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Instructions for Submitting and Completing the Application for IRB Review

The instructions are broken into 4 parts. You may jump to a specific part of the instructions page by clicking on any of the following links:

• Part 1: Submission Requirements
• Part 2: Completing the Application for IRB Review
• Part 3: Completing the Protocol Narrative for IRB Review
• Part 4: Conditions of Approval

Part 1: Submission Requirements

In order to demonstrate appropriate oversight of human research activities and to comply with federal and state statutes, regulations, policies and guidelines, and applicable University policies and procedures, no human subjects research, clinical investigation, derivation and use of human stem cells, or use of state death data records shall be initiated prior to obtaining UCI IRB review and approval or registration.

UCI's Human Research Protection Program (HRPP) 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 Associate Director of Research Protections at 949-824-1558 or karen.allen@uci.edu.

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.

See the UCI HRPP website for guidance on the Levels of Review. Once the level of review has been determined, investigators should complete the application and submit it for IRB review. No human research may begin until an IRB registration or approval letter is provided.

Pre-Requisitse

Other Required UCI Reviews

Before submitting the Application for IRB Review, other prerequisite UCI reviews may be required.

Human Research Education Requirements

All study team members must complete the UCI human research tutorial (some exceptions are provided below) in order to be approved to perform human subjects research at UCI. The UCI Tutorials are located on the ORA website.

UCI Human Research Tutorial

• This tutorial is required for all UCI employees (faculty, staff) and students.
• Non-UCI affiliated study team members may take the UCI 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 study 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

All 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.

IRB Application:

• Complete the entire application and give special consideration to the sections with Appendices. Many of the check boxes in these sections generate appendices that provide additional information required for IRB review. IRB review will be delayed if the application is submitted without the required appendices.

IRB Protocol Narrative:

• The IRB Application will prompt the user to download the Protocol Narrative. Alternatively, the protocol narrative is available on the IRB Forms webpage.
• 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 IRB forms page on the web.
• Full committee studies almost always require a written informed consent document. An informed consent document should be uploaded to the electronic IRB Application.
• Expedited studiesrequire a written informed consent document unless a waiver of informed consent or a waiver of documentation of consent can be justified (See Appendices O and P).
• Exempt studiesdo 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 from the IRB forms page on the web.
• 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.
• Once the Informed Consent Document is completed, it must be uploaded to the electronic IRB Application module.
• Remember to download and save the consent to your computer before uploading it to the electronic IRB application.

Other Documents for IRB Review:

Be sure to upload other documents to the electronic IRB application for review and approval. Additional attachments may include but are not limited to:

• Sponsor investigator brochures and master protocols (required for clinical trials)
• The "Human Subjects" section of funding proposals (required for DHHS proposals and funded studies)
• Recruitment materials such as advertisements and flyers
• Questionnaires and survey instruments
• Permission letters from offsite locations
• IRB approval letters from offsite collaborators
• Verbal scripts and study information sheets
• Data and safety monitoring plans
• Data collection instruments (required for all un-validated measurements)
• Other UCI committee review and approval letters (e.g., DSRC, CTPRMC, GAC, CFRA, hSCRO)

Materials to Submit in Hard Copy After Electronic Submission

After the Lead Researcher has electronically submitted the e-IRBAPP the following hard copy documentation must be submitted:

• 1 copy of e-IRB Application (including the Investigator's Assurance(s) and Disclosure of Financial Interests Statement) with original signatures of Lead Researcher and Department Chair or Organized Research Unit Director, and Faculty Sponsor, if required.
• For clinical investigations, 4 copies of the Sponsor/Master Protocol and the Investigator's Brochure

For studies where some of the required documentation (e.g., survey packets, interview schedules, and permission letters) was not uploaded and submitted during the e-IRBAPP process, 4 copies of these materials.

Submit the required hard copy documentation to the Office of Research Administration (ORA), Institutional Review Board, 4199 Campus Drive, Suite 300 University Tower, Zot Code 7600.

Note: Applications will be reviewed by the IRB once the application has been submitted electronically and the hard copies with required signatures are received in the ORA.

Full Committee Meeting Deadlines

Protocols requiring Full Committee review must be submitted electronically and the hard copies received in the Office of Research Administration no later than 5:00 pm on the deadline day* to be considered for inclusion on the agenda of the next full Committee meeting.

See the HRPP 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 and sometimes protocols are deferred by the Research Administration to the next meeting date even when they are received by 5:00 pm on a deadline day.
• Biomedical committee agendas are limited to 25 items each; modifications and continuing review of existing studies with enrolled subjects take priority over new submissions.
• Up to 10 new protocols are accepted for each full committee meeting agenda.
• Investigators should allow 30 to 60 days for full committee review of new protocols.

To Which Committee Should I Submit?

UCI has three IRBs: 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 fMRI may be reviewed by IRB-C because the protocol for the use of the experimental 4T fMRI has been approved by one of the biomedical IRBs. All subjects will be required to sign a separate informed consent document for 4T fMRI imaging.

What Occurs After Protocol Submission?

Protocol Tracking:

When a completed protocol application packet is received it is assigned a unique protocol identification number (beginning with "HS#") that 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 protocol. 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 protocols are not posted to the web. Lead Researchers should allow at least 10 working 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:

Protocols that receive a Committee vote of A- Approval:

• Stamped approval documents and an approval letter will be sent to the Lead Researcher within 3 to 5 working days.
• Research studies should not begin until stamped approval documents are received.

Protocols that receive a Committee vote of M - Minor Changes or T - Tabled for Re-Review:

• Detailed feedback from the IRB will be sent via e-mail within 10 working days of the review.
• Research studies must not begin until stamped approval documents are received.

Part 2: Completing the Application for IRB Review

Please review the Human Research Protection Program (HRPP) 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. Investigators 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

Review the HRPP website to determine the required Level of Review.

Notes:

• 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.

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 the review of 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.

Notes:

• If any of the boxes in Question 1 are checked, HIPAA regulations apply to the study and additional information is necessary in Question 3 of this section.
• Appendix T is required for IRB review when a total or partial waiver of HIPAA research authorization is requested.
• The HIPAA Authorization for Release of PHI for Research Purposes-2004, is located the IRB Forms webpage. This form must be signed by each subject consented to the study, unless a waiver is granted by the IRB. This 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.

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 records or data for the purposes of study performance. Individuals who will be authors on presentations or manuscripts related to the research are also "engaged" and should be included as study team members.

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.

Notes:

• 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.

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.

Notes:

• In addition to the Lead Researcher (and the Faculty Sponsor when required), only those individuals listed as Co-researchers may be involved in the informed consent process of full committee studies.
• 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.

Note: 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.

Notes:

• 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; duplicate e-mails will be sent.

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 or 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.

Note:

• Campus or medical center units or programs that provide research infrastructure (support), such as the General Clinical Research Center 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 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.
• 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.

• The first check box should be checked only for studies that involve no interaction with living individuals.
• The last check box should be checked only when California death records will be accessed (IRB review is required per California statute)
• The remaining check boxes apply to the recruitment of specific population(s) to be studied.
• More than one check box may apply to the subject population(s) to be studied.

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.

Notes:

• 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.

SECTION J: Data and Safety Monitoring Plan

Indicate whether an independent monitor, board or committee exists to review the study for safety and adherence to the study protocol.

Important Notes:

• Full Committee protocols that involve clinical investigations must have a data and safety monitoring plan (DSMP).
• The IRB will accept DSMPs from the GCRC and the CTPRMC. Generally, these DSMPs are required for their committee reviews.
• • For links to these committees, see Other UCI Reviews on the HRPP website.
• The IRB will accept DSMPs from the Sponsor of the trial.

SECTION K: Potentially Hazardous Materials to be Used

Check all of the boxes that apply to the research study and where indicated, list the material(s) to be used. This information is collected for the UCI Dept. of Environmental Health & Safety for occupational health purposes.

SECTION L: Other UCI Committee Reviews

Check all of the applicable committee 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.

Important Note: All Committees marked with an asterisk (*) below are a pre-requisite for IRB review. Before submission to 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 pre-requisite committee reviews have taken place.

Clinical Trials Protocol Review and Monitoring Committee (CTPRMC)*

• The CTPRMC reviews all human studies that involve patients with cancer, participants at risk for cancer, or participants of a study involving a specific cancer focus.
• A copy of the CTPRMC approval letter must accompany the IRB submission.

Clinical Research Finance Assessment (CRFA)

• The CRFA is responsible for ensuring proper registration and billing practices for all human subjects receiving clinical care while enrolled on clinical research studies.
• A copy of the CRFA approval letter should accompany the IRB submission.

