Investigator Training
Requirements Heading link
Requirements
- All UIC Investigators and key research personnel* are required to complete the initial investigator training requirements in human subject protections, a CITI Human Subjects Protections (HSP) Basic Course, before their involvement in the research.
- All UIC investigators and key research personnel involved in human subjects research must also complete a minimum of two hours of continuing investigator training in human subjects protection every three years.
- You must use your UIC email address as your primary email address in CITI or OPRS will not receive your training certificates.
Requirements
Research Role | From | Training Requirement |
---|---|---|
Key Research Personnel* | UIC | • CITI HSP Basic • 2 hours of UIC OPRS approved continuing training every 3 years |
Key Research Personnel* | Non-UIC site w/ their own IRB & study is reviewed at their institution | • Proof of IRB approval of research at their site from their IRB |
Key Research Personnel* | Non-UIC site w/out their own IRB (UIC is IRB of record for the study) | • CITI HSP Basic • 2 hours of UIC OPRS approved continuing training every 3 years |
Key Research Personnel* | Originally from UIC, no longer affiliated with UIC except for the role in the research | • CITI HSP Basic • No continuing training requirement |
Key Research Personnel* in cases where the research has ended & protocol is only active for data analysis and/or publication | UIC & non-UIC w/out their own IRB | • 2 hours of UIC OPRS approved continuing training every 3 years |
Students or others who do not fit in the role of Key Research Personnel* | UIC/non-UIC | • None – However, the PI is responsible to ensure that the individuals receive both adequate training, including human subjects protection, and oversight in accordance to their research roles. |
Key Research Personnel
*Key Research Personnel includes all persons who will have a significant role in the design or conduct of the research, and includes at a minimum all Principal Investigators and Co-Investigators, and any individuals who are individually named on a grant or contract application, who are listed on an FDA form 1572 (for the conduct of the research at UIC), who are named as contact persons in the informed consent documents or recruitment materials for research, and persons who are, or who provide supervision of the persons who are, obtaining informed consent to participate in research.
Additionally, any individuals (including student researchers and coordinators) who are involved with the research by handling identifiable data or protected health information or are using the research information/data set as part of their own research should be included as research personnel on a protocol application.
Initial
UIC’s initial investigator training requirement for investigators and key personnel involved in human subject research can be met by completing the following, before their involvement in the research:
One (1) of the following CITI Human Subjects Protections (HSP) Basic Courses (depending upon the type of research one conducts):
either
Group 1. HSP, Biomedical Research Investigators and Key Personnel, Stage 1 Basic Course
or
Group 2. HSP, Social / Behavioral Research Investigators and Key Personnel, Stage 1 Basic Course
Additional Guidance regarding initial investigator training:
- When registering on CITI you must use your UIC email address as your primary email address. Doing so allows completion reports to be automatically uploaded into the UIC Research database. Using another email address will result in significant delays in processing of IRB applications.
- When registering for CITI courses, you must indicate your affiliation with “University of Illinois, Chicago”.
- The CITI Human Subjects Protections (HSP) Stage 1 Basic Courses is the ONLY beginning program that qualifies for Initial Investigator Training.
- If you completed the required CITI courses at a non-UIC site, please contact OPRS at 312-996-1711 or uicirb@uic.edu.
- UIC may accept non-UIC performance site’s documentation of IRB approval as documentation of training from non-UIC research personnel involved in non-UIC performance sites.
- CITI electronically sends batched completion reports to OPRS overnight if you use your UIC email address as your primary email address. The completion reports are then automatically uploaded into the OPRS database. While not immediate, this process is significantly faster and more accurate than manual updates.
- UIC Investigators accessing UIC PHI for research purposes are not required to complete HIPAA research training through OPRS. UI Health HIPAA training is separate from OPRS training requirements. UI Health HIPAA training information may be found at https://www.uillinois.edu/hipaa/training.
- If you have any questions regarding UIC’s investigator training requirements, please contact OPRS at 312-996-1711 or uicirb@uic.edu.
Continuing
Every 3 years you are required to fulfill 2 continuing investigator training credits. Don’t let lapsed training requirements hold up your protocol!
What qualifies for Continuing Investigator Training?
- Online courses
- CITI Human Subjects Research (HSR) Refresher Course (2 credits)
- Biomedical (Biomed) Refresher Course; or
- Social-Behavioral-Education (SBE) Refresher Course
- CITI Human Subjects Research (HSR) Refresher Course (2 credits)
- OPRS presentations: check our calendar
- Department presentations (requires OPRS pre-approval): check with your department
- Conferences and seminars (requires OPRS pre-approval)
GCPs
The National Institutes of Health (NIH) implemented a Good Clinical Practices (GCP) training requirement with the “expectation that all NIH-funded clinical investigators and clinical trial staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP)”. NIH defines a clinical trials as: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
For additional information on the NIH’s GCP policy and/or to learn about the GCP training options, please refer to the following website: https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
Training History and Certificates
- Within UIC Research, you can check your training status on the “Training” tab in any protocol in which you are associated.
- Send an email to uicirb@uic.edu or contact OPRS at 312-996-1711 to inquire about your training status and to obtain copies of your training history.