Institutional Review Board
The Institutional Review Board (IRB) regulates all research activities involving human subjects on the AUM campus. The IRB is a committee appointed to ensure rights, safety, and welfare of human research subjects; ensure compliance with all applicable federal and state laws/regulations; and conduct ethical reviews of human research activities including initial, continuation, modification, unanticipated problems and alleged noncompliance. Its primary responsibility is to assure AUM researchers operate within the provisions of the Federalwide Assurance of Compliance filed with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP).
AUM now has CITI training for our researchers!
To provide a comprehensive educational program on human subjects protection, AUM has joined the Collaborative Institutional Training Initiative (CITI). This comprehensive program is web-based and hosted by the University of Miami and serves over 830 institutions.
All researchers, staff, students, and others who interact with human subjects in the performance of research and assisting of research must complete a required educational program on the protection of human subjects before the Institutional Review Board (IRB) may approve a proposal. This certification process must be completed and documented with the IRB every three years. Beginning January 1, 2010, a new protocol will not be accepted by the IRB until all members of the research team have completed the CITI training and the completion of the training is documented in AUM’s IRB Office.
CITI certification from other institutions is acceptable provided the certification was obtained within the last three years. If CITI training is obtained at another institution, the completion report must be provided to the AUM IRB. Non-AUM personnel can provide certifications of human research protections programs that may have been required at another institution. AUM IRB personnel and IRB members are required to complete the CITI training as well. Please visit the website: www.citiprogram.org .
Federalwide Assurance
To certify that AUM complies with all applicable federal regulations, the Office of Sponsored Programs (OSP) at AUM filed Institutional Assurance of Compilance with DHHS Regulations with OHRP. The assurance includes a statement of ethical principles and institutional policy, a detailed identification of AUM's responsibilities, general procedures, the Institutional Review Board's policies and procedures, and the general responsibilities of the research investigator. As part of its assurance, AUM's IRB reviews all research involving human subjects regardless of sponsorship. The current Institutional Assurance of Compilance at AUM is an effect from February 28, 2008 through February 27, 2010. The Assurance number assigned to AUM is FWA00012889.