School of Medicine - Dean's Scientific Review Committee (DSRC)*

• The DSRC performs scientific review for projects that have not been externally peer-reviewed. DSRC review is required for all protocols that involve SOM faculty or where research-related tests or procedures are performed at any SOM facility or clinical site.
• A copy of the DSRC approval letter must accompany the IRB submission.

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.

General Clinical Research Center Protocols Advisory Committee (GAC)

• The GAC reviews all protocols requesting utilization of GCRC services. The GAC performs scientific review of the proposed research, and review for allocation of available resources.
• An application must be submitted to the GAC in order for the IRB review to occur.

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 more information about the IBC contact Karla Cornejo, IBC Administrator, 949-824-3757.

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.

UCI Radiation Safety Committee Review

• 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 Campus or Medical Radiation Safety Committee.

SECTION M: Departmental or Organized Research Unit Approval

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 protocol indicating approval before IRB review may occur.

Notes:

• 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, no signature is required.

If the study will be performed under the auspices of an Organized Research Unit (ORU) the ORU Director must read and sign the protocol indicating approval before IRB review may occur.

• Note: If the ORU Director is a member of the research team on this application (including Faculty Sponsor), no approval signature is required from the Vice Chancellor for Research.

INVESTIGATOR'S ASSURANCE

The Lead Researcher and Faculty Sponsor (if required) must read and sign the Investigator's Assurance document.

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.

Final COIOC approval is conditioned upon the IRB's review of the COIOC findings and communication from the IRB 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.

Part 3: Completing the Protocol Narrative for IRB Review

The protocol narrative describes the research methodology and procedures that will be performed. It is the primary document used by the IRB to assure that all of the federal criteria for review and approval of human subjects research have been satisfied. The protocol narrative must reflect the duties of all study team members involved in the study, and all research procedures, recruitment and informed consent procedures, etc. that will be used.

Detailed information for completing various sections of the protocol narrative is available on the Human Research Protections Program website and in the instructions below.

NON-TECHNICAL SUMMARY

Provide a non-technical summary of the proposed research project that can be understood by IRB members with varied research backgrounds, non-scientists and community members. The summary should include a brief statement of the purpose of the research and related theory/data supporting the intent of the study and a brief description of the procedure(s) involving human subjects. This summary should not exceed more than ½ a page.

SECTION 1: Purpose and Background of the Research

Review all the items in this section and provide a brief response to each. Emphasize those aspects that justify involving individuals and/or the use of private, identifiable information about living individuals in the research. Do not include detailed information on the methods and experimental procedures. These details should be included in Section 3.

SECTION 2: Roles and Expertise of the Study Team

List all study team members listed in Section C of the application in this section of the protocol narrative. Provide detailed information for each study team member as requested.

Notes:

• The information described here should provide the committee with adequate information to assess each person's training and experience in relation to the role they will serve as a part of the study team.
• This information provided here should not read like a NIH bio-sketch or curriculum vitae.

SECTION 3: Research Methodology/Study Procedures

1. Provide a detailed description of each phase of the study (e.g., pilot, screening, intervention, and follow-up).
2. Include the sequence and timing of all study procedures to be performed (e.g., blood volume, repetitions, name of standardized measure).
3. For procedures that involve collection of sensitive information (e.g., information that could place subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation) describe how you will protect the privacy of the subjects during data collected.

Note: Do not "cut and paste" the research design and methods section of a funding proposal into the protocol narrative. Funding proposals typically are abstract and do not adequately delineate or define the research procedures to be performed. The IRB needs specific details about what procedures will be performed, when they will be performed and why they are necessary. For more complex protocols, a simple flow chart can be provided to help explain the sequence of procedures. If preliminary studies will need to be completed on human subjects before the procedures for additional study phases can be defined, please state that modification requests will be submitted to the IRB before the new procedures will be performed.

Information to include for research involving survey, interviews, questionnaires, focus groups, cognitive or perceptual studies, etc.:

• Describe the setting and mode> of administering the instrument (e.g., telephone, in-person, group setting, computer-based).
• Include the approximate duration, intervals of administration and overall length of participation.
• For cognitive or perceptual studies, include the number of trials per session, the intervals between sessions, and breaks provided for subjects.
• Provide a copy of all data collection instrument(s) that will be used. Examples include:
• interview schedules (required for all studies),
• standardized instruments (required for all social-behavioral studies) and
• un-validated surveys and questionnaires (required for all studies).
• If a study instrument is not yet designed, provide a sample of the questions or describe the subject matter to be covered. If the instrument is available in draft format, please provide a copy. All final instruments must be reviewed and approved by the UCI IRB before they may be used.

