Carle Foundation Hospital (CFH) requires all research studies that could potentially engage CFH in research or will utilize CFH commercial services, be submitted for review in order to meet the Joint Commission and 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.

CFH is considered to be "engaged" in human research if it is funded or administered by CFH or if the person conducting or supervising the research is a CFH faculty or staff member, trainee, or other agent acting on CFH's behalf, or if CFH 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 CFH to determine the level of its involvement, the feasibility of conducting the study at CFH, and to meet all IRB regulations, the researcher should submit the study information by one of the following methods:

The CFH Research Office will then forward all documents to the Carle Scientific Review Committee (Carle SRC). The Carle SRC will evaluate the feasibility of the study, the appropriateness for the study to occur at CFH, and ensure compliance with Joint Commission and HIPAA regulations. The determination of the SRC will be either in support of the research or denial of the research to occur at CFH. The determination of the Carle SRC will be sent via IRBNet to the Principal Investigator within 1 week for CFH commercial services requests and within 4 weeks for engagement requests and forwarded in writing to the external IRB, if applicable. If CFH is only providing commercial services for the study, the documents will be forwarded to the necessary departments to ensure appropriate billing for requested commercial services. In both cases, the Principal Investigator is responsible to ensure that all subjects' signed informed consent and HIPAA forms will be scanned into the hospital's EMR.

The CFH Director of the Human Subject Protections office will contact the external IRB to initiate the development of an IAA. The Principal Investigator must ensure that CFH is listed as a study site, per requirements of the Federal Wide Assurance, on all required documents submitted to the external IRB.