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Instructions for Completing the IRB Protocol Narrative

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:

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.:

Information to include for research involving clinical interactions and interventions:

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

SECTION 4: SUBJECTS (PERSONS/CHARTS/RECORDS/SPECIMENS)

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.

  1. Number of Subjects
    2.
    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.

  2. Inclusion and Exclusion Criteria
    3.
    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. Pay close attention to the bullet points in blue under each recruitment method.

Important Recruitment Notes:

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.

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:

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:

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: