Step 1: Do you need to submit to the IRB?

All NIH investigators conducting activities that meet the definition of both "research" and "human subject" must submit for Institutional Review Board (IRB) approval before beginning any research activity. 

IRB approval cannot be retroactive.

If you are not doing Human Subjects Research but would like or need an official IRB determination, you can submit for a Not Human Subject Research (NHSR) determination.