How To Submit IRB Applications For Review

Overview

Federal regulations divide human subjects research into three categories based upon risk to subjects. For an explanation of each, visit Levels of Review.

The UC Irvine IRB is required to review and approve all research involving human subjects. No human research may begin until an UCI IRB exempt confirmation (including exempt self determination) or UCI IRB approval letter is provided. There are instances when a commercial IRB may be used. For more information, visit the HRP Single IRB (sIRB) webpage.

If the research requires IRB review, then the next step is to determine the level of IRB review required: exempt, expedited or full committee.

The level of review is dependent on the level of risk to study subjects. For research to qualify for exempt or expedited review, it must be no more than minimal risk.

What is minimal risk research?

As defined by 45 C.F.R. § 46.102(i), “Minimal risk means that 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.”

Minimal risk studies may be eligible for exempt confirmation or expedited review.

Any research considered greater than minimal risk requires IRB full committee review.

Exempt Confirmation and Expedited Review

Human research that is exempt is less than minimal risk to subjects and may either be self determined through the Exempt Self Determination Tool or requires UCI IRB confirmation.

Human research that is no more than minimal risk to subjects qualifies for expedited review if it falls within the 7 expedited categories of review. All expedited applications must be reviewed and approved by the IRB.

The above processes are facilitated via Kuali Research (KR) Protocols.

Important:

Refer to the Research Personnel Heat Map for additional information on who should be listed in the IRB Application.
All prerequisite human research tutorials must be completed by every study team member before the protocol can be submitted or reviewed.
There are no submission deadlines for exempt confirmation or expedited review; they are reviewed on a rolling basis.
Use the Protocol Preparation Checklist and refer to it when preparing your protocol.
Some expedited research qualifies for a waiver of written (signed) informed consent or a waiver of consent all together. See Informed Consent Preparation for more information.
If the human research study does not qualify under the exempt categories or any of the seven expedited criteria for review, the protocol will require full committee review.
OHRP: Exempt Review Categories
OHRP: Expedited Review Categories

As illustrated by the below Research Personnel Heat Map, only Research Personnel involved in the below activities (illustrated in orange) should be listed in the IRB Application and Protocol Narrative. All other Research Personnel should be tracked in the Study Team Tracking Log. (Note: For more information on IRB COI disclosure requirements, click here).

Role of Research Personnel	Minimal Risk Protocol	Greater Than Minimal Risk Protocol
Access to subject identifiable data including Protected Health Information (PHI) for screening/ determining eligibility	List only the LR and Co-Researcher(s) in the Study Team section in KRP. The LR is required to maintain a Study Team log or something similar to track Research Personnel independently.
Recruiting subjects directly via phone, email or in person
Access to subject identifiable data which may include PHI for data collection purposes
Involvement in the informed consent process (i.e., explaining the study to prospective subject)
Performing research procedures that involve greater than minimal risk		List the LR, Co-Researcher(s) and Research Personnel in the Study Team section in KRP.
Involvement in the interpretation of study data
Finalization of the informed consent process (i.e., able to sign off as the individual obtaining consent)
Has a disclosable financial conflict of interest

KR Protocols

UCI's submission and management system for IRB, sIRB and hSCRO.

KR Protocols User's Guide

Common IRB Submission Errors

The UCI IRB application and consent documentation are designed to obtain information necessary for compliance with federal regulations, state statutes, and UC and UCI Policy regarding the protection of human subjects in research. The IRB Committees evaluate the application and consent document, when applicable, to assure that all procedures are adequately described and documented. The following is a list of errors that may contribute to a delay in IRB review:

The protocol requires the approval of another UCI Committee, prior to the release of final IRB approval. See Other Required UCI Review Committees.
Research is to be conducted at a non-UCI site. Additional documentation is required for research conducted at a non-UCI site. (e.g., letter of cooperation, letter of approval from other site’s IRB). See Human Research Activities Performed at Other Institutions.
Safeguards to protect personal health information and research data from an erroneous breach of confidentiality are inadequate (e.g., investigator stores personal information and research data on portable device).
Research team members have not completed the required tutorials – the CITI Human Research Tutorial (required) and the UCI or CITI HIPAA Research Tutorial (required if accessing, creating, or disclosing PHI). See Electronic Research Tutorials and Videos.

Full Committee Review

Human research that does not qualify for exempt confirmation or expedited review involves more than minimal risk to subjects and must be reviewed by the IRB at a convened meeting.

Important Tips:

Virtually all full committee protocols require written informed consent. See Informed Consent Preparation for more information.
All prerequisite human research tutorials must be completed by every study team member before the protocol can be submitted or reviewed.
There are submission deadlines for Full Committee Review, and protocols must be received by 5 pm on the deadline day to be considered for the IRB meeting agenda.
Use the Protocol Preparation Checklist and refer to it when preparing your protocol.

Renewal

Investigators that have their exemption confirmed by the UCI IRB may renew their exemption every 3 years. A brief renewal will need to be completed. The purpose of this is namely for the UCI IRB to keep track of open research protocols and close out those research protocols that have been completed.

A renewal is not required for Investigators that complete a Exempt Self-Determination Tool. However, Investigators must maintain signed and dated Exempt Self-Determination Too along with consents and recruitment materials in their research file for 10 years beyond the completion of the research. Note: the Education and Quality Improvement Program (EQUIP) may routinely monitor the completion of the Exempt Self-Determination Tool through Kuali Research (KR) Protocols as part of the HRP quality assurance process.

To submit a renewal, visit Kuali Research (KR) Protocols. For more information on renewals, visit the HRP Protocol Renewal webpage.

Amendment

Per federal regulations, once a human research study has received IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation except when necessary to avoid an immediate, apparent hazard to a subject. See Reporting of Unanticipated Problems.

To request approval of a proposed amendment, complete and submit an amendment via Kuali Research (KR) Protocols. For more information on amendments, visit the HRP Protocol Amendment section under Researcher Responsibilities after IRB Review.