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Human Subjects Protection Program

Carle’s Human Subjects Protection Program (HSPP) is responsible for facilitating safe and ethical conduct of research with human subjects and works in daily administrative support of the Carle Institutional Review Board (IRB). To ensure research at Carle takes place in an ethically rigorous and compliant manner, the HSPP office requires IRB review and approval for all human subjects research at Carle prior to including human subjects in any research study. The HSPP processes all IRB-related documentation, provides regular education for those interested in conducting research at Carle, and addresses the needs of researchers via IRB consultation services.

Details on the Program

Did you know?

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)]. If there are “human subjects” involved in the activity and the proposed activity is “research” as defined by 45 CFR 46, then IRB approval is required.

Carle Institutional Review Board

The Carle Institutional Review Board (IRB) is an independent review committee charged with the protection of people who participate in research studies. All human subjects research with Carle or its employees must be reviewed and approved by the Carle IRB before the research is initiated. Carle’s Human Subjects Protection Program (HSPP) supports and guides the Carle IRB in ensuring research is conducted in accordance with federal, state, and local regulations, as well as Carle policies. In limited circumstances, Carle IRB may rely on another IRB to provide oversight for research in which Carle is engaged. In such cases, there are certain institutional approvals that must be obtained before such agreements are finalized.

Submission Deadlines

Once received via IRBNet (Carle IRB’s electronic submission system), research submissions are pre-reviewed by the Carle HSPP office prior to IRB review. The HSPP pre-review process determines the type of IRB review the project will undergo (e.g., exempt, expedited, full) and identifies any deficiencies which may require revisions. A project is not allowed to proceed to IRB review until all HSPP pre-review concerns have been resolved.

Submissions requiring full board review must be determined to be ready, with pre-review issues resolved, by the submission deadline date (i.e., two weeks prior to a scheduled Carle IRB meeting). Researchers must allow adequate time to finalize all requested revisions from the HSPP pre-review process. If deficiencies are identified during the pre-review which could include study design/protocol inconsistencies and risk concerns, missing or incomplete submission documents, lack of human subject research protection training, etc., Carle IRB reserves the right to postpone full board consideration.

Submission Deadline for New Projects Requiring
Full Board Review (noon deadline)
Carle IRB Meeting
1/5/2022 1/19/2022
2/2/2022 2/16/2022
3/2/2022 3/16/2022
4/6/2022 4/20/2022
5/4/2022 5/18/2022
6/1/2022 6/15/2022
7/6/2022 7/20/2022
8/3/2022 8/17/2022
9/7/2022 9/21/2022
10/5/2022 10/19/2022
11/2/2022 11/16/2022
12/7/2022 12/21/2022

Education Requirements

All investigators and key research personnel must complete human subject protection education requirements before initiating human subject research. Documentation of this education must be on file with Carle IRB before a study can be approved. This applies to new and ongoing projects at the time of Carle IRB annual review.

The Carle IRB utilizes web based education courses through the Collaborative Institutional Training Initiative (CITI) Program. The materials and courses are designed to educate researchers in topics specific to biomedical research. Questions related to training access should be directed to Carle CITI Administrator at IRB@carle.com or (217) 326-4509. Education Certificates from CITI are sent automatically to the Carle CITI Administrator.

CITI initial education can be accessed by registering as a Carle affiliate and completing the basic Carle Foundation Hospital training modules, plus one elective via the CITI website. Depending upon level of experience with the subject matter, course completion should take between three and six hours. For more complete instructions on how to affiliate with Carle, please review the CITI_TrainingAid.

Once initial training requirements are met, all Carle affiliated investigators and key research personnel must complete continuing education in human subject protection every two years via the Carle Foundation Hospital CITI Refresher Course.

For University of Illinois researchers seeking to conduct research involving Carle, University of Illinois Urbana-Champaign (UIUC) CITI training certificates may be accepted. However, additional Research and HIPAA Privacy Protections and Carle Foundation Hospital Policy Training modules may be required. 

Good Clinical Practice

Effective January 1, 2017, National Institutes of Health (NIH) expects all NIH-funded investigators and clinical trial staff involved in design, conduct, oversight or management of clinical trials to be trained in Good Clinical Practice (GCP). GCP training can be obtained through the CITI program or at NIH. If your project is NIH-funded and the Carle IRB will serve as the IRB of oversight, please contact the Carle HSPP office for additional information. 

Initiating Research at Carle

Prior to submitting to Carle IRB, all research projects must be coordinated through Carle’s Stephens Family Clinical Research Institute (SFCRI). Before including Carle in a research grant proposal or research protocol you must first request or inquire about services from SFCRI. To initiate contact with SFCRI and express interest in beginning a research effort, please complete a Carle Research Services Request Form. This form is not a Carle IRB form nor is it a submission to Carle IRB.

IRBNet

Carle IRB uses IRBNet, an online study management and submission system, which helps researchers and our administrative office better manage protocol submission, modification, and tracking processes. IRBNet allows access to study materials from any computer, as long as internet access is available. All Carle IRB submissions must come through IRBNet.

The Regulatory Office within SFCRI will assist with all IRBNet submissions to Carle IRB. Any principal investigator or key research personnel desiring approval on study submissions must have an account with IRBNet. To sign up for an account, please visit irbnet.org. The use of IRBNet is provided to investigators without charge. For more complete instructions on how to obtain an account with IRBNet, please review the IRBNet job aid.