Determining if a Proposal Needs IRB Review
The following definitions and questions are designed to assist the IRB and investigators with deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. While this guidance is provided to investigators for informational purposes, it is the responsibility of the IRB to make the final determination about when research requires IRB review and oversight.
The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. More...
Are you conducting Human Subjects Research?
Human subject means a living individual who is or becomes a participant in research, either as a recipient of the test article or as a control about whom an investigator (whether professional or student) conducting research obtains:
1. Data through intervention or interaction with the individual, or
2. Identifiable private information
What is an example of Non-Human Subject Research?
A systematic investigation in which
Data/samples from living individuals are obtained:
To develop or contribute to generalizable knowledge
Without intervention or interaction and
Include no identifiable private information (e.g. de-identified data/specimens)
Because an incorrect guess by the investigator might have serious consequences, proposals that may not meet criteria for human subject research should be submitted in eIRB for IRB determination. An investigator who fails to submit an IRB application will be found to be in serious non-compliance if later found to be engaged in HSR. If you are unsure, please contact the IRB.
Are you conducting research with decedents?
Research with decedents is not governed by the Office of Human Research Protection or the FDA. However, this type of research is governed by HIPAA regulations. More…
Who can submit studies?
Refer to IRB SOP: Requirements & Qualifications to Serve as a Principal Investigator regarding who can act as the Principal Investigator for studies at MCW. More...
Coordinated IRB Review
To learn more about multi-site site projects and established IRB Partnerships with other institutions, click here.