- Part 1: Submission Requirements
- Part 2: Completing the Application for IRB Review
- Part 3: Conditions of Approval
Part 1: Submission Requirements
In order to demonstrate appropriate oversight of human research activities and to comply with federal regulations, state statutes, and applicable University policies and procedures, no human subjects research activities can be initiated prior to obtaining UCI IRB review and approval or registration.
UCI's Human Research Protections (HRP) staff are available to assist investigators with IRB application submission questions or problems. Any comments concerning the instructions or the application are welcome and can be made to the Karen Allen, Director of Human Research Protections at 949-824-1558 or email@example.com.
Other Required UCI Reviews
Before the IRB can review or approve the research, other prerequisite UCI reviews may be required. Please review the other prerequisite UCI reviews web page and the Other UCI Committee Reviews section of the IRB Application. Please note that many of the other UCI Committees have their own applications. In addition, they may require submission of the IRB Application, protocol narrative, consent forms, and other applicable documentation for their review.
Human Research Education Requirements
All research team members must complete the UCI Human Research tutorial (some exceptions are provided below) in order to be approved to perform human subjects research activities on a UCI IRB approved protocol. The UCI Tutorials are located on the ORA website.
- Human Research Tutorial
- Effective October 15, 2011, it is required that all UCI employees (faculty, staff) and students complete the Collaborative Institutional Training Institute (CITI) Human Research Protections Course. A module for social behavioral research, as well as biomedical research, is available. A refresher course is also required every 5 years to maintain a current understanding of human research protections.
- Non-UCI affiliated study team members may take the CITI Human Research tutorial or submit verification of human research training from their own institution. The verification must accompany the IRB application and include their name and institutional affiliation.
- Non-UCI affiliated study team members may also take the NIH Human Participant Protection Education for Research Teams tutorial. The NIH certificate of completion must accompany the IRB application.
- UC HIPAA Research Tutorial
- The UC HIPAA Research Tutorial must be completed by all UCI employees (faculty, staff), students, and non-UCI affiliated study team members if the research involves the creation, use, or disclosure of Protected Health Information (PHI).
- Other UC collaborators who have completed the UC HIPAA Research Tutorial at their home campus may submit their campus verification of completion with the IRB application.
Electronic Submission of the IRB Application
Applications for IRB Review must be submitted electronically to the Office of Research Administration via the Electronic Application for IRB Review module. The module will guide the investigator through a series of sections that are designed to obtain specific information required by human research regulations, statutes and campus policies. Specific instructions, suggestions, and website references for completing each section of the application are provided in these instructions. A submission checklist also is available on the web.
The IRBs must apply applicable federal regulations and UCI research policies pertaining to human subjects research to all protocols. Investigators are advised to review each section of the application carefully to prevent oversights of information required for review and approval.
There are several elements to the IRB application that need to be submitted for review. At minimum, a complete submission includes an IRB Application for Review and Protocol Narrative.
- Complete the entire application and give special consideration to the Populations and Procedures sections. Many of the check boxes in these sections are linked to appendices that provide additional information required for IRB review. IRB review will be delayed if the application is submitted without the required appendices.
- All sections must be completed prior to the submission of the IRB Application.
- Only the Lead Researcher is authorized to submit the application.
IRB Protocol Narrative:
- The IRB Application will prompt the user to download the Protocol Narrative. Alternatively, the protocol narrative is available on the Applications and Forms webpage under IRB Forms.
- Remember to download and save the protocol narrative to your computer before uploading it to the electronic IRB application.
- Once the Protocol Narrative is completed, it must be uploaded to the electronic IRB Application module.
- Only the most current version of the protocol narrative is acceptable for uploading to the electronic IRB Application module. Older versions of the protocol narrative will not be accepted for review.
Informed Consent Document:
- Studies that require a written informed consent document must have a consent form uploaded to the IRB Application. The user may develop the consent document by downloading and completing an informed consent template from the Applications and Forms webpage under IRB forms.
- Full committee studies almost always require a written informed consent document. An informed consent document should be uploaded to the electronic IRB Application.
- Expedited studies require a written informed consent document unless a waiver of informed consent or a waiver of documentation of (signed) consent can be justified (Appendix O or P must be completed). When a waiver of documentation is requested, it is recommended that you upload a Study Information sheet for IRB approval. A Study Information sheet template is available on the Applications and Forms webpage under IRB Consent Forms.
- Exempt studies do not require a written informed consent document. Often no consent is required or a Study Information sheet may be used when interactions with living individuals will occur. If a Study Information sheet will be used it should be uploaded to the electronic IRB Application. A study information sheet template is available on the Applications and Forms webpage under IRB Consent Forms.
- Only the most current versions of the informed consent document templates are acceptable for uploading to the electronic IRB Application module.
NOTE: Older versions of the consent template will be held to the current consent form template standards.
- Remember to download and save the consent template to your computer before uploading it to the electronic IRB application.
- The Informed Consent Document must be uploaded to the electronic IRB Application module.
Other Documents for IRB Review:
Be sure to upload other requisite documents to the electronic IRB application for review and approval. Additional documents may include but are not limited to:
- Sponsor investigator brochures and master protocols (required for clinical investigations)
- The "Human Subjects" section of funding proposals (required for DHHS proposals and funded studies)
- Recruitment materials such as advertisements and flyers
- Data collection instruments - questionnaires and survey instruments, interview questions (required for all un-validated measurements)
- Permission letters from offsite locations
- IRB approval letters from offsite collaborators
- Verbal scripts and Study Information sheets
- Other UCI committee review and approval letters (e.g., ICTS SRC, PRMC, hSCRO, IBC, etc.)
Materials to Submit in Hard Copy After Electronic Submission
After the Lead Researcher has electronically submitted the IRBAPP, the following documentation must be submitted:
- For clinical investigations, two hard copies of the Sponsor’s Master Protocol and the Investigator’s Brochure.
- For studies where some required documentation (e.g., survey packets, interview schedules, and permission letters) was not uploaded and submitted during the e-IRBAPP process, two copies of these materials.
- Note: Hard copies of documentation may be delivered to the Office of Research, 5171 California Avenue, Suite 150, Irvine, CA 92697-7600 (Zot Code 7600).
- A signed e-IRBAPP (electronic or hard copy). Print the PDF of the e-IRBAPP. Obtain signatures of the Lead Researcher, Department Chair or ORU Director, and Faculty Sponsor (if applicable).
- Note: The signed e-IRBAPP may be delivered to the Office of Research, 5171 California Avenue, Suite 150, Irvine, CA 92697-7600 (Zot Code 7600), sent via email to: firstname.lastname@example.org or faxed to: 949-824-2094.
- For Full Committee submissions, hard copies of the Sponsor/Master Protocol and the Investigator's Brochure must be provided to the HRP staff by 5 pm on the Friday immediately following the Thursday IRB deadline. If the hard copies are not received within this timeframe the IRB application will be held for placement on a future IRB agenda.
- : IRB Applications are scheduled for review once the application has been submitted electronically and all applicable required documentation has been provided. Receipt of the e-IRB Application with signatures is required before the HRP staff will release the IRB Approval letter and IRB-approved documentation.
Full Committee Meeting Deadlines
- Protocols requiring Full Committee review must be submitted electronically and any requisite hard copies received in the Office of Research Administration by no later than
- to be considered for inclusion on the agenda of the next full Committee meeting.
- See the HRP website for protocol submission deadline dates. Incomplete submissions will not be added to full committee agendas. Please be sure all submission pre-requisites have been met.
*Important Notes for Full Committee Submission to the Biomedical Committees:
- Agendas fill up quickly. Sometimes protocols received by the deadline are deferred by the Research Administration to the next meeting date.
- Biomedical committee agendas are limited to 25 items.
- Modifications/amendments and continuing reviews of existing studies with enrolled subjects take priority over new IRB Application submissions.
- Up to 10 new IRB Applications are accepted for each full committee meeting agenda.
