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    Institutional Review Board (IRB)
    Protocol Summary Form

    Printer-friendly verson: Protocol Summary Form [MSWord 58KB]
    If you have problems using the Word document listed above, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, 5th Floor, P-Campus,
    San Francisco, CA 94115

    For questions and help, please call:
    Leigh Pruneau, PhD, RN, CIP.
    Human Research Protection Program Administrