A1.1175 Investigator Concerns/Appeals of IRB Decisions
The investigator communicates directly with the IRB committee to resolve any concerns that may arise regarding a specific IRB decision. (See the Initial Full Review SOP, Expedited Review SOP, and Exempt Review SOP.)
A1.1200 CROSS-INSTITUTIONAL ROLES AND RESPONSIBILITIES FOR THE UK HRPP
In addition to the institutional official, the IRB, the ORI, and investigators, other designated units and personnel share institutional responsibility for human research protection. These include but are not limited to the following: individual unit leaders, i.e., deans, department chairs, and departmental administrators; the Office of Sponsored Projects Administration, which also administers the University Conflict of Interest Policy; the Conflict of Interest Committee; Office of Legal Counsel; the Committee on Safety and Environmental Health, the Institutional Biosafety Committee, the institutional Biological Safety Officer, the Radiation Safety Committee, and the Radiation Safety Officer; the Radioactive Drug Research Committee; the Investigational Drug Service; the UK CR-DOC; and the VAMC Research and Development Committee. Shared membership on the committees and co-signed ORI/IRB SOPs facilitate coordination, communication, and implementation of human research in compliance with all provisions of the UK HRPP and ensure that required approvals are in place prior to commencement of research.
The colleges and/or departments in which research is to be conducted are responsible for nominating members to serve on the IRB; assisting investigators in identifying the projects requiring IRB review; and, in cooperation with the ORI, educating faculty, staff, and students about responsibilities and requirements for human research protections, including compliance with regulatory guidance.
In addition, the department chair conducts preliminary scientific and scholarly review of the human research protocol and is responsible for signing both the Chairperson’s Assurance Statement on the IRB application for full, expedited, or exempt review and the institutional Internal Approval Form (IAF) for sponsored programs. The chair’s signature on the IRB application is a statement of assurance of scientific validity, investigator qualifications, adequate and appropriate resources, and direct mentoring to ensure adherence to established standards of scientific integrity.
The IAF, administered by the Office of Sponsored Projects Administration, is an internal form required prior to submission of a proposal to an external funding agency. It provides a summary of pertinent details regarding the proposed research, including the involvement of human subjects. The department chair’s signature on this form certifies that he/she has reviewed the proposed research and agrees it is consistent with the educational and research objectives of the unit. The investigator also submits the IAF to the following personnel for approval: deans or center directors, and OSPA Director. Institutional policy assigns OSPA the responsibility for assuring that the investigator has routed the IAF through the appropriate channels and obtained necessary approvals.