Preparation for IRB Submission
To ensure that a submission has sufficient information for the IRB to conduct a thorough review and that the submission is handled efficiently by OPRS, investigators should:
- Submit items requiring review by the convened IRB by 11:59 p.m. on the submission deadline date. (Note that this deadline includes approval of the submission by the Department Head, when required.)
- An appropriate research application, research protocol (when applicable), and other documents required for review by the IRB must be submitted via OPRS Live.
- Submissions with an incorrect form or no form will be returned to investigators without review.
- Submissions that require review by the convened IRB will be placed on the next available agenda for an IRB meeting, based on the submission date and which IRB has the expertise necessary to conduct the review.
- Submission of amendments to previously approved research that are minor in nature may be submitted at anytime. Generally minor changes are those that do not affect the risk-benefit assessment and do not change the purpose of the research, the procedures involved in the research, or the subject population.
- Research protocols that were initially reviewed under expedited procedures (involve no more than minimal risk and are in one or more specific categories listed in the federal regulations) may subsequently be reviewed under expedited review procedures if no changes have been made that affect risk level.
- When continuing review is required, the continuing review submission should be made 4-6 weeks prior to the protocol expiration date to allow time for the IRB to conduct the and for you to respond to any questions or concerns they may have.
- Each submission must be submitted separately via OPRS Live. For instance, if changes to the research are being proposed (i.e., amendment) at the same time as the continuing review, the continuing review documents are submitted via OPRS Live and the amendment documents are submitted as a separate submission via OPRS Live.
- Investigators are required to submit a Final Report when the research is complete.
What type of training is required for investigators and key research personnel?
You cannot submit your research proposal without completing the required training. All investigators and key research personnel must complete the required training and continuing education in order to participate in the research.
Please see Investigator Training for complete details.
What is the definition of Human Subject Research?
“Research involving human subjects” means any activity that meets the definition of “research” and involves “human subjects” as defined by DHHS.
- “Research” means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(l)] Activities are deemed not to be research are specified in the UIC HSPP policy Determination Whether Activities Represent Human Subjects Research at UIC.
- “Human Subject” means a living individual about whom an investigator (whether professional or student) conducting research (1) obtains data or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the data or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]
- “Intervention” includes both physical procedures by which data or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(e)(2)]
- “Interaction” includes communication or interpersonal contact between investigator and subject. [45 CFR 46.102(e)(3)]
- “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(e)(4)]
- “Identifiable private information” is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]
- “Identifiable biospecimen” is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
What are the types of Review of Research Submissions?
Convened IRB Review (Full Board)
Studies that involve more than minimal risk and/or involve particularly vulnerable populations (i.e., prisoners, individuals with diminished capacities) require Convened Review. These studies require a review of the proposed research at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members present.
Expedited IRB Review
Federal rules permit expedited review for certain kinds of research involving no more than minimal risk* and for minor changes in approved research. Expedited review is performed by the IRB chair, a designated voting member, or a group of voting members rather than by the entire convened IRB.
*Minimal risk – The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
When it is determined that the involvement of human subjects is in one of the exempt categories listed in the UIC HSPP policy Exempt Review of Research, it is exempt. The exempt categories include certain educational practices and tests, innocuous surveys of adults, secondary research, public service programs, and food evaluations. Any research study involving human subjects thought to be exempt must be submitted to the OPRS for an exemption determination. Exemption review is performed by senior OPRS staff and designated IRB members.
Determination Whether an Activity Represents Human Subject Research at UIC
When an activity is thought to not represent human subjects research, the form, Determination Whether An Activity Represents Human Subjects Research at UIC, must be completed and submitted to the OPRS for a determination. The determination whether an activity representing human subject research is performed by designated OPRS staff.
The OPRS has determined that specific activities do not represent human subjects research, and, therefore, the submission of a Determination Whether An Activity Represents Human Subjects Research at UIC form is not required. Refer to the UIC HSPP policy Determination Whether Activities Represent Human Subjects Research at UIC for the list of specific activities.
Decision Trees to help determine if you are conducting Human Subjects Research
DHHS has provided numerous decision trees regarding whether an activity meets the definition of human subjects research; whether research is eligible for a Claim of Exemption, and whether research can be reviewed via expedited review.
NIH has provided decision trees regarding whether an activity meets the definition of human subjects research when funded by NIH.