Can doctors administer an experimental treatment without patient consent in an emergency?

Question

Is it legal for doctors to administer an experimental treatment or drug to a patient in an emergency situation where the patient is unable to provide consent?

To provide an example scenario: An unconscious patient is brought into emergency and will die without immediate treatment. For some reason - an allergy, a pre-existing condition, the hospital being short on supplies - conventional drugs or treatments aren't an option but experimental ones are. The patient, however, is unconscious so they can't provide consent for the treatment and have nobody that can consent for them. Doctors have an obligation to help but also to not harm, so what happens in a situation like this?

Answer 1

united-states

Yes. This is specifically covered by 21 CFR 50.24. It is not ad-hoc but the study has to be approved by an IRB, it has to be a life-threatening situation, consent cannot be reasonably obtained before intervention, appropriate animal studies and similar have been carried out so that it is believed the treatment is beneficial, etc.

A key element is public disclosure. For example, notices for a study conducted for cardiac arrest treatment at a certain hospital's emergency room could be published in newspapers. There could be an opt-out mechanism, for example, by the patient carrying a form on them.

Similar mechanisms exist in other countries.

Answer 2

germany

In Germany everybody — even third parties entirely unrelated to the events or their protagonists — is obliged to help people in danger or in an emergency per §323c StGB, as long as it is not an unreasonable burden, in particular does not substantially endanger the helper, and as long as it does not conflict with other important duties. (This idea is quite foreign to common law systems where such an obligation mostly arises for people with some circumstantial or personal relation to the events.)

In Germany, this principle applies to the the doctor-patient relationship: A doctor generally has an obligation to treat any and all patients in emergencies.

I must assume that the concrete application depends on the concrete case, especially the cost/benefit calculation a qualified observer would make regarding the experimental treatment, especially compared to possible more conservative treatments. But, if we want to construct an extreme situation:

• Death is imminent and virtually ensured without treatment
• No established treatment is available
• But an experimental treatment is available
• While that treatment is still officially experimental and could normally not legally be administered outside clinical trials, it has shown great promise and on the verge of being approved.

In such a situation I would even construct an obligation to treat for a doctor. It's as if you have a rope you could throw to a drowning swimmer but you refuse to because it's just a clothesline and might break, so you stand back and do nothing instead. That seems utterly wrong.