Monday, May 20, 2013

Some Nuances about IRB Processes

I am always grateful that we have so many people at our campuses willing to conduct research. And I know that for those that are new to it, the IRB and its procedures and processes can seem a bit mystifying, as well as look like an impediment to what you wish to do. Since all IRB submissions initially are sent to me, I have noted some continuing issues that occur fairly frequently, and I thought I might here describe them to you.

On Initial Submission: When you first submit an application to the IRB, please make sure that you do complete every question on the form. Many will require no answer at all, so just put an NA as your response (for example, if you are conducting a survey, the entire series of questions related to the use of ionizing radiology are not applicable). And make sure you get the last page signed by your immediate supervisor. This ensures that your supervisor is okay with the time that you will need to do your research. When you submit, you will need to provide the IRB secretary with proof that all investigators have up-to-date certificates of Protection of Human Research Participants training, and that you send a roster as well. Forms for this are found on the IRB website ( And take time to complete the application and provide detail. We cannot move your application forward without these pieces of information, and ensuring you have them at initial submission will smooth the process of approving your application.
Amendments: Any time you make a change in an approved protocol, you need to submit an amendment form to the IRB. This is for any change at all, since your project was approved only for what you initially told us you would do. So, if an investigator left the college and you added someone new, send the form. If you decide to change a question on a survey, it needs an amendment. And if it affects the consent document that was already approved, it will need to go back to the IRB for reconsideration.

Renewal and Termination: All approvals for projects are good only for one year. At the end of that year, you must submit a renewal form, so that the IRB can take another look at your work and okay its continuation. This is your responsibility; if you get a note from the IRB reminding you about this, you are already late and in danger of having your work stopped until such time as you complete the renewal application. This is a legal requirement. Also, when you are done with your work, you are required to send a notice of termination to the IRB so that it can remove your project from those which are annually tracked. This uses the same form as the renewal request.
I know this may at times seem arcane and complicated, but it really isn’t. It takes just a bit of time and some thoughtfulness to ensure your work is handled correctly. And all of us working with and for the IRB thank you for that.

1 comment:

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