On behalf of Elon University, the Institutional Review Board's (IRB) major role is to safeguard the rights and welfare of all human subjects who participate in research projects conducted by Elon. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB. All biomedical, social and behavioral research projects conducted by the faculty, the staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board.
Please note: Students may not serve as a Principal Investigator (PI) on an IRB study. A faculty advisor must serve as the PI and submit a protocol on the student's behalf. Students do not have access to IRB Mentor.
The scope of the Institutional Review Board's (IRB) charge is broad. Generally, any research that uses humans, human tissue, surveys or interviews of human subjects, or human subjects' records requires IRB review, regardless of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.
IRB review and approval is required for any research involving human subjects that: is conducted by University faculty, staff, students; is performed on the premises of the University (even if conducted by persons not affiliated with Elon); is performed with or involves the use of facilities or equipment belonging to the University (even if conducted by persons not affiliated with Elon); or involves University, students, staff, or faculty (even if conducted off-campus).
On some occasions when two FWA institutions are engaged in the same research study, it may be appropriate for one institution to rely on the IRB of the second for review and continuing oversight of that research. Circumstances in which this arrangement might be considered would typically involve studies primarily based at one institution, with somewhat peripheral involvement by investigators at the other. In effect, this constitutes a deferral of the right of review by the institution with lesser involvement, which retains responsibility for ensuring compliance with all IRB requirements.
An “IRB Authorization Agreement” is the form of agreement executed between the institutions to document this delegation of IRB oversight. Elon University may be either the institution deferring to another institution or the institution to which the IRB review is delegated. All requests for such delegations should be referred to the Institutional Official/Director of Sponsored Programs. The Institutional Official/Director of Sponsored Programs, in consultation with the IRB Chair will determine whether the University will agree to the deferral. If the decision is to agree to the IRB delegation, the Institutional Official/Director of Sponsored Programs will be responsible for executing the Authorization Agreement form. Copies of this agreement will be filed with the IRB accepting responsibility for ongoing oversight, the IRB deferring, and the Office of Sponsored Programs at Elon University.
Authorization Agreement – Reviewing Institution: Use this version if Elon University’s IRB is providing review.
Authorization Agreement – Relying Institution: Use this version if an external IRB is providing review and the organization does not have their own Authorization Agreement.
Please note: These directions are for Faculty and Staff only
Starting June 1, 2010 all IRB applicants must complete CITI human research subjects' training and upload the certificate of completion along with their IRB application via IRB Mentor.
Starting August 1, 2011, all IRB submissions must be made through our new electronic management system, IRB Mentor.