IRB Submission Procedures and Application Forms
STEP 1: COMPLETE TRAINING
All investigators, key personnel, and faculty advisors are required to complete human subjects research training at least once every three years and provide a copy of training documentation to the Institutional Review Board (IRB) with all applications submitted for review. EKU provides a subscription to the Collaborative Institutional Training Initiative (CITI) online training system,and the Basic Course for Human Subjects Research is used to satisfy training requirements. Click here for instructions on registering and using the CITI training system. At the end of the training, a Completion Report will be issued. This document must be attached to the application at the time of submission for the principal investigator, key personnel, and faculty advisors.
Please note: When adding courses in CITI, Questions 1 and 2 are critical in ensuring that you are completing the correct course. You must select one of the two investigator groups in Question 1 to register for the Basic Course. Please choose "no" or "not at this time" for the Responsible Conduct of Research, Conflicts of Interest, and Laboratory Animal Welfare, and Biosafety items. These courses are not for IRB purposes. Please be sure the Course you complete is called Biomedical Research - Basic/Refresher or Social & Behavioral Research - Basic/Refresher and that the Stage is Basic. The only exception to this is if you completed the Basic Course three years ago and need to complete the Refresher course, which will show as "Due Now" in your course menu.
STEP 2: CLASSIFY THE RESEARCH
STEP 3: COMPLETE THE APPLICATION MATERIALS
Complete the appropriate application materials and all required attachments.
- Exemption Certification Application
- While projects approved for exemption do not require the use of signed informed consent forms, investigators are encouraged to provide information to subjects similar to that which would be provided on a consent form. Please see Elements of Informed Consent for a list of items that may be appropriate to include in a cover letter or as introductory text for an online survey.
- Expedited/Full Review Application
- Form M: Research Involving Minors (required attachment if project involves individuals under the age of 18 years)
- Form P: Research Involving Prisoners (required attachment if project involves prisoners)
- Form I: Research Involving Decisionally-Impaired Individuals (required attachment if project involves decisionally-impaired individuals)
- Form W: Research Involving Wards (required attachment if project involves wards)
- Informed Consent Template
- Required Elements of Informed Consent (If the consent template is altered or if a different format is used, these items are required).
- Research Involving Children as Subjects
- Form M: Research Involving Minors
- Child Assent Script Template (for children under the age of 7 years)
- Child Assent Form Template (children between the ages of 7 and 12 years)
- Minor Assent Form Template (for minors between the ages of 13 and 17 years)
- Parent/Guardian Permission Form Template (for parents/guardians of minors of all ages)
- Letter of Support Template for Off-Campus Research
- Sample Applications: Full Review; Expedited Review
STEP 4: SUBMIT APPLICATION MATERIALS
All applications for IRB review must be submitted online by the Principal Investigator. After completing the application form and all required attachments, access the online submission portal. Choose Application for Exemption Certification or Application for Expedited/Full Review from the list of available opportunities and click the Apply button on the right. If needed, you can filter the category column by Institutional Review Board (Human Subjects Research) to make these applications easier to find.
If you are a current EKU employee or student, click the option to log in as an EKU user. Your user name and password are the same as what you use to log in to EKU’s network. Your user name is not your email address. In the online system, you will complete some basic information and upload the application form and all required attachments in their original file formats (i.e., Microsoft Word documents). Please do not save your files as PDFs.
Upon receipt of a new online application, an IRB administrator will review the submission for completeness and return incomplete applications for updates prior to processing. Once an application is accepted by an IRB administrator, it will be assigned to the faculty advisor/committee members (if the principal investigator is a student) and the department chair for approvals prior to being reviewed by the IRB.
There is no deadline for exempt or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive notification of approval in approximately two weeks from the time department chairs approve the submission. Approval times may be extended during the summer months and other times when faculty are away from campus. Applications submitted for full review must be submitted by the published deadlines. Applications submitted after the deadline for an upcoming meeting will be scheduled for review at the following meeting.
STEP 5: CHECK EKU EMAIL FOR CORRESPONDENCE FROM IRB
If the IRB reviewers have questions or request updates to the application materials, the principal investigator will be notified by email and asked to resubmit the application online. Once the IRB has approved the application, the principal investigator will be notified by email.
All IRB communication is sent through the online review system to official EKU email accounts. It is the responsibility of the investigators to check email regularly during the review process and respond to inquiries promptly. Delayed responses will always result in a delay in the approval process.