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OPRS requires all faculty, IRB members, staff, students, and researchers listed on an IRB protocol complete IRB training.
One component of a comprehensive human research protection program is an education program for all individuals involved with research subjects. The University of Illinois at Urbana-Champaign is committed to providing training and an on-going educational process for investigators and members of their research team related to ethical concerns and regulatory and institutional requirements for the protection of human subjects.
All Responsible Principal Investigators and members of their research team (also known as “key personnel”) must review core training documentation including:
- the “Illinois Policies and Procedures for Human Research Protection Manual,”
- the “Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” and,
- the University of Illinois Investigator’s Handbook.
All members of the research team are required to complete human research subject training. Illinois recognizes the Collaborative Institutional Training Initiative (CITI) as a leader in providing human research subject training. Completion of the required modules in CITI will meet the OPRS training requirement. Researchers are required to complete the Core Basic Training for either social/behavioral research or biomedical research. There are additional modules offered, you may elect to complete any of these. Please note that there are certain modules that may need to be completed based on the nature of the research. For example, research conducted with children, FDA regulated research, international research, etc. The IRB application will indicate if any of these modules are required based upon how the form is completed.
Initial education certification is good for three (3) years, after which recertification and continuing education requirements must be met.
Waiver of Initial Education
If investigators or members of their research team can verify that they have successfully completed human subjects’ research training equivalent to that required by the University, they may request a waiver of the requirement for Initial Education. However, these investigators or members of their research team must complete the requirements for continuing education.
Continuing Education and Recertification
All investigators and members of their research teams must meet the Urbana Campus continuing education requirement every three (3) years after certification of Initial Education for as long as they are involved in human subject research. There is no exception to this requirement. Review of appropriate modules at the CITI Program web-based training site is required.
Human research protection information will be made available on the OPRS website on an ongoing basis to ensure that the University research community is apprised of current regulatory and policy requirements and training opportunities.
NIH Training Requirements
NIH requirement: All NIH investigators who receive funding, including new awardees, and those who receive continuing or competing renewals for projects involving human subjects, must provide a description of education completed in the protection of human subjects for each individual identified as "key personnel" in the proposed research.
Key personnel: All individuals responsible for the design and conduct of the study are considered "key personnel." This may include personnel from subcontractor institutions, consultants, fellowship applicants, and training grant trainees if they are involved in the design and conduct of research involving human subjects. Individuals do not necessarily have to be paid on the NIH award to be considered "key personnel" if they are involved in the design and conduct of the study.
Frequently asked questions: Consult the NIH Web site for answers to frequently asked questions.
Competing proposals and competing renewals: Just-in-time procedures will be followed. If a proposal is in a fundable range, NIH will request a letter documenting education (see below) and IRB approval. These will need to be provided before an award can be issued.
Noncompeting renewals: A statement should be included in the annual progress report identifying key personnel for purposes of the education requirement along with a description of the education completed (see below).
Meeting the training requirement: NIH will permit several options to satisfy the training requirement.
- NIH has an intramural Web-based training program (the link was broken on the IRB website) that is medically oriented but presents basic information on the ethics of human subject research. It provides a certification of completion.
- For subcontracts and consultants, completion of either a training program at their home institution or completion of the Urbana campus training module will be sufficient. Principal investigators should maintain documentation of completion.
- Other organized educational programs are acceptable to NIH (see their Web site), but it will be the principal investigator's responsibility to maintain documentation of content and completion by all key personnel.
Letter to NIH documenting training: The principal investigator should prepare a letter with the following format:
"In compliance with NIH Notice OD-00-039, the required education in the protection of human subjects has been completed by the key personnel listed below. The description of the education that each named personnel received is also included."
The principal investigator must sign the letter and submit it with other material required for a proposal renewal or award to Illinois Office of Grants and Contracts (this was a link on the website and it is broken). The required institutional signature will be coordinated through that office. Click here to see detailed instructions for completing CITI training.
CITI Training Information
The Collaborative Institutional Training Initiative (CITI) offers online access to training for individuals engaged in research. Training modules specific to the University of Illinois are available once a users has created an account and completed the registration process. CITI keeps track of your progress, and you can leave and return to training at any time.