Standards and Procedures

OPRS SOP 102: Training and Education

  1. Office for the Protection of Research Subjects (OPRS)
  2. Forms, Guidance, Resources
  3. OPRS SOP 102: Training and Education

Approved Date

Revised Date

Full Details

PURPOSE

Training of OPRS staff and IRB members is critical to fulfilling its mandate to protect the rights and welfare of research subjects consistently throughout the University of Illinois Urbana-Champaign research community. The training and education of those who conduct research is equally important to ensure that human subjects are being adequately protected. Therefore, training and continuing education is valued and required for OPRS staff, IRB members, and for those conducting human subject research at the University of Illinois Urbana-Champaign.

SCOPE

This SOP applies University of Illinois Urbana-Champaign OPRS staff and IRB members. The SOP also applies to those who conduct human subject research at the University of Illinois Urbana-Champaign and its affiliates, namely investigators and key study personnel.

DEFINITIONS

  1. Affiliated institutions (i.e., affiliates) have a Memorandum of Understanding (MOU) with the University of Illinois Urbana-Champaign designating the University of Illinois Urbana-Champaign IRB as the IRB of record. The University of Illinois Urbana-Champaign IRB has oversight of research conducted at affiliated institutions.
  2. Key study personnel are individuals engaged in the conduct of research activity, including investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants' identifiable private information during the research.

POLICY

The IRB Director or designee establishes the educational and training requirements for OPRS staff and IRB members. OPRS staff and IRB members receive initial training and continuing education regarding the responsible review and oversight of human subject research including the University of Illinois Urbana-Champaign IRB standard operating procedures (SOPs).

IRB members must complete initial training and continuing education on human subject research ethics and regulations. As appropriate, instruction pertaining to existing or new IRB SOPs is provided to IRB members.

Investigators and key study personnel conducting research at the University of Illinois Urbana-Champaign and its affiliates must complete the Collaborative IRB Training Initiative (CITI) human subject research training program. The individual must complete the Core IRB Training module.  Documentation of completion of Carle's CITI training requirements will be accepted in lieu of the Core IRB Training module for a Carle employee with an appointment at the University of Illinois Urbana-Champaign who is working in collaboration with Carle Illinois College of Medicine students. 

All investigators and key study personnel conducting a clinical trial must also complete Good Clinical Practice (GCP) training for projects with federal funding sources or federal oversight. CITI and GCP training must be recertified every three years.

PROCEDURES

  1. ORPS Staff Training
    • OPRS staff must complete human subject research training. OPRS staff may complete the training offered for researchers that is approved by the University of Illinois Urbana-Champaign Verification of training is recorded in the OVCRI Training Portal or in OPRS records.
    • OPRS staff must complete initial training and continuing education. A training and education plan approved by the OPRS Director is provided to OPRS staff. Training and continuing education requirements are outlined in the plan. OPRS staff members should retain documentation of the completion of any required training.
    • OPRS staff are encouraged to attend workshops and other educational opportunities focused on IRB functions and human subject research. The University of Illinois Urbana-Champaign IRB supports such activities to the extent possible and as appropriate for staff responsibilities. Attendance may be used toward continuing education requirements as determined by the IRB Director or designee. Certificates of completion should be retained by the OPRS staff member.
  2. IRB Member Training
    • IRB members must complete human subject research training. IRB members may complete the training offered for researchers that is approved by the University of Illinois Urbana-Champaign Verification of training is recorded in the OVCRI Training Portal or in OPRS records.
    • IRB members must complete initial training and continuing education in areas germane to their responsibilities. The options for training and continuing education must be approved by the OPRS Director or designee. The method of documenting completion of training or continuing education is determined by the OPRS Director or designee.
    • IRB members are encouraged to attend workshops and other educational opportunities focused on IRB functions and human subject research. The University of Illinois Urbana-Champaign IRB supports such activities to the extent possible and as appropriate for member responsibilities. Certificates of completion should be retained by the IRB member and may submitted to the IRB office as necessary.
    • IRB Chair(s) and IRB Vice-Chair(s) receive supplementary training in areas germane to their additional responsibilities as necessary.
  3. Investigator and Study Personnel Training
    • Investigators and key study personnel must provide a certification of completion or recertification to the University of Illinois Urbana-Champaign IRB to conduct human subject research. Verification of training is recorded in the OVCRI Training Portal or OPRS records.
    • Investigators and key study personnel must provide a certificate of completion for other required training (e.g., GCP training) to the University of Illinois Urbana-Champaign. Verification of training is recorded in the OVCRI Training Portal or OPRS records.
    • Investigators and key study personnel may complete required training concurrently during the initial IRB review process of the research. The OPRS staff member verifies the completion of required training program(s) by investigators and key study personnel before notification of final approval is issued and the application is moved to an approved status..
    • The Office of the Vice Chancellor for Research and Innovation offers continuing education and training opportunities designed to support, develop, and maintain a standardized body of knowledge and best practice methodology for all research personnel at the University of Illinois Urbana-Champaign. Investigators and key study personnel have an open invitation to attend or complete as many of the educational sessions as available. Certificates of completion should be retained by the individual completing the training or continuing education.