Submitting Your Protocol to the IRB
Before you submit your protocol, you must complete the following steps:
- Read carefully all of the information on the IRB website, particularly the “Review Categories” page, which will help you to determine what application form to use. The IRB webpages should contain all the information you need to prepare your protocol.
- Complete the online training program from CITI for research involving human subjects (CITE training from this or any other institution is valid for five years).
- Download the necessary IRB application form for your specific research from the IRB “Forms & Templates” page.
*Note that as of July 2018, there are separate forms for research Exempt from review, research qualifying for Expedited review, and res earch requiring Full review.
- Download any templates that might help you prepare your application (we have templates for informed consent, video release forms, debriefing forms, etc.)
- Complete the application form and gather all supporting material. Convert all supporting material to PDF format.
- Email firstname.lastname@example.org and attach your application and all other supporting documents (in PDF format).
- If you are a student, work closely with your faculty advisor as you develop your materials. Make sure your advisor has a final copy of your protocol exactly as it will be submitted. After you have incorporated all of the changes your advisor recommends, make sure that your advisor sends an e-mail to email@example.com containing the following statement:
“I assume responsibility for ensuring that [student's(s') name(s)] is/are aware of their responsibilities as researcher(s). I have mentored him/her/them in filling out this proposal and have reviewed the final draft, which I approve. I will oversee this research in its entirety.”
Time-Frame for IRB Review
Applications for Exempt and Expedited review can be submitted at any time and will be reviewed within two weeks (except, in some cases, when an application arrives during a break). An application for Full review will be reviewed at our next monthly meeting, providing it arrives a week before the meeting. Meeting are held on Tuesdays of the third week of the month.
Possible Outcomes of IRB Review
Approval: The P.I. will receive a letter from the IRB confirming approval, and research can begin immediately.
Revise & Resubmit: The P.I. will receive a letter from the IRB suggesting revisions to the protocol, requesting additional information, and/or requesting supplemental materials.
Reject: a protocol that has been rejected generally indicates an inappropriate use of research that may impact the rights or well-being of the anticipated human participants, or a research project for which the benefits clearly do not justify the risks. This is extremely rare, since the IRB usually works with researchers to develop ethically sound research through a revise and resubmit process that includes extensive feedback.
Revisions to Approved Research
Federal regulations require “prompt reporting to the IRB of proposed changes in a research activity” and that “such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to subject.” If a P.I. finds that s/he needs to make substantial changes to the previously approved research protocol, s/he is required to submit a completed Revision Form and cease data collection until the IRB chair notifies him/her in writing that s/he is permitted to resume the project.
Continuation of Research
Exempt Research, having been validated as “exempt,” can proceed indefinitely and has no time-limit
Expedited Research, as per the revised Common Rule (implemented in January 2019), can also continue indefinitely without any further IRB review.
Full Review, in most cases, will result in approval granted for one calendar year in duration, beginning from the date appearing on the formal letter confirming the protocol's approval. If a P.I. needs to extend the research beyond this approved time period, s/he is required to submit a Continuation Form to the IRB Administrator who will notify the P.I. in writing as to whether the P.I. is permitted to continue the study beyond the original approval date. Data collection may not continue past the original approval date until this permission has been received.
The revised Common Rule (implemented in January 2019) allows some research activities under a Full review application to extend beyond the one-year mark without necessitating submission of the Continuation form. These research activities include:
- Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable
- Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures