Guest post: Ethically, morally and legally monstrous

Originally a comment by Claire on For observation.

This is horrifying. Ethically, morally and legally monstrous.

Concern is mounting after a doctor at a Texas nursing home started giving the anti-malarial drug hydroxychloroquine to dozens of elderly patients diagnosed with COVID-19 and tracking the outcomes in what he’s calling an “observational study.”

This is not how observational studies work. Any clinical trial, including observational studies, must have a clearly written protocol approved by the relevant IRB. Patient recruitment is done using an IRB-approved consent form. Fully informed consent is legally required. If a patient is unable to consent, they must have a legal proxy to consent for them. Patients or their proxies must be assured that they do not have to consent and that their standard of care will not be adversely affected by that refusal.

Not to do this is a crime, even with competent adults. With what the USG calls a “vulnerable population”, the standards are even stricter in terms of how you consent and treat patients.

I run several clinical studies and I can bore you for hours about trying to construct protocols that satisfy the IRB that the research is ethical, appropriate and safe. This report makes me so angry. He thought he could blow off the reporters by claiming he is running a research study. He is not. In some jurisdictions, this could be considered assault.

In some cases, he did not discuss prescribing the tablets with anyone at all before doing so. He said it is common for physicians to prescribe new medications to patients without explicit consent from the patient or family members. “It’s not required,” he said.

This is a flat out lie. Doctors have the latitude to administer drugs or treatments unconsented only in the case of an emergency when the time needed to obtain consent would endanger the patient. Otherwise, patients have the right to refuse treatment, even when that refusal may result in death or disability. The only thing doctors can do in that situation is advise and ensure the patient fully understands the potential outcomes of all the choices before them.

This is why cancer patients can decide not to continue radio- or chemotherapy. It’s how relatives of a person in a coma from which they are unlikely to recover can decide to withdraw the life support.

Whether or not he is prosecuted (or pardoned), the relatives can sue the ass off the company running the nursing home.

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