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Human Subjects Research Applications

Is it human subjects research?

Application for Human Subjects Research Determination

Exemption: [45 CFR 46.101(b)]

1. Human subjects research involving no more than minimal risk that satisfies one or more exempt categories;
2. An application for approval is required;
3. No submission deadline;
4. Required for submission process: one complete, signed original application + one complete copy of the original;
5. Prisoners may not be the subject of exempt research;
6. Exempt categories apply to research involving children except Category 2, survey or interview procedures, or observations of public behavior when the investigator(s) participate in the activities being observed.
7. Get Application for Exempt Research 

Expedited Review: [45 CFR 45.110]

1. Non-exempt human subjects research involving no more than minimal risk that satisfies one or more expedited review categories;
2. IRB review and approval outside of a convened meeting;
3. No submission deadline;
4. Required for submission process: one complete, signed original application + one complete copy of the original;
5. Reviewed outside a convened meeting of the IRB.
6. Get Application for Research Involving Human Subjects 

Full Board Review: [45 CFR 46.111]

1. Non-exempt human subjects research involving greater than minimal risk;
2. IRB review at convened meeting is required;
3. Submission deadline applies;
4. Required for submission process: one complete, signed original application + one complete copy of the original;
   • See Full Board Meeting Schedule
5. Application reviewed during a convened meeting of the IRB
6. Get Application for Research Involving Human Subjects 
7. Clinical trial applications → the sponsor protocol and the investigator brochure may be submitted electronically to JanAnderson@unr.edu in lieu of paper copies.