Research ethics during medical disruption

A couple years ago, I experienced first-hand the effects of political turmoil on research. My university was conducting epidemiological research involving sex workers in Antananarivo, Madagascar. Special clinics were being piloted for this stigmatized, hard-to-reach and vulnerable population. Then the political crisis of 2009 hit. Everything ground to a halt, including much of the activity in the hospitals where the research was taking place. The sudden upheaval in the routines of everyday life caused much confusion and disarray: what now?

A new publication in the Journal of Medical Ethics by House et. al. is therefore very welcome, because it covers some neglected ground. In the rare case that bioethicists discuss ethical challenges within politically unstable contexts, they tend to concentrate on the reliable delivery of health care. Instead, this article focuses on the conduct of health research when social life gets gnarly, and more specifically when medical services are disrupted, based on the authors' experiences in Kenya. The authors make a useful three-way distinction between the ethics of not starting research, stopping it once it has started, and keeping on going in the face of communal strife.

The authors argue that the ethics of not starting research, and continuing it once it has started, are different. If the political upheaval is so disruptive that ethical standards of research cannot be upheld, research should wait. But an ongoing study may involve serious commitments and expectations, a relationship of trust between researchers and communities, and research participants may benefit from research-related interventions. Stopping an ongoing study requires deliberation with the local community and a careful collaborative weighing of options and trade-offs.

One shortcoming of the discussion is its strong focus on clinical, biomedical research, where data collection is closely bound up with the provision of health care. Not all research one can imagine during a political crisis is like that. Anthropologists and political scientists -- who unlike physician-researchers do not have a role-related duty to care for patients -- may in fact jump at the chance to study what goes on during periods of political turmoil, and it is not clear that the biomedical framework of House et. al. captures the kinds of challenges they might have, or if their recommendations are applicable to them.  

Connecting the recent Ebola crisis to this article reveals a certain tension. According to this House et. al., would research during the highly disruptive Ebola crisis be permissible or not? The answer seems to be: yes and no. At some points, House et. al. rule such research out as unethical: "While research has the potential to benefit the health of populations, the risks overall are too high to start research during medical care disruption. The prudent course is to wait until after resolution of these episodes when ethical standards can be met, the safety of patients and research subjects assured, and the likelihood of completing a study is maximized." However, the authors later seem to build in a loophole: "... if the aims of the study are of particular importance during times of medical care disruption such as studies that address how to optimise healthcare during times of disruption, it may shift the balance of decision-making in favour of starting or continuing research." That would, under a charitable interpretation, rule in favor of research-during-Ebola-like-outbreak.

We seem to be still in two minds: do we categorically state that conditions during political upheaval simply make responsible conduct of research impossible, or do we permit research that might be useful and could not be conducted other than in those non-ideal conditions? The House et. al. article may not answer this question, but it has helpfully opened lines of inquiry into ethical questions that arise all to often in research in developing countries.    

Guidelines on standards of care in research: when is deviancy acceptable?

For years there have been overheated discussions about the standard of care provided to participants in health research, particularly in low-resource settings. Is it ever ethically justified to design a research study where participants in Benin with a standard of care inferior to what patients would routinely receive in (say) Baltimore, Maryland? There is no consensus on the issue, and even an influential international ethics document speaks out of both sides of its mouth on this one.

Every once in awhile, a study emerges that seems to offer (some) research participants inferior care, and the whole tumultuous debate is unleashed anew. This is what happened with the Starting Antiretroviral Therapy at Three Points in Tuberculosis Therapy (SAPIT) study in South Africa a couple of years ago. This randomized controlled trial randomized HIV-positive patients with tuberculosis to receive antiretroviral treatment earlier or later after starting TB treatment. The 'delayed arm' of the study seemed to violate WHO guidelines that recommended starting antiretroviral treatment in such patients as soon as possible after TB treatment was initiated. When the study was stopped due to heightened mortality in the delayed arm, commentators cried foul. The researchers, they claimed, should have followed the guidelines, and should have known what would happen in the delayed arm when they did not.

