Office of Human Research Protection

Types of Human Subjects Research Applications

Exemption
Expedited Protocol
Full Board Protocol
Support for Protocol Application

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.

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.

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;
  5. Application reviewed during a convened meeting of the IRB
  6. Clinical trial applications → the sponsor protocol and the investigator brochure may be submitted electronically to ohrp@unr.edu in lieu of paper copies.

Support for Protocol Application:

Valerie Smith, CIP
valeries@unr.edu
775-327-2370

Gwenn Snow, MS, RD, CIP
gwenns@unr.edu
775-784-3506

Rebecca Thomas
rebeccat@unr.edu
775-327-2372

 

Serving:
UNR | UNSOM | Truckee Meadows Community College | Desert Research Institute | VA Sierra Nevada Health Care System

Office of Human Research Protection
Ross Hall, Room 218, Mail Stop 0331, Reno, NV 89557-0331
Phone: (775) 327-2368 | FAX: (775) 327-2369 
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Site last updated on March 1, 2012