- For any project involved with live human subjects/participants, it is the responsibility of the Principle Investigator (PI) to apply to the Virginia Western Institutional Review Board.
- Prior to submission for IRB review, the PI must complete IRB training to include, at a minimum, the Virginia Western IRB overview and the THREE (3) modules of Assurance Training provided by the U.S. Department of Health & Human Services. The online course must be taken each year of the project.
- The PI must ensure that all researchers working with the subjects and the project director of a human subject research project complete the Virginia Western IRB overview. It is at the discretion of the PI as to what other training may be required.
- No contact with human subjects may be conducted until the PI’s IRB training is complete and the Documentation of Training in Human Subject Protection form has been submitted to the Virginia Western IRB.
- If it is determined that the study is human subject research, the PI must submit the appropriate applications to the IRB two (2) months prior to the anticipated start date of the project. No contact with human subjects may begin prior to IRB approval.
- It is the PI’s responsibility to submit the application for IRB continuation review at least two (2) months before the expiration of the existing IRB approval. The IRB can refuse to accept late applications for renewal or continuation.
- All work on the project must stop on the IRB approval expiration date unless continuation has been formally approved.
- Records of all PI and researchers’ IRB training must be maintained in the Office of Institutional Effectiveness.
- The PI must maintain records of all human subject research projects for a minimum of three (3) years after completion of the project.
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