IRB Review & Approval

About

The UCSD Office of IRB Administration (OIA) exists to promote high quality, ethical research. The OIA does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by UCSD faculty, staff, and students.

Though located within the School of Medicine, the OIA has responsibility for review of research involving human subjects conducted by all Schools, Centers and Programs of UCSD.  The OIA assists researchers in complying with federal, state and University policies regarding experimentation involving human subjects, and oversees the review and conduct of research conducted by federally-registered Institutional Review Boards (IRBs).

Federal Wide Assurance | FWA

The program operates under Federalwide Assurance number, FWA00004495. A statement letter about the FWA is available here.

Institutional Review Boards | IRB

UCSD's OIA supports six federally registered IRBs:

• Biomedical IRBs:
  • IRB00000353
  • IRB00000354
  • IRB00002758
  • IRB00005945 (specializes in pediatric projects)
  • IRB00009940 (specializes in oncology projects)

• Social and Behavioral Sciences IRB:
  • IRB00000355

The IORG number for UCSD is 0000210 (effective through March 3, 2020).

 Guidance & SOPPs

The current versions of the UCSD OIA Guidance & Standard Operating Policies and Procedures (SOPPs) have been "revised" to provide these policies and procedures separately rather than as one guideline.

Submission/Review Types

Simplified UCSD IRB Review Flowchart 
Detailed UCSD IRB Review Flowchart

Submitted research activities may fall into one of the following four regulatory classifications:

• Not “Human Research”

  Activities must meet the organizational definition of “Human Research” to fall under IRB oversight. Activities that do not meet this definition are not subject to IRB oversight or review. Review the OIA Box Diagram to help determine whether research is "Human Subjects".  Contact the OIA in cases where it is unclear whether an activity is Human Research.

• Exempt

  Certain categories of Human Research may be exempt from regulation but require IRB review. It is the responsibility of the organization, not the investigator, to determine whether Human Research is exempt from IRB review. Review the IRB Administration’s Exemption Determination Sheet for reference on the categories of research that may be 'Exempt'.

• Expedited

  Certain categories of non-exempt Human Research may qualify for review using the expedited procedure, meaning that the project may be approved by a single designated IRB reviewer, rather than the convened board.  Review the IRB Administration’s SOPP regarding Expedited Review for reference on the categories of research that may be reviewed using the expedited procedure.

• Convened IRB | Full Board

  Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB (Full Board)

Access IRB Handbook here

IRB Review

Criteria for IRB Approval

In order to evaluate and potentially approve human subjects research, the UC San Diego IRB must review the protocol and determine that all of the federal requirements for approval - as outlined in 45 CFR 46.111(a)(1-7)(b) - are satisfied.  

► Research cannot commence until fully approved by the IRB.

► IRB approval occurs when the OIA releases an approval letter containing the approval date.

Categories of IRB Review

After reviewing a research proposal, the IRB has the authority to take one of the actions outlined below.  Except when the expedited review process is used, these actions will be taken by a vote of a majority of the regular and alternate members present, except for those members present but unable to vote in accordance with IRB's conflict of interest policies.

• Approved

  Made when all criteria for approval are met. 

• Approved Pending

  Made when IRB members require specific modifications to the research before approval can be finalized.

• Deferred

  Made when the IRB determines that the board is unable to approve research and the IRB suggests modifications the might make the research approvable. When making this motion, the IRB describes its reasons for this decision, describes modifications that might make the research approvable, and gives the investigator an opportunity to respond to the IRB in person or in writing.

• Disapproval

  Made when the IRB determines that it is unable to approve research and the IRB cannot describe modifications the might make the research approvable. When making this motion, the IRB describes its reasons for this decision and gives the investigator an opportunity to respond to the IRB in person or in writing.

 How will I learn the outcome of the IRB review?

The IRB will provide you with a notification indicating one of the following determinations:

• The submission is not human subjects research (NHSR)
  • If your submission is NHSR, you may start the research when all other required
    institutional approvals have been obtained.

• The submission is human subjects research – not engaged
  • If your submission is human subjects research – not engaged, you may start the
    research when all other required institutional approvals have been obtained.

