A day later than promised, let’s kick off our discussion of “Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site” (PDF). The case study concerns a clinical trial of whether tenofovir, an antiretroviral drug, could prevent HIV infection. Before it was halted in the face of concerns raised by activists and the media, the particular clinical trial discussed in this case was conducted in Cameroon. Indeed, one of the big questions the activists raised about the trial was whether it was ethical to site it in Cameroon.
From the case study:
Category Archives: Ethical research
Coming Monday: our discussion the case of a halted international clinical trial in Cameroon.
Almost a month ago, I told you about a pair of new case studies released by The Global Campaign for Microbicides which examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of antiretrovirals in preventing HIV infection were halted. In that post, I also proposed that we read and discuss these case studies as a sort of ethics book club.
Next Monday, June 15, we’ll be kicking off our discussion of the first case study, “Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site” (PDF).
Candid Engineer on data handling and ethics.
In a recent post, Candid Engineer raised some interesting questions about data and ethics:
Proposed guidelines for embryonic stem cells: applying new ethical rules to old research.
You may have heard that the Obama administration has proposed new rules for federal funding of embryonic stem cell (ESC) research. (The proposed rules are available in draft form through the end of the public comment period; the NIH expects to finalize the rules in July).
While researchers are enthusiastic at the prospect under this administration of more funding for ESC research, not everyone is happy about the details of the proposed rules. Indeed, in a recent article in Cell Stem Cell [1], Patrick L. Taylor argues that there is something fundamentally misguided about the way the new rules would be applied to old research:
Cleaning up scientific competition: an interview with Sean Cutler (part 2).
Yesterday, I posted the first part of my interview with Sean Cutler, a biology professor on a mission to get the tribe of science to understand that good scientific competition is not antithetical to cooperation. Cutler argues that the problem scientists (and journal editors, and granting agencies) need to tackle is scientists who try to get an edge in the competition by unethical means. As Cutler put it (in a post at TierneyLab):
Scientists who violate these standards [e.g., not making use of information gained when reviewing manuscripts submitted for publication] are unethical – this is the proverbial no-brainer. But as my colleague and ethicist Coleen Macnamara says, “There is more to ethics than just following the rules- it’s also about helping people when assistance comes at little cost to oneself.” The “little experiment” I did was an exercise in this form of ethical competition. Yes, I could have rushed to the finish line as secretly and quickly as possible and scoop everyone, but I like to play out scenarios and live my life as an experimentalist. By bringing others on board, I turned my competitors turn into collaborators. The paper is better as a result and no one got scooped. A good ethical choice led to a more competitive product.
But how easy is it to change entrenched patterns of behavior? When scientists have been trained to take advantage of every competitive advantage to stay in the scientific game, what might it take to make ethical behavior seem like an advantage rather than an impediment to success?
My interview with Sean Cutler continues:
Cleaning up scientific competition: an interview with Sean Cutler (part 1).
Sean Cutler is an assistant professor of plant cell biology at the University of California, Riverside and the corresponding author of a paper in Science published online at the end of April. Beyond its scientific content, this paper is interesting because of the long list of authors, and the way it is they ended up as coauthors on this work. As described by John Tierney,
Two new case studies on international clinical trials (and a plan to read them together).
Earlier this week, I found out about a pair of new case studies being released by The Global Campaign for Microbicides. These cases examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of microbicides antiretrovirals in preventing HIV infection were halted. Here are some details:
Impediments to dialogue about animal research (part 4).
As we continue our look at ways that attempted dialogues about the use of animals in research run off the rails, let’s take up one more kind of substantial disagreement about the facts. Today’s featured impediment:
Disagreement about whether animals used in research experience discomfort, distress, pain, or torture.
This disagreement at least points to a patch of common ground shared by the people disagreeing: that it would be a bad thing for animals to suffer. If one party to the discussion accepts the premise that animal suffering is of no consequence, that party won’t waste time haggling over how much suffering animal research actually produces.
Sniffing out bias in a sea of industry research funding.
One arena in which members of the public seem to understand their interest in good and unbiased scientific research is drug testing. Yet a significant portion of the research on new drugs and their use in treating patients is funded by drug manufacturers — parties that have an interest in more than just generating objective results to scientific questions. Given how much money goes to fund scientific research in which the public has a profound interest, how can we tell which reports of scientific research findings are biased?
This is the question taken up by Bruce M. Psaty in a Commentary in the Journal of the American Medical Association [1]. Our first inclination in distinguishing biased reports from unbiased ones might be to look at the magnitude of the goodies one is getting from one’s private funders. But Psaty draws on his own experience to suggest that bias is a more complicated phenomenon.
A glimpse into how not to conduct an ethical drug trial.
The Independent reports that drug giant Pfizer has agreed to pay a $75 million settlement nine years after Nigerian parents whose children died in a drug trial brought legal action against the company.
It’s the details of that drug trial that are of interest here: