What are the criteria for NONENGAGED in Human Subject Research?

The criteria for non-engaged in human subject research is provided by DHHS.  If the study is regulated by the FDA, this criteria may not be applied.

 

The criteria for not engaged for a study not regulated by the FDA may be found at  ENGAGEMENT GUIDANCE.

 

If, after reviewing the guidance, you have determined you are not engaged in human subject research you must go to Protocol Builder and submit a Non-Engaged application to the IRB-HSR.