Investigator Training
Requirements
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Requirements
- All UIC Investigators and key research personnel* are required to meet the initial investigator training requirements in human subject protections AND Information Privacy and Security (IPS) research training before their involvement in the research.
- Principal investigators and faculty sponsors will not be able to submit new applications to OPRS unless they have completed the initial training and continuing training requirements
- 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.
- For additional training requirements information, please see UIC HSPP policy Investigator and Research Personnel Training Requirements.
Requirements
Research Role From Training Requirement Key Research Personnel* UIC - Initial Investigator Training & IPS
- 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) - Initial Investigator Training & IPS
- 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 - Initial Investigator Training & IPS
- 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 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.
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Initial
- All UIC Investigators and key research personnel are required to meet the initial investigator training requirements in human subjects protections before their involvement in the research.
- The Principal Investigator is ultimately responsible to ensure that all individuals involved in the research receive both adequate training, including human subjects protection training, and oversight in accordance to the roles these individuals perform in the research. This includes students or other individuals having minor roles in the research who are not required to be listed on the research protocol.
- UIC’s initial investigator training requirement for investigators and key research personnel involved in human subject research can be met by completing one of the following the CITI Basic Courses:
- CITI Human Subjects Research (HSR) Basic Course
- Group 1. HSP, Biomedical (Biomed) Basic Course; or
- Group 1. HSP, Social-Behavioral-Education (SBE) Basic Course
- The CITI Human Subjects Research (HSR) Courses are the ONLY beginning programs that qualify.
- 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.
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HIPAA/IPS
- In addition, all investigator and key research personnel are required to complete a CITI Information Privacy and Security (IPS) course before their involvement in the research.
- CITI Information Privacy and Security (IPS) Basic Course
- Courses taken at University of Illinois Hospital & Health Sciences System (UI Health) or at other institutions WILL NOT qualify
- In addition, all investigator and key research personnel are required to complete a CITI Information Privacy and Security (IPS) course before their involvement in the research.
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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)
- Online courses
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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.”
As a result, all investigators and key research personnel conducting NIH-funded clinical trial research must have on file evidence of completion of an approved GCP Training course:
- Investigators and key research personnel are required to complete a Good Clinical Practices (GCP) course and a GCP refresher course at least every three years if they are involved in NIH-funded clinical trials.
- Investigators are required to maintain the documentation of GCP training of the personnel on the NIH-funded clinical trial.
Examples of Good Clinical Practice (GCP) courses are:
- CITI Good Clinical Practice (GCP):
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Basic Course
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Basic Course
- GCP for Clinical Investigations of Devices Basic Course
- GCP Social and Behavioral Research Best Practices for Clinical Research
- National Drug Abuse Treatment Clinical Trials Network – Good Clinical Practice
- Frequently Asked Questions regarding the NIH GCP policy:
- What is the effective date of the Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials policy?
A. The NIH policy became effective January 1, 2017. - Does the NIH GCP policy apply to all NIH-funded research?
A. No. The NIH GCP training policy applies only to those investigators and their research staff who are conducting NIH funded clinical trials. That said, it is important to understand that this policy is not limited to clinical trials utilizing a drug or device. The policy also applies to clinical investigations of behavioral interventions, surgical interventions etc. - How does NIH define “clinical trial”?
A: A clinical trial is defined by NIH 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”. - Does the GCP policy apply to personnel on grants and contracts awarded before the January 1, 2017 effective date?
A: The policy applies to all active grants and contracts, no matter what point they are in the life cycle of the trial. - Is there a difference between the CITI GCP training courses and the NIDA training course?
A: The courses are roughly equivalent. The CITI courses are more directly relatable to clinical trial research involving investigational drugs, and biologics. The NIDA course focuses a bit more on behavioral interventions. - Is this considered to be a new IRB requirement?
A: No. This training is mandated by NIH. The UIC Office for the Protection of Research Subjects (OPRS) role is to promote awareness of the requirement and to provide information to UIC investigators to help them satisfy the requirement. - How long does it take to complete the training?
A: Approximately six hours, so please do not wait until the 11th hour to begin this important training requirement. - Does the training need to be repeated?
A: Yes, training must be completed every three years. - How do I obtain my completion certificate?
A: NIH requires investigators and key research personnel who are subject to the training requirement to maintain evidence the training has been successfully completed. It is therefore important to print the completion certificate both CITI and NIDA make available at the successful completion of the training. The completion certificates are provided by CITI and/or NIDA, not OPRS. - Will OPRS award Investigator Continuing Training credit for completing GCP training?
A: Yes, in recognition of the significant time commitment required to complete the training, OPRS will award three contact hours for completion of either the CITI or NIDA courses; however, in order to receive investigator CE credit, investigators will need to email a copy of their completion certificates to rwdataentry@uic.edu. - Who should I contact if I have questions about this training requirement?
A: Please contact your NIH Program Officer for additional information.
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Training History and Certificates
- Personnel may receive their training record by logging into OPRS Live (https://oprslive.ovcr.uic.edu/) and checking the training status.
- Personnel may also send an email to rwdataentry@uic.edu or contact OPRS reception at 312-996-1711 to receive their training record.
- UIC OPRS maintains training attendance records for all personnel who have attended training presented or authorized by OPRS/OVCR, completed the UIC CITI Course, or have completed and submitted external training.