Human Research Review Committee (HRRC-IRB)

Supported by the Human Research Protections Office

Emergency Use Review

1 copy of each of the following documents should be delivered to our office. You can also view/print this checklist from a word document.

Items Required for EVERY Study - All forms are in MS Word except where noted

ü Independently written assessment of justification

ü The following PDF forms must be filled out by every investigator listed on attachment 1, as well as the Principal Investigator

ü One of the Following:

Investigators Protocol: Guidelines for developing the Protocol
NIH Grant Application (If study is supported by NIH, a copy of the grant application must be submitted)
Cooperative Group Protocol
Sponsor's Protocol (for commercially sponsored studies)

Items Required if applicable to Study - All forms are in MS Word except where noted

ü Any Applicable Attachments:

	1. Additional Investigators List
	2. Studies Involving Minors	8. Request for Waiver of Informed Consent/HIPAA
	3. Studies Involving Drugs/Radiopharmaceuticals	9. Studies Involving Unapproved Use of Medical Devices
	4. Studies Involving Biological Specimens	10. Studies Involving Prisoners
	5. Studies Involving Exposure to Ionizing Radiation	11. Studies Involving Use of General Clinical Research Center (GCRC)

ü Investigator's Brochure or device manual (for commercially sponsored studies)

ü Sponsor's non-significant risk determination (if device study and no IDE was submitted to FDA)