Basics of the Review Process
- All systematic investigations designed to acquire generalizable knowledge involving human subjects must be reviewed and approved by the IRB
Approval is required before studies begin
- Must have approval before collection of any new data or use of any existing data
- Some sponsors require approval before funding can start
- Some sponsors require approval before accepting grant application!
Principal Investigator (PI) has primary responsibility for IRB Application
The PI must:
- educate IRB about their application
- document risks and benefits of their activity
- Applicants are encouraged to discuss how to apply (exempt vs. expedited vs. full application) with IRB
- Application is a process - the applicant works with IRB to develop, document an ethically responsible investigation
- The PI must:
- Exemptions & expedited reviews are processed on a continuous basis.
- Full reviews are discussed at monthly meetings (during the academic year).
To determine if your activity needs IRB review, and if so, how, proceed to the WPI IRB Review Process Decision Tree...
- IRB Protocol Review Standards - Describes how the IRB reviews your application.
- Human Subject Regulations Decision Charts - Gives the decision tree charts used by the U.S. government Office for Human Research Protections (OHRP).