South Africa’s Northern Cape is one of the most ethnographically unique locations on Earth. It is home to the San people, a nomadic hunter-gatherer group that carries some of the oldest human DNA. While their unique genetic make-up could reveal much about human development, it has also made them a target for scrutiny by curious scientists and opened them up to exploitation.
Research organisations have conducted investigations on the San people without respect for their heritage or culture. “Our knowledge has been taken by clever people who come and tempt us with 10 rand or five rand,” San elder Petrus Vaalbooi explained in an interview with the TRUST project. This exploitation is part of a practice known as ‘ethics dumping’.
Until now, the San had no way to protect themselves from such mistreatment. But TRUST, a collaborative effort between the EU and the San people, has seen the development of a code of ethical guidelines that will work to eliminate exploitative practices in research across the globe.
The term ‘ethics dumping’ was coined in 2013 by the European Commission (EC) to describe the act of doing research deemed unethical in a scientist’s home country in a foreign setting with more lax regulations. The concept is part of a wider story of unethical domestic research practices that were documented in the mid-20th century, such as Nazi physicians’ experimentation on minority groups, or the infamous Tuskegee trials, which saw 600 African American sharecroppers enrolled in a 40-year trial to observe the impact of syphilis if left untreated. None of the participants were informed that they had the disease, or offered treatment. By the time the trial came to an end in 1972, 128 of the original participants had died from syphilis or related complications.
Due to the nature of political and legislative progress across developed and emerging economies, ethical guidelines have not been adopted in a uniform manner worldwide
“Within Germany and the US, extremely vulnerable populations that couldn’t defend themselves were exploited for research,” explained Professor Doris Schroeder, Director for the Centre of Professional Ethics at the University of Central Lancashire. “These horrendous experiments were possible because of a divided domestic society and extreme racism.” What took place during the Second World War and at Tuskegee emphasised the dire need for ethical regulation of research trials, which was gradually implemented at a national level over the course of the 20th century.
Due to the nature of political and legislative progress across developed and emerging economies, however, ethical guidelines have not been adopted in a uniform manner worldwide. This has paved the way for ethics dumping as we know it today. “Ethics dumping requires strong ethics legislation and compliance mechanisms in one setting (high income) and the lack [thereof] in another setting (low or middle income),” explained Schroeder. “This legislative and compliance gap is then used to undertake research abroad that would be prohibited or severely restricted at home.” As such, ethics dumping should not be conflated with unethical domestic research practices, but understood as the act of travelling abroad to evade ethical guidelines.
Destination for exploitation
Over the past 50 or so years, many prominent pharmaceutical companies and prestigious research organisations have been known to engage in ethics dumping, particularly as part of clinical trials. One recent example involved three cervical cancer screening trials that took place in India between 1995 and 2015 in Mumbai, Osmanabad and Dindigul. The trials, which were partly funded by the US National Cancer Institute and the Bill and Melinda Gates Foundation, aimed to determine whether trained healthcare workers could conduct screenings using inexpensive materials, which would help reduce incidences of cervical cancer in poorer communities.
The Tuskegee trials in numbers
Participants died from syphilis or related complications
According to a study by Sandhya Srinivasan, Veena Johari and Amar Jesani, the trials were conducted on 374,000 women, 141,000 of whom were placed in a control group and given no screening, risking the disease going undetected if it developed. In that group, 254 women died from cervical cancer. Had this research taken place in the US, a control group with no access to the screening would not have been allowed, as it would have been classed as an ethical violation. However, because the trials took place abroad, where regulations are more lax, US funders were able to bypass the usual protections.
India in particular has become something of a hotspot for ethics dumping. Denny John, an evidence synthesis specialist at the Delhi-based Campbell Collaboration, explained: “A clinical trial comes at a huge cost, so bringing that down is a key consideration for a lot of research organisations.” By relocating to countries such as India, where costs are lower, companies can cut their overheads. John added: “India also has a large and varied population, so that’s also part of the reason why trials are being conducted in this part of the world.” The country became an even more attractive environment for medical research in 2005, when ethics laws were relaxed in a bid to strengthen India’s position as a key player on the global pharmaceutical stage.
However, the development of this advantageous environment for trials has inadvertently opened Indian people up to exploitation by unscrupulous researchers. In 2012, a BBC investigation found that US pharmaceutical firm Biogen Idec had enrolled people from the lowest caste of Indian society into trials for a heart-failure-prevention drug without seeking their consent. The women interviewed were from the Dalit caste, a group that has been ostracised, impoverished and poorly educated in Indian society, meaning they were unable to read the documents given to them or fully understand the process they were entering into. According to the BBC, one of the women, Chandrakala Bai, suffered heart abnormalities as a result of taking the trial drug; she died of a heart attack less than a month after being taken off the medication.
Biogen Idec is not the only organisation to have been accused of exploiting Indian people in this way: AstraZeneca, GlaxoSmithKline, Johns Hopkins and Sanofi have all been implicated in Indian trials where consent was not sought from participants. John explained that much of the issue lies in a lack of local regulatory oversight. “India’s [national] ethics committee cannot actually monitor on the ground, and that is where it is needed,” he said. In terms of corporations, “the funding for studies is done by [large pharmaceutical companies], but the recruitment is done by local hospitals”, meaning there can be a mismatch between the protocols set and the actual trial carried out. This can also result in the exploitation of those from lower socioeconomic classes, as was discovered by the BBC’s investigation.
