The Institutional Review Board (IRB) at the University of Kansas Medical Center (KUMC) must review and approve all human subjects research prior to initiation. The IRB is comprised of two boards that serve all KUMC campuses. The IRB’s jurisdiction includes all research involving human subjects conducted by KUMC faculty, students and employees, both on campus and at off-site locations. Additionally, the IRB reviews any proposed human subjects research that uses the physical or patient resources of the institution to determine whether or not its jurisdiction applies. All research conducted by full-time faculty is subject to IRB review. For part-time or volunteer faculty, the IRB has jurisdiction over those human research projects that are being conducted as part of the individual’s KUMC duties.
NOTE: When KUMC faculty collaborate on research at other institutions, reliance agreements can be developed to help streamline the IRB review process. Additional information is available on the IRB Reliance webpage
The IRB Office can provide investigators with a formal determination of not human subjects research when applicable. The formal determination ensures that federal regulations on human subjects research do not apply to the project. Additionally, the determination letter may be required by funding sources or journals. Complete the Human Subjects Determination Form
and include the study protocol. Determinations are typically made within 2-3 business days.
Faculty members often ask whether or not a case report or case series needs prior approval from the IRB. Decision criteria are outlined in the IRB SOPs and briefly described here.
A report of a small number of cases (generally not more than three), is considered human subjects research, provided that: (1) the report is compiled by persons already involved in the patient's care; (2) the information is presented/published in de-identified form; and, (3) no changes were made in the patient's care or diagnostic testing for the sake of reportability.
Case reports may become human subjects research, or may have other compliance requirements, if these three stipulations are not met, or if multiple cases are analyzed in a manner that tests an hypothesis.
Criteria and Types of Review
KUMC faculty who serve as both the principal investigator and the sponsor of an investigational new drug (IND) or investigational device exemption (IDE) have significant additional responsibilities under FDA regulations. Because the investigator and KUMC assume greater responsibility in these studies, the PI must demonstrate that s/he has adequate resources to oversee the conduct of the trial, obtain and maintain IRB approval at all study sites, ensure the quality and security of the data, control the use of the test article, monitor and report adverse events, and fulfill the administrative duties required by the FDA.
Investigators who sponsor the IND or IDE are required to undergo a pre-initiation evaluation to confirm that resources exist to meet all the additional FDA requirements. At its discretion, the IRB may require additional study personnel, monitors or consultants as a condition of study approval, to ensure that these regulatory obligations are met. SOP 11.5
provides additional details on the duties of sponsor-investigators.
Aug 04, 2021