The first step in the process of securing approval to conduct research with human subjects is to make the determination that the study does, in fact, meet the federal definition of research with human subjects. If you are unsure, please consult IRB staff.

If the study does meet the definition, there are two things investigators must do:

1. Become certified to conduct research with human subjects and keep their certification current through the life of the project.
2. Secure approval of the protocol from the IRB (or in the case of exempt research, from the IRB administrator)

Please note that the regulations also apply to student researchers. (Student advisors also must become certified, even if they are not actively participating in the research.)

The management of an approved protocol is subject to regulations, too. For example, amendments must be approved prior to implementation, and protocols must be renewed at least once a year in accordance. These processes are all described within this site.