General Information

Protocol Review Process

General Information

We will ask you everything we need to know
You do not have to have a prepared written document (that explains your research) when you submit a protocol for review. Just answer the questions the application asks, and then submit the application to the IRB. If you have a thesis, a grant proposal or other summary of your project, you may attach that as a supporting document in the Attachment section of eProtocol. To assist in preparing for an eProtocol submission Sample eProtocol Applications are available.

Be Patient 
The application can be lengthy and completing it can be time consuming, so be patient!  Be prepared to spend a few hours on this. However, you do not have to write the entire application in one sitting. You can complete some sections and then save, exit the system and come back the next day. In other words, you do not have to start a new application every time you log into the e-protocol system. If your protocol requires a consent form(s), please follow the consent form templates provided.

Submission Deadlines
Non-medical protocols should be submitted by the first working day of the month. For example, if you are planning on conducting the research in March, your protocol should be submitted no later than February 1st.

If your project is complicated or involves sensitive information, you would be wise to submit your protocol by January 1st, in case questions arise that require longer consideration.

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Convened IRB Meetings
The non-medical IRB meeting is usually on the last Friday of the month (see the schedule of meeting dates and submission deadlines). If your protocol will be presented at the meeting, the protocol review takes place in the weeks leading up to the meeting. All IRB concerns should be addressed before the proposal is presented to the Panel. Investigators are NOT required to attend the meetings. You will be notified if the IRB would like you to attend the meeting.

How long does the review take?
Although it is possible that the review process takes only a week or two, please also be aware that due to a high volume of submitted protocols, it can take up to 4-5 weeks before you receive notification that your protocol has been approved. Therefore, please submit your protocol well before you plan to start your research.

Protocol Format
Your protocol should be written for the lay person. The IRB members represent a variety of disciplines.  This means that some reviewers will not be as familiar with the terminology as you are, so please use language that a lay person would understand.

Academic Sponsor
If you are a student (undergrad, grad or post-doc), you must list an academic sponsor on the protocol. Please note that protocols cannot be approved without academic sponsor approval.

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Protocol Review Process

What happens after I have submitted the protocol?

• Once the application has been submitted via eProtocol, it is reviewed by the IRB Staff and assigned to one or more IRB members.
• IRB members' comments are collected by the IRB Manager and forwarded to the Protocol Director (PD), who will be notified via email that the IRB has reviewed the protocol. 
• The PD will generally have about three days to address the comments and revise the protocol section per those comments. In other words, it is important to respond to the comment but also to revise the applicable protocol sections and/or documents.
• When you have revised the protocol, click the Submit to Manager button.
• The revised protocol is then forwarded to the assigned reviewer.
• If the reviewers have further comments, you will be notified of this via email, just as in the first stage of the process. 
• If all concerns have been satisfactorily addressed, the reviewer will recommend approval and the protocol can be presented at a convened meeting or approved, depending on the review type.

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