Certain types of projects meet the DHHS definition of "Not Engaged in Human Subject Research". A common example of this type of project is described below. For the full OHRP guidance see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html
You are collaborating with a colleague from another institution and your colleague is sending you data or specimens without any HIPAA identifiers (see below). The data/specimens will be/were collected for the same research project on which you are collaborating. Your colleague may keep a key to the code which could identify the subject from whom the data or specimen was collected- but will never share the subjects' identity or HIPAA identifiers with you.
If your project meets the criteria of Not Engaged in Human Subject Research- an alternate submission process is required.
IRB-HSR Submission ProcessProceed to Protocol Builder and answer the question " Does this study meet the criteria of "not engaged" in human subject research" YES. Protocol Builder will then provide you with the appropriate documents to complete. NOTE: This is a DHHS definition. Therefore this alternate application process does not apply if the protocol involves FDA oversight.