Institutional Review Board Reporting Forms
Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. Form R: Protocol Revision Request is to be used to request approval to implement changes to a previously approved protocol. Such changes may include:
- Revisions to the study’s research procedures
- Extension of a study’s end date
- Revisions to recruitment materials and/or procedures
- Revisions to consent, assent, and/or parent/guardian permission form(s) and/or procedures
- Revisions to data collection instrument(s)
- Revisions to the number of subjects to be recruited
- Revisions to study personnel
- Other revisions
Research protocols that have been approved by the IRB are approved only for the period indicated on the approval notification. If used to request approval to extend the study beyond the approved expiration date, this form must be submitted at least two weeks in advance of the project’s expiration date and may be used to request an extension of a study up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the initial approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms and submission process.
- Please note: Form R must be downloaded, completed, and submitted online through InfoReady ReviewTM.The final report must be filed with the IRB within 30 days of the project’s expiration date.
Research protocols that were initially approved by the IRB through either expedited or full review procedures prior to January 21, 2019 are subject to annual review by the IRB if the project extends for more than one year. Studies that were initially approved through expedited review procedures on or after January 21, 2019 may not be subject to continuing annual review, and investigators should review their approval notification for continuing review requirements. All studies approved through full review, regardless of the initial approval date, are subject to annual continuing review.
A completed Form C: Continuing Review must be submitted to the IRB prior at least two weeks prior to the anniversary date of the protocol’s approval for each year the study is active, up to a maximum of three years from the study’s initial approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms.
To request approval to extend the project beyond the approved study period, Form R: Protocol Revision is required and may be used to satisfy the annual continuing review requirement.
- Please note: Form C must be downloaded, completed, and submitted online through InfoReady ReviewTM.
For all non-exempt studies, a final report must be filed with the IRB within 30 days of the project’s expiration date. A final report must be filed with the IRB within 30 days of a study's completion expiration date, unless the study was approved for exemption. Final reports must be submitted through your InfoReady Review account following the instructions below:
- Log in to your InfoReady Review account using your EKU credentials (email address and password).
- Click the Applications link from the top menu bar.
- Select the title of your initial application.
- Click the Progress Report button for your application from the far right column.
- Complete the information fields and attach a copy of the results obtained in the study (i.e., summary, article, paper, abstract from a resulting publication or presentation, etc.).
- Click the Finalize button to submit your report. This button is located just above the attachment fields.