Carle requires all research studies that could potentially engage Carle in research or will utilize Carle commercial services, be submitted for review in order to meet the Office for Human Subject Protections requirements.
Definition of Engaged in Research: Engaged is defined to include research involving human subjects under the Common Rule and clinical investigations under corresponding FDA regulations, and is subject to the requirements of the CFH Office of Human Subject Protections.
Carle is considered to be "engaged" in human research if it is funded or administered by Carle or if the person conducting or supervising the research is a CFH faculty or staff member, trainee, or other agent acting on Carle's behalf, or if Carle resources or patients are utilized in a study. For information regarding engagement determinations, you may review the Office for Human Subject Protections guidance
In order for Carle to determine the level of its involvement, the feasibility of conducting the study at Carle, and to meet all IRB regulations, the researcher should submit the study information by one of the following methods: