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?