Abandoning research participants is an unconscionable betrayal

In 1964, the Declaration of Helsinki created a set of universal ethical principles to protect human participants in health research.1 Described as “the cornerstone of research ethics,”2 these principles establish an overarching duty to safeguard the safety, dignity, and rights of people involved in medical research. In the United States this was followed, in 1979, by the Belmont Report, sub-titled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research.”3 It set out three principles: respect for persons, and especially those with diminished autonomy; beneficence, maximising benefits and minimising harms; and justice, avoiding research conducted on groups who will not ultimately benefit from it. For poorer or otherwise vulnerable populations that have been historically mistreated, such protections are all the more critical.4 No research can be conducted ethically that lacks an absolute commitment to the wellbeing of participants.5

Sixty-one years later, the sudden cessation of multiple trials across the world threatens all of these duties at the foundation of research ethics. Specifically, by signing an executive order to freeze all foreign aid provided by the United States for at least 90 days, Trump effectively and instantaneously halted numerous USAID funded research studies already in progress.6 A recent article in the New York Times sets out the human consequences of interrupting these studies.7 In South Africa, women who had vaginal rings implanted to prevent pregnancy and HIV infection were summoned to have them removed immediately. Those unable to attend risked being left with implanted devices but no monitoring. In England, volunteers in a malaria vaccine study also lost access to medical oversight and were thus placed at risk of unmonitored adverse reactions.8 Participants in the CATALYST trial, which is evaluating an innovative package of Pre-exposure prophylaxis (PrEP) of HIV,9 were left without treatment and thus at risk of developing drug-resistant strains of the virus. In Uganda, children in a trial of a new tuberculosis treatment were left without access to potentially lifesaving medication.

In these ways, Trump has placed many thousands of people across the world at risk of some of the most profound violations of their fundamental rights as research participants. And in doing so, he has thrown down a challenge to the global research community, given that the executive order is incompatible with Article 10 of the Declaration of Helsinki: “No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research participants set forth in this Declaration”.5 How can or should we respond to what is, unequivocally, a gross breach of the most fundamental ethical principles?

Firstly, researchers involved in these studies must immediately seek guidance from the research ethics committees that approved them.

Secondly, scientific and professional bodies everywhere should state publicly that the safety and wellbeing of research participants be prioritised and that they will stand by all health professionals who are doing whatever they can to protect the study participants within their care, even at risk of their personal safety and livelihoods.10

Thirdly, we must not fall into the trap that this behaviour can be countered by rational argument. Commentators invest enormous effort in trying to interpret Trump’s vague and capricious words and to decide whether he means what he says, knowing he can change his mind within hours.11 It is futile pointing out that the attack on American science will damage the prosperity or reputation of the United States. There is not a scintilla of evidence that Trump or Elon Musk, his effective co-president, care. Nor is it useful to appeal to their humanity, given that their entire approach is characterised by performative cruelty.12 Rather, one should look to the literature on denialism for ideas about how to respond, focusing on the motivations and tactics of one’s opponents rather than the content of their arguments.13

Fourth, at least for now the United States is a country under the rule of law. Many of Trump’s executive orders are illegal or even, as with his order to remove citizenship of those born in the United States, unconstitutional.14 While Trump’s use of “shock and awe” has, at least initially, dazed and disoriented the academic community, there is a growing number of successful legal challenges.15 It is already becoming clear that Attorneys General in Democrat-run states are creating a nucleus of opposition.16 Of course, questions remain as to whether these court orders will be obeyed.17

Fifth, universities, learned societies, and similar organisations must avoid anticipative compliance. There have already been some shameful examples of self-censorship, including writing women and people of colour out of their history.18 Equally, those who are violating these ethical norms should have no place in the scientific community. Why has the UK’s Royal Society not rescinded Elon Musk’s honorary fellowship?19

Finally, the international scientific community must speak with one voice. We must say, loudly and consistently, that what is happening is entirely unacceptable. Our ethical obligations do not vary according to the whims of politicians. We must forcefully take a stand against these profound violations of our most essential duties to participants in health research. When ethical lines are crossed and people’s lives are at risk, we must not remain silent.