Protecting Rights and Welfare

Mission

Aligning with federal and state regulations, as well as Carle policy, the mission of the IRB is to facilitate the safe and ethical conduct of human research.

Reliance Agreements

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.

Carle IRB Submission Deadlines and Pre-Review Requirements

Once received via IRBNet (Carle IRB’s electronic submission system), submissions are pre-reviewed by Carle IRB staff before moving to final IRB review. The pre-review process determines the type of 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 final IRB review until all 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 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 research protection training, etc., Carle IRB reserves the right to postpone full board consideration.

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 with internet access. All IRB submissions must come through IRBNet.

Any principal investigator or key research personnel seeking approval on study submissions must have an account with IRBNet. The use of IRBNet is provided to investigators without charge. To sign up for an account, please visit irbnet.org. 

Health Insurance Portability and Accountability Act (HIPAA) and Research

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HITECH Act (2013) are federal laws governing the way certain health information is collected, maintained, used and disclosed by a covered entity. Carle, as a covered entity, is subject to these regulations.

Protected Health Information (PHI) is that which is individually identifiable and created or held by a covered entity. Health information is individually identifiable if it identifies an individual or there is a reasonable basis to believe the information could be used to identify an individual including past, present and future health information (mental and physical) about the condition of an individual, the provision of care, or payment for an individual’s care. Under HIPAA, entities can use and disclose PHI for research only with the individual’s authorization, except under limited circumstances. For information on how HIPAA affects research at Carle, email the Institutional Review Board.

Public Health Service (PHS) Funded Research

As required by federal regulation, PHS-funded investigators must disclose sponsored or reimbursed travel. To disclose sponsored or reimbursed travel:

• Complete the Conflict of Interest Disclosure form.
• Or submit the Travel Log for PHS Funded Researchers.

Note: Once investigators have made their initial disclosure, they are required to update their disclosures within 30 days of discovering or acquiring a new significant financial interest and annually during the period of award. For more information, visit NIH Policy Clarification.

Federal regulations also require all investigators involved in the design, conduct or reporting of any research funded by the Public Health Service (such as grants from National Institutes of Health) to complete Financial Conflict of Interest training prior to engaging in PHS-funded research. “Investigator” includes any person, regardless of title or position, responsible for the design, conduct or reporting of research. To complete the Financial Conflict of Interest training:

• Log onto citiprogram.org and complete the Conflict of Interest module under Carle Foundation Hospital.
• Upon completion of this module, both you and Carle will receive a certificate of completion. Please keep this certificate for your records.

Most PHS funded projects are through the National Institutes of Health (NIH) but may also come from other agencies under the Department of Health and Human Services as well such as the Agency for Healthcare Research and Quality, Centers for Disease Control, Health Resources and Services Administration and Substance Abuse and Mental Health Services Administration.

Carle expects institutions who receive federal sub-awards to comply with either their own Conflict of Interest policy or the Carle Research Conflict of Interest policy.

If complying with their own Conflict of Interest policy, the sub-recipient institution must provide a publicly accessible policy that complies with PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

Several non-PHS agencies funding research have also chosen to adopt the PHS Financial Conflict of Interest regulations. These include:

• Alliance for Lupus Research
• Alpha-I Foundation
• American Asthma Foundation
• American Cancer Society
• American Heart Association
• American Lung Association
• Arthritis Foundation
• CurePSP
• Juvenile Diabetes Research Foundation
• Lupus Foundation of America
• Patient-Centered Outcomes Research Institute
• Susan G. Komen for the Cure

To disclose significant financial interest related to PHS funding, email ResearchCOI@carle.com.

Conflict of Interest

Carle is committed to ensuring financial interests, or other personal interests of investigators, do not compromise or appear to compromise the integrity of research performed at Carle. Read our Research Conflict of Interest Policy. Download the Conflict of Interest Disclosure Form.

Contact: ResearchCOI@carle.com | (217) 902-5392

Regulatory Guidance

Carle is patient-care focused. The patient’s experience within the Carle healthcare system, the care and treatment they receive, and their safety will always be prioritized above the needs of a research study.

Factors to be considered when conducting research within a clinical environment at Carle:

• In addition to research regulations outlined by Health and Human Services, the Food and Drug Administration, and state law, the healthcare industry and clinical environment are regulated by dozens of other governing and monitoring bodies. Clinical care requirements and standards must be followed to protect the health and safety of Carle patients and maintain the proper licensures to provide healthcare. These requirements cannot be excused to accommodate research procedures.
• Patients present to Carle for the care and treatment of their health, and are often very ill. Investigators must be respectful and courteous when conducting research activities in the clinical environment and may only enter the clinical space after obtaining departmental approvals from the clinicians and individuals with administrative oversight.
• In addition to departmental approvals, Carle Security will require certain badge access be granted prior to entering a Carle facility for research purposes.
• It is important to be aware that sterile clinical care environments must not be breached. If any Carle clinical staff ask an investigator to leave the clinical space, they must do so immediately.
• Research-only procedures and tests may be deemed unnecessary if they are already being performed for clinical purposes. In limited circumstances, to reduce risks, data collected for clinical purposes may be used for research purposes, if IRB approved.
• Operationalizing research-related activities within the clinical context can be challenging. Interrupting clinical workflow to incorporate research recruitment, procedures, and interventions may create or increase risk to patients. Depending upon the patient population and clinical environment, it may not be feasible to conduct the research and maintain patient safety.
• Strategies to recruit Carle patients as research participants should respect an individual’s reasonable expectations for privacy. For example, it is not permitted for non-authorized persons to recruit from clinical waiting areas.
• Most patients are not familiar with clinical trials and the terms used when conducting them (e.g., randomization, placebo). Coupling a patient’s unfamiliarity with clinical research and their need for care and treatment may cause them to be vulnerable to undue influence. If the informed consent process is not conducted properly, the patient may believe the research will be therapeutic to their condition and be unable to appreciate the difference between the research and standard treatment (i.e., therapeutic misconception).
• When conducting research with Carle patients and/or their private medical data, investigators must comply with the Health Insurance Portability and Accountability Act (HIPAA) which requires the protection and confidential handling of protected health information. Due to the additional regulatory requirements set forth by the HIPAA Privacy Rule, investigators may be required to complete a Research & HIPAA Privacy training course.
• Carle gives priority to collaborative research between our clinicians and University of Illinois Urbana-Champaign faculty.