- Investigators should allow between 30 to 60 days for full committee review of new IRB Application.
To Which Committee Should I Submit?
UCI has three Institutional Review Boards: Two that review biomedical research (IRB-A and IRB-B) and one that reviews social/behavioral research (IRB-C). Each committee has weekly subcommittee meetings and one full committee meeting per month.
In general, a protocol's hypothesis or research question (medical vs. social/behavioral) determines whether a protocol is reviewed by a biomedical Committee or the social/behavioral Committee.
Social-behavioral research may include prospective collection of biological specimens (e.g., blood, saliva, deciduous teeth) and/or collection of data via non-invasive measures (e.g. magnetic resonance imaging, tests of sensory acuity, electrocardiography) that are usually considered clinical in nature. Such research studies may be considered social/behavioral in nature if: 1) the purpose of the research is to develop or contribute to generalizable knowledge that is primarily social/behavioral in nature; and 2) the physiological interventions* are sufficiently benign as to involve no more than minimal risk to subjects (i.e., the procedures qualify for Expedited review under Categories 2, 3 or 4 of the Federal Regulations.)
*Exception: Social/behavioral studies involving the experimental 4T MRI may be reviewed by IRB-C because the protocol for the use of the experimental 4T MRI has been approved by a biomedical IRB. All subjects will be required to sign a separate informed consent document for 4T MRI imaging.
What Occurs After Protocol Submission?
When a completed electronic IRB Application is received it is assigned a unique identification number (beginning with "HS#"). This HS# will be referenced on all subsequent IRB correspondence. This number is provided to the Lead Researcher in an electronic memo confirming IRB receipt of the submission. Additional information about Protocol Tracking is available on the web.
Full Committee Meeting Results:
Full committee meeting results are posted after 3 p.m. on the day of the full committee meeting on the web.
Subcommittee Meeting Results:
Determinations on Exempt and Expedited submissions are not posted to the web. Lead Researchers should allow approximately 10 business days for e-mail correspondence from the IRB before contacting HRP staff about the status of Exempt and Expedited protocols.
Correspondence from the IRB after Review:
Applications that receive a Committee vote of A - Approval:
- Stamped approval documents and an approval letter will be sent to the Lead Researcher within 4 - 6 business days electronically via the IRB Document Depot.
- Research studies must not begin until the Lead Researcher electronically receives a stamped IRB Approval letter and the IRB approved (stamped) documents.
Applications that receive a Committee vote of M - Minor Changes Required or T - Tabled for Re-Review:
- A memo from the IRB providing detailed feedback will be sent via e-mail within 10 business days of the review.
- Research studies must not begin until the Lead Researcher receives a stamped IRB Approval letter and the approved documents.
Part 2: Completing the Application for IRB Review
Please review the Human Research Protections (HRP) website, and use these instructions to complete the electronic Application for IRB Review.
The IRBs must apply applicable federal regulations and UCI research policies pertaining to human subjects research to all protocols. Lead Researchers are advised to review each section of the application carefully to prevent oversights of information required for review and approval.
Title of Study
Provide a title for the research described in the application. This title will be connected with the protocol number assigned by the IRB for all protocol-related correspondence. Some funding agencies may require the title of the protocol to match the title of the funding proposal.
SECTION A: Level of Review and Scientific or Scholarly Review
Review the HRP website to determine the required Level of Review.
- Research that is "Exempt" must fall within 6 federally-defined categories of research. More than one exempt category may apply.
- Research that is "Expedited" must fall within 7 federally-defined categories of research. More than one expedited category may apply.
Explain whether the research described in this IRB Application has received scientific/scholarly peer review. All new IRB submissions must receive scientific/scholarly peer review prior to IRB review.
SECTION B: Department or Research Unit for this Study
Specify whether the research will be performed under the auspices of a Department (includes campus centers and school-based research units) or an Organized Research Unit (ORU). The signature of the Department Chair or the Director of the ORU is required on the completed IRB application.
