Step 2: Before You Submit

Complete Required CITI Training MANDATORY

NIH IRB requires initial and continuing (every 3 years) education through the Collaborative Institutional Training Initiative (CITI) in the protection of human research participants for individuals conducting human subjects research.  

All CITI training requirements for relevant study personnel must be complete before approval can be granted for any NIH IRB submission. 

In some instances, researchers may be required to complete additional CITI training. For example, investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). For more detailed information and instructions please visit the NIH CITI Training Page.

NIH CITI Training

Request NIH PROTECT Account MANDATORY

NIH PROTECT is the web-based application system that the NIH IRB researchers use to complete their submissions for the use of human subjects in research.

If you are new to the NIH, please note that you will not be able to access to PROTECT until you receive an PROTECT account.  To request an PROTECT account or for additional PROTECT resources visit NIH PROTECT Training and Resources.

NIH PROTECT Training and Resources

Ancillary Reviews DEPENDS ON STUDY

Please note you might need to complete Ancillary Reviews before submission to the IRB.  Please navigate to our ancillary review resource page for more information. 

Ancillary Reviews

What's Next?  

If you do need to submit, move on to Step 3 below for more details on how to submit.