Carle and University of Illinois Collaborative Research

Research projects involving Carle and the University of Illinois Urbana-Champaign (UIUC) may fall under a Memorandum of Understanding (MOU) between Carle and UIUC. The MOU allows new projects that involve both Carle and UIUC to be reviewed by one IRB after initial oversight and deferral designation has been determined. Since the IRBs cannot defer oversight of a research project they have never reviewed, new research must be submitted to both IRBs.

Prior to an IRB deferring oversight, they will evaluate the research to ensure the recruitment and research procedures are compliant with that institution’s policies and procedures. Any recruitment and research activities that occur at Carle must also be compliant with clinical context, standards, and workflow, as well as the HIPAA Privacy Rule.

Only after an evaluation of the research project documents can the Carle IRB and UIUC IRB establish which IRB should provide initial approval and be responsible for continued oversight of the research, and which IRB should defer their oversight and rely on the other IRB. The investigator(s) cannot choose which site and/or IRB will review the research project. For UIUC researchers wishing to include Carle in a research grant proposal or research protocol, these research studies, whether already approved by UIUC IRB or awaiting submission, must be coordinated through Carle’s Stephens Family Clinical Research Institute (SFCRI) prior to submitting to either IRB. To initiate contact with SFCRI and express interest in beginning a research effort, please complete a Carle Research Services Request Form.

Your services request form will be routed directly to Carle’s Investigator Initiated Research Services (IIRS) office, a service provided by SFCRI. The IIRS office will respond within two weeks. Do not submit the new research project, or amendment to an existing research project, to UIUC IRB or Carle IRB until SFCRI has determined the project is operationally feasible at Carle.

Contact: ResearchCOI@carle.com | (217) 902-5392

Determining Carle Engagement

Per federal regulations and guidance, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

The criteria below describes the types of institutional involvement that generally result in an institution being engaged or not engaged in human subjects research. These examples are not intended to be all-inclusive. There may be additional scenarios in which an institution would be engaged or not engaged in human subjects research. The determination of engagement depends on the specific research study in question (no two studies are alike) and may be complex.

To verify whether a project engages Carle in research, please contact Carle’s Human Subjects Protection Program (HSPP)/Institutional Review Board (IRB) Manager at (217) 383-3036.

Engaged

• Carle physician/employee serves as co-investigator.*
• Carle physician/employee serves as key research personnel.**
• Carle physician/employee obtains informed consent or provides supervision of the person(s) obtaining informed consent. 
• Carle physician/employee accesses or handles protected health information.
• Carle physician/employee generates a list of potential subjects from the electronic medical record for recruitment purposes (e.g., mailings).
• Carle physician/employee conducts patient medical record review.
• Carle physician/employee accesses clinical schedules to identify potential subjects. 
• Carle physician/employee reviews electronic medical record for inclusion/exclusion.

Not Engaged

• Carle physician/employee hands out study recruitment materials to potential subjects.
• Carle physician/employee informs prospective subjects about the availability of the research.
• Carle physician/employee provides prospective subjects with information about the research but does not obtain subjects’ consent for the research or act as representatives of the investigators.
• Carle physician/employee provides prospective subjects with information about contacting investigators for information or enrollment.
• Carle physician/employee seeks or obtains the prospective subjects’ permission for investigators to contact them.
• Carle physicians with appointments at UIUC conducting research activities under their “UIUC” hat and not their “Carle” hat.***
• Carle Research employee provides biostatistical, study start-up, or research design consultation and support.
• Carle’s only involvement is permitting use of their facilities for intervention or interaction with subjects by investigators from another institution.

*Co-Investigators: Persons who will have direct responsibility for the project’s design or implementation, the consent process, data collection, data analysis, or follow-up. Includes collaborators, outside consultants, and students if they will be responsible for any of these activities. Includes all investigators named on grant proposals.

**Key Research Personnel: Persons who will have a significant role in the design or conduct of the research, are named as contact persons in the informed consent documents or recruitment materials, obtain informed consent or provide supervision of the persons who are obtaining informed consent, access or handle protected health information, or use the research information/data set.

***Carle Physicians as UIUC Faculty: Some Carle physicians may also have appointments with the University of Illinois at Urbana-Champaign. When a Carle physician has a dual appointment, determining their engagement in a research project (and with which institution they are engaged) is not always straightforward.

Things to consider:

• Where will research activities take place that involve the physician?
• Will the physician be providing more than medical education?
• Will the physician be interacting or intervening for research purposes with any potential participants or human subjects of the research?
• Will the physician be working with identifiable private information, or will it be de-identified?
• Will the physician be providing their clinical interpretation of data that results in a medical recommendation or action dictated by the protocol?

To assess a Carle physician’s engagement in a research project, Carle IRB may ask to review the study protocol, IRB application, and/or statement of work. Please contact Carle’s Human Subjects Protection Program (HSPP)/Institutional Review Board (IRB) Manager (217) 383-3036.