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 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 detailed instructions on registering and using the CITI training system. At the end of the training, a completion certificate and report will be issued. Documentation 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. In Question 2, please choose “I have not completed the Basic Course.” Please choose "no" or "not at this time" for the Responsible Conduct of Research, Conflicts of Interest, Laboratory Animal Welfare, and Biosafety items. These courses are not required for IRB purposes. Please be sure the course you complete is called Biomedical Research - Basic/Refresher orSocial & 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. If your current training is a Refresher course, you must also attach documentation of your past completion of the Basic Course.
STEP 2: CLASSIFY THE RESEARCH
Once you have completed training and learned about how to protect human subjects in research, your next step is to classify your study into one of three Federally-defined categories. The level of review required for a study depends on the specific activities to be undertaken in the study. For the exemption and expedited levels of review, the study must present no greater than minimal risk to the subjects, and all activities must fall within specific categories of research activities. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
For more information about classifying your study, please visit the links below to view details about each level of review.
STEP 3: COMPLETE THE APPLICATION MATERIALS
After classifying your study, your next step is to prepare application materials for the specific level of review appropriate for your study. If you are a student, be sure to work closely with your faculty research advisor in preparing your application materials.
- Limited Review Application for Exemption Certification
- Expedited Review Application
- Full Review Application
Templates and Guidance Documents:
- IRB Investigator Handbook
- Cover Consent Guidance and Template for Exempt Studies
- Informed Consent Guidance and Template for Non-Exempt Studies
- Guidance for Research Involving Children with Parent/Guardian Permission and Assent Templates
- Letter of Support Template for Off-Campus Research
- Guidance for Projects Using Gift Cards as Subject Payments
- Translation Certification for Projects Using Non-English Research Materials
- Request for Waiver of Informed Consent Documentation for Non-Exempt Studies
- Continuation Page for List of Other Investigators
STEP 4: SUBMIT ONLINE
When your application materials are ready for submission, please follow the steps below to submit online.
- 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 system. Choose the appropriate review level 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).
- 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.
- Complete the basic information in the online application and upload the application form and all required attachments in their original file formats (i.e., Microsoft Word documents). Please do not convert files to PDFs. PDFs are allowable for signed documents, CITI training documentation, and other files that were provided to you in PDF format. If you copy and paste text into the application’s form fields, please format your text to Tahoma font in size 10 prior to copying.
- Upon receipt of a new online application, the IRB administrator will review the submission for completeness and return incomplete applications for updates prior to processing.
- Once an application is accepted by the IRB administrator, it will be assigned to the faculty advisor (if the principal investigator is a student) and then to the department chair for approvals prior to being reviewed by the 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 application materials by email.
- Once the IRB has approved the application, the principal investigator will be notified by email.
There is no deadline for the submission of limited review or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive feedback from an IRB reviewer or notification of approval in approximately two weeks from the time department chair approves the submission. Approval times will be extended during the summer months, winter break, 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. Investigators will be notified when an application is scheduled for review and invited to attend the meeting. Attendance at the full review meeting provides the opportunity to answer questions from the IRB members during the review process. If the investigator is unable to attend the meeting, a list of questions and concerns will be prepared after the meeting and sent to the investigator by email. If there are outstanding concerns, the committee will not be able to vote on the application, and investigators should expect a delay in the approval process until the next scheduled meeting.
STEP 5: CHECK EKU EMAIL FOR CORRESPONDENCE FROM IRB
If the faculty advisors, department chair, or IRB reviewers have questions or request updates to the application materials, the principal investigator will be notified by email and asked to resubmit updated application documents by email. Once the IRB has approved the application, the principal investigator will be notified by email.
All IRB communication is sent 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.