Note: A listing of Organized Research Units is available on the Research website. If the research unit is not listed here, it is likely a school based center or informal center and Department approval should be sought.
SECTION C: Determining Whether HIPAA Regulations Apply to this Study
If the research involves access to person-identifiable medical records, or the study will result in new information that is added to medical records, the research is using or creating Protected Health Information (PHI) and is subject to HIPAA Privacy Rule provisions.
- If any of the boxes in Question 1 are checked, HIPAA regulations apply to the study. Check "yes" to Question 2 and answer Questions 3 and 4.
- Appendix T is required for IRB review when a total waiver or a partial waiver (recruitment purposes) of HIPAA Authorization is requested.
- The HIPAA Authorization for Release of PHI for Research Purposes-2009, is located on the Applications and Forms webpage under the IRB Forms. This form must be filled out by the Lead Researcher and uploaded to this IRB Application. Once the research is approved, this form must be signed by each subject during the informed consent process along with the consent form, unless a waiver is granted by the IRB. The text in this authorization form cannot be altered.
SECTION D: Study Team Members
All individuals, including collaborators and colleagues at other institutions, engaged in human subjects research must be listed here and in the protocol narrative – Section 2.
Who is Considered "Engaged" in Human Subjects Research?
An individual is "engaged" when they will interact with individuals and/or will have access to subject identifiable private information, records, data or biospecimens for the purposes of study performance.
1. Lead Researcher Name
Provide the name of the Lead Researcher for this study. Only one individual may serve as the Lead Researcher. Additional study team members may serve as either co-researchers or research personnel.
- The Lead Researcher must have a formal affiliation (i.e., a faculty or staff appointment; enrolled student) with UCI.
- Lead Researchers who do not meet Principal Investigator criteria need a Faculty Sponsor. See Lead Researcher Eligibility for details.
Faculty Sponsor requirement: This requirement appears on the application when the Lead Researcher (LR) needs a Faculty Sponsor because they are not eligible to serve as LR on their own. The type of appointment an individual has with UCI determines whether they may serve as a Lead Researcher on their own or whether a Faculty Sponsor is required.
- Provide the name of the Faculty Sponsor for this study. Only one individual may be listed.
- The Faculty Sponsor must have a formal affiliation with UCI (i.e., a faculty or administrator appointment).
- Faculty Sponsors must satisfy the campus policy requirements for eligibility to be Principal Investigators. See Lead Researcher Eligibility for details.
2. Co-Researcher Names (if applicable)
List the Co-researchers who will be involved in conducting the research. "Co-researchers" are equivalent to NIH's definition of "key personnel" and are typically individuals who are:
- involved in the design and conduct of the study;
- determining subject eligibility;
- performing data collection;
- interpreting and/or analyzing subject identifiable records or data; and
- authors on presentations or manuscripts related to the research.
- Undergraduates who are conducting data collection and data entry may be listed as Research Personnel if they are working under the direct supervision of the Lead Researcher or a qualified Co-Researcher.
3. Other Research Personnel (if applicable)
List any other study team members who will be engaged in conducting the research.
Undergraduates who are conducting data collection and data entry may be listed as Research Personnel if they are working under the direct supervision of the Lead Researcher or a qualified Co-Researcher.
SECTION E: Administrative Contact
The administrative contact will be copied on automated notices from the UCI human protocol database and general protocol correspondence (e.g., protocol memos, renewal notices, study expiration notices, and confirmations of protocol receipt) to facilitate communication with the Lead Researcher of the study and the IRB.
- An administrative contact is not required.
- An administrative contact must be a UCI employee with a UCI e-mail address.
- Up to 3 administrative contacts may be listed.
- Do not list the Lead Researcher here as s/he will receive duplicate e-mails.
SECTION F: Study Funding
Indicate how the study costs will be supported. Information in this section is used to link extramural awards to the applicable human subjects approvals and to assure all study costs are supported.
Please check all of the applicable boxes as funding sources for this research, including any pending sources. List all extramural proposals/awards that will support the study, as applicable.
