Procedures for Submitting Materials to the IRB
A. When should an application be submitted?
B. Where should an application be submitted?
C. What materials are required?
D. Response to Tabled Decisions
E. Renewals
F. Amendments
G. Instructor Facilitated Classroom Projects
A. When should an application be submitted?
The time required for IRB review may vary depending on the type of review mechanism (full, expedited, or exempt). However, regardless of the type of review, the investigator must take into account that approval is not guaranteed at the time of review, or at all. An initial IRB review yields one of four possible outcomes: 1) approval, 2) conditional approval, 3) table or 4) disapproval. Should a project be conditionally approved or tabled (which is often the case), the investigator will need sufficient time to submit a response to the IRB chairperson or the Board. All members of the IRB understand that investigators are anxious to begin their research. Every effort is made to respond to investigators in a timely fashion. The IRB's duty to review projects thoroughly and in accordance with Federal and ethical guidelines overrides all other considerations. It is the recommendation of the IRB that investigators submit research applications two or more months prior to the anticipated start date to avoid delays in beginning research.
Investigators intending to submit their project to a funding source outside the University should apply to the IRB well in advance of the agency's deadline for receipt of proposals.
B. Where should an application be submitted?
In person or through inter-campus mail:
c/o Research Services
Granada Center, Suite 400
Lake Shore Campus
Sent by U.S. Mail to:
c/o Research Services/Granada Center, Suite 400
Loyola University of Chicago
6525 N. Sheridan Road.
Chicago, IL 60626
Sent by Expressmail (UPS Preferred) to:
c/o Research Services
6439 N. Sheridan Rd.
Granada Center, Suite 400
Chicago, IL 60626
Top
C. What materials are required?
Top
D. Response to Tabled Decisions
Top
Please submit an original and 16 copies (17 total) of responses to tabled conditions and all other supporting materials. Each packet should include a copy of the IRB letter to which you are responding and a careful response to each IRB question that is signed by the researcher and faculty sponsor. If your protocol was tabled via the expedited review procedure, only an original and 1 copy are required (2 total).
E. Renewals
Please submit one copy of the Application for Renewal of IRB Approval form to the IRB chair for review. Attach to the application 1 sample copy of any consent forms that were approved. Consent forms must always be approved annually at the time of renewal. We ask that you return all materials to Research Services, two weeks prior to the expiration date to allow ample time for the approval process. If renewal applications are not submitted in a timely fashion, the Research Services Compliance Manager reserves the right to suspend all research activity until the application is reviewed and approved.
F. Amendments
Please submit an original and 1 copy (2 total) of the completed Amendment Application form and any supporting materials that are also being amended (e.g., consent forms, recruitment materials, instruments, letters from cooperating institutions, etc.). Faculty sponsors must read and approve the proposed amendment before submitting to the IRB. (Please note that changes in original protocol must not be implemented until the IRB has approved them).
Application materials not properly collated and submitted in the proper number will be returned to the researcher without review.
G. Instructor Facilitated Classroom Projects
One copy of Faculty Insurance Form for Classroom Projects