The Institutional Review Board (IRB) is the University Committee which is responsible for ensuring that the University is in compliance with the terms of the Federalwide Assurance (FWA) issued by the US Department of Health and Human Services. Under the FWA, the University has agreed to ensure that all research projects of RMUoHP faculty, students and employees involving human subjects comply with the ethical principles in the Belmont Report and the federal regulations regarding the health and welfare of human research subjects. The IRB is further governed by the Human Research Protection Plan (HRPP) and the Standard Operating Procedures adopted to implement the HRPP.
Generally dissertation and evidence-based system change projects must be reviewed and approved by the IRB. Classroom activities and case reports generally do not have to be filed or approved by the IRB because they usually do not meet the federal definition of human subjects research. However, investigators (students, faculty, or University employees) must bear in mind that the IRB is not permitted under federal regulations or University policies to grant approval of a project that it determines meets the definition of human subjects research “after the fact,” even if it could have been classified as exempt.
Project activities may not begin before the IRB:
- approves the project,
- determines the project is exempt from federal regulations, or
- determines the project does not meet the definition of human subjects research.
Student investigators who are unsure whether their project needs to be reviewed by the IRB should first check with their faculty advisor. Other investigators who are in doubt as to whether a project needs to be submitted to the IRB, should contact the IRB Manager at [email protected].