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. These pages contain all the information you need to prepare your protocol.
- Complete the online training program from CITI for research involving human subjects.
- Download all of the necessary forms and example documents for your specific research project from the IRB Forms page.
- Complete the main application form with a detailed and carefully written description of your study (make sure to include research hypotheses and detailed description of your methods).
- Complete any and all additional forms that are required, including consent forms, video release forms, etc.
- Email your protocol to email@example.com and attach your application, as well as all other supporting documents, forms, and scripts.
- 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 firstname.lastname@example.org containing the following statement: "I have reviewed [your name]'s proposal and I will oversee this research in its entirety."
If you think your protocol will require a Full Review, you must submit it no later than the 10th of the month in order to receive timely consideration. In addition, the following sentence will also be added: If you want to start your research at the beginning of the Spring 2014 semester, you need to submit it to IRB no later than 12/10/13. NO EXCEPTIONS.
Possible Outcomes of IRB Protocol Review
- Approval: a protocol that has been approved by the IRB requires no further action by the principal investigator (P.I.) before the research may commence. The P.I. will receive a letter from the IRB confirming this.
- Revise/Resubmit: a protocol that has been deferred by the IRB usually requires that additional information be submitted. 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 usually 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 the benefits clearly do not justify the risks.
Keeping Your Submitted Protocol Up-to-Date
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 being notified by the IRB Administrator in writing that s/he is permitted to resume the study by the IRB.
IRB approval for a given study will be 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.
Federal regulations require that when a research project has been completed, the P.I. must submit a Closure Form to the IRB that describes the outcomes of the research, as well as any adverse effects experienced by participants during the research process.