Dump Ethics Dumping!

In my previous blogs I have discussed two cases from the recently published book Ethics Dumping. Case Studies from North-South Collaborations. I have shown that the analysis of these two cases is flawed. Unfortunately, most of the other cases are not cases of what could reasonably be called Ethics Dumping. Basically, therefore, the project that was funded by the European Commission to illuminate an important issue for EC research policy is fundamentally flawed.

First a note about the definition of Ethics dumping.  The term dumping is taken from Economics where it describes the practice of exporting a product from one country to another, and selling it a much lower price in the receiving country so that local production suffers. It can also mean transporting (dangerous) waste from one country to another. The sending country may have strict environmental laws in order to protect their populations, which are absent in the receiving country which is typically poorer. Generally, therefore, dumping refers to an activity that provides some advantage to the person or country that does the dumping, and injures or makes the receiving country worse off.

The typical example of research ethics dumping would therefore be when a country carries out research in a poor country that harms the poor country or makes the poor country worse off, and that is carried out for the benefit of the rich country. The book, however, defines it more broadly, as intentional or unintentional exploitation of poor countries. Exploitation is, unfortunately, not defined by the authors. A standard definition is the following:

Action of treating someone unfairly in order to benefit from it

The essential part of this definition, which it shares with dumping, is that the person who does the dumping, or the exploitation, has to benefit from it. While the harm that occurs to the exploited or those who receive the products may not be intended or expected, the benefit that accrues to the exploiter or the dumper has to be expected or intended. The problem with the book is that the authors do not even attempt to show, for most of the cases, how they are supposed to benefit the sponsors of the research. In fact, most cases are examples of research that clearly are intended to benefit people in low and middle income countries.

The first case is about an NGO that undertook a research project on health seeking behavior for childhood diarrhea in a rural area in an African country. As is well known diarrheal diseases are important causes of death among children, and it is important to identify ways that will increase utilization of appropriate health care services. During the research it was discovered that one traditional treatment for diarrheal disease was genital mutilation for girls. This was unexpected. The research team decided to inform the authorities as the practice is illegal in the country, which created antagonism among the local population towards the NGO.

It is really hard to see why this should be a case of “Ethics dumping”: The project did cause unexpected harm, but it was not done in order to benefit the researcher or the funding country. On the contrary, the NGO clearly expected the project to benefit the receiving country only.

The third case in the book is about the personal experience of a local researcher who worked on a project among sex workers in a Nairobi slum. The person describes how the project has led to the empowerment of the women, and their inclusion in the decision making process. Basically, one has to conclude that this described a fairly successful research collaboration, and is not an example of ethics dumping at all.

The fourth case of the book is the cervical cancer screening trials in India that I have discussed at length. They also were not done for the benefit of rich countries, and therefore for that reason alone do not quality as examples of ethics dumping.

The fifth case in the book is about a phase I/II Ebola vaccine trial in an African country in early 2015. It was a Randomized Controlled Trial, with the active vaccine against placebo, recruiting both adults and children. The public protested and the trial was suspended. The authors of the case description argue the following:

• Members of the national ethics committee that approved the trial were not really independent of the government but would be expected to do what the Minister of the Public Health decreed.
• No justification was provided for inclusion of children in the study
• The informed consent process was deficient both in terms of the process and the content of the forms. This is the main part of the criticism of the trial

In addition, there is a description of a separate phase I trial that was carried out in Nova Scotia in Canada of a Canadian vaccine candidate. In contrast with the African trial that was suspended, the Canadian trial recruited lots of volunteers. The authors explain this as a difference in level of trust between researchers and potential trial subjects in the two countries.

Again, it may very well be that there was a lack of trust in the African country, and that the local ethics review was insufficient. But that does not make this an example of ethics dumping. It was carried out for the benefit of people in countries at risk for Ebola epidemics. In fact, it is an example of reverse dumping: Canadians being willing to take risk for the sake of developing a vaccine that is not going to be useful for them.

The sixth case is a trial testing a hepatitis B vaccine in Russia. The protocol was submitted to a local research ethics review committee. The vaccine was already approved in other countries and was marketed and available there. The trial in Russia would compare the “new” vaccine against one that was already available in the Russian market. The trial was labeled as a phase I/II study. It was claimed that the trial provided benefit to the participants because they would be protected against hepatitis B. The ethics review committee found among other things that there is no benefit to the participants since an approved hepatitis B vaccine is already available, and the participation in the trial involves a lot of inconvenience for the participants, and possible risks, especially for women who might get pregnant. The trial was therefore not approved by the committee.

One important fact is left out in this description, and that is the regulatory requirement in Russia that any drug or vaccine that is to be marketed in Russia needs to be tested out first on Russians. This was probably the most likely reason for carrying out a trial of a vaccine that was already known to be effective and approved in many other countries. Therefore, this case is also not a case of ethics dumping, done primarily for the benefit of sponsors. The problem is the irrationality of the Russian requirement, which it shares with some other countries, of having to do trials on their own subjects in order for products to be approved in the country.

The seventh case is a description of the general problem of recruitment of healthy volunteers for clinical research in low income settings. The point is made that one should be particularly careful to avoid exploitation so that participants are not recruited to high risk trials against their better judgment. This, of course, is a general and important issue, but again is not really an example of ethics dumping in itself.

The eighth case is an old case from China (1990s) that has already been well described in the literature. It is a complex case, and it is impossible to do justice to it here. The same holds for the second case in the book about the San research.

The next three cases take up important ethical challenges in various types of research, but they do not provide any clear cases of ethics dumping. They simply point out that in these areas it is possible to cause harm to local communities. The ninth case takes up the issue of use on non-human primates in research. The tenth case is about trials of transgenic fruit. The eleventh case concerns the use of mobile data collection methods. The twelfth case is about CRISPR research.

The thirteenth case is about an attempt to get retrospective approval for a research project in Liberia for an anthropological study of the psychosocial and economic consequences of survivors of Ebola disease. The study was carried out before ethics approval but the protocol was sent to the local ethics committee for approval after the data had been gathered. The ethics committee naturally rejected the application. Clearly this was unacceptable behavior by the (foreign) researcher, but it is not clear that it is a case of ethics dumping.

The fourteenth, and final case is the research injury case from China that I have already analyzed in a previous blog.

In conclusion, then, at most two of the fourteen cases presented in the book are examples of ethics dumping. This does not mean that the twelve other cases describe acceptable ethical practices. Of course it is not acceptable to seek retrospective approval for human subjects research. Or use informed consent forms that do not contain appropriate descriptions of the risk and the benefits of the research. Or provide high payments in order to recruit subjects to high risk research with no benefit to them. But these are wrongs no matter where the research occurs. The term ethics dumping was presumably introduced to identify an additional wrong: causing local harm or doing something unacceptable locally, in order to benefit us. The problem with the book is that it has not provided us with many examples of that practice. And at least some of the cases that are described do not identify any problematic practice at all, in spite of what is claimed about these cases (in particular the cervical cancer case, the research injury case described at length earlier, and some of the cases described here: The Nairobi sex worker case, and perhaps also the hepatitis B vaccine case from Russia).