Completing the table for extramural funding sources:
- Agency/Sponsor: List the name of the agency or sponsor (e.g., NIH). If the funding is a subaward, list the funding agency and the awardee institution (e.g., NIH—subaward thru USC). If the proposal hasn't been submitted yet, list as "submission pending".
- Award # or Proposal #: If the funds have been awarded, list the award number. If a proposal for funding has been submitted, list the Sponsored Projects (SP) proposal number. If the proposal hasn't been submitted yet, list as "pending".
- PI of the Award: List the PI of the award if it is not the same person as the Lead Researcher.
- Campus or medical center units or programs that provide research infrastructure (support), such as the Institute for Clinical and Translational Science and the Undergraduate Research Opportunities Program, should not be listed as a funding source.
SECTION G: Performance Sites
Check the box for all of the performance sites for the research study.
- A performance site is any location where study procedures, research activities, or subject identifiable private data will be used for the study.
- Identify all sites where UCI IRB approved research will be performed (i.e., where recruitment, interaction with subjects, data collection and/or analysis will take place).
- If any of the performance sites are off-site (i.e., not at the UCI campus, UCIMC or other UCI owned/leased space), Appendix A is required. Also, additional documentation may be required such as a letter of cooperation or documentation of IRB Approval from another IRB.
- If UCI will serve as a coordinating center of a multi-site study, Appendix A is required.
SECTION H: Subject Population/Data Sources
Check all subject populations/data sources that apply to the research study. More than one check box may apply to the proposed subject population(s) to be studied.
- In general, the check boxes apply to the recruitment of specific population(s) to be studied.
- Check the box, "Use of identifiable or coded data, specimens, records, charts" if the study involves no interaction with living individuals.
- Check the box, "State Death Data Files Containing Personal Identifying Information" only when California death records will be accessed (IRB review is required per California statute).
Important Note: Please review and complete this section carefully. Depending on your response to this section required appendices will be included for submission with IRB Application for Review.
SECTION I: Research Procedures Involved in the Study
Check all of the research procedures that apply to the study.
- This section includes the appendices required for informed consent waiver requests.
- More than one check box may apply to the procedures involved in the study.
Important Note: Please review and complete this section carefully. Depending on your response to this section required appendices will be included for submission with IRB Application for Review. Missing appendices required for IRB review will delay review of the application.
SECTION J: Data and Safety Monitoring Plan
- All clinical investigations, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III), involving greater than minimal risk to participants (i.e., full Committee review) are, at a minimum, required to have a data and safety monitoring plan (DSMP) to assure the safety and welfare of the research subjects.
- Although the IRB will accept the DSMPs of an outside entity (e.g., NIH, Industry Sponsor, Cooperative Groups) submission of a completed Appendix S is still required.
SECTION K: Controlled Substances/Potentially Hazardous Materials to be Used
This information is collected for the UCI Dept. of Environmental Health & Safety for occupational health purposes.
If the research will involve controlled substance(s) include the information in this section.
Check all of the boxes that apply to the research study and where indicated, list the potentially hazardous material(s) to be used.
SECTION L: Other UCI Committee Reviews
Check all of the applicable committee or departmental reviews that are required for this research. Click on the committee links for detailed information about the committee's oversight and the type of research that requires their approval or contact the Administrator.
Important Note: Before review by the IRB it is important to determine if your protocol requires review by one of the committees listed below. IRB review will not occur until all prerequisite committee reviews have taken place.
The Chao Family Comprehensive Cancer Center (Cancer Center) Protocol Review and Monitoring Committee (PRMC)
- The PRMC reviews all human studies that involve patients with cancer, participants at risk for cancer, or participants of a study involving a specific cancer focus even if the proposed research has been peer-reviewed by NIH.
- Documentation of PRMC Approval for full committee protocols is required prior to IRB review. PRMC Reviewer comments must be provided to the IRB.
- For Expedited and Exempt research, IRB approval is held pending receipt of PRMC Approval or Exemption.
