Hi

James M. Clark
Professor of Psychology
204-786-9757
204-774-4134 Fax
[EMAIL PROTECTED]

>>> <[EMAIL PROTECTED]> 15-Oct-07 7:23 AM >>>
I think everyone who is critical of IRBs needs to sit on one. Once you see the 
horrendous proposals that come through you will begin to see the logic of the 
necessity to pay some attention to methodology. 

JC:
No Annette.  This is an indication that there is something fundamentally wrong 
with teaching, hiring, and evaluation processes in some academic departments.  
It is not the job of IRBs to cover up for these inadequacies.

Annette:
I completely agree with others about the need to examine the methodology, at 
least for fundamentals. Having sat on our IRB for several years, primarily 
because I was disgusted with some of their decisions, I quickly was able to 
reach the conclusion that poor methodology, which clearly results in no gain in 
knowledge is an abuse of human subjects.  

JC:
I fail to see how flawed studies constitute an abuse of subjects.  In many 
(most? all?) cases I would expect that subjects would not even be aware of the 
flaws (see below).  I think this is an example of how "harm" (i.e., abuse) gets 
redefined in social science research to include things that it was never 
intended to include in its original context.  The reason this happens, of 
course, is that there is no danger of any real harm, so "harms" get invented in 
order to justify the ethics enterprise.

Annette:
The risk value is NOT zero, it uses up the subject's time and energy that could 
better be devoted to a more gainful  use of time. Therefore there is an 
investment that is going to be wasted, and will also prevent that person from 
participating in a more useful study. This is not zero, it is a minus situation 
for the risk factors. 

JC:
As above, I do not perceive these consequences as harms or risks in any 
ethics-related sense of the terms.  The threshold for "harm" has simply been 
lowered from what should properly be the concern of IRBs (in disciplines where 
real harms are possible).

Annette:
Furthermore, at least at our university, we see participation in research as 
part of learning about the research process. When students participate in 
studies that even they can see are poorly designed, they come to distrust the 
whole research process and its checks and balances. 

JC:
Do you have any evidence about what proportion of subjects participating in 
flawed studies themselves identified the flaws?  Any evidence that it promotes 
distrust of the research process?  One of the criticisms of IRBs is that in 
fact evidence on most IRB-related issues has never been presented or sought. 
And cannot students finding flaws in studies (including published ones, of 
course) be useful for teaching rather than an impediment. Or does pointing out 
the flaws of published studies in class undermine the research process or 
instill in students a sense of the complexity of research and competencies to 
identify weaknesses?

Annette:
Most universities have a subject pool and if it is depleted by studies that end 
up in the trash can then not only have you wasted the subjects' time but you 
have denied good studies from being completed for lack of subjects. 

JC:
Isn't this something for departments to deal with, not IRBs?  And wouldn't 
departments be in a better position to evaluate whether its own studies are 
methodologically sound and/or the teaching value of weak studies?  These are 
fundamentally not ethical issues that concern the protection of research 
participants from harm.

Annette:
Finally, the researcher with the poor study lost the benefit of some 
constructive feedback, putting in tremendous effort and sometimes years of work 
into something that ends up in the trashcan.

JC:
Again, this is not the purpose of IRBs.  Faculty mentors, administrators, and 
perhaps even faculty associations might be concerned about such matters, but by 
what rational are IRBs suppose to protect researchers from their own idiocy, as 
opposed to protecting subjects from real harms that exceed those met in daily 
life?

Annette:
I have found, on every occasion when a weakness was pointed out in the methods, 
that the researcher was grateful for the extra set of eyes. And it was NEVER a 
matter of qualitative versus quantitative studies. 

JC:
That Annette has had such positive experiences probably says more about Annette 
than about IRBs.  And nothing in the criticism of IRBs's intruding into 
research methodologies prevents researchers from soliciting methodological 
comments from people qualified to provide such judgments.

Annette:
It's all in one's attitude and experiences I guess, which is why I advocate for 
anyone with negative feelings towards IRBs to sit on one. It will be quite eye 
opening.

JC:
We should not be basing our decisions about IRBs on our own experiences, but on 
the collective experiences across the research community, including those of 
people who have not sat on IRBs.  Indeed, it may even be that non-IRB 
researchers are a better source of objective information given the 
psychological factors that could influence past and present IRB members 
(group-think, cognitive dissonance, ...).

Take care
Jim


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