Re: IRB - Emergency Room Rx Research Scott Smith 24 Mar 1995 12:05 EST

My apologies for the delay in responding to this request.  The University of
Oklahoma Health Sciences Center Institutional Review Board has dealt with a
similar (or perhaps the same) study.  This began in early 1993, with a protocol
which involved "deferred" consent by the patient/family in head-trauma E.R.
cases.  Our IRB reviewed the protocol and after much deliberation with the
investigators would *not* approve the deferred consent.  They *did* approve
"witnessed telephone consent" by next-of-kin/family member with the stipulation
that as soon as that family member was present s/he would sign the consent form.

Sometime later, the investigators requested that the Board reconsider their
decision because of the low enrollment.  The Board did reconsider but maintained
their original dicision.

Since then, the file indicates the company has modified the protocol to disallow
deferred consent at *all sites*; this, I believe, was due to the attention this
type of activity was receiving nationally (possibly even involving some
congressional hearings.

If you would like more information, please feel free to contact me (e-mail and
phone below) or our IRB cooridnator (


* Scott R. Smith                   *  Office of Research Administration *
* Sponsored Programs Administrator *  University of Oklahoma            *
* Phone:  405/271-2090             *       Health Sciences Center       *
* Fax:  405/271-8651               *  P. O. Box 26901                   *
* E-mail:        *  Oklahoma City, OK  73190          *

______________________________ Reply Separator _________________________________
Subject: IRB - Emergency Room Rx Research
Author:  Research Administration Discussion Group
<RESADM-L%xxxxxx@UACSC2.ALBANY.EDU> at cclink
Date:    3/21/95 5:44 PM

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.