UK docs fight plans to hand over personal health information

This isn't a research ethics story per se, but it's clearly relevant.
From The Daily Telegraph: Doctors fight plans to hand medical records to researchers and private companies

The [British Medical] association said the Government was "dancing with the devil" with its proposals to give researchers, which could include commercial organisations, access to a giant computer database of patient records.
The Government's own health information watchdog has also written to ministers to express his concern about the plans, which could see patients' names and addresses handed over.
Medical researchers claim being given access to the new database would make it easier to carry out studies.

The move being proposed amounts to a decision, on the part of the UK government, to consent to a wide range of research on behalf of its citizens, apparently removing the need for individual consent - in fact, the article refers to "removing the right to consent" which sounds much more purposeful than simply neglecting to acknowledge that consent for sharing of this kind of information might be a good idea. The researchers are certainly right: It would make it easier to carry out studies; however, with the removal of the right to consent, it would be done at the expense of privacy and choice of individuals as well as public trust.

It is difficult to decide what is most worrisome about this proposal. A few obvious things come to mind at first glance.

This story illustrates one of the standard worries about databases: Information gathered for one purpose (e.g., quality-control for a government-funded programme) may end up getting used for a purpose (e.g., research on who-knows-what) that may not have been anticipated when the database was originally set up. Another obvious worry is that persons or, in this case, organisations, may be able to access private information about you without your consent. Finally, this isn't just about health care researchers having access to identifiable personal information to conduct research on whatever they wish. According to the article, the database would also be made available to pharmaceutical firms and companies that sell health products, who would then quite easily be able to target their products and services to persons with identified diagnoses.

While we often gripe about the privacy legislation in Canada, it does work to address and restrict this kind of activity and in doing so, protects individuals and helps to foster public trust in the institutions that hold private information about us. Sounds good, right about now.

Publishing, and the Subtleties of Conflict of Interest

A conflict of interest (COI) is (very roughly) a situation in which a person has a private or personal interest sufficient to appear to influence his or her professional judgment.
One important category of COI involves scientific (or, more generally, scholarly) publication. It is typically regarded as a COI, for example, for a researcher to publish findings (typically not just reporting, but interpreting data) based on research funded by a drug company whose fortunes may rise or fall based on those findings. (In publishing, COI is typically referred to by means of the more genteel term, "competing interests.")

Now, it's crucial to make clear that to be in a COI is not, in and of itself, unethical; what matters is how you deal with it. Most science journals now require that authors disclose "competing interests" (i.e., primarily financial interests) that might reasonably be suspected of biasing the things they write. See, for example, the Nature journals' competing financial interests policy.

Requiring authors to declare competing interests is a good idea, but it's unclear just how it helps readers. The theory, in principle, is that if I, as reader, know that an author's work was funded by a drug company, I can attenuate my level of credence suitably. OK, but just how do I do that?

Here's an example. This story in the journal, Nature, garnered a lot of press last week: Towards responsible use of cognitive-enhancing drugs by the healthy. I agree with a lot of what the authors say. But it's a useful example of the complexity of COI. Note that at the end of the article, there's a notice saying that two of the authors declare "competing financial interests". Basically, two of the article's 7 authors work as consultants for pharmaceutical companies.

How should that revelation affect our evaluation of the article? I teach my first-year Critical Thinking students that you can't discredit an argument simply by telling me about the person who wrote it: that's called an ad hominem argument, and those are generally considered fallacious. (Crude example: if my argument is that All A's are B's, that all B's are C's, and that therefore all A's are C's, it doesn't matter who I am or who funds my research, because that's a valid deductive argument. Period.)

But not all arguments are so straightforward. The Nature article cited above, for instance, puts forward a multi-pronged argument, citing various reasons that the authors take, in the aggregate, to lead to the conclusion that we ought to adopt a more permissive attitude towards drugs that enhance brain function. And in putting forward that argument, the authors necessarily faced choices about what words to use, what analogies to employ, and what rhetorical devices to rely on. And it's at least conceivable that those choices could be swayed by interests other than the pursuit of truth and the public good.

As I said above, I think the Nature article puts forward a pretty good argument. But I'm more comfortable with that assessment, knowing that I've thought carefully about the way the authors' choice of words and analogies might (or might not) have been affected by the funding of their research.

Milgram's work replicated

For those of you who haven't heard, Jerry Burger, a psychologist from Santa Clara University in California has replicated the Milgram experiment from 1961. The full article will be a special supplementary of the January issue of American Psychologist. Here is a link to the story as reported on CNN.com:
Charting the psychology of evil, decades after 'shock' experiment

For most of us who work or teach in the area of research ethics, when we talk about experiments like Milgram's, typically to initiate a classroom discussion on whether or not "bad ethics" necessarily implies "bad science", we usually end by saying something definitive like, "But most ethics review boards would never allow Milgram's work to be done today." Arguably, a perfect replication of the Milgram study couldn't happen today with ethics review board oversight of research. The level of deception and degree of potential psychological risk would not be viewed as justifiable by the degree of expected benefit. In Burger's experiment, he included a number of strategies, some of which were in place, arguably, to mitigate potential risk. These included pre-participation screening by a clinical psychologist to exclude anyone who was felt would be negatively affected by taking part, an informed consent process that included reminding participants on an ongoing basis about the voluntary nature of participation and their right to withdraw at any time with full compensation and finally, a maximum delivery voltage of 150 volts compared to 450 volts in Milgram's experiment (150 volts was the point at which most people in Milgram's work hesitated or demonstrated some degree of reluctance to continue). Additionally, the sample shock delivered to Burger's participants (to show them that the machine was "real") was much lower. While Milgram delivered a (pretty painful) shock of 45 volts to all participants to help convince them that the machine was real, Burger only delivered a sample shock of 15 volts - which is still painful.