Information to include for research involving clinical interactions and interventions:

• For all procedures and interventions, distinguish between those procedures that are considered experimental, investigational and/or are carried out solely for research purposes versus those procedures that are considered standard treatment or therapy (i.e., procedures that participants would receive even if not participating in the research).
• Standard treatments, therapies and procedures performed exclusively for research purposes must be clearly identified (e.g., blood draw, MRI).
• Standard treatments, therapies or procedures are those that are covered routinely by Medicare. For more information contact the Office of Clinical Research Finance Assessment.

Information to include for research involving existing records, data or specimens:

• Identify the source(s) of the records/data/specimens and how/why they are available for research purposes.
• Specify whether the records/data/specimens were collected for non-research (e.g., clinical) or research purposes.
• Specify whether the records/data/specimens contain individually identifiable information about living individuals or whether the records/data/specimens are de-identified or coded (i.e., identifiers for the records/data/specimens exist, but they will not be used and/or are not available to the study team.)
• Research records/data/specimens explain what the subjects were told during the informed consent process about the use of their records/data/specimens for future research. Provide the IRB protocol number if records/data/specimens were collected under another UCI research study.

SECTION 4: Subjects (Persons/Charts/Records/Speciments)

Review and provide a response for all of the items in this section. The IRB’s review must include consideration of all subjects who will be contacted for possible recruitment to participation in the study.

A: Number of Subjects

1. Indicate the maximum number of subjects to be consented on this UCI protocol.
2. Of the maximum number of subjects listed above, indicate the target sample size for the study.
3. Explain how the target sample size was determined (e.g., power analysis; review of related literature).
4. For multi-center research, indicate the overall sample size for the entire project (across all sites).

Consented means:

• those subjects who will be approached for recruitment, participate in an informed consent process and screened for participation--be sure to factor in any screen failures, projected subject withdrawals and early terminations of subject participation, or
• the number of existing charts, records, specimens, that will be reviewed/analyzed to compile the data or sample population necessary to address the research question, the number of individuals represented in a dataset, or
• the number of people directly solicited (for mail or internet surveys).
• The number of subjects consented, or the number of charts records and specimens to be reviewed/analyzed must not exceed the number approved by the IRB (unless a modification request to increase the sample size is approved).

Target sample size means:

• the number of subjects expected to complete the study, or
• the number of subjects to be enrolled to fulfill study aims or the number necessary to address the research question.
• If the study only involves use of existing records, charts, specimens, specify the target number needed to address the research question.

How the target sample size was determined:

• Explain how the number of subjects, charts, records, or specimens was determined to be sufficient to test the specific aims and/or hypotheses of the study.
• If it is difficult to predict how many subjects will be eligible or interested in a study, the optimum number of subjects should be specified.

Multi-center research studies include clinical trials, cooperative group studies, etc. where the identical research is being conducted by non-UCI personnel at other sites/institutions.

Notes:

• Investigators must keep track of the number of subjects enrolled or charts, records, or specimens used each year and the cumulative total from initial approval. These totals, as well as a breakdown of subjects by gender and ethnicity, must be reported to the IRB at the time of continuing review.
• Inclusion and Exclusion Criteria:
  1. Describe the characteristics and provide justification for inclusion of the proposed subject population. At a minimum include information about the age and gender of the study population.
  2. Provide the inclusion and/or exclusion criteria for the proposed subject population, as applicable.
  3. If exclusion is based on age, gender, pregnancy or childbearing potential, or race/ethnicity, provide a scientific rationale.

Notes:

• Inclusion and exclusion criteria should be listed in tabular form.
• Equitable inclusion of men and women of all ages and individuals from diverse racial/ethnic backgrounds is important to assure that they receive an equal share of the benefits of research and do not bear a disproportionate share of its burdens.
• Studies with the potential to address issues relevant to both sexes must recruit both genders.

SECTION 5: Recruitment Methods and Process

A. Recruitment Methods

Review all the items in this section and choose which methods will be used to identify and recruit subjects for this study.

