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Blogging Ethics

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01/21/2010 - 4:13pm

This does not look like it will be pretty. The World Health Organization (WHO) announced this week that it plans to launch an investigation into the global response to the H1N1 pandemic. The organization interest in such an investigation is not neutral . The WHO has been accused in many quarters of overestimating the scope and impact of the pandemic, i.e. overselling the threat. The rhetoric of urgency emanating from the WHO was in counterpoint to relatively modest statistics in terms of mortality and morbidity. It does not help that major pharmaceutical companies are the chief beneficiaries of the rapid production and distribution of H1N1, since this obviously makes delicious fodder for conspiracy theorists. You can imagine how it goes: credulous populations living in fear of death, a fear whipped up by a respected international health body, a fear that can only be managed by purchasing pharmaceutical products in vast quantities.

01/21/2010 - 4:13pm

This does not look like it will be pretty. The World Health Organization (WHO) announced this week that it plans to launch an investigation into the global response to the H1N1 pandemic. The organization interest in such an investigation is not neutral . The WHO has been accused in many quarters of overestimating the scope and impact of the pandemic, i.e. overselling the threat. The rhetoric of urgency emanating from the WHO was in counterpoint to relatively modest statistics in terms of mortality and morbidity. It does not help that major pharmaceutical companies are the chief beneficiaries of the rapid production and distribution of H1N1, since this obviously makes delicious fodder for conspiracy theorists. You can imagine how it goes: credulous populations living in fear of death, a fear whipped up by a respected international health body, a fear that can only be managed by purchasing pharmaceutical products in vast quantities.

01/14/2010 - 3:38pm

Writing in the Journal of Broadcasting & Electronic Media, Ruthann Weaver Lariscy of the University of Georgia argues that "Communication journal editors and concerned participants in the system should implement a policy that assures non-U.S. generated communication scholarship report procedures for assuring the protection of human subjects, the use of informed consent, and compliance with comparable IRB protocols."

[Ruthann Weaver Lariscy, "IRBs and Communication Research: Some Perplexing Issues," Journal of Broadcasting & Electronic Media 53 (October 2009): 668 - 671.]

Lariscy notes that IRB review degrades research. She recalls helping to plan a study of eighth-graders in Georgia, only to find that "the human subjects protection protocol required for this study made the research more difficult and depressed response rates," so that she and her colleagues got a participation rate of only 30 percent. In contrast, she refereed a study--apparently done abroad without IRB intervention--which got a participation rate of more than 85 percent. "I am left to conclude that IRB controls may have a considerable impact on our data collection, and the claims we make based on the data," she writes.

She does not claim that such IRB restrictions protect participants in communication research. To the contrary, she applauds the Illinois White Paper's position that "not all methodologies require the same rigorous overview and approval by IRBs, and that procedural changes should be made that acknowledge such methodological and content area differences."

If IRB review is degrading research without protecting anyone, why does Lariscy want journals to impose it on scholars who are currently free of such review?

First, she argues, "Failure to have uniform reporting requirements tarnishes the blind review process. Once a reviewer can identify that a piece of work originated either domestically or internationally, there is potential for bias." Well, yes. But there are dozens of factors that can flag a manuscript as originating outside of the U.S., including the spellings of words, the places studied, the literature cited, and even the proportions of the document. (While I am doing less work on paper, I still notice when a manuscript is formatted for A4.) This is a pretty thin benefit for a significant cost.

And a cost-free alternative exists. Journals could ask that U.S. authors omit descriptions of human protections procedures from their submissions, just as they now omit their own names. This would retain blind review without destroying data.

Bad as her first argument is, Lariscy follows it with an even worse one: "A non-level playing field exists for those of us conducting human subjects studies in the United States compared to the relative ease of conducting similar studies elsewhere." In other words, IRBs are wrecking our research, so let's be sure they wreck everyone's else's.

If Lariscy wants to make the case that journals should insist on IRB review of non-U.S. research in order to protect children, then let her do it. But it is unworthy of a scholar to advocate interference with research for the sake of interference itself.

