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Carle 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.

Human Subject Protection/Carle Institutional Review Board (HSP/Carle IRB) office works in daily support of the Carle IRB. The department collaborates with investigators, research coordinators, subjects and regulatory agencies to ensure that research at Carle takes place in an ethically rigorous and compliant manner. HSP/Carle IRB also handles IRB related documentation and provides regular educational opportunities for those interested in conducting research at Carle.

Carle Research Collaboration Guidelines

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

  • Carle’s mission is to serve people through high quality care, medical research and education. 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 in order 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 Carle 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 subjects 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 coercion. 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 Carle clinicians and University of Illinois at Urbana-Champaign (UIUC) faculty.

Carle and University of Illinois Collaborative Research

Research projects involving Carle and University of Illinois at 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. Please see Carle-UIUC IRB FAQ for more detailed information. 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 2 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.

Stephens Family Clinical Research Institute gives priority to collaborative research between Carle clinicians and UIUC faculty.


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 table 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

Not-Engaged
Carle physician/employee serves as co-investigator*
 Carle physician/employee hands out study recruitment materials to potential subjects


Carle physician/employee serves as key research personnel**
 Carle physician/employee informs prospective subjects about the availability of the research


Carle physician/employee obtains informed consent or provides supervision of the person(s) obtaining informed consent
 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 accesses or handles protected health information Carle physician/employee provides prospective subjects with information about contacting investigators for information or enrollment


Carle physician/employee generates a list of potential subjects from the electronic medical record for recruitment purposes (e.g., mailings)
 Carle physician/employee seeks or obtains the prospective subjects’ permission for investigators to contact them


Carle physician/employee conducts patient medical record review
 Carle physicians with appointments at UIUC conducting research activities under their “UIUC” hat and not their “Carle” hat***


Carle physician/employee accesses clinical schedules to identify potential subjects
 Carle Research employee provides biostatistical, study start-up, or research design consultation and support


Carle physician/employee reviews electronic medical record for inclusion/exclusion
 Carle’s only involvement is permitting use of their facilities for intervention or interaction with subjects by investigators from another institution

Glossary

*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?

In order 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.