Clinical Research Billing (CRB)
- CRB is responsible for ensuring proper registration and billing practices for all human subjects receiving clinical care while enrolled on clinical research studies.
- CRB approval is required prior to initiation of the human subjects research study.
Conflict of Interest Oversight Committee (COIOC)
- The COIOC is charged with ensuring that a researcher's personal interest in, or commitment to, entities outside the University's purview does not compromise or appear to compromise his/her objectivity in performing a research project.
- IRB review of new study applications may run concurrent with COIOC review. However, if the COIOC report and suggested consent language are not available at the time IRB review, the IRB must "T" the new study pending this information. Once the report is available, the new study must return to the full IRB for final review and approval.
Institute for Clinical and Translational Science - Scientific Review Committee (ICTS SRC)
Only greater than minimal risk protocols that meet the following criteria require peer scientific review by the Scientific Review Committee (SRC) of the ICTS:
- Greater than minimal risk protocols that meet the following criteria:
- College of Health Sciences (COHS) faculty as Lead Researcher;
- investigator-initiated studies; and
- research has not received peer scientific review.
- Exempt and Expedited level protocols DO NOT require SRC review, unless mandated by the IRB Subcommittee. The IRB can require SRC review of Exempt and Expedited level protocols when the IRB is concerned about a protocol's scientific aims and testable hypotheses, scientific validity and feasibility, relevant preliminary results or published data, etc.
- All UCI studies requesting ICTS resources of any kind require ICTS SRC and resource review.
- ICTS SRC clearance for full committee protocols is required before IRB review. ICTS SRC reviewer comments, including ICTS SRC clearance must be provided to the IRB at the time of their review.
Radioactive Drug Research Committee (RDRC)
- The Radioactive Drug Research Committee (RDRC) is charged with the review and approval of human subjects research that involves a radioactive drug. RDRC approval can be granted if the radioactive drug is generally recognized as safe and effective when administered under conditions specified in the RDRC regulations (21 CFR 361.1). RDRC approval permits basic research using radioactive drugs in humans without an IND when the drug is administered under specific conditions.
- When the research involves radioactive materials, documentation of RDRC review, including RDRC comments OR documentation of an IND from the FDA is required before IRB review. RDRC comments, including RDRC approval OR documentation of receipt of an IND from the FDA must be provided to the IRB at the time of their review.
- For more information about the RDRC contact Cathryn Lucas, RDRC Administrator, 949-824-7735 or email@example.com.
UCI Institutional Biosafety Committee (IBC)
- The IBC reviews the use of all potentially hazardous biological agents including but not limited to infectious agents, human and non human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer.
- The IBC ensures that research involving these agents is conducted in a manner that does not endanger the researcher, laboratory worker, human research subjects, the public or the environment.
- * For research involving recombinant DNA activities evidence of IBC approval is required prior to IRB approval. IBC comments, including IBC approval must be provided to the IRB at the time of their review.
- Securing IBC approval for biosafety issues (e.g., blood draws, specimens transferred from clinic to UCI lab, etc.) is the responsibility of the LR and is required before clinical research procedures are initiated.
- For more information about the IBC contact Alice Lee, IBC Administrator, 949-824-8024.
UCI Human Stem Cell Research Oversight (hSCRO) Committee
The hSCRO Committee reviews all research involving derivation and/or use of human stem cells from any source, regardless of funding. This includes:
- Use of human gametes and blastocysts (embryos),
- Derivation and/or use of human embryonic stem cells (hESCs),
- human embryonic or fetal germ cells,
- human adult and fetal stem cells, and
- Any other human pluripotent stem cells.
- hSCRO approval is required before IRB review can proceed. hSCRO comments, including hSCRO approval must be provided to the IRB at the time of their review. OR staff will facilitate the review process for investigators.
UCI Radiation Safety Committee (RSC)
- All protocols involving human use of radioactive materials and/or radiation-producing equipment must be performed under a Radiation Use Authorization (RUA) approved by the Medical Radiation Safety Committee.
