Monday, September 27, 2010

What are the rules and regulations for multicenter studies?

It depends.
If it's being funded out of your private pocket, involves no living creatures or hazardous substances or lab procedures, and will hold less than a week, afterwards standard lab procedures plus communication and data collection protocols may meet your requirements. For instance, an early study of photic sneeze be done by four neurologists (who met at a convention) reporting on their families' sneeze reflex. This kind of study is somewhat unusual, and today would probably require an IRB.
After that - who's the funding agency? Are children or women of child-bearing age potentially involved? Will animals be used? Is any group excluded (by age, race or femininity?) Is it national or international? Which states are involved? The rules vary beside case.
The nearest university will own a Research Office with two or three folks who are _experts_ in study design. Work near them, before the admit is written - or even outlined - to be sure that all of the hundreds of nagging rules are in place.
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