IRB Review Categories

When is IRB Review Required?
All proposed research that involves :
(1) Intervention or interaction with human subjects.
(2)The collection of identifiable private data on living individuals.
[ and/or ]
(3) Data analysis of identifiable private information on living individuals
requires review and approval by the IRB prior to the initiation of the research.

- What is a Human subject?
- What is Research?

IRB Review Categories 

   - Question 1: Does the project involve human subjects? 

   - Question 2: Is the project considered research? 

   - Question 3: Does the project qualify for exemption review?

 Certain research activities involving human subjects have been given exemptions from IRB full board review. If an investigator believes that the research activities being proposed fall into one of the exemption categories, the protocol should be submitted to the IRB for exemption review. The decision to approve a project submitted for exemption review will be made by the Chair of the IRB or his/her designee and two additional IRB members. All IRB decisions regarding approval, disapproval, or required modifications will be communicated to the Principal Investigator in writing. The purpose of the exemption review process is to provide assurance that a particular research project does indeed meet the criteria for exemption. All of the research activities in a project that involve human subjects must be exempt in order for the project to be submitted for exemption review. If even one activity is not exempt, the project is not exempt.

   - Question 4: Does the project qualify for expedited review? 

Certain research activities involving human subjects qualify for an expedited review process. The decision to approve projects submitted for expedited review will be made by the Chair of the IRB, or his/her designee, and two additional member of the review board. Projects submitted for expedited review that are not recommended for the expedited process will be submitted to the IRB for a full review.