Some commentators question the ethics of performing clinical studies or basic research in developing countries. Is it ethical to conduct or benefit from research in another country if the studies would be unlawful, or generally regarded as unethical, in their own country? Is it ethical to perform studies abroad to take advantage of a more favourable regulatory system and use the results at home? In a policy paper in PLoS Medicine Loane Skene, Professor of Law at the University of Melbourne, Australia, examines these vexed issues. While the comments are based on Australian law, the analysis offers a framework to consider these issues in other countries.
Skene notes that scientists undertake research abroad for numerous reasons including gaining “access to more diverse research facilities and participants in research." They may also “acquire kudos, academic advancement, or commercial benefits from an enhanced international reputation." In some cases, they undertake activities abroad that would not be permitted at home due to legal or ethical constraints. Skene cites the example of an Australian researcher who wants to obtain and study stem cells from a human embryo created by somatic cell nuclear transfer. “In Australia, it is unlawful to create an embryo by SCNT and derive stem cells from it, but in the UK, those practices are lawful,” she writes.
Skene points out that in most cases, it’s lawful in their home country to undertake such activities overseas. So an Australian scientist working on SCNT in the UK won’t face prosecution down under. “It is rare for countries to have laws directly preventing their nationals doing research overseas that would not be permitted at home, or even bringing back the products of such research, unless they pose a safety risk, such as importing genetically manipulated organisms created overseas," she says.
An ethical barometer
But even if it is legal, is it ethical? Skene devised a barometer (based on Australian law) that gauges whether it would be ethical to do research abroad that is banned at home. The barometer has through five zones. Research in the red zone (such as developing chemical weapons, paedophilia and female genital mutilation) is prohibited under national and extra-territorial laws, may be unethical and should be banned, says Skene. "If scientists in the home country seem inclined to do ‘red zone’ research in other countries, the home country can enact extraterritorial laws to prevent them doing so,” she says
At the other extreme, the white zone, research such as observing people in a public place, linking information from public records and research on stored human tissue is permitted without any specific laws or oversight.
Many pharma activities fall between the two extremes. Skene places medical research involving competent adults, children and vulnerable populations in the green zone (one up from white). Skene also places research on victims of capital punishment or torture in this zone. These studies are permitted with ethical oversight. Medical research involving animals falls in the middle yellow zone: permitted with national laws and ethical oversight. Creating SCNT embryos, paying volunteers for medical research, producing human animal hybrids and destructive animal research using endangered species fall in the orange zone: prohibited under national (Australian) law.
Whether the results can be used at home depends on the ethical and legal status. In the white, green and yellow zone, Skene notes “there is no legislation preventing the use of research results from trials in developing countries, even if they fall short of Australian requirements”. For example, capital punishment is not allowed in Australia. However, Australia is “unlikely” to enact legislation preventing the use of results from research on victims of capital punishment.
This may not the case in the orange zone for issues such as reproductive cloning or causing animals severe suffering, particularly for cosmetic rather than scientific purposes. “Even if these types of research were allowed in another country and arguments could be advanced to support them, Australians might reject a relativist approach and not allow the results to be used in Australia (though if there were a real benefit from the research, the initial repugnance might be overcome, which involves different moral issues),” she writers. “If activities were widely regarded as morally or ethically wrong, then no requirement of scientific rigour or ethical oversight in the other country would make them acceptable in Australia.”