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Wed, 27 Mar 2002 19:36:37 EST

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A question to the group concerning a troubling flap we are currently having 
over an already published paper--our paper, a typical Class2-3 review of an 
experience with a group of patients  over an 8 year period, was never 
subjected to IRB approval.  We have not been in the habit of doing so, and it 
is clear to me that few if any others do this.  This goes beyond the usual 
IRB oversight of human experimentation, which goes without saying--but 
reviews of charts and databases?  The IRB's position is that this has been 
their requirement for years--how many they cannot say (so then--how am I 
supposed to say?), and tho there is no "experiemntation" here, this covers 
the issue of assuring patient confidentiality in the review and publication 
process.  They claim ANY research -oriented activity destined for 
dissemination beyond one's own institution must be approved by the IRB before 
it is begun. They claim this even covers case reports even without any 
identification whatever of the patient! I know of no journal that has ever 
required this as a condition of publication of retrospective studies or case 
reports, as they certainly do for the usual studies involving some 
intervention on human or animal subjects--does anyone else know of such a 
journal requirement?  If the peer-review process of professional journals do 
not require this, what does this say about such a policy on the part of the 
IRB?  How many who have submitted this class of retrospective study abstract 
to, say, the AAST this year first obtained IRB approval?
I must say, I have some conceptual difficulty with this, and wonder where 
this bureaucracy will stop--are classified ads next? Editorials?  Review 
articles? After all, they too deal with human subjects, no?
ERF

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<HTML>A question to the group concerning a troubling flap we are currently having over an already published paper--our paper, a typical Class2-3 review of an experience with a group of patients&nbsp; over an 8 year period, was never subjected to IRB approval.&nbsp; We have not been in the habit of doing so, and it is clear to me that few if any others do this.&nbsp; This goes beyond the usual IRB oversight of human experimentation, which goes without saying--but reviews of charts and databases?&nbsp; The IRB's position is that this has been their requirement for years--how many they cannot say (so then--how am I supposed to say?), and tho there is no "experiemntation" here, this covers the issue of assuring patient confidentiality in the review and publication process.&nbsp; They claim ANY research -oriented activity destined for dissemination beyond one's own institution must be approved by the IRB before it is begun. They claim this even covers case reports even without any identification whatever of the patient! I know of no journal that has ever required this as a condition of publication of retrospective studies or case reports, as they certainly do for the usual studies involving some intervention on human or animal subjects--does anyone else know of such a journal requirement?&nbsp; If the peer-review process of professional journals do not require this, what does this say about such a policy on the part of the IRB?&nbsp; How many who have submitted this class of retrospective study abstract to, say, the AAST this year first obtained IRB approval? 
I must say, I have some conceptual difficulty with this, and wonder where this bureaucracy will stop--are classified ads next? Editorials?&nbsp; Review articles? After all, they too deal with human subjects, no? 
ERF</HTML>

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