• The research is exempt from the requirement for IRB review
  • If your protocol is exempt, you may start the research when all other required institutional
    approvals have been obtained.

• The IRB-approved the human subjects research
  • If your protocol is approved, you may start the research when all other required institutional approvals have been obtained.

• The IRB-approved the human subjects research pending additional modifications
  • If a protocol is not fully approved and the IRB requires modifications to secure
    approval, you will receive notification of this determination with details of the requested
    modifications. If you accept the modifications, you must make the requested
    modifications and submit them to the IRB through Kuali IRB.
  • Any revised documents must be submitted in both a tracked changes and clean version. Upon submission of the modifications, the IRB will review the application and if all requested modifications are made, the IRB will issue a final approval.
  • If you do not accept the modifications, you must develop responses to each of the modifications requested addressing the rationale for not making the requested modification and submit your responses to the IRB through Kuali IRB.
  • If appropriate, this response can also include alternative modifications which intend to address the concern(s) of the IRB. The responses will be placed on the next available agenda for review by a convened IRB. In either case, research cannot commence until the final approval letter is received through Kuali IRB and all other required institutional approvals have been obtained.

• The IRB deferred the human subjects research
  • If the IRB defers the human subjects research, the notification of this determination will
    include the reasons for deferral, suggestions to make the study approvable, and any
    questions or requests for clarification from the IRB. The notification will give you an
    opportunity to respond and you will need to address each individual suggestion,
    question, and request for clarification separately, and submit the responses to the IRB in
    Kuali IRB.
  • Any revised documents must be submitted in both a tracked changes and
    clean version. The responses will be placed on the next available agenda for review by a
    convened IRB with appropriate and available expertise. Generally, this will be the same
    committee that reviewed the previous submission. In most cases, if the IRB’s reasons for
    the deferral are addressed in the modifications, the human subjects research can be
    approved.

• The IRB disapproved the human subjects research
  • If the IRB disapproves the human subjects research, the notification of this
    determination will include a statement of the reasons for disapproval and will give you an
    opportunity to respond.

How do I submit a continuing review?

Complete a renewal submission in Kuali IRB and upload required documents. The KBA on ”Steps to
Submitting a Continuing Review/Renewal” provides step-by-step directions on how to complete this
process.

• Ensure all financial disclosures are current and accurate. If necessary, submit an updated disclosure via Kuali COI.
• Ensure that each member of the research team has completed the required Human Subjects
• Protection Training and has been trained on the protocol procedures they will complete.
• Obtain verbal or written agreement from each member of the research staff that they understand and will perform their role in the research.

Continuing review must be received by IRB at least 30 days before the protocol expiration date stated in
the current IRB approval letter. The IRB will review the application and provide a notification of the review
determination via Kuali IRB.

If modifications are required at continuing review, the modification must be submitted separately from thecontinuing review application. However, a modification submission and continuing review submission are permitted in Kuali IRB at the same time. 

If the continuing review submission is not received at least 30 days before the protocol expiration date in
the approval letter, you will be required to develop and implement a suitable corrective and preventive
action plan (CAPA).

If the continuing review submission is not received by the protocol expiration date in the approval letter,
meaning the research approval expires, you will be required to develop and implement a suitable CAPA
and may be restricted from submitting new human subjects research until the completed continuing
review submission has been received and approved.

When human subjects research approval expires, all human subjects research procedures related to the
protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent,
interventions and interactions with subjects, and collection or analysis of identifiable private information.

Continuing human subjects research procedures during an approval lapse is a violation of UCSD policy
and, in some cases, federal regulations. If current subjects will be harmed by stopping human subjects
research procedures that are available outside the human subjects research context, provide these on a
clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping
research procedures that are not available outside the human subjects research context, request IRB

You may contact the OIA by phone or email.  General inquiries by telephone or email are automatically converted to Service Now (SNOW) tickets.  OIA staff do their best to respond to SNOW tickets within 48 hours.

General Inquiries

Leadership

Intake & Researcher Support

Committee Reviews

Non-Committee Reviews

Expedited and Exempt Research, Non-Regulated Determinations

Reliance Services

UCSD serving as IRB-of-Record for other institutions or UCSD relying on non-UCSD IRBs