In 1996, pharmaceutical company Pfizer tested the new antibiotic Trovin on children in Nigeria during a major meningitis epidemic. It became a drama. Of the 200 children who participated in the study, 11 died within a month. Others experienced serious side effects such as liver damage. It later turned out that many parents were unaware that the drug was experimental in nature, unlike the regular drugs they could get at the neighboring MSF camp. Consent forms were not read by many because of their illiteracy and the verbal explanations they received were often brief and inscrutable.
These are practices that ethics committees in Europe or the United States would never approve, but that more easily go under the radar in places where supervision and rights of subjects are less regulated. The Trovin tragedy does not stand alone. The road to scientific knowledge is paved with studies of so-called ‘ethical dumping’ in regions such as Africa and Asia. The problem is also broader than just medical science, it also affects archeology and anthropology, for example. Think of the famous British Museum in London, which is full of controversial objects that countries like Egypt and Greece have been reclaiming for decades. Or the indigenous San population from southern Africa, who are still regularly referred to as the derogatory ‘bushmen’ in scientific publications.
Lab facilities
Recently, a different wind has been blowing in the academic world. The self-awareness of many non-Western countries has grown in the wake of their socio-economic development. The relationship with, for example, former colonizing countries is changing as a result. ‘Scientific decolonization and more mutual respect are part of this,’ says anthropologist Tâm Ngô of the Netherlands Institute for War Documentation (Niod). The Vietnamese-born investigates, among other things, how victims from the Vietnam War can still be identified using modern DNA techniques. ‘There is a lot of discussion going on in our project about who is allowed to examine the bone remains. In the past this would happen automatically in the West, now they say in Vietnam: we also have good lab facilities, it has to happen here.’
‘It fits in with the zeitgeist’, says Professor of Methodology and Integrity Lex Bouter (Free University). ‘Equality, diversity and inclusiveness are receiving much more attention these days. At an integrity conference in Cape Town that I attended in June, a statement on these themes was still being worked on.’
Major scientific journals are also increasingly targeting so-called ‘ethical dumping’. A striking example of this is a recent firm statement by Nature Portfolio, the range of scientific journals that are covered by top journals. Nature to hang. The scientific exploitation of non-Western countries must end, the authorities write Natureeditors: ‘The legacy of exclusion must be dismantled.’
From now on, they want authors to answer questions about ethics and inclusion when they work in less developed countries. Such as: how are local researchers involved? Were they allowed to contribute ideas about the study design and are they also co-authors on the publication? And to what extent have animal experiments been carried out that are banned in the West? Other major magazines such as The Lancet and the British Medical Journal have similar developments.
The tightened ethical course of Nature and other trade journals generally follow the Global Code of Conduct for Research in Resource-Poor Settings. This 2018 code of conduct is the result of a project funded by the European Union (EU) in which scientists worldwide explored how to prevent scientific exploitation. For example, this states that, in addition to Western committees, a local ethics committee must also approve an investigation.
Another important point is that the local population benefits from the outcomes. Profit means, for example, that medicines that are tested in an African country will also become available in that country after the study has been completed. And not that they are unaffordable, as was the case with HIV medication for years. Another example of what not to do is Janssen’s corona vaccine. This was tested and subsequently produced in South Africa, but the majority of the vaccines made then went to Europe and the US.
The fact that magazines now also subscribe to the Global Code is the final piece in a broader process, says Michael Makanga, who co-wrote the code of conduct. Makanga is director of the European & Developing Countries Clinical Trials Partnership in The Hague. This EDCTP is an organization set up by the EU that funds medical research for poverty-related diseases, such as malaria, HIV and Ebola. ‘Now the entire research process has been covered, from design to publication. Many financiers already demanded that subsidy applicants adhere to the code of conduct.’ The Dutch NWO, which finances scientific projects on behalf of the government, has also been requiring this for certain subsidy programs for the past two years.
The stricter requirements of magazines and subsidy providers are not just for the stage, but rather an important stick behind the door, says integrity expert Bouter. ‘They reduce the non-commitment.’ After all, not all researchers or pharmaceutical companies will be equally sympathetic. But they have to now, explains the professor, because it is important for them to publish in top journals. ‘You also saw the same shift in the sharing of research data, which journals had already encouraged. That was rare, now it’s the standard.’
In the meantime, the emancipation of former developing countries is continuing, says Radboudumc professor Teun Bousema, who conducts malaria research in Ethiopia and Uganda, among others. The Bill and Melinda Gates Foundation (a major philanthropic organization, red.), for example, nowadays gives money directly to institutions in areas where malaria is prevalent. Those institutions can then decide for themselves whether they hire a Western institute, and which one exactly.’ That does require adaptability, emphasizes Bousema. ‘Suddenly we now have to prove our added value.’
Malaria research
He believes this is a good development, because it allows countries to better set up their own, independent research infrastructure. Of such capacity building, in development jargon, he also emphatically sees it as his task as a scientist. This goes further than just having local scientists co-author an article. ‘I am committed to long-term partnerships with local institutions. More than half of my PhD students have African nationality. And a former PhD student now has his own research group in Ethiopia. I now try to continue to support him, for example when writing grant applications.’
Yet there is still a world to be won. For example, (financial) power differences are difficult to remove. Corona, for example, has financially hit sub-Saharan countries harder than Europe and the US. As a result, the budgets of local ethics committees are sometimes decimated, says EDCTP director Makanga. There are also large differences in education level. Bousema: ‘Many young Dutch researchers here roll from pre-university education to university and in a PhD programme. Some of my African PhD students had to walk 10 kilometers to school as children. They have to come from so much further.’
Daily research practice is also more unruly than the theoretical ideal of codes of conduct and guidelines. Bousema tells how Japanese researchers discovered last year that some malaria parasites in Uganda had become resistant to a commonly used malaria drug. They did not share this finding, which is important for public health, with the local authorities. ‘They only learned of this when the publication appeared in the New England Journal of Medicine (a top medical journal, red.), more than a year later. That is actually no longer possible, in the 21st century.’
And, finally, what to do with published research that is no longer acceptable according to current standards? ‘I often discuss these kinds of difficult dilemmas with my students. I don’t have a simple answer to that,” says integrity professor Bouter. ‘If local researchers are not given enough credit, it seems pointless to ignore the findings. It is very different with the Nazi experiments of the Second World War. But where is the limit? You also don’t want the contribution of test subjects to ethically dubious studies to have been completely in vain.’
Three times ethically questionable investigation
– At least 250 Indian women died of cervical cancer in American-funded research into a new way of recognizing the disease early this century. The victims were in the control group and had not been offered alternative screening. Had the study been conducted in the United States, such an alternative would have been mandatory.
– In the 1990s, geneticists at Harvard University collected thousands of blood samples from residents in the poor Chinese province of Anhui. The researchers received a subsidy of millions from a pharmaceutical company, which became the owner of the genetic database. Test subjects did not benefit, some were not even aware that they were participating in scientific research.
– At the end of the 19th century, the Dutch physician and paleontologist Eugene Dubois found bone remains of Java man, a precursor of modern man, in the then Dutch East Indies. Dubois had the excavations done by forced laborers. The Java Man is now one of the showpieces of the Naturalis Museum, but would fit better in an Indonesian museum, according to some looted art experts.