SEKESC-IRB Checklists and Forms
- Determination of IRB – This checklist will provide guidance for investigators new to the IRB process and will help them determine if they need to submit research for their IRB review. Additional information can be found in articles from UNICEF Office of Research and the National Institutes of Health. UNICEF Taxonomy for Defining and Classifying UNICEF Research, Evaluation & Studies and Program Evaluation vs Research: Do I need to Submit for an Exemption or IRB Approval?
- Informed Consent Checklist – This checklist provides both the investigator(s) and the reviewers all the key points that should be provided by the Principal Investigator (PI) when seeking informed consent
- Exempt Categories – The Exempt Categories document lists the explanations for the 6 categories of exemption.
- Exempt Determination** – This checklist provides reviewers with the key points that should be covered by a PI if they are applying for an exemption. By completing this checklist, reviewers will be able to determine if PIs have provided all information required to obtain an exemption.
- Expedited Review Categories – The Expedited Categories document lists the 9 categories of expedited review.
- Expedited/Full Board Review** – This checklist provides reviewers with all the items and sections that should be completed from the to-do list before approving a PI and the new protocol.
**For use by IRB Chair and/or designee
- Policy Handbook**
- The IRB protocol application for projects requiring an IRB can be found at Greenbush Central under Employee Resources Tools.
**This handbook follows the revised 2018 Common Rule, effective January 2019.