Seema Shah and Reider Lie have just published an interesting piece in the Journal of Medical Ethics on this topic, asking about when it can be justified to deviate from guidelines about standards of care and prevention. They remind us that guidelines, while useful, are not fixed and divine commandments: they may be based on insufficient evidence, they may change while a study is being conducted, they may be objects of controversy and disagreement. Not everyone is likely to agree with Shah and Lie's account of when deviations from clinical or prevention guidelines are ethically justified, or their interpretation of the SAPIT trial on the basis of their account, but they may have found tranquil angle to the passionate debate over standard of care in research. If such a thing exists.

Globally embarrassing bioethics

February continues to be a trying month in bioethics circles. This week we have a firestorm concerning an article published a couple of days ago in the Journal of Medical Ethics, entitled After-Birth Abortion: Why Should the Baby Live? The authors Alberto Giubilini and Francesca Minerva argue that as a matter of consistency, if we accept that fetuses can be aborted for certain reasons (severe abnormality, psychological or financial burden on the family) then we must rationally accept that newborns can be put to death for the same reasons, because both fetuses and newborns have the same moral status as non-persons. Reactions from non-fans of infanticide have been swift and ugly, with the usual accusations of Nazism and dire assessments of where the world is headed when intellectual life is not constrained by religious faith. Editors at the JME, laughably, act as if shocked by all the fuss, as if they seriously expected all readers to receive the paper in a spirit of cool, robotic detachment.

What I found surprising about the paper was how old the main arguments are. Check the references: the philosophical papers cited are all between 20 and 30 years old. Peter Singer and Michael Tooley made the same basic arguments with the same basic premises and with the same rationalistic mindset. So it is not clear why what makes this paper especially publishable, unless the publishers were thinking the time was ripe for stirring up the culture wars (yet again) with a big, fat stick.

But the editors at JME are right that it would be good, ultimately, have a reasoned debate about the article's content. There is plenty in the article to question, including the key premises that our attitudes towards persons is based on their possession of mental capacities (especially their ability to plan for the future) and the idea that our moral sentiments (including our feelings towards newborns) ought or can as a general rule be governed solely by logic and consistency. Those outraged by the Giubilini and Minerva article should take some consolation in the fact that those old arguments by Singer and Tooley did not exactly popularize infanticide, even among other academics. To the extent that the new article has a shock value, the old article has had little effect on common morality.

There is another concern, though: how this all looks to those outside North America and Western Europe, the traditional bastions of bioethics. High-minded arguments in favor of dispatching unwanted babies (and other non-persons) setting off a torrent of mud-slinging and breast-beating. Bioethics: so that's how you do it.

Update: the Journal of Medical Ethics Blog has published some further responses to the paper by Giubilini and Minerva in an apparent effort to open reasoned dialogue on the subject. Giubilini and Minerva have published an open letter to clarify their position, interestingly claiming that they only meant their audience to be other bioethicists familiar with abortion/infanticide debates, emphasizing that they were only making an academic argument, without any practical implications for policy, law, or for what people ought to do.

Research ethics committees in developing countries: something old, something new

February has been a rough month for bioethics in the USA. Alleged conflicts of interest at the American Journal of Bioethics -- the top ranked bioethics journal -- has lead to a kind of feeding frenzy of accusation, distain and soul-searching in regard to the whole idea of bioethics and how it is practiced in it's most powerful home. Is bioethics a lousy kind of philosophy? Does it just consist in rationalizing the newest biotechnology that comes along, and running intellectual roughshod over whatever traditional values (often religious) might be threatened by that technology? Is that why bioethicists are lured to agencies and institutions that are part of one might call the military-industrial-university-biotech-pharma complex? Is bioethics losing ability to speak truth to power, because they are part of (or eating hors d'oeuvres with) the 1%?

