OPRS SOP 101: Policies and Procedures Management
Approved Date
Revised Date
Full Details
PURPOSE
University of Illinois Urbana-Champaign Institutional Review Board (IRB) and Office for the Protection of Research Subjects standard operating procedures (SOPs) provide a framework for the ethical and scientifically sound conduct of human research. This SOP outlines the UIUC IRB and OPRS practice for creating, publishing, and routine review of its policies, procedures, and guidance documents. Supported by institutional policies and written procedures, the OPRS SOPs ensure that the rights and welfare of human research subjects are overseen and protected uniformly, regardless of personnel changes.
SCOPE
This SOP applies to the University of Illinois Urbana-Champaign Institutional Review Board and Office for the Protection of Research Subjects’ staff.
POLICY
The University Illinois Urbana-Champaign Institutional Review Board functions independently. Federal regulations governing human subjects research, and the University of Illinois Urbana-Champaign Administration, through the Vice Chancellor for Research and Innovation, grant the IRB this authority as part of the Human Research Protection Program. (see Campus Administrative Manual RP—09)
The IRB maintains an active Federal Wide Assurance (FWA) and agrees to apply 45 CFR 46 whenever the University of Illinois Urbana-Champaign is engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule) of the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.
The University of Illinois Urbana-Champaign will also apply 45 CFR 46 whenever the University of Illinois Urbana-Champaign is engaged in human subjects research that is not federally funded, supported or otherwise subject to federal oversight.
The IRB adheres to 21 CFR 50 and 56 for clinical investigations regulated by the Food and Drug Administration (FDA). The IRB applies the principles of the International Conference on Harmonization’s Good Clinical Practices (ICH-GCP) to clinical investigations, as adopted by the FDA and insofar as the standards and requirements are consistent with 21 CFR.
The University of Illinois Urbana-Champaign IRB applies the standards of the HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) to research that involves the use of protected health information.
PROCEDURES
- Review, Approval, and Revision of IRB SOPs
- If the creation of a new SOP is necessary, the SOP will be approved by the IRB/OPRS Director with input from the IRB Chairs and Vice-Chairs as needed.
- Each SOP that has been approved and published on the IRB/OPRS website will be reviewed no less than three years from the date of approval as described in this policy. The review date is determined as three years from the last date of approval. The IRB/OPRS Director may extend the review date as deemed necessary.
- For the review of an approved SOP, an OPRS staff member as designated by the Director initially reviews the SOP for consistency with state or federal guidelines, current practices or institutional polices. If minor clarifications and changes are necessary, the reviewer provides the revised SOP to the Director or an IRB Chair for approval. If the OPRS staff member determines that significant changes to a policy must be made, the revised SOP may be sent to the Director with input from the IRB Chairs and Vice-Chairs for approval.
- Review and approval of the SOP is documented by an OPRS staff member who records the date approved, and the Director or IRB Chair responsible for approval. The approval date is the effective date.
- SOP Dissemination
- Approved SOPs are posted on the IRB/OPRS website by an OPRS staff member or designee.
- Creating and Using IRB Forms
Forms are used to ensure that policies are integrated into the daily research and review operations and enable the IRB/OPRS to manage review, tracking, and notification functions consistently. Forms are not subject to the same standards of control cited in sections 1 and 2. Forms include checklists, applications, and automated notifications sent by the IRB electronic submission system.
- Forms are created and revised by OPRS staff members or designee under the direction of the IRB/OPRS Director.
- As applicable, forms will be implemented in the IRB electronic submission system by OVCRI programmer(s) pending creation of the electronic submission system.