. So far, though, most of Mr. Trujillo's videos have about 100 views each, and no participation from actual celebrities.

In the second study, a MySpace web page for a goth industrial band called
Blood Jewel has been created by Neil Whitehead, a professor of sociology at the University of Wisconsin in Madison. The website features images of violence and sexual bondage and a video commentary on the Virginia Tech shooter. Before the videos were pulled from YouTube for profanity, they attracted over 50,000 viewers. Whitehead characterizes this as a new kind of participant observation, in which a researcher first becomes embedded in a culture and then reflects on his or her experience from that particular perspective. Whitehead claims — and many would agree — that there is no way for a researcher to observe on-line phenomena other than by participating actively in cyberculture. While some have questioned his use of provocative and unsettling images to achieve his ends, others have lauded Whitehead for spearheading a new kind of anthropological ethnography.

Michael L. Wesch, an assistant professor of cultural anthropology at Kansas State University who has studied the culture of YouTube, called Mr. Whitehead "a wild guy" but argued that his approach is worthy of serious discussion.
"I personally think that that may be sort of the future of fieldwork in anthropology," Mr. Wesch told me. "What he's doing is, he's kind of entering a culture and actually participating in it. It gives him an insight that I think others can't have. And he still maintains his ethnographer status."

From the article, it isn't clear whether the two studies have undergone research ethics review, although both professors label their work as "research". A professor from the computer club at the University of Waterloo in Ontario, Canada wrote a letter to Trujillo's university, claiming that principles of research ethics had in fact been violated, as the mass email had been sent out to Waterloo's students without first getting clearance from Waterloo's ethics review board. The Waterloo professor also stated that the project lacked rigor and would produce only "meaningless" results.

Although both professors consider their work to be research using innovative methods and new technologies, it's not clear that any ethics review board would have pushed for review of either project. Performance art carried out in a public sphere accompanied by the researcher/performer's self-reflection, while often important and worthy, may not need ethics review. Furthermore, millions of people log onto YouTube and view videos and images every day without having an ethics review board overseeing this activity or offering protection.

It's also not clear, from the article, what kind of data are being collected in either project nor is it clear what exactly constitutes a participant in either study. While anyone can view the images and videos created by both researchers, I'm not sure that there is any kind of risk involved — other than the risk that the researchers/performers may endure extensive criticism of their work and credibility by less open-minded colleagues.

The Panel on Research Ethics (PRE) has produced a document with guidelines on Internet-based Research. However, projects like these ones involve issues beyond the use of the internet in research. An important challenge these two projects demonstrate is the difficulty deciding — for the purposes of research ethics review — what is performance art or creative practice and what is research. Furthermore, while the PRE document is a helpful beginning point to think about some of the issues of internet-based research, technology changes quickly and this limits the degree to which a static (and therefore instantly "dated") document like this one can guide the deliberations of ethics review boards. With this rapid rate of change, the emergence and adoption of new media in research and the extensive use of the internet and social networks in research, it may be that rich discussion, dialogue and sharing of decisions between research ethics boards may be of greater value than static guidelines.

CAREB Keynote: Technology, Values & Ethics Review

This morning I gave a keynote address at the Annual Meeting of CAREB (the Canadian Association of Research Ethics Boards) in Vancouver.

The title of my talk was "Shifting Technology, Shifting Values: New Challenges in Research Ethics." The basic idea was this. Technology — by definition — lets us do new things, and so presents us with new choices. We make those choices, and engage in evaluation of new technologies, based on what we value and what we don't. So, values play a role in how we think about technology.

But technology also stands to influence what we value. For example: the availability of new reproductive technologies make pre-implantation genetic screening less "unthinkable" than it once was. (I owe that example to Daniel J. Kevles). Or consider how our values related to privacy are likely to shift — maybe already are shifting — in response to increasingly pervasive surveillance technologies.

So, there's a loop, or cycle: we use our values to evaluate new technologies, but new technologies seem capable of changing what we value.

Shift focus, now, to biomedical research. Consider how the availability of at-home genetic testing puts pressure on values related to genetic privacy. And think about how social networking sites like Facebook and MySpace are (probably?) changing how people (especially younger people) think about personal privacy. Now consider the way those 2 technologies are being combined: witness the 23andMe Facebook fan-page, where personal genomics 'fans' chat about the results of their gene tests. That's pretty far (for better or for worse!) from the "old days" (about 5 years ago) when the results of a genetic test would only be discussed between you & your physician or genetic counsellor, and maybe very close family.

What does this imply for the work of Research Ethics Boards? REB's are part of the tech/value cycle I described above. REB's, informed by social values, evaluate the use of new technologies in research projects. But those new technologies in turn affect social values. So, I suggested this morning, REB's need not just to keep up to date on new technologies, but also need to be aware of technology-induced changes in social values.

One thing I wasn't sufficiently clear about this morning: I'm not at all saying that REB's should simply soak up changes in social values: the fact that some people with Facebook accounts seem to care surprisingly little about privacy is not a reason to cast privacy to the wind. My point is merely that ethics review needs to be cognizant not just of our long-term value commitments, but also of current trends, even if only to guard against the pernicious effects of those trends.