Ethics dumping of this nature flouts basic rules of consent, both within the field of medical research and as a human right. The inequitable power dynamic between research organisations and unwitting test subjects also makes it very difficult for the latter to claim any kind of recourse if they do suffer ill effects as a result of a trial. Many of those implicated in unethical Indian clinical research are not in the position to instruct lawyers given their lack of social mobility and low-income economic background. “In India, there’s no structured patient groups to fight for compensation,” added John, which means almost all avenues for recourse are also closed off. In this sense, trialling drugs on these people carries little risk of repercussions for large companies, the majority of which have an arsenal of lawyers and funds at their disposal to fend off legal challenges.
While national regulations aren’t able to prevent companies from conducting trials in India and other low-income societies, there are international regulations designed to do just that. The first of these, the Nuremberg Code, was drawn up during the eponymous trials in 1945 to prevent a repeat of the atrocities committed by Nazi physicians. The document sets out initial principles of “absolutely essential” voluntary consent, the need to “avoid all unnecessary physical and mental suffering and injury” and only undertake experiments that “yield fruitful results for the good of society”. However, many saw the code as a largely needless endeavour. Physician and Yale Law School professor Jay Katz notably called it “a good code for barbarians but an unnecessary code for ordinary physicians”.
The code’s successor, the Declaration of Helsinki, was more widely adopted when it was published by the World Medical Association in 1964. Its principles have since been codified into international documentation, such as the UN International Covenant on Civil and Political Rights and the World Health Organisation’s research ethics guidelines. Yet, these are not legally binding instruments under international law.
“I do believe that a legal instrument such as a code of conduct tailored to the problem of ethics dumping can reduce the practice significantly and hopefully eradicate it in the future,” Schroeder told The New Economy. “However, a code needs strong support, and this support is best given by the funder of research.” With this in mind, Schroeder worked alongside other renowned academics, lawyers and research experts on the TRUST task force to “catalyse a global collaborative effort to improve adherence to high ethical standards around the world”. The group developed a value framework, from which two codes of conduct were drawn up. One code “was adopted by the EC as a mandatory reference document for framework programmes and covers all research in resource-poor settings”, explained Schroeder.
This decision is particularly powerful given that the EC manages Horizon 2020, an €80bn ($90bn) programme that any EU-based scientist can apply to for financial assistance in conducting research. By making funding contingent on ethical practices from the outset, the EC is sending a powerful message that it will do everything in its power to ensure ethics dumping doesn’t take place under its jurisdiction. “It is much better if funders are proactive, not reactive,” Schroeder added.
It is worth noting that the practice is not always predicated on a conscious decision to exploit a group of people, but rather can be borne out of a lack of cultural understanding. “Because of ignorance, [ethics dumping] flourishes in an environment where researcher mobility is put above all else and the home culture is taken abroad without asking self-reflective questions,” explained Schroeder. In the best case, this ignorance leads to wasted resources as methods developed by researchers in high-income settings are proved to be unsuitable for local needs. “At the maximum harm end, lives can be lost, as in [the cervical cancer study in India],” Schroeder said.
To go about solving this, TRUST has developed a second code, in partnership with the San people, that researchers must adhere to when undertaking projects in the region. The code states that studies must respect the San’s values and way of life. Codes like these ensure local communities retain their autonomy, and research becomes an equitable, not exploitative, exchange.
Under the microscope
While the action taken by the TRUST project is certainly a step in the right direction, there is more to be done to eliminate ethics dumping, particularly at a corporate level. This is more difficult than targeting individual researchers or learning organisations, as businesses are often less reliant on external funding to conduct trials. As such, a two-pronged approach is needed; legally binding, international ethical regulations must combine with court challenges for past transgressions.
The inequitable power dynamic between research organisations and unwitting test subjects makes it very difficult for the latter to claim any kind of recourse
In January this year, for example, a US district judge said that Johns Hopkins, Bristol-Myers Squibb and the Rockefeller Foundation should face a $1bn lawsuit over their role in a US Government experiment in the 1940s that infected hundreds of Guatemalans with syphilis. The plaintiffs’ incredulous lawyer said: “This experiment began 72 years ago. It’s hard to believe.” But while the three companies may have put it to the backs of their minds, the 444 Guatemalan victims and their relatives certainly haven’t. The case will ensure they receive the recognition they deserve. After all, justice has no expiry date.
Processes must also be put in place to ensure research participants are fully cognisant of the possible side effects during trials and are appropriately compensated if they do suffer any ill effects. Given the substantial financial gap between patients and large corporations, it’s vital that organisations are set up to allow individuals to seek compensation through collective legal action. This will go some way in closing the substantial power gap
between the two parties.
Delivering financial recompense for past cases and making it impossible to gain funding for exploitative future research will go some way towards eliminating ethics dumping on a systematic level. Sadly, chances are there will still be individuals that engage in dubious ethical practices, such as scientist He Jiankui, who modified the DNA of unborn twin girls late last year. However, if such practices are denounced at an intergovernmental and corporate level, as well as within the international research community, those cases will become fewer and farther between.
Although not all cases of ethics dumping are born from a choice to mistreat members of another culture, the practice, whether consciously or not, legitimises the belief that some people are candidates for exploitation. It implicitly categorises those from lower-income societies as pawns in the race for progress, less important than scientific and economic goals. This discriminatory belief has no place in our modern, globalised society, and only serves to discredit vital work undertaken by the research community.