Research Review Process
To initiate the IRB process, researchers need to submit an application detailing the proposed research they would like to perform.
Keep in mind that the IRB application, which includes the protocol, is a planning tool to help you design your research. It documents an official account of the intended research methods and procedures you would like to perform.
The best protocols demonstrate to the IRB that the proposed research is respectful to the needs of the subjects, that the researcher has carefully and thoughtfully delineated the potential risks to the participants and that those risks have been reduced to a minimum, and clearly shows that the benefits of the research more than justify any risk, inconvenience, or other cost to the subject it might create.
Remember, the key to effectively developing an ethically responsible IRB protocol is to plan your research project early and begin writing your protocol along with your research proposal.
All forms and application instructions can be found in Forms and Applications.
Once both the electronic pdf and the original, signed hard copy of an application has been received by the IRB office, the IRB administrator will confirm receipt of the application and review it. She may send you some suggestions for improving your application before it is sent to the committee for review.
If you do receive suggestions, please make the appropriate changes to your application, and send the corrected pdf back to the IRB administrator at firstname.lastname@example.org.
If the application qualifies for exempt status or expedited review, the IRB administrator will then send it to the committee for review on a rolling basis.
If the application requires full committee review, the IRB administrator will save your protocol for review at the monthly IRB meeting.
If the committee requires any revisions to the protocol, the IRB administrator will communicate the requested revisions to the researcher. The researcher should then make the requested changes and return the corrected pdf to the IRB administrator. The IRB administrator will then send the application back to the committee for final review, and usually, the protocol will be approved.
The researcher will receive an email containing the IRB determination from the IRB administrator. Researchers should print out and keep their determination notification with their IRB application for their own records.
Please contact the IRB Administrator if you need an official copy of your IRB determination from the IRB Office.
Researchers should carefully note the following requirements in their IRB determination:
|Start date||The date upon which researchers may begin their project, not before (please remember, there is no "retroactive" IRB approval for projects).|
|End date||The final date upon which the researcher may collect or analyze data. If the research is Exempt, there is not an end date.|
If the research project will continue beyond the end date, researchers must complete a Progress Report and Continuing Review Request 30 days prior to the end date.
(Suggestion: Mark the 30-day-prior date on your calendar and set a reminder one week in advance so that you don't forget!)
If a project is complete — even for exempt research — the researcher must complete a Final Report and Termination Notice.
|Additional requests||Sometimes the IRB will approve a protocol but require additional information from the researcher. Please submit this information as soon as possible so that your file will be complete.|