Important Recruitment Notes:

• All recruitment materials must be submitted for IRB review and approval before they may be used. Samples of all advertisements, such as flyers, newspaper ads, radio and television announcements, URLs, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting subjects, must be submitted to the IRB.
• Recruitment materials are stamped with an approval date and they do not expire unless they are altered.
• The UCI Medical Center Clinical Trials Web Page Standard Research Recruitment advertisement must be submitted for IRB review.
• All advertisements for the Social Sciences human subject pool must be submitted for IRB review.

A description of the recruitment procedures must be provided in Section 5B as indicated. If more than one method will be used, describe which groups of subjects or phases of the study will involve each recruitment method.

Additional requirements for recruitment using patient referrals and medical records:

Recruitment Method #1 - Referrals:
UCI IRB approved recruitment materials (e.g., recruitment flyer, introductory letter) sent to colleagues asking for referral of eligible participants and colleagues. Permission from interested individuals is given to release contact information to the study team for recruitment.*

*Requirements:

1. Any patient contact information about ineligible patients or patients who declined participation must not be shared with other researchers and cannot be retained for future recruitment to other studies.
2. Written UC HIPAA Research Authorization will be obtained from the subject if they agree to participate and before any further study team access to PHI.

Recruitment Method #2 - Medical Records:
UCI study team members will screen UCIMC medical records to determine subject eligibility and approach patients directly about study participation.*

*Requirements:

1. Only patients who have read and acknowledged (signed) the UC Notice of Privacy Practices may have their UCIMC medical records reviewed by the study team;
2. When feasible, the treating physician should be notified of the intent to contact the patient for research recruitment.
3. Any patient information obtained for subject selection will not leave the covered entity (UCI) and will not be shared with non-UCI entities.
4. Information about ineligible patients will not be retained for future recruitment to other studies.
5. Written UC HIPAA Research Authorization will be obtained from the subject if they agree to participate and before any further access to PHI.

B. Recruitment Process

1. Based on the boxes checked in Part A, describe and provide details of the recruitment process (i.e., when, where, by whom and how potential subjects will be approached).
2. If active recruitment methods will be used, explain how the individual's privacy will be protected.

SECTION 6: Informed Consent Process

Describe the specific steps for obtaining informed consent from subjects.

1. Include information about the when and where consent will take place and the length of time subjects are given to decide whether they wish to participate.
2. If study team members will approach their own patients, students, or employees for participation in the study, explain what precautions will be taken to minimize potential undue influence or coercion, and how compromised objectivity will be avoided.
3. Explain whether all adult subjects likely will have the capacity to give informed consent. Note: If decision making capacity assessments will be performed or surrogate consent is requested, Appendix D must be submitted for IRB review.
4. Explain whether any information will be withheld from the potential subjects about the research purpose or study design. If yes, Appendices G and O must be submitted for IRB review.
5. If requesting a waiver of documentation of informed consent (will obtain verbal consent), Complete Appendix P.

Notes:

• There are two consent templates on the IRB forms page: one for biomedical research and one for social behavioral research.
• Please review the Informed Consent Process webpage before completing this section.
• If children are involved, parental consent and child assent procedures should be described. Appendix D is required. See the page on Vulnerable Subject Populations for more information.
• If you are requesting the use of a short form consent process, please describe the process that will be used and complete Appendix Q. The IRB will not approve the use of the Short Form Consent Process for studies that involve vulnerable populations, placebo groups/phases, or Phase 1 clinical trials.

SECTION 7: Risk Assessment and Possible Benefits

1. Risk Assessment
• Choose the appropriate level of review based upon the investigator’s risk assessment.
• If the study qualifies for exempt or expedited review status, list the applicable category and provide a justification for the level of review and category chosen.
• See levels of review on IRB website for more information.
• See assessing risks and benefits on the IRB website for more information.


2. Risks and Discomforts
• Describe the potential risks/discomforts (e.g., physical, psychological, social, economic) associated with each intervention or research procedure.
• Estimate the probability (e.g., chance or likeliness of occurrence) that a given harm may occur and its severity (e.g., mild, moderate, severe).
• Discuss what measures will be taken to prevent and minimize any potential risks/discomforts.
• For Full Committee protocols, state whether study procedures may involve risks to the subject (or embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.


3. Potential Benefits
• Discuss the benefits that may accrue directly to the subjects. Note: Compensation is not a benefit. Do not include it in this section.
• Describe the potential societal benefit(s) that may be expected from this research.

