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August 15, 2007

Writing an IRB (eResearch)

When residents need to write an IRB application...what steps ought to be taken?

When residents need to write an IRB application, they can contact Angela Thomas [adt@umich.edu] for consultation. Angela will send them a study protocol template that the department put together that has sample language in it [http://www.med.umich.edu/obgyn/research/forms.htm]. Angela will ask them to take a stab at completing the protocol FIRST before doing the application because the protocol is (a) necessary for the application (i.e. must be attached to the application), (b) the protocol addresses many of the issues that must be addressed in the application and (c) many items in the application it allows you to type "see attached protocol." After the protocol is completed the resident has the option of sending it to Angela for review and she will make comments and suggestions. After that, she instruct them to take a stab at the eResearch application and again, after that is complete, they have the option of having Angela review and make comments and suggestions. That's the process. They have to actually do it, but Angela will definitely help and consult along the way.

Posted by lebovic at August 15, 2007 08:46 AM

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