- RSC approval is required before IRB review. RSC comments, consent language and RSC authorization must be provided to the IRB at the time of their review.
OR/Procedural Services Committee
- LR's conducting human subjects research in the surgical units must notify the UCIMC OR/Procedural Services Committee before study procedures can be initiated. A copy of the protocol must be provided to the Committee.
- Notifying the OR/Procedural Services Committee is the responsibility of the LR and is required before clinical research procedures can be initiated in the surgical units. Notification should be sent to Ms. Laura Bruzzone at firstname.lastname@example.org.
SECTION M: Disclosure of Investigators' Financial Interests
The Conflict of Interest Oversight Committee (COIOC) must consider the effect of disclosed financial interests on the rights and welfare of the human subjects participants. The COIOC must consider whether the rights of the participants would be better protected by reduction or disclosure of a financial interest, separation of responsibilities for financial and research decisions, additional oversight, elimination of a financial interest, implementation of an independent data and monitoring committee, modification of roles in research staff, or any other mechanism which would mitigate effects of the financial interest.
In an effort to facilitate the regulatory review process, FOR NEW STUDIES ONLY, IRB review may run concurrent with COIOC review. However, if the COIOC report and suggested consent language are not available at the time IRB review, the IRB must "T" the new study pending this information. Once the report is available, the new study must return to the full IRB for final review and approval. COIOC review and acceptance of the COIOC's recommendations are required prior to IRB review. The COIOC's findings will be provided to the IRB and the IRB will confirm that the COIOC has adequately considered the effect of the disclosed financial interests on the rights and welfare of the participants.
Investigators shall report for themselves, their spouses and dependent children the following disclosable financial interests:
- Ownership interest, stock, stock options, or other financial interest related to the research, unless it meets all four tests:
- Less than $10,000 when aggregated for the immediate family and
- Publicly traded on a stock exchange and
- Value will not be affected by the outcome of the research and
- Less than 5% interest in any one single entity.
- Compensation related to the research, including salary, consultant payments, honoraria, royalty payments, dividends, loans, or any other payments or consideration with value, including payments made to the University Health Sciences Compensation Plan, unless it meets both of the following tests:
- Less than $10,000 in the past year when aggregated for the immediate family and the
- Amount will not be affected by the outcome of the research.
- Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
- Board or executive relationship (e.g., director, officer, partner, or trustee) related to the research, regardless of compensation.
DEPARTMENTAL OR ORGANIZED RESEARCH UNIT APPROVAL
Once the IRB application has been electronically submitted a PDF version of the IRB application will be available for printing.
This signature page will be included in the IRB Application print out and will require the signature of your Department Chair or ORU Director.
If the study will be performed under the auspices of a Department (includes campus centers and school-based research units) the Department Chair of the Lead Researcher (or the Faculty Sponsor when applicable) must read and sign the IRB Application indicating departmental approval. Submission of the signed IRB Application must be provided to the IRB before the IRB approval letter and IRB approved documents will be released.
A scanned version of the signed document may be forwarded to the IRB mailbox in lieu of providing the original hard copy. We will also accept a faxed version of the signed document @ 949-824-1465.
- If the Department Chair is a member of the research team on this application (including Faculty Sponsor), approval must be obtained from the next highest level of administrative authority (e.g., School Dean).
In situations where the Executive Vice Chancellor or the Vice Chancellor for Research is the next highest level of administrative authority, a signature is required, as applicable. If the study will be performed under the auspices of an Organized Research Unit (ORU) the ORU Director must read and sign the IRB Application indicating ORU approval. Submission of the signed IRB Application must be provided to the IRB before the IRB approval letter and IRB approved documents will be released. If the ORU Director is a member of the research team on this application (including Faculty Sponsor), signature is required from the Vice Chancellor for Research.
Once the IRB application has been electronically submitted, a PDF version of the IRB application will be available for printing.
This assurance will be included in the IRB Application print out and will require the signature of the Lead Researcher and Faculty Sponsor (if required).
Please read and sign the Investigator's Assurance document.
