How and When do I Submit My Study?
- Institutional Review Board
- Getting Started
- New Research Submission
- Existing Research Submissions
- Conflict of Interest
- Meeting Dates
- Policies and Procedures
- Clinical Trials
When you have completed all applicable forms, please submit them to the IU Health Bloomington IRB Office.
Upon submission, a study is first reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," submissions will be processed for review, and then sent to the IRB Full Board meeting. Expedited and Exempt studies will also need to meet these two criteria before being sent to an IRB reviewer or designee for approval. In the event a submission is deemed "incomplete," the IRB Office will contact the Principal Investigator or identified study contact person to notify him/her as to what is needed and how to proceed. Please note that your submission will not move forward in the process until it qualifies as a complete submission as defined below.
This priority determination will be based on two major factors:
- Are all investigator requirements completed and all documents necessary for review included?
A complete submission will include the following:
- Conflict of Interest Disclosure for all investigators. Please see the Conflict of Interest page for more information.
- Documented ‘Letter of Support’, as applicable.
- Completion of the required CITI modules by each investigator. Completion of comparable human subjects training may meet the IRB requirements.Please see the CITI program page for more information.
- All pertinent required submission documents for the type of action being submitted
(For more information regarding what documents are required, please see the Forms page.)
Applications are to be reviewed according to where the research is to take place, as well as according to the "home campus" of the individual.
If a project will take place solely at IU Health Bloomington, the project must be reviewed by our IRB.
For principal investigators located at other campuses where the research will be conducted at multiple sites, the application shall be submitted to the IRB Office of that institution. If the research will be conducted, in part, on the IU Health Bloomington campus, the approved research must be reviewed by the IU Health Bloomington IRB prior to its initiation at this facility.
If the principal investigator is affiliated with IU Health Bloomington but will conduct research at another facility AND will not conduct research at our facility, the IRB application shall be submitted to the appropriate IRB at the facility where the research will be conducted.