01/07/2010 - 6:27am

The corks from the New Year's celebrations have hardly even been swept up, and already we have the first ugly bioethics conflict of the new decade. It about the concept of dignity, and more specifically whether the concept is coherent and useful in tackling bioethical problems. In 2003, Ruth Macklin wrote a paper in the British Medical Journal with the unambiguous title, "Dignity is a useless concept." But the concept of dignity has not made a dignified exit from the bioethics scene in the meantime. To the contrary, there have been a number of scholarly attempts to demonstrate its importance and usefulness, UNESCO's contribution to bioethics (Universal Declaration of Bioethics and Human Rights) in 2005 gave the concept of dignity a pride of place, and there are a number of bioethics-related blogs that clutch onto the concept of dignity as though their lives (and ours) literally depended on it.

The most important of them, I think, are the arguments against the second meaning of dignity: inherent moral worth. This is probably the most popular of the four meanings that Cochrane discusses, with the Kantian concept of dignity running a close second, at least in philosophical circles. One problem with the idea of 'inherent moral worth' is that it is very difficult to articulate what this means independently of descriptions of how we think that persons ought to be treated. This means that the analysis tends to be circular, and leads to the question: why bother talking about inherent moral worth, why not concentrate on the ways people ought to be treated, and why they should be treated that way? If you say "They ought to be treated that way, because they have intrinsic moral worth", you have gotten nowhere. As Cochrane points out, one way out of the circularity is to say that humans have intrinsic moral worth -- not just because we are apt to regard them in certain ways -- but because God has given us dignity/inherent moral worth. It is an objective, inalienable property of us, written in by the Creator. Of course, if you don't believe in God, or the kind of God who does this sort of thing, then this concept falls flat. But even if you do believe in that sort of God, it may fall flat anyway: dignity in this sense can be invoked to, for example, ethically defend or object to cases of assisted suicide....

01/07/2010 - 6:27am

The corks from the New Year's celebrations have hardly even been swept up, and already we have the first ugly bioethics conflict of the new decade. It about the concept of dignity, and more specifically whether the concept is coherent and useful in tackling bioethical problems. In 2003, Ruth Macklin wrote a paper in the British Medical Journal with the unambiguous title, "Dignity is a useless concept." But the concept of dignity has not made a dignified exit from the bioethics scene in the meantime. To the contrary, there have been a number of scholarly attempts to demonstrate its importance and usefulness, UNESCO's contribution to bioethics (Universal Declaration of Bioethics and Human Rights) in 2005 gave the concept of dignity a pride of place, and there are a number of bioethics-related blogs that clutch onto the concept of dignity as though their lives (and ours) literally depended on it.

The most important of them, I think, are the arguments against the second meaning of dignity: inherent moral worth. This is probably the most popular of the four meanings that Cochrane discusses, with the Kantian concept of dignity running a close second, at least in philosophical circles. One problem with the idea of 'inherent moral worth' is that it is very difficult to articulate what this means independently of descriptions of how we think that persons ought to be treated. This means that the analysis tends to be circular, and leads to the question: why bother talking about inherent moral worth, why not concentrate on the ways people ought to be treated, and why they should be treated that way? If you say "They ought to be treated that way, because they have intrinsic moral worth", you have gotten nowhere. As Cochrane points out, one way out of the circularity is to say that humans have intrinsic moral worth -- not just because we are apt to regard them in certain ways -- but because God has given us dignity/inherent moral worth. It is an objective, inalienable property of us, written in by the Creator. Of course, if you don't believe in God, or the kind of God who does this sort of thing, then this concept falls flat. But even if you do believe in that sort of God, it may fall flat anyway: dignity in this sense can be invoked to, for example, ethically defend or object to cases of assisted suicide....

01/01/2010 - 9:59am

On October 26, 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."

By the December 26, 2007, deadline, 65 people and institutions submitted comments, two-thirds of which concerned oral history or folklore.