Submission of the signed IRB Application must be provided to the IRB before the IRB approval letter and IRB approved documents will be released.
A scanned version of the signed document may be forwarded to the IRB mailbox in lieu of providing the original hard copy. We will also accept a faxed version of the signed document @ 949-824-1465. Researchers should save a copy of the signed IRB Application as part of their research record-keeping responsibilities.
Submission of the signed IRB Application must be provided to the IRB before the IRB approval letter and IRB approved documents will be released.
Part 3: Conditions of Approval
UCI Research Policies
All individuals engaged in human subjects research are responsible for compliance with all applicable UCI Research Policies. The Lead Researcher of the study is ultimately responsible for assuring all study team members review and adhere to applicable policies for the conduct of human subjects research.
Lead Researcher Recordkeeping Responsibilities
The Office of Research Administration is the office of record for the UCI Human Research Protections Program. Lead Researchers are responsible for keeping protocol and study records. The following web pages should be reviewed for more information about the Lead Researcher's recordkeeping responsibilities, and preparation and maintenance of research files. See Lead Researcher's recordkeeping responsibilities and preparation and maintenance of research files for more information.
IRB Protocol Exempt Registrations
- All exempt protocols are registered for a period of 3 years. If the study will continue beyond 3 years, a new IRB application is required.
- No annual continuing renewals are required.
- Exempt registrations are subject to modification requests, adverse event/unanticipated problems, and closing report requirements (see below).
IRB Protocol Approvals and Continuing Review (Expedited and Full Committee)
Continuing Review information is available on the IRB website.
- The majority of protocols are approved for a maximum of 365 days and require annual continuing review. Some minimal risk studies that do not require federal oversight may be granted a three year approval. Researchers will be notified by staff and the period of approval will be listed on the IRB Approval Letter.
- An electronic Continuing Protocol Application (e-CPA) must be submitted, reviewed and approved before the protocol expiration date in order for research to continue.
- The level of review of the e-CPA is based upon the last level of review (e.g., a protocol reviewed at the full committee will require the e-CPA to be reviewed at full committee).
- All protocols are subject to modification requests, adverse event/unanticipated problems, and closing report requirements (see below).
Lapses in approval should be avoided to protect the safety and welfare of enrolled subjects.
- Federal regulations do not allow for a grace period extending the conduct of the research beyond the expiration date of IRB approval period unless the safety and welfare of subjects would be jeopardized if the study procedures were to be discontinued.
- If subjects are enrolled and their safety or welfare is at risk, a request to continue care of these individuals must be submitted for IRB consideration.
- Under this circumstance, the IRB may determine that appropriate medical care may continue beyond the expiration date for a reasonable amount of time to eliminate apparent immediate hazards to the subjects; however, the data collected during the lapsed approval period may not be used for research and new subjects cannot be enrolled into the study.
If IRB Approval Expires:
If the IRB has not reviewed and approved a research study by the study expiration date, all research activities must stop. This includes:
- Recruitment and informed consent procedures
- Collection of data/information from or about living individuals
- All research-related interventions or interactions with currently enrolled subjects (unless the IRB finds that it is in the best interests of the individual subjects to continue participating in the research interventions or interactions.)
- Analyses involving private identifiable human subjects data
Investigators will be asked to confirm the above information when continuing protocol applications are submitted after protocol expiration.
IRB Protocol Modifications
Protocol Modifications information is available on the IRB website.
- The approved or registered IRB protocol must be strictly followed.
- Unlike a funding proposal, any changes to the research as approved in the protocol narrative must be requested prospectively and approved by the IRB.
- All changes (e.g., a change in procedure, number of subjects, personnel, study locations, new recruitment materials, study instruments, etc.) must be prospectively reviewed and approved by the IRB before they are implemented.
- An electronic Modification Request (e-MOD) must be submitted for all proposed changes.
Adverse Event and Unanticipated Problems
All adverse events and unanticipated problems must be reported to the IRB per UCI IRB reporting requirements.
An electronic closing report must be filed with the IRB when the research concludes.