We are doing a study on hepatic encephalopathy. Some people of course may or may not be able to consent. Our director wants us to blanket surrogate consent everyone. Participants will sign an assent but they want to have a surrogate with full mental capacity making the legal decision to protect themselves from liability. Is it legal to obtain surrogate consent from everyone instead of evaluate to see who is capable of consenting for themselves? I'm in MA.
When is surrogate consent OK?
- Thread starter vivacious
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Your institutional IRB should offer some guidance. Yes, you can have surrogate consent, however there are special protections for patients without mental capacity for consent. For children, it is typically parental consent with child assent, for incapacitated patients, it is surrogate consent with patient consent upon improvement in mental status. I don't know how this would be classified since the patients may not recover from the encephalopathy and lack the capacity for consent. I would ask the IRB specifically since they will be the ones who have to approve it.
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