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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.

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I'm confused. The wording of the headline suggests that USAID is not conducting trials in-house, they are giving grants to other organizations that conduct trials. If that's the case, the only way this makes sense is if the researchers went ahead and started treating patients before the government's check hit their bank accounts - that the researchers started the experiment without having enough money already in their own bank accounts to safely wrap up their work with their already enrolled subjects. That can't be ethical, can it? For precisely this reason? Shouldn't the headline be grossly unethical conduct by government-funded researchers?

I'm assuming the grants are paid in installments. If a research organization has a contract with the government that says they will be paid a total of $X in Y installments over Z years, it seems completely normal that they would start the trial after receiving the first installment (indeed, it seems likely that the timeline in their grant proposal to USAID would have promised that they would do this).

That seems reasonable up to a certain point. It seems reasonable for long-term grants to be paid out on some schedule and for a researcher to arrange a study such that a loss of funding would force them to wrap up early and without the data they were hoping for. But I think a researcher should still have an obligation to have enough money in their own bank account that, if funding gets cut, they can wrap up the study in a way that is safe for the subjects - they should have enough cash to ween the subjects off drugs or remove devices early or whatever else is involved in wrapping up. Funding getting cut is a risk that I would think would be fairly obvious when planning a study - especially if your source of funding is a government agency in a country that you know will have an election before the study concludes.

There is a word that educated liberals need to learn or relearn: evil.

Flagrant disregard for human life is evil.

The cruelty is heartbreaking.

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