The Virginia Tech Human Subjects Research Protection Program (HRPP) and the Institutional Review Board (IRB) are committed to ensuring the safety and protecting the rights of human subjects participating in research conducted by faculty, staff, students, and affiliates of the University. To facilitate timely review of human subjects research protocols and to implement the new requirements for single IRB review of multisite projects, Virginia Tech augmented its program with the services of a commercial IRB.
A commercial IRB is an IRB that is external to a university or research institution that provides services for academic and non-academic researchers. Commercial IRBs and university-based IRBs must comply with the same federal regulations governing research with human participants.
The Virginia Tech HRPP office strongly recommends or requires the following to STAY with the Virginia Tech HRPP:
- If your protocol consists of activities that do not require expertise found outside of the Virginia Tech HRPP/IRB.
- If your protocol requires compliance with Virginia Tech-specific policies (such as the use of Virginia Tech students or NCAA athletes as potential participants, or the use of drones on campus)
- If your protocol requires that the Virginia Tech IRB rely on another institution’s IRB to review.
- If your protocol falls under the NIH single IRB (sIRB) requirements as a secondary site (not the primary site) – unless our commercial IRB is serving as the IRB of record or representing other institutions.
Protocols will be evaluated on a case-by-case basis to determine eligibility to transfer to our commercial IRB for review.
The Virginia Tech HRPP office strongly recommends or requires the following to protocols be submitted to the commercial IRB:
- If your protocol includes activities conducted outside of the United States.
- If your protocol is biomedical in nature and study activities are considered greater than minimal risk (minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46]).
- If your protocol includes a device or drug that requires compliance with FDA regulations.
- If your protocol falls under the NIH sIRB requirements as the primary site, with Virginia Tech requesting to be the lead IRB of record
For all other submissions (or if you are unsure whether your protocol meets the requirements above), the principal investigator can request that the protocol be reviewed by either the Virginia Tech IRB or the commercial IRB. Each request will be reviewed by Virginia Tech’s HRPP staff to assess whether any circumstances exist requiring it to be directed one way or the other.
If you are collaborating with another institution, you may request to rely on their IRB – please contact the Virginia Tech HRPP office.
If you wish to request that your Virginia Tech HRPP submission(s) be considered for transfer to the commercial IRB for review, you will need to indicate this in your Protocol Management submission by answering “Yes” to the question, "Is this study seeking transfer to the commercial IRB)?"
HRPP will quickly review your request and either provide you with an authorization letter to begin the transfer process or notify you that your protocol has been assigned to a Virginia Tech HRPP Protocol Coordinator.