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Sep. 25th, 2008 11:05 amIf you're looking for a great way to jump-start a grey and chilly morning, I can heartily recommend an IRB audit. I am feeling very... awake.
The IRB is the Institutional Review Board, the university entity charged with protecting research participants and making sure that investigators follow all possible regulations. Last month they sent me a "self-assessment," a 15-page MS Word form with lots of checkboxes, most of which didn't apply to me. I had to go through and check them anyway. Which, in Word, means double-clicking each one to open it and then selecting the "check box" radio button and then closing it. For hundreds of checkboxes, most of which needed to be marked N/A.
This morning, bright and early, they showed up in my office. They spent about an hour asking me questions. Then they took all my informed consent documents, my regulatory paperwork binder, and my HIPAA (health privacy) forms and disappeared to a vacant cubicle down the hall. They're planning to come back in a little while and look over my "source documents" - the actual questionnaires completed by actual research participants.
I already have a list of things to fix from our friendly conversation. I'm waiting to find out if they have major problems with anything else. If they do - and they shouldn't; I am a careful researcher, and am particularly careful about subjects' rights - they can shut me down.
This is not fun.
The IRB is the Institutional Review Board, the university entity charged with protecting research participants and making sure that investigators follow all possible regulations. Last month they sent me a "self-assessment," a 15-page MS Word form with lots of checkboxes, most of which didn't apply to me. I had to go through and check them anyway. Which, in Word, means double-clicking each one to open it and then selecting the "check box" radio button and then closing it. For hundreds of checkboxes, most of which needed to be marked N/A.
This morning, bright and early, they showed up in my office. They spent about an hour asking me questions. Then they took all my informed consent documents, my regulatory paperwork binder, and my HIPAA (health privacy) forms and disappeared to a vacant cubicle down the hall. They're planning to come back in a little while and look over my "source documents" - the actual questionnaires completed by actual research participants.
I already have a list of things to fix from our friendly conversation. I'm waiting to find out if they have major problems with anything else. If they do - and they shouldn't; I am a careful researcher, and am particularly careful about subjects' rights - they can shut me down.
This is not fun.
