Things to Do and Know Before Preparing your IRB Application
1. Determine whether your project requires IRB review
The IRB must review all research involving human subjects, but determining whether a project fits that definition is not always simple. The federal regulations offer a specific definition and guidance on what is “human subject research” and what is not. For example, evaluations of programs or of marketing campaigns are not human subjects research and therefore do not require IRB review. Similarly, classroom projects that are not presented outside of the classroom do not meet the definition either.
Please consult Human Subject Regulations Decision Charts found on the Office for Human Research Protections (OHRP) website. Also, please read our page, “Does My Project Need IRB Review?”. If you are still not sure, please contact the IRB Administrator, Carole Moran Krus, (216) 397-1527, email@example.com.
2. Complete CITI Training
All investigators, co-investigators, faculty sponsors and research assistants must complete the Research with Human Subjects Training Course offered by the Collaborative Institutional Training Initiative (CITI Program). Please see the CITI Training pages for instruction on creating a user profile and registering for the correct online course. Once you have completed the required course, CITI certification is valid for three years. The IRB will not review any application where any of the investigators (anyone engaged in the research activity) or sponsors have not completed the course within the last three years.
If you received CITI training while working or studying at a different institution: log in to your CITI profile and open the “Main Menu/My Courses” tab. Select the last tab at the bottom of the page, “Affiliate With Another Institution”, then choose “John Carroll University”. Your CITI training records will then be accessible to the JCU IRB. If you have questions about verifying your CITI training, contact the IRB Administrator.
If you received OTHER Human Subjects Research Training (such as NIH training or institution-specific training), please contact the IRB Administrator to validate this training.
3. Familiarize yourself with the IRB review process
Even if you’ve successfully submitted an application before, please review this entire Investigators’ Guide to make sure you understand the process and your responsibilities as an Investigator. Also review the Special Guidance topics and Informed Consent sections of this website. Reviewing these sections should help you avoid common problems and delays in your application process.
All human subjects research projects will be classified into one of three types of review categories: Exempt, Expedited, and Full Board. The type of review required is determined by the level of risk that the research poses to the participants. Please see Types of IRB Review for a description of these categories. In each case, no research activity can begin until the IRB has issued a Notice of Exemption or Notice of Approval for your application.