Ethics dumping — doing research deemed unethical in a scientist’s home country in a foreign setting with laxer ethical rules — will be rooted out in research funded by the European Union, officials announced last week.
Applications to the EU’s €80-billion (US$93-billion) Horizon 2020 research fund will face fresh levels of scrutiny to make sure that research practices deemed unethical in Europe are not exported to other parts of the world. Wolfgang Burtscher, the European Commission’s deputy director-general for research, made the announcement at the European Parliament in Brussels on 29 June.
Burtscher said that a new code of conduct developed to curb ethics dumping will soon be applied to all EU-funded research projects. That means applicants will be referred to the code when they submit their proposals, and ethics committees will use the document when considering grant applications.
Isidoros Karatzas, whose office is in charge of ethics review in the European Commission, calls ethics dumping “a real threat to the quality of science” and compares it to research misconduct. “What is important is that it does not take place, and that our researchers have the knowledge and awareness not to allow it to happen,” he adds.
The rules will apply to all research funded under Horizon 2020, and to all future EU funding programmes. The EU had banned ethics dumping in Horizon 2020 grants since 2013. But no clear guidelines existed to help ethics reviewers and researchers identify potential digressions in grant applications. The code, which was drafted as part of a Horizon 2020-funded project called TRUST, was published in May; the latest announcement gives it teeth.
The code provides clear guidance for doing research in resource-poor settings. Animal research, for example, must not be conducted outside the EU if it would not be allowed in the scientists’ home country. Another provision states that “lower educational standards, illiteracy or language barriers” among research participants can never be an excuse to hide information from them or provide it incompletely. The code also addresses situations that might not arise in Europe-based studies. For instance, sex work is legal in many countries in Europe but not in Kenya. And homosexuality is illegal in many countries worldwide. So studies involving sex workers or gay people, for example, must take measures to ensure the safety of participants.
The ethics-dumping guidelines were produced with representatives from such vulnerable populations. Joyce Adhiambo, a Kenyan former sex worker who promotes sex worker rights in research and in HIV-prevention services, sees the code as a matter of mutual respect. “When [researchers] want something from sex workers, we deal with it respectfully. We ask the same in return,” she said at the Brussels event.
Adhiambo told Nature that researchers must use their privileged position to encourage communities to become actively involved in studies. Members could be hired as research assistants, for example, or to help translate and explain consent forms to participants. “We come from a poor setting but we have a voice. We have a culture and a way of living. We have our traditional knowledge, and when we walk in the path together we are going to make a brighter future for all these research projects.”
Ethics dumping — coined by the European Commission in 2013 — is a contentious term and few researchers admit to the practice. In a book published recently, researchers with the TRUST project cited research carried out on wild-caught monkeys in Africa, and clinical trials in India in which people living in poverty were denied life-saving screening in the control arm, as examples of ethics dumping.
None of those projects was funded by the EU, says Doris Schroeder, a lead investigator on the TRUST project. But in her 15 years chairing ethics review panels for EU funding programmes, Schroeder has seen many applications that would violate the new code. These ranged from researchers wanting to interview workers about their rights in dictatorial states (potentially placing these people at risk) to art installations portraying vulnerable populations without their involvement. Those projects were changed before getting funding approval, Schroeder says. But without a clear code of conduct it’s possible that other ethics committees might have let them through.
Ron Iphofen, an adviser on research ethics to the European Commission, believes the code will have a profound impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers now looking suspiciously at any application for funds that entailed research by wealthy nations on the less wealthy that did not mention the code,” he says.
Opportunities for ethics dumping have grown with the globalization of research, says Philip Brey, a research ethics specialist at the University of Twente in the Netherlands. Increasingly, researchers from high-income countries carry out projects in low- and middle-income ones. But Brey says that the decision to export research is often driven by scientific opportunities or economic realities, rather than a desire to skirt ethics. Moreover, some scientists in poorer countries find the term ‘ethics dumping’ offensive. “They tend to see themselves not as having lower ethical standards, but different ethical standards,” says Brey.
Reinhard Hiller, managing director of the Centre for Proteomic and Genomic Research in Cape Town, South Africa, worries that in some cases developed nations’ ethical standards could stifle research in developing nations. For example, to speed up and improve the quality of their diagnoses, doctors in Africa might want to use WhatsApp to share patient information such as X-rays, says Hiller. Yet this could fall foul of Europe’s strict data privacy rules, for example. “It’s not black or white, but needs to be assessed on a case-by-case basis."