That was two years ago. And as far as I can tell, OHRP has taken no action on these comments.

Meanwhile, OHRP's new guidance on what constitutes research subject to regulation, which Bernard Schwetz promised before the end of 2007, is now two years overdue.

12/29/2009 - 2:20pm

Time to review the year 2009 for cutting edge clinical research. For the field of gene transfer, it has been an annus mirabilis: a year that has seen very encouraging results in a wide variety of human clinical studies, as well as preclinical studies. Indeed, I regret that this blog has only been able to cover a few of the former, and very little of the latter. Here are a few highlights from clinical studies:
• in March 2009, Italian researchers reported major clinical improvement in eight of ten children participating in a gene transfer study involving ADA-SCID. [discussed here]
• in June 2009, researchers at Penn / Scheie Eye Institute reported very encouraging outcomes in three children with hereditary blindness, including evidence of visual recovery. [discussed here]
• in September 2009, researchers reported "marginal effectiveness" in preventing HIV infection for a gene transfer-based vaccine. These findings from this trial (the "RV144 trial") were unexpected after abysmal trial results involving a related strategy (the STEP trials). These are the first encouraging results from any HIV vaccine study conducted to date. [described here and here].
• in November 2009, researchers at Paris-Necker reported very encouraging outcomes in two children with adreno leukodystrophy who received a vector derived from lentiviruses [discussed here]
The decade began with a series of very inauspicious clinical outcomes in gene transfer, and a sharp abatement in the volume of clinical testing. The decade ends with several highly encouraging results from well designed and executed clinical trials. (photo credit: Xavier Luque 2009)

12/28/2009 - 3:32pm

This is one of these stories in ethical flux. Human Rights Watch (HRW) has claimed that earlier this month the Cambodian police rounded up at least 17 drug users and brought them to a government-run drug detention center on the outskirts of Phnom Penh, where they were forced to participate in a drug study. The drug being tested is 'Bong Sen', a herbal substance that is alleged (by the company that makes it) to detoxify heroin/opiate users in 4-5 days. HRW lays out the ethical problems with the experiment: coercive recruitment and lack of informed consent; lack of review of the study by the ethical committee of the Ministry of Health; unknown (and possibly shoddy) study methodology, including apparent lack of follow-up of research participants.

Just to show how deep the government is involved in the Bong Sen trial, the Cambodian prime minister is said to have given the Vietnamese doctors written permission to administer Bong Sen to drug users. When the Orkas Knhom drug treatment center could not come up with sufficient 'volunteers', staff from the NACD are said to have demanded that clients at local NGOs take the medicine. The NGOs hesitated, given that the herbal medicine being pushed did not seem to go through routine drug trial procedures. Staff from the NACD then threatened the NGOs with closures and withholding their licences for needle-exchange programs. That is apparently what went on before the police arrested drug users and had them enter the Bong Sen study. For its part, the NACD has denied everything: the drug users were volunteers; the herbal treatment is not really a drug, and does not have to go through drug approval procedures; there is no real trial at all. Just giving out medicine....

12/28/2009 - 3:32pm

This is one of these stories in ethical flux. Human Rights Watch (HRW) has claimed that earlier this month the Cambodian police rounded up at least 17 drug users and brought them to a government-run drug detention center on the outskirts of Phnom Penh, where they were forced to participate in a drug study. The drug being tested is 'Bong Sen', a herbal substance that is alleged (by the company that makes it) to detoxify heroin/opiate users in 4-5 days. HRW lays out the ethical problems with the experiment: coercive recruitment and lack of informed consent; lack of review of the study by the ethical committee of the Ministry of Health; unknown (and possibly shoddy) study methodology, including apparent lack of follow-up of research participants.

