Back in July, Science ran an interesting news article about an on again, off again clinical trial of chelation therapy in the treatment of autistic children. I found the story fascinating because it highlights some of the challenges in setting up ethical research with human subjects — not to mention some of the challenges inherent in trying to help humans to make good decisions grounded in the best available scientific knowledge.
From the Science article:
In the July 18, 2008 issue of Science, I noticed a news item, “Old Samples Trip Up Tokyo Team”:
A University of Tokyo team has retracted a published research paper because it apparently failed to obtain informed consent from tissue donors or approval from an institutional review board (IRB). Other papers by the same group are under investigation by the university. Observers believe problems stem in part from guidelines that don’t sufficiently explain how to handle samples collected before Japan established informed consent procedures.
The samples in question were “legacy samples”, samples that had been previously collected for other research projects. The fact that these samples were collected before the institution of the rules for research with human subjects to which Japanese researchers are now bound complicates the ethical considerations for the researchers.
One of the key requirements that researchers conducting studies with human subjects must meet is that they obtain the informed consent of the participating subjects (or of a parent or guardian, if the subject is not able to give informed consent himself or herself). However, there are particular instances where giving the subjects complete information about the study at the outset may change the outcome of the study — namely, it may make it practically impossible to measure what the research is trying to measure. If these studies are not to be ruled out completely, doing them necessitates some amount of deception or concealment, which seems to be at odds with the need to establish informed consent.
Of course, there are ethical guidelines for dealing with studies that require deception. But recently a reader emailed me about a particular study where there might have been concealment that was an impediment to informed consent rather than a methodological requirement of the study. Here are the broad details*:
Faculty members are solicited to participate in a sociological study of networking within their academic departments. Indeed, a university administrator strongly encourages faculty members to participate in the research by noting that the data it collects is expected to bolster a grant application geared toward funding “institutional transformations”.
The information provided to prospective subjects on the consent form makes no mention of using the results of this study to secure further grants. Some of the faculty who are being solicited to participate in the present study have objections to the sorts of “institutional transformations” promoted by the grant program mentioned in the administrator’s encouragement to participate.
Is the failure to mention this intended use of the study results in the consent forms a violation of informed consent?
A colleague of mine (who has time to read actual printed-on-paper newspapers in the morning) pointed me toward an essay by Andrew Vickers in the New York Times (22 January 2008) wondering why cancer researchers are so unwilling to share their data. Here’s Vickers’ point of entry to the issue:
You’ve probably heard that UCLA scientist Edythe London, whose house was earlier vandalized to the tune of tens of thousands of dollars by animal rights activists, has once again been targeted. This time an incendiary device was left on her front door.
Abel and Mark weighed in on this appalling use of tactics to terrorize a scientist doing work on approved protocols — protocols that had to meet the stringent standards imposed by federal regulations. But while the NIH and the odd newspaper columnist stands up to make the case for animal use in medical research and against the violent intimidation of medical researchers, there seems not to be much in the way of public outcry.
Do people really feel like firebombing is a legitimate means of persuasion?
My guess is that they don’t. However, some of the details of the situation as described in a recent article in the Los Angeles Times may explain why the public is conflicted. Beyond animal use, the area of London’s research and the source of her funding seem to be raising discomfort, creating a tangled knot of controversy that’s begging to be untangled.
In an earlier post, I looked at a research study by Nelson et al. [1] on how the cognitive development of young abandoned children in Romania was affected by being raised in institutional versus foster care conditions. Specifically, I examined the explanation the researchers gave to argue that their work was not only scientifically sound but also ethical.
In this post, I examine the accompanying policy forum article, Millum and Emmanuel, “The Ethics of International Research with Abandoned Children” [2]. Millum and Emanuel are in the Department of Bioethics at the Clinical Center of the National Institutes of Health. As such, it’s not unreasonable to assume that they are not coming to their understanding of this research — and to the question of whether it rises to the appropriate ethical level — from the point of view that good science should trump all other interests.
“Why don’t they make a birth control pill for men?”
There are important considerations from medical ethics that might explain why a birth control pill for men has not happened yet.
The Neurocritic alerted me, in a comment on an earlier post, to a pair of papers in the 21 December 2007 issue of Science that raise some difficult ethical questions about what sorts of research are permissible. Quoth the Neurocritic:
This may be a little off-topic, but I was wondering if you read this article in Science, beginning of abstract pasted below.
In a randomized controlled trial, we compared abandoned children reared in institutions to abandoned children placed in institutions but then moved to foster care. Young children living in institutions were randomly assigned to continued institutional care or to placement in foster care, and their cognitive development was tracked through 54 months of age.
Rather horrifying! Can you imagine this experiment being performed in a first- (or second-)world country in the 21st century? But the title of the paper is:
Cognitive Recovery in Socially Deprived Young Children: The Bucharest Early Intervention Project
Is it now OK to perform this experimental intervention, since it’s in Romania? …
The authors of the study, Nelson et al., do have a lengthy discussion of ethical issues within the paper (e.g., the secretary of state for child protection in Romania invited them to do the study, the IRBs at Minnesota, Tulane, and Maryland [PI home institutions] approved the study, etc.). However, to me it seems to set off alarm bells in terms of ethics. I’m definitely not a developmental psychologist, but this statement seems odd:
Clinical equipoise is the notion that there must be uncertainty in the expert community about the relative merits of experimental and control interventions such that no subject should be randomized to an intervention known to be inferior to the standard of care (27). Because of the uncertainty in the results of prior research [??], it had not been established unequivocally that foster care was superior to institutionalized care across all domains of functioning… [Is the superiority of foster care really in doubt?]
In this post, I’ll look at both Nelson et al., “Cognitive Recovery in Socially Deprived Young Children: The Bucharest Early Intervention Project”. [1] In a second post in the not-too-distant future, I’ll look at the accompanying policy forum article, Millum and Emmanuel, “The Ethics of International Research with Abandoned Children” [2]. (I’m breaking it up into two posts because otherwise it may require you a full pot of coffee, rather than a mug, to get through it all.) My aim in these two posts will be to lay out the recognized ethical guidelines for research with human subjects as they apply to the Bucharest Early Intervention Project (BEIP), and to identify the worries we might raise about this kind of research — and, by extension, with the prevailing standards.
One of the strengths of science is its systematic approach to getting reliable information about the world by comparing outcomes of experiments where one parameter is varied while the others are held constant. This experimental approach comes satisfyingly close to letting us compare different ways the world could be — at least on many occasions.
There are some questions, though, where good experimental design requires more cunning.
Last May, on my way back from a mini-conference in Stockholm, I had a long layover in Munich. Since major airports are now essentially shopping malls with parking for commercial jets, I used a little bit of that time to wander through a pretty impressive airport book store, where I picked up a copy of Never Let Me Go by Kazuo Ishiguro. I had heard a bit about it (maybe in reviews on the radio, if memory serves), and knew that it had some connection to ethical issues around biomedical technologies that seem not to be too far off from where we are now.
Because I was taking a stab at using my layover time wisely, though, I spent the hours at the airport reading a couple of other books I had promised to review for journals. Then, once on the plane, I slept. Then, I was back home fighting the twin demons of end-of-semester grading and jet lag.
A couple days ago, while straightening up some piles of books, I found Never Let Me Go and decided I needed some “me-time” reading a novel. Less than 48 hours later, I was finishing it and wondering what would count as a decent interval to wait before rereading it.
It’s a very good book. I’ll try to explain why without giving away too much, since a lot of the pleasure of reading this book is the way in which the reader comes into possession of key details as the story unfolds.