Initial Protocol Submission Forms                

Instructions                                

Initial Submission Checklist

Initial Application for Human Research

Submit this application for any new non-exempt human research activities unless the proposed activities are limited to secondary use of research data/specimens. Refer to our Reviewer Checklists to ensure that all criteria for approval are addressed.

Protocol Summary

Submit this document for any new non-exempt human research activities unless the proposed activities are limited to secondary use of research data/specimens. This document is also required to be submitted at continuing review. Please see continuing review instructions for additional information. Refer to our Reviewer Checklists to ensure that all criteria for approval are addressed.

Detailed Protocol  

Submit this document when there is no sponsor protocol and/or grant application available. Refer to our Reviewer Checklists to ensure that all criteria for approval are addressed.

Secondary Use Application

Submit this application in lieu of the Initial Application for Human Research if 1) the study activities are limited only to secondary use of research samples and/or data 2) re-consent is not planned (if re-consent is planned, submit the Initial Application for Human Research) and 3) the samples/data were collected under another IRB approved protocol.

Submit this form for exemption requests. For further explanation of what qualifies for exemption and Human Subjects Research, open this form. Use the Exemption Request Checklist (rather than the above Initial Submission Checklist) to ensure that your submission is complete. Refer to our Exemption Determination Reviewer Checklist to ensure that all criteria for approval are addressed.

Investigators are responsible for not conducting Human Research without prior IRB review and approval. If investigators have questions about whether an activity is Human Research, contact the IRB office.  If an investigator wishes to obtain a written determination, complete this request form and and submit it to the IRB office. Use the Not Human Subjects Research Request Checklist (rather than the above Initial Submission Checklist) to ensure that your submission is complete. Refer to our Human Research Determination Reviewer Worksheet to ensure that all criteria for approval are addressed.