Perhaps on another occasion there will be room for reflection about whether all this should be a cautionary tale for bioethics in other countries in the world, how much of it is true, and how much of it is overblown to serve the interests of other agendas. For my part, I have been lying low, staying away from bioethics news, and looking at what other journals have been putting out. A recent research ethics article in the Journal of Medical Ethics caught my eye, called 'Ethical Approval in Developing Countries is not an Option' (Online First, requiring subscription, goddammit).

What struck me initially was the obviousness of the title: how is that news? It is like having an article called 'Eating people: some arguments against'. And in a certain way, the point of the article is obvious: when there is an appropriate body in developing countries to review human subjects research conducted by anyone (local or from abroad), then it should be reviewed. The authors cite a published article about research conducted in Nepal, which did not have local Nepalese research ethics committee approval. It doesn't sound like a very risky study, but that is not the point. Nepal has an ethics committee that could have reviewed it, and it was not even submitted.

What makes the article publication-worthy are the underlying issues. Central among them is who should have ensured that the study was submitted to local review. Ethics committees are not detective agencies, who scour the community to find out who is doing research on what. Researchers have to volunteer this information; they also have to know that there is a committee to submit their research to. In many developing countries, this is not straightforward: in some settings, research ethics committees may not exist; where they exist, they may only review certain kinds of (biomedical) studies; and even if they do exist and they could review a certain study, getting information about them and their procedures can be unreasonably taxing for scientists. Compounding the problems, some committees may be dysfunctional and intolerably slow, undermining motivations to bother looking for them.

Perhaps if a study is conducted by a developed world institution, their own research ethics committee should ensure that scientists make good faith efforts to get their research reviewed where it will be conducted, or help them get it reviewed. Or journals should not publish articles in which researchers failed to get their research reviewed where it really is human subjects research, and there really is an adequate body that can appropriately assess its ethics. The authors rightly point out that if researchers from Nepal were to do a research study in the UK or USA, but only sought ethics approval for it in Nepal, and published it, this would be considered scandalous -- but when developed world institutions do the same in the developing world, there is far less concern, even when committee members do not know much more about Nepal than Everest expeditions.

So it is not news that local ethics committee review in developing world ought to be reviewed; the news is how this requirement continues to fall through the gaps.

Getting the ethical ideals right in international health research

The free, open access Editor's Choice at the Journal of Medical Ethics this month is "Responsibilities in international research: a new look revisited" by Solomon Benatar and Peter A. Singer. Back a decade ago, Benatar and Singer advocated for vision of international research ethics less focused on risks and benefits for individual research participants. They wanted to see more attention directed towards the 'big picture' issues, i.e. the background of global (social, political, economic, gender) inequalities in which international health is embedded, and which gives rise to most of the ethical problems in any particular study. Looking back, Benatar and Singer see that some of the ideas they alluded to (such as ancilliary care obligations of researchers, community engagement in research and strategic partnerships among stakeholders) have been taken up in mainstream theoretical discussions about the ethics of global health research, and, to a much more limited extent, put into practice in the field. Meeting ideals of conducting 'responsible health research' in a global context, they suggest, still has a very long way to go.

To stimulate further ethical progress, Benatar and Singer offer some (fairly obvious) ethical principles, and suggest (less obviously) that these principles are based on the ethical value of solidarity. Benatar and Singer write that, first, research undertaken in poor countries should contribute to improved health care in the community in which the research is undertaken. Second, research should enable, or empower, host country researchers to solve their own research problems in the future. Behind these principles stands solidarity, a value they see expressed in:

[A]ttitudes and determination to work for the common good across the globe in an era when interdependence is greater than ever and in which progress should be defined as enhancing capabilities and social justice rather than sustaining dependency.

It is refreshing to see this attempt to put solidarity back into currency among those involved in bioethics. On the other hand, it is somewhat sad to be reminded, in 2010, of ethical principles that should not even require a reminder, and to become conscious of the relative disuse into which the notion of solidarity has fallen. But maybe getting the ideals right is the first step to getting the practices right.