My one experience with IRB was unsettling.
Three times I was asked for inclusion criteria
Three times I stated that all would be included. but to no avail.
Then I explained that asking the entire group for numbers to represent degrees
of satisfaction or dissatisfaction would involve minimal stress.
The IRB rep. agreed but stated that the class professor should not
be asking for those numbers. A substitute should take the class for that period.
Knowing the difficulty of an untrained person getting the experiment right, I refused.
Obviously I ran the experiment myself.
None of the subjects had a problem.
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Harvey Blumberg
Original Message:
Sent: 04-05-2016 07:49
From: Nancy Buderer
Subject: IRB Sample Generation
The IRB's job is to protect human subjects. One consideration is the risk/benefit ratio. If the scientific merits of the study ( in your case, an inappropriate population for the inclusion criteria) are questionable, then the risks to subjects may outweigh the benefits of the research, at least at your college.
I think it's fair to give the investigator an opportunity to explain how your college sample meet's his/her inclusion criteria and will adequately answer the research objectives.
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Nancy Buderer, MS
Consulting
Biostatistician, Program Evaluator, Research Consultant