It’s also dangerous to the health of thousands of trial participants

The path from the atrocities of Nuremberg and Tuskegee to today’s robust ethics of medical research has not been easy.

In response to these horrific events, a remarkable global consensus emerged, across countries in very different parts of the world and with very different types of governments: Medical researchers, and the institutions and companies who fund their work, are bound by a series of ethical obligations. These obligations are designed to protect and respect the interests of people who participate in their research. They include minimizing foreseeable harms to participants and keeping the promises that researchers make to study volunteers.  

While the fate of USAID remains murky, one thing absolutely is clear. The abrupt termination of critical USAID-funded clinical trials, with insufficient time to safeguard the welfare of people who are participating, is profoundly unethical and utterly inexcusable. Such actions threaten the health and lives of thousands of patients.

The stop-work orders affect research designed to answer important questions about HIV or TB treatments, where immediate withdrawal of drugs not only takes away what may be lifesaving treatments but also risks exacerbating or creating drug-resistant strains, leaving participants potentially worse off than if they had never joined the study and creating additional, unacceptable risks for others in the community.

The “pause” has also ensnared studies of experimental devices that, in accordance with scientific and ethics principles, require regular monitoring of participant well-being and opportunities to remove the device at an appropriate time. Telling a medical researcher they must abruptly abandon study participants is akin to telling a surgeon they cannot treat a patient who has a post-operative infection that resulted from a surgery they performed the week before. All medical ethics codes forbid this. And for obvious reason.