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INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS In accordance with federal and institutional regulations, any undertaking in which University faculty, staff, or students investigate and/or collect data on human subjects for research purposes must be reviewed by the Institutional Review Board (IRB). It is the responsibility of each investigator to seek review of any study involving human subjects prior to initiation of the project. Purpose and Mission Required Procedures for Submitting Research Protocols for IRB Review STEP 1: COMPLETE TRAINING Meet the federally mandated educational requirement by completing the Collaborative Institutional Training Initiative (CITI) online training system. Click here for instructions on registering and using the CITI training system. At the end of the training, a Completion Report will be issued. This document must be attached to the application at the time of submission for the principal investigator and all other key personnel. If the Principal Investigator is a student, the faculty advisor must also complete the training and attach a copy of his or her Completion Report. Individuals must first complete the Basic Course; the Refresher Course is used only for recertification (every three years) of individuals who have previously completed the Basic Course and provided a completion report to the IRB. Certifications are valid for a period of three years, after which time investigators (including all key personnel and faculty advisors) must be recertified. The initial certification can take several hours to complete, depending on each individual's familiarity with human subjects research regulations. IRB proposals are not reviewed until all required certifications have been submitted. If an expired certificate is submitted with a new protocol, the investigator and the individual whose certificate has expired will be contacted and asked to provide an updated education certificate. If an investigator has previously (prior to October 22, 2008) completed one of the NIH (Protecting Human Research Participants or Human Participant Protections Education for Research Teams) tutorials within the last three years, the IRB will continue to accept those certificates as evidence of meeting the federally-mandated educational requirement. However, if the date on the certificate is more than three years old, investigators are required to complete the CITI training module (Basic Course) before a research protocol will be reviewed by the IRB. STEP 2: CLASSIFY THE RESEARCH Classify the research project as an exempt, expedited, or full review study. The resources below may also assist in appropriately classifying the research. Researchers may contact IRB representatives with questions regarding the appropriate classification of research. STEP 3: COMPLETE THE APPLICATION MATERIALS Complete the appropriate application and write the research protocol narrative and other appropriate materials.
STEP 4: SUBMIT APPLICATION MATERIALS Submit the application and supplementary information, including the CITI Completion Report and all required attachments, to Sponsored Programs, Jones 414/Coates CPO 20. There is no deadline for exempt or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive notification of approval in approximately two weeks from the submission date. Approval times may be extended during the summer months and other times when faculty are away from campus. Applications submitted for full review must be received by Sponsored Programs by the 20th day of the month in order to be reviewed during the meeting scheduled for the following month. Applications submitted after the deadline will be scheduled for review at the next meeting. If full review applications are received during the summer months, a meeting will be scheduled for their review as soon as possible and typically within two weeks of receipt of the application. Reporting Requirements and Forms
Resources
Contact Information |
Forms & DocumentsResourcesFunding SourcesPolicies & ProceduresElectronic Research AdministrationReportsUniversity Research CommitteeInstitutional Animal Care and Use CommitteeStaff Sponsored Programs Jones 414 / Coates CPO 20 521 Lancaster Avenue Richmond, KY 40475-3102 (859) 622-3636 (Phone) (859) 622-6610 (Fax) |
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Comments to Sponsored Programs | EO/AA Statement |
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