Exception to informed consent question

[voicesinmyhead]

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A 49-‐year-‐old trauma patient comes into the ER unconscious and in need of surgery. There is a research study being conducted at this institution on a new orthopedic device which can be used easily on this patient. The old orthopedic reduction methods exists too.

(patient is unconscious with no bystanders)

Does this count as an exception to informed consent?

 

[theshellyb]

A 49-‐year-‐old trauma patient comes into the ER unconscious and in need of surgery. There is a research study being conducted at this institution on a new orthopedic device which can be used easily on this patient. The old orthopedic reduction methods exists too.

(patient is unconscious with no bystanders)

Does this count as an exception to informed consent?

Consent is implied in emergency situations but I doubt you can say that consent beyond the currently accepted standard of care would be implied. If you're asking whether you can enroll him in the study, the answer is no.

Additionally, I think that the inability to have the patient sign an informed consent form would preclude him from the study per the IRB.

On a related note though, say you have a trauma patient come in and they have a messed up leg that has a few options for how to repair it, and something traumatic like a pneumothorax that has to be dealt with right now. Is consent implied for both surgeries, or only the life-threatening one? Would you go in and fix the pneumothorax, wait until the patient wakes up, and then ask how they'd like their leg fixed, or would you just go ahead and do both at once?

 

[thawunandonly]

Consent is implied in emergency situations but I doubt you can say that consent beyond the currently accepted standard of care would be implied. If you're asking whether you can enroll him in the study, the answer is no.

Additionally, I think that the inability to have the patient sign an informed consent form would preclude him from the study per the IRB.

On a related note though, say you have a trauma patient come in and they have a messed up leg that has a few options for how to repair it, and something traumatic like a pneumothorax that has to be dealt with right now. Is consent implied for both surgeries, or only the life-threatening one? Would you go in and fix the pneumothorax, wait until the patient wakes up, and then ask how they'd like their leg fixed, or would you just go ahead and do both at once?

Correct me if I'm wrong, but the pneumothorax or the emergency has to be dealt with. Anything else can wait. Right?

 

[theshellyb]

Correct me if I'm wrong, but the pneumothorax or the emergency has to be dealt with. Anything else can wait. Right?

But then you have the issue of, well, will there be a worse outcome if you wait? And how much worse? And it it "worse enough" to waive informed consent?

 

[voicesinmyhead]

say you have a trauma patient come in and they have a messed up leg that has a few options for how to repair it, and something traumatic like a pneumothorax that has to be dealt with right now. Is consent implied for both surgeries, or only the life-threatening one? Would you go in and fix the pneumothorax, wait until the patient wakes up, and then ask how they'd like their leg fixed, or would you just go ahead and do both at once?

Awesome question, this!

Hope there was a widely accepted answer though.

 

[CDI]

On a related note though, say you have a trauma patient come in and they have a messed up leg that has a few options for how to repair it, and something traumatic like a pneumothorax that has to be dealt with right now. Is consent implied for both surgeries, or only the life-threatening one? Would you go in and fix the pneumothorax, wait until the patient wakes up, and then ask how they'd like their leg fixed, or would you just go ahead and do both at once?

Life-threatening injuries get the fix. The leg is based on the specifics of the case (open wound/life threatening), can't apply a broad filter = wont be asked.

 

[ijn]

Consent is implied in emergency situations but I doubt you can say that consent beyond the currently accepted standard of care would be implied. If you're asking whether you can enroll him in the study, the answer is no.

You're correct in this case, but there is a concept out there called community consent. You especially see it practiced in big county hospitals that are part of stroke trials. Once obtained from the populace it allows you to begin treatment beyond the current accepted standard of care with experimental methods. Anyone who shows up the the county hospital door is automatically enrolled within the trial.

 

[webgenius]

I have a question;

What are the information that I can tell the husband of a pregnant women without her consent or her approval?

For example she requested a C/S, can I tell the husband that directly or do I have to ask her if I'm allowed to tell him?

 

[voicesinmyhead]

i think you need to get the approval of the wife for everything related to the unborn baby