[Air-L] IRBs

Lois Ann Scheidt lscheidt at indiana.edu
Mon Mar 10 10:09:00 PDT 2008


I have definitely heard researchers say exactly what you have said 
Mark, and I know the following doesn't apply to you directly.  However, 
when I have heard those stories f2f and asked the researcher about 
their discussions with IRB personnel I have almost unanimously heard 
something that amounts to the following "Well I didn't talk to them 
directly."  So I have to admit that the researchers supposition that 
their research was declined (or simply sent back for revisions) was 
made for legal protection issues is very suspect in my book.

In every case when I have talked to IRB personnel at a variety of 
universities in the US, I have heard about the difficulty they are 
having slotting new research media and methods into the existing legal 
definitions, and how frustrated they have become with the legal 
environment IRBs operate within - particularly from Washington.  I 
agree that by definition IRB personnel are conservative administrative 
folks who have to plainly see a comparison to be willing to crawl out 
on a limb with something new...and anything new is by definition out on 
a limb.

On our IRB we have several ex officio members, including a 
representative from legal, and one from out computer technical 
division.  We also have several voting community members who represent 
the local community.

I can tell you from sitting through five years of monthly meetings that 
I have never once seen a study sent back or declined because something 
about it might get the university sued.  I have seen studies sent back 
because something in the protocol made us wonder about possible impact 
to the subjects, which then could have lead to legal action, but the 
potential for legal action was not the reason the study was sent 
back...it was an after thought at best.  I do know that some 
intransigent researchers have been invited to have conversations with 
legal about their returned research, but that is only after they 
refused to work with the IRB to resolve problems with the application.  
But again that does not make the legal issue the primary one, in these 
cases it just makes it the issue that was likely to get the researchers 
attention.

I have also read a variety of professional publications for IRB pros, 
that discussed this issue and how it is often not the actual reason 
behind a study not being accepted in it's initial form...but sadly I 
don't have any of them in front of me and none of them are available 
through the libraries resources.

Mark, I don't doubt for a moment that there are colleges or 
universities out there who have given researchers the "We don't want to 
get sued" response.  The only first hand experience I have is at IU 
(beyond being a Research One institution, IU is the home of the Kinsey 
Institute so we deal with a lot of research that is controversial among 
one subculture or another) and from official publications.  Anything 
else I have is hear-say.

Now as an afterward, I can say that some of my early applications for 
research online with anonymous teens probably came as close to being 
questioned because of legal liability issues as anything I have seen on 
the board.  But of course I do think that is the nature of working with 
protected populations and I don't think that part of the regulations is 
likely to change.  The underlying reasons that these "protections" 
exist are not controlled by the IRBs but rather they are US societal 
issues with our relationship to teens (a dichotomy between protecting 
them from adults, and protecting adults from them).

Lois Ann Scheidt

Doctoral Student - School of Library and Information Science, Indiana
University, Bloomington IN USA

Adjunct Instructor - School of Informatics, IUPUI, Indianapolis IN USA and
IUPUC, Columbus IN USA

Webpage:  http://www.loisscheidt.com
Blog:  http://www.professional-lurker.com


Quoting "Mark D. Johns" <mjohns at luther.edu>:

> Lois Ann Scheidt wrote:
>> Most - if not all - IRBs in the USA are most definitely NOT making up
>> rules...
>
> Unless you've got some data on that, Lois, I must respectfully disagree.
> There is far too much anecdotal evidence suggesting that the guiding
> principle for many, if not most IRBs in the U.S. has shifted from the
> federal guidelines to covering the corporate backside from litigation.
> When the guiding principle shifts, so do the rules.
> --
> Mark D. Johns, Ph.D.
> Associate Professor and Head of the
>  Department of Communication Studies
> Luther College, Decorah, Iowa USA
> http://academic.luther.edu/~johnsmar/
> -----------------------------------------------
> "Get the facts first. You can distort them later."
>     ---Mark Twain
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