There are plenty of questions that remain about Burger's work (some much broader, including what many people are wondering, "Was there a good scientific reason to replicate this work in the first place? What more do we need to know?"). Hopefully, some of these will be answered in the American Psychologist article in January. I'll post an update once the article is published.

Mauritius: Open for Business (Ethically, of Course)

Research in developing countries always raises interesting issues, and often serious worries. But then, it's often also true that research dollars are a crucial financial boost for an impoverished nation. Keep that in mind as you read the African Press Agency's report that "Mauritius gov’t gives its approval to clinical tests of new medical drugs" [subscription/payment required]

A law dealing with clinical tests and research of new pharmaceutical products in Mauritius has just been finalized by the medical authorities which will give the right to foreign pharmaceutical companies to test their drugs in Mauritius....
According to informed sources at the Ministry of Health in Port Louis, a number of foreign pharmaceutical companies have already indicated their willingness to set up laboratories in the island but have been waiting with impatience for a legal framework from the government.

Yes, the tiny island nation of Mauritius is open for business.

Naturally, ethics is part of the equation. It's not clear, yet, whether that means pre-approval of clinical trials, or not:

For his part, Dr Neerunjun Gopee, the Director of Health Services in Mauritius indicated that apart from the law, the government will set up a Clinical Research Council which will have the responsibility to issue licenses to operators. Also an Ethics Committee will be constituted to hear complaints from those employed in this sector.

Hmm. Not much mention of protecting research subjects. Though the story does note, in an alarmingly candid turn of phrase, that "Neerunjun further indicated that pharmaceutical companies will have to hold an insurance policy in order to compensate potential victims."

Advertising as research?

Here's an interesting piece of "independent research" for Burger King that has a lot of people pretty upset. This ad campaign, presented as a documentary, has BK researchers traveling to remote areas and asking people who have never had a hamburger, to take part in taste testing to indicate a preference for a Whopper versus a Big Mac. You can watch the video yourself here: Whopper Virgins.

Okay, so this isn't really scholarly research nor is it any kind of research that would be subject to the guidelines of the Tri Council Policy Statement (TCPS), if it was conducted in Canada. Likely it would be deemed marketing research or even more simply the everyday work of marketing and not research at all. Suffice it to say, it likely would never be reviewed by an ethics review board.

But let's step back a bit and think: If this research, which essentially asks persons who have not been previously exposed to a phenomenon (in this case, the hamburger) to indicate a preference (Whopper versus Big Mac), was instead conducted by a psychologist at a Canadian University or a hospital, it would in fact be deemed to be research and would in fact be then subject to the principles and guidelines articulated in the TCPS.

What would your ethics review board say about this "study"?

A few points or questions come to mind, at first glance.

What kind of informed consent process were the participants offered? Seeing as the researchers note that they did not have an understanding of the notion of a hamburger, can we expect that they would then understand that their images (and thus their identity) would be used to promote a product using Western style advertising (and perhaps not even their preferred product!)?

Interestingly, when the researchers appear on camera in the commercial/documentary, they are labelled as "independent" researchers. Seeing as ethics review boards are in fact justifiably concerned with, among other things, researchers' potential conflicts of interest, the use of deception, and dissemination of research findings (such as a documentary in which the researchers are represented as "independent"), would this be seen as either a conflict of interest, an inappropriate use of deception or a misrepresentation in the dissemination of findings?

What people seem most upset about, and perhaps justifiably, when they view this video is what they see as the exploitation of the participants. Those who chose to take part made a conceivably non-coerced choice (many are shown refusing to take part; some are shown choosing the Big Mac), which was validated and included as part of a data set, we assume... They likely weren't aware that people might be viewing them as naïve or even primitive — the narration of the video emphasizes the difficulty many people had in figuring out how to simply hold and eat the hamburger. It would have taken only a few seconds to show someone how to hold a Western-style hamburger...however, clearly, the success of the campaign, in part, rests upon the ability of BK to not only illustrate the naivety of the people in the campaign but also to highlight how BK then brought the flame broiled Whopper, in an apparent act of Western altruism (some have noted that this is far less like altruism and much more like the kind of misplaced altruism we call colonialism), to remote villages and communities.

At the end of the day, even though those in the video call themselves "researchers", this really isn't research, of course. But it does demonstrate some of the problems ethics review boards are having with projects that exist at the edge of the domain of "research" — e.g. quality assurance, program evaluation, professional practice. While these kinds of projects, according to the TCPS, do not require ethics review and are clearly outside of the jurisdiction of review boards, reasonable people would agree that they should be ethically sound and that there should be some kind of oversight.

