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How To Submit Electronic IRB Applications For Review

Overview

Federal regulations divide human subjects research into three categories (based upon risk to subjects), each of which has a corresponding requirement for institutional approval or registration. For an explanation of each, visit Levels of Review. Once the level of review has been determined, investigators need to submit an application for exempt registration or IRB review. No human research may begin until an IRB registration or approval letter is provided.

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Exempt Registration Confirmation

Exempt research involves no more than minimal risk to subjects. The same level of risk that we experience going about our daily lives. There are 6 categories of exempt research.

In an effort to facilitate research, Investigators may self determine research that qualifies as exempt with some exceptions. Self-determination is made by completing the Exempt Self-Determination Tool.

If your research meets one or more of the exceptions to self-determination, an IRB application along with a protocol narrative, consent document, and recruitment materials, as applicable, must be completed and submitted for review by the UCI IRB.

Continuing Review:

Investigators that have their exemption confirmed by the UCI IRB may renew their exemption every 3 years. A brief Continuing Protocol Application (CPA) will need to be completed. The purpose of this “Short CPA” is namely for the UCI IRB to keep track of open research protocols and close out those research protocols that have been completed. Please note that individuals who require a faculty sponsor will need to secure faculty sponsor concurrence/signature.

A Short CPA is not required for Investigators that complete a Self-Determination of Exemption Tool. However, Investigators must maintain signed and dated Self-Determination along with consents and recruitment materials in their research file for 10 years beyond the completion of the research.

Routine Monitoring:

Remember that although exempt, whether a self-determination is made or an IRB review is confirmed, the research is subject to routine monitoring by the Human Research Protections (HRP) unit of the Office of Research. Through the Education Quality and Improvement Program (EQUIP) program, HRP staff conduct periodic quality improvement monitoring and educational outreach.

Self-Determination of Exempt Research:

Exempt Category Abbreviated Category Description
1 Established or commonly accepted educational settings that specifically involves normal educational practices
2 Interactions involving educational tests, survey, interview procedures, or observation of public behavior (including visual or auditory recording) 
3 Interactions involving educational tests, survey, interview procedures, or observation of public behavior (including auditory recording) and the participants are public officials
UCI IRB EXCEPTIONS: UCI IRB review and confirmation of exemption is required per UCI policy. 
  1. Exempt Categories 4-6
  2. Inclusion of the following target populations:
    • Children (under the age of 18)
    • Prisoners
    • Adults (age 18 or older) who may not be legally/mentally/cognitively competent to consent
    • Students or employees of the study team
    • American Indian/Alaska Native tribes
  3. Use of UCI Social Science Human Subject Lab
  4. Access to or the collection of:
  5. Collecting participant identifiers and asking participants to disclose sensitive information that could place subjects at risk for criminal or civil liability, or might be damaging to subjects’ financial standing, employability or reputation
  6. Disclosure of participant identifiers in presentations and/or publications
  7. Use of Deception in research
  8. Non-UCI personnel involved in research: a) intervening or interacting with the participants and/or b) having access to participant identifiable private information for research purposes. See OHRP Engagement Guidance for examples.
  9. International Research
  10. A study team member has a Disclosable Financial Interest

Reminders for Exempt Protocols Requiring IRB Review:

  • For those exempt applications that require IRB review, visit our Application and Forms page to complete the electronic Application for IRB Review.
  • Be sure to submit the applicable exempt Protocol Narrative and all other attachments with the electronic IRB Application (e.g., consent document, recruitment material, data collection instrument, survey or interview questions).
  • 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 registration protocols; they are reviewed on a rolling basis.
  • If the human research study does not qualify under any exempt categories, the application will require expedited or full committee review.
  • After the Lead Researcher has electronically submitted the APP, the following documentation must be submitted:
  • 1 copy of the Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with signatures of the Lead Researcher, Department Chair or ORU Director and Faculty Sponsor (if applicable). Please note that the signed Application may be delivered to the Office of Research, 141 Innovation Drive, Suite 250, Irvine, CA 92697-7600 (Zot Code 7600), sent via email to: irb@research.uci.edu or faxed to: 949-824-3400.

Reminders for Use of the Exempt Self-Determination Tool:

  • For those exempt applications that DO NOT require IRB review, as noted in the above table, please complete the Exempt Self-Determination Tool.
  • OPTIONAL - The Exempt Self-Determination Tool may be submitted to the UCI IRB for review and confirmation. Send the Exempt Self-Determination Tool via email to: irb@research.uci.edu.
  • The Lead Researcher (and Faculty Sponsor if applicable) is responsible for record-keeping.
  • Further, the Lead Researcher (and Faculty Sponsor if applicable) must confirm that all members of their research team have completed the required educational tutorials.
  • A complete list of responsibilities is included in the Exempt Self-Determination Tool.

Expedited Review

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 IRB will require a complete description of the research to adequately assess risks and benefits, and to determine whether the project falls within the 7 expedited categories of review.

  • Visit our Application and Forms page to complete the electronic Application for IRB Review.
  • Be sure to include the Protocol Narrative and all other attachments with the electronic IRB application (e.g., informed consent documents, data collection instrument, survey or questionnaire, recruitment materials).
  • 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.
  • 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 Expedited Review; they are reviewed on a rolling basis.
  • Print out the Protocol Preparation Checklist and refer to it when preparing your protocol.
  • If the human research study does not qualify under any of the seven expedited criteria for review, the protocol will require full committee review.

To apply for Expedited Review, investigators submit the following to the IRB:

  • Submit the electronic IRB Application and the Protocol Narrative with all applicable attachments.
  • After the Lead Researcher has electronically submitted the APP, the following documentation must be submitted:
    • 1 copy of the Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with signatures of Lead Researcher and Department Chair or ORU Director and Faculty Sponsor (if applicable). Please note that the signed Application may be delivered to the Office of Research, 141 Innovation Drive, Suite 250, Irvine, CA 92697-7600 (Zot Code 7600), sent via email to: irb@rgs.uci.edu or faxed to: 949-824-3400.

Full Committee Review

Human research that does not qualify for exempt or expedited review involves more than minimal risk to subjects and must be reviewed by the full IRB at a convened meeting. The IRB will require a complete description of the research to adequately assess risks and benefits and to assure appropriate protections for subjects.

  • Visit our Application and Forms page to complete the electronic Application for IRB Review. Be sure to include the Protocol Narrative and all other attachments with the electronic IRB application (e.g., Sponsor's master protocol, informed consent document(s), data collection instrument, survey or questionnaire, recruitment materials).
  • 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.
  • Print out the Protocol Preparation Checklist and refer to it when preparing your protocol.

To apply for full committee review, investigators submit the following to the IRB:

  • Submit the electronic IRB Application and the Protocol Narrative with all applicable attachments.
  • After the Lead Researcher has electronically submitted the APP, the following documentation must be submitted:
    • 1 copy of the Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with signatures of the Lead Researcher, Department Chair or ORU Director and Faculty Sponsor (if applicable). Please note that the signed Application may be delivered to the Office of Research, 141 Innovation Drive, Suite 250, Irvine, CA 92697-7600 (Zot Code 7600), sent via email to: irb@rgs.uci.edu or faxed to: 949-824-3400.

For full committee, the Application will not be considered for IRB review until all requisite documents are provided to the UCI IRB by no later than 5:00PM, the following day after a full committee submission deadline.

For expedited or exempt Applications, submissions will be placed in the queue for IRB review upon receipt of the electronic submission. Final approval will be held pending receipt of the required signatures.

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