IRB Application Creation and Submission
Getting Started with Submitting An Application
Information on submitting research applications to committees other than the Institutional Review Board can be found on their respective committee pages. Investigators who are unsure about whether they will need to submit their research to other committees can make that determination by reviewing the information here. These human subjects regulations decision charts may be helpful.
Information about submitting to internal versus external IRBs can be found here.
In order to begin the process of submitting the first application to the Institutional Review Board, the following steps will need to be complete:
- CITI training must be complete (more information available here).
- Register in eResearch. When you complete the registration form, you will encounter a question about your network ID. Please provide your computer login ID for that question.
- Conflict of interest (COI) form. A COI form will be sent out electronically in the form of an email upon registration in eResearch. The investigator or staff member will need to complete the COI form electronically every year.
Once the above steps are complete, the application can be created and submitted in eResearch by following the instructions here.
It is important to keep in mind that there are other documents that must be provided along with the application. The checklist and information on what is needed before starting can be found here.
Information about submitting an application for human subjects research
Knowing what to expect and what is expected from the investigator will facilitate a smooth and timely application process. Below are some of the steps and the resources available to investigators, so that they can ensure that their research applications are complete and well-prepared.
Prior to starting a research project, investigators must obtain the appropriate approvals from the departments involved in the study, as well as from the ancillary reviews (contracts and budgets). These approvals signal that the research submitted meets all institutional requirements for review and the departments involved agree to be a part of the research being conducted.
After the application has received the appropriate sign-offs, it moves on to the Office of Research Integrity for the human research protection review. At that point, a staff member ensures that the investigators and study team members have completed their required CITI training and that they have completed their Conflict of Interest forms. Once those have been verified, the application undergoes a staff member pre-review to ensure that all of the basic elements of the application are present and consistent. Lastly, if applicable, the application is sent to the relevant committee(s) for approval. The investigator may only commence his or her research upon receipt of an approval letter and must adhere to any requirements that may be relevant during the course of the study, such as submitting continuing reviews or amendments.”
Frequently asked questions can be found here.