SECTION 8: Alternatives to Participation

Describe appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject or indicate that the only alternative is non-participation. Assure that these will be discussed with potential subjects before they are enrolled. If no alternatives exist, indicate that the only alternative is not to participate in the research study.

Note: If standard treatments, therapies or procedures are a part of the study, indicate that potential subjects may receive these treatment/therapies off study (i.e., without participating in the research study.)

SECTION 9: Adverse Event Reporting/Management and Compensation for Injury

1. Adverse Events and Unanticipated Problems
• Indicate that you are familiar with UCI's Adverse Events/Unanticipated Problems reporting policy and procedures. See http://www.research.uci.edu/ora/hrpp/adverseexperiences.htm for details.
• Explain how the research team will respond to adverse events and unanticipated problems that may occur during the study or after completion of the study.
2. Compensation for Injury
• For Full Committee protocols, explain how costs of treatment for research related injury will be covered.

SECTION 10: Participant Costs

Identify and estimate those costs to be borne by subjects or their insurers, including costs of standard medical interventions or procedures or indicate that there are no costs to subjects/insurers.

In general, neither subjects nor their insurers should be billed for research-related costs. Research-related costs are those costs generated specifically as a result of the subject's participation in a research project and which would not otherwise have been generated in the course of the subject's routine and customary health care.

The Clinical Research Finance Assessment (CRFA) at UCIMC determines what costs may be billed to subjects/third party payors. See Other UCI Reviews on the HRPP website for more details.

CRFA uses the following guidance, based upon the Medicare NCD:

• Research-related costs may be billed to subjects who participate in studies where the experimental intervention is thought to be the most appropriate course of treatment or is considered to be conventional care for the subjects/patients, and
• No other funding (e.g., sponsor support) is available to cover such costs, and
• Most 3rd party payors will cover the costs.

Note: If subjects/insurers will be billed for an experimental drug or device, evidence of prior FDA approval for billing of subjects must be provided.

SECTION 11: Participant Compensation and Reimbursement

If subjects will be compensated for their participation, provide detailed information about the amount and the method/terms of payment (e.g., money; check; extra credit; gift certificate). In addition:

1. Describe the schedule of compensation (e.g., at end of study; after each session/visit).
2. Compensation will be offered on a prorated basis.
3. Specify whether subjects will be reimbursed for out-of pocket expenses. If so, describe any requirements for reimbursement (e.g., receipt).

SECTION 12: Confidentiality of Research Data

1. Explain how data will be collected and recorded (e.g., hard copy documents, audio and/or video recordings, computer files, specimens).
2. Indicate whether subject identifiers will be linked (directly or indirectly via a code) to the research data.
3. Indicate how data will be secured including paper records, electronic files, audio/video tapes, specimens, etc. NOTE: The more sensitive the study data, the more sophisticated the methods should be to maintain confidentiality.
4. Data on portable devices:
• Describe the portable device(s) to be used (e.g. laptop, PDA).
• Specify whether subject identifiable data will be stored on the device. If so, justify why it is necessary to store subject identifiers on the device.
5. Specify who will have access to subject identifiable data and records (e.g., study team, FDA, OHRP, Sponsor).
6. Explain how long the research data (hard copy documents, computer files, recordings) will be retained once the research has been completed (e.g., destroyed upon study completion; stored for future research; retained for a specified timeframe, etc.) Note: If your study involves the creation of a research database or specimen repository, or you plan to share data or specimens for secondary uses or analyses, Appendix M is required.
7. If a Certificate of Confidentiality (COC) will be/has been sought from NIH, explain in what situations personally identifiable information protected by a COC will be disclosed by the UCI study team. A copy of the COC should accompany the IRB application or be provided to the IRB upon receipt.

Notes on Certificates of Confidentiality:

• See Certificates of Confidentiality for more information.
• When applying for an NIH Certificate, the application should be sent to the Office of Research Administration first for institutional endorsement from the Vice Chancellor for Research.

Part 4: 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 three year renewal application is required.
• No annual continuing renewals are required.
• Exempt registrations are subject to IRB protocol modification, adverse event/unanticipated problems, and closing report requirements (see below).

IRB Protocol Approvals and Continuing Review (Expedited and Full Committee)

Continuing Renewal information is available on the IRB website.

• Protocols are approved for a maximum of 365 days and require annual continuing review.
• 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 IRB protocol modification, 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 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.

Closing Report

An electronic closing report must be filed with the IRB when the research concludes.

 

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Last Updated: June 23, 2008