Does my project need IRB approval?
Federal regulations require that any project or proposal involving research ("a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge") with living individuals 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, must be reviewed by the Pacific University IRB. Personnel affiliated with Pacific University (e.g., faculty, students, or staff) who plan to conduct research utilizing human subjects must work with the Pacific University IRB to ensure that the project is properly registered and/or reviewed.
The Pacific IRB is registered with the Office of Human Research Protections in the DHHS and is thus subject to periodic audits to verify that we are in compliance with all relevant federal regulations. To uphold this charge, Pacific University policy requires all faculty, students, or staff involved with human subject research activities to work directly and conscientiously with the IRB:
- Before research activity is initiated
- During research activity if the protocol requires continuing review
- During research activity if the research protocol needs to change
- During research activity if an adverse reaction occurs
- After research activity ends, to close the file
Use the decision tree to help you decide which template you need to use.
To further assist you in learning if your project needs IRB-approval, please use the following flowchart. If you have questions, please feel free to write us at irb@pacificu.edu.