Re: IRB - Emergency Room Rx Research
Len Paplauskas 22 Mar 1995 08:15 EST
Rebecca Clark writes:
>My IRB has been asked to review an emergency room drug study that would
>involve serious head injury patients as subjects. The nature of the injury
>would mean that the patient could not give consent and there may or may not
>be any relative available to consent. I was told that the university medical
>center had obtained a waiver for patient consent and gotten permission for
>the surgeon to give consent for the patient. The study drug is being tested
>to see if it will help prevent secondary injury due to intracranial pressure,
>so the study sounds fine.
>
>What do you do or how would you handle this situation? I have no clear cut
>guidelines for this and can use any input you may have.
Obtained a waiver from whom? Obtained permission from whom?
Len