Corporate Research, Study Design and Genome Wide Association Studies

There's an interesting point about methodology in this item from today's JAMA: An Unwelcome Side Effect of Direct-to-Consumer Personal Genome Testing: Raiding the Medical Commons (by Amy L. McGuire and Wylie Burke). The article is about "personal genome" testing, based on genome-wide association studies. (Such testing has been discussed on this blog here, here, and here.) The main worry presented in the article is that such tests are sold on the basis of fairly weak association studies, and the customers of these studies will often become patients of an increasingly overburdened healthcare system. Such companies might be seen as offloading (in economic terms, externalizing) costs in the form of burdens on the "medical commons." (It's a decent point, though I wish the authors had said more about the nature of that commons, and what kind of obligations various kinds of agents have to preserve it, and why.)

Here's the bit about study design:

In addition, many companies may use a scientific advisory board to determine which scientific findings to include in their service. Information about the research relied on, as well as its potential limitations, should be shared with consumers. Moreover, some direct-to-consumer personal genome companies are leveraging consumer data and using it, along with phenotypic information collected with consent, to study genotype-phenotype associations.2 For this research to be interpretable, it must conform to best practices of measurement and study design, including attention to biases in sample selection and limitations of self-reported phenotype. Although these companies are not subject to federal regulation for the protection of human subjects of research, their studies should be conducted according to accepted scientific and ethical standards. These standards may be difficult for companies to accomplish, but ad hoc, underpowered, or biased analyses cannot provide an adequate substitute. In addition, results of these studies should be provided in the form of peer-reviewed publications when possible.

Update: Ethics and autism research

Last week I wrote about an Associated Press release which stated that Dr. Stanley Greenspan, a prominent and well published researcher and expert of emotional and developmental disorders, was conducting research on children, under five, at risk for or diagnosed with autism, in which half the children will receive intensive treatment while the other half receive no treatment.

Dr. Greenspan wrote to me this week and indicated that, although the AP report is out there, it is completely inaccurate. He is not conducting (nor would he ever conduct) studies on children at risk of or diagnosed with autism in which no treatment was offered. Furthermore, his research is not on IBI (ABA) therapy at all -- but on his own approach to treating children with autism -- an approach called the DIR/Floortime Approach, which is, as he notes and as you'll gather if you read his publications, very different from IBI therapy.

I've actually read his book called The Child With Special Needs: Encouraging Intellectual and Emotional Growth and it is an excellent read. It's a very unique approach to engaging children with autism and if you're interested in this topic, it is well worth reading.

Dr. Greenspan's current research involves examining videotapes of children with autism to see if there "are any clues in pre-diagnosis tapes that would help children and families begin building healthy foundations at even earlier ages." He also has published studies on the progress of autism and the factors that contribute to the way that autism progresses. Finally, he is providing consultation for researchers in Canada at the Ethel and Milton Harris Research Center at York University, who are conducting work on Greenspan's Floortime approach as well.

Interestingly, at the most recent meeting of the Interdisciplinary Council for Developmental and Learning Disorders (founded by Greenspan and his colleague Serena Weider), they had a panel session looking at the education of children with autism from an ethical perspective, led by Glenn McGee (Editor-in-Chief, AJOB). This is good news. Dr. Greenspan and I both agreed that a panel discussion on ethical issues in the conduct of research on children with autism would be an interesting and very timely contribution to their next meeting.

Here is another of Dr. Greenspan's publications:

Engaging Autism: Using the Floortime Approach to Help Children Relate, Communicate, and Think

Research Ethics on the Business Ethics Blog

Research ethics often intersects with the corporate world. So it's not surprising that issues relevant to research ethics have popped up from time to time on my other blog, the Business Ethics Blog. Those of you not already familiar with that blog might be interested to see some of the research ethics-related blog entries from the BEB over the last couple of years:

• Advertising Clinical Trials
  
• Pharmacos Hire Docs With Rap-Sheets
  
• Get the Ethics Right, Gain a Billion Customers
  
• Corporate Responsibility for a Drug Trial Gone Bad
  
• Can an Ethically-Challenged Scientist Attract Venture Capital?
  
• Pfizer's Unapproved Drug Tested on Nigerian Children
  
• India, Drug Trials, and So-Called Imperialism
  
• Big Pharma & Drug Trials in Developing Nations
  
• Business Ethics & Commercial Clinical Trials
  
• Truth, Fiction, and Wrongdoing in the Pharma Industry
  
• Pharma, Heroes, and Ethics in Publishing
  
• Big Pharma, Big Money, and Big Medicine
  

It's worth pointing out that the business ethics perspective on the events discussed in those blog entries is likely to be interestingly different from the perspective of people versed in research ethics or bioethics. At some level, ethics is ethics, but business ethics is its own academic field, with its own intellectual history. If nothing else, it's worth taking a glance to see how familiar problems get framed differently by someone whose audience is concerned with understanding ethical issues from the point of view of corporate behaviour, generally.