Research Engagement

Research Institute


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:
  • Method 1: Regular Carle IRB Submission
    Contact the Research Institute via email to research@carle.com for assistance with this process.
     
  • Method 2: External IRB Submission or CFH Commercial Services Only Request
    If you plan to use an external IRB or are requesting Carle commercial services only, submit the Determination of Engagement in Human Research form along with the required documents listed below, to the Carle Research Office via IRBNet. Completion of the "Determination of Engagement in Human Research" form assists in assessing the level of involvement of Carle in your research study. (If you answer "no" to all questions on the form, no submission to Carle is needed.)
    Required documents: Completed Determination of Engagement in Human Research form Study protocol Carle HIPAA authorization or waiver Consent form template(s) Schedule of events or Medical Coverage Analysis Grant Application (if applicable) Research Resource Disclosure form (if the Principal Investigator has more than 20 research studies)

If you have questions about the engagement processes, please contact the Research Institute at (217) 326-4508 or by sending email to Research@carle.com.

Clinical Trials At Carle

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