Just to show how deep the government is involved in the Bong Sen trial, the Cambodian prime minister is said to have given the Vietnamese doctors written permission to administer Bong Sen to drug users. When the Orkas Knhom drug treatment center could not come up with sufficient 'volunteers', staff from the NACD are said to have demanded that clients at local NGOs take the medicine. The NGOs hesitated, given that the herbal medicine being pushed did not seem to go through routine drug trial procedures. Staff from the NACD then threatened the NGOs with closures and withholding their licences for needle-exchange programs. That is apparently what went on before the police arrested drug users and had them enter the Bong Sen study. For its part, the NACD has denied everything: the drug users were volunteers; the herbal treatment is not really a drug, and does not have to go through drug approval procedures; there is no real trial at all. Just giving out medicine....

12/25/2009 - 8:30am

Earlier this month, the American Anthropological Association's Commission on the Engagement of Anthropology with the US Security and Intelligence Communities (CEAUSSIC) issued its Final Report on The Army's Human Terrain System Proof of Concept Program.

The report argues that the Human Terrain System (HTS) combines scholarly research and military information-gathering in a way that muddles ethical issues:

HTS ethnographers attempt to juggle dual loyalties both to civilian populations and to their military units, under conditions which almost inevitably lead to conflicting demands. Potentially conflicting demands (between serving occupied, studied populations, and serving the needs of the military with whom [Human Terrain Teams] embed) almost necessitates that HTS social scientists choose between multiple interests in ways that stand to undermine basic ethical principles that govern research with human subjects among anthropologists and among government researchers. (52)

Significantly, the report more or less recognizes that the choice of interests could go either way. One possibility would be to bring HTS wholly into the realm of scholarly research, with all of its ethical codes and legal regulations, including IRBs:

If HTS carries out a research function as advertised, and if it encourages its social scientists to use ethical research practices, then it should comply with 32CFR219, regulations issued by the Office of the Secretary of Defense (OSD) that address human subjects protection. (47)

Alternatively, the report hints that the real problem is merely a poor choice of words. "We should consider the work of HTTs to be sharply different, in its goals, from conventional disciplinary ethnographic pursuits and not to be 'ethnography' in any credible sense." (54) If HTS were re-branded to avoid the terms "anthropology," "ethnography," and "social science," and instead present itself as a counterinsurgency program pure and simple, then--it seems--CEAUSSIC would not expect it to follow either the AAA ethics codes or the Common Rule. All of this points to the need for clear definitions when discussing ethical and legal obligations.

For the purposes of this blog, a more interesting document is the October 13 blog post, "Why not Mandate Ethics Education for Professional Training of Anthropologists?" by CEAUSSIC member Carolyn Fluehr-Lobban.

Fluehr-Lobban calls for "ethics education as a mandatory part  of anthropology curricula." As she describes it,

A future standard ethics curriculum would minimally include a history of the discipline and ethics– this would help to correct misconstruing history, as has been the case in security engagement polemics where a standard of "voluntary informed consent" is often cited as 'traditional' or normative when, in fact, language on informed consent appears for the first time in the 1998 AAA code.  It would also include case studies representing a realistic spectrum of scenarios and dilemmas where mixed outcomes are the likely norm, and clear positive or negative outcomes are likely exceptions.

But while Fluehr-Lobban seems open to questioning such standards as "informed consent" and to exploring the nuances of real-world research, she is dismissive of comparable discussion of the legitimacy of IRBs:

There is still a tradition of resistance to the annoyance of having to go before an IRB. Part of this history rests with anthropology as the study of "the other," of "subjects," using "informants," whereby the anthropologist is ideally unfettered with unlimited freedom to conduct research. But, clearly, this is not the world we live in. As standard practice, all anthropological research is, or should be, subject to external review.

In other words, Fluehr-Lobban suggests that anyone who doesn't like IRBs wants unlimited freedom to study "the other." This is an insult to the many thoughtful critics who, over the decades, have shown that IRBs and their attendant apparatus can be a barrier to true ethical reflection. It is also an indicator of how entrenched the belief in IRBs has become within the AAA leadership. But has the organization ever really debated whether IRBs are the best way to promote its ethical standards? If not, CEAUSSIC should seize this opportunity for such a discussion within the profession.