1. How do I know when to submit a project to the IRB and what type of IRB protocol review to apply for?
Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group, and includes a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d).
For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts. Please note that all Exempt studies MUST be submitted to the RU IRB for review. For further information, please contact the IRB Office at 540-831-5290 or firstname.lastname@example.org.
The Radford University IRB website also provides information about each review category and what type of research falls under each category. It further provides information about classroom exercises. The IRB Application form also contains additional information and also includes a logic flow near the end of the application to help you with this determination.
Radford University is committed to protecting the rights and ensuring the safety of human subjects participating in research conducted by faculty, staff, and students of the University. This commitment is guided by the ethical principles described in the “Belmont Report” and in applicable federal regulations.
For operational purposes, as required by federal law, this commitment is vested in the Institutional Review Board (IRB) for Research involving Human Subjects, which operates under a Federalwide Assurance (FWA) on file with the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (DHHS):
FWA Number: FWA00004850 (Exp: 12/4/2022)
IRB Registration Number: IRB00003066
Reciprocity Agreement with Carilion: IRB00001142, IRB00001190
To comply with the Code of Virginia § 32.1-162.19, Radford University reviews, in the same manner, all research involving human subjects conducted by its faculty, staff, and students.
The Radford University IRB is appointed by the Institutional Official, the Dean of the College of Graduate Studies and Research. Members of the IRB serve a 3-year term that is renewable at the discretion of the Institutional Official.
IRB review is not meant to impose judgment on the merits of individual research projects. The review is meant to assess any potential risks to human subjects as defined by the Office of Human Research Protection (OHRP). The Radford University IRB will make every attempt to streamline the approval process while still evaluating and ensuring the protection of human subjects involved in research. Researchers are encouraged to contact the Research Compliance Manager with any questions or concerns about the IRB review process.
Timeline to Review
Please plan ahead and submit your protocol well in advance. Exempt and Expedited protocols normally take at least 3 weeks from intitial submission to approval, but this is entirely dependant on the turn-around of revisions by the PI and the amount of protocols currently in rotation.
Full Board protocols must be submitted by the cut off date listed under "Meeting Dates & Deadlines" to be reviewed at the next convened IRB meeting, dependent on meeting the requirements for a quorum. Please have your pre-review comments submitted 1 week prior to the meeting date so the IRB has an updated protocol to review.
WHERE TO DIRECT FEEDBACK, QUESTIONS, CONCERNS, OR COMPLAINTS:
Questions concerning the approval process, human subjects research regulations, etc. may be directed to the Research Compliance Office at email@example.com or 540-831-5290. Alternatively, you may contact the Institutional Official Dr. Orion Rogers at firstname.lastname@example.org. All communication will be handled confidentially, if requested.
We invite IRB or IACUC comments and feedback to help improve our operations.
Confidential reporting is also available to register concerns or to file a complaint.
It is very difficult to provide any results, findings, or feedback, or to request additional information regarding anonymous comments or concerns without at least minimal contact information. The Comment Form and Complaint Form do not require contact information to be provided but the IRB and IACUC Committees and Research Compliance Office greatly appreciates at least minimal contact information being provided so that the most thorough investigation of the concerns may be conducted.