Use of Human Subjects in Research  

Federalwide Assurance  

If a research activity is not exempt, then the investigator fills out a regular protocol that describes the proposed research activity and submits the research protocol to the IRB for regular review.

An IRB may approve, disapprove, or ask for modification of the protocol.

Research may begin only after IRB and other necessary approvals are obtained.

Protocol forms are linked to "Resources" at the end of the Case Study, or you may get one from the Research Compliance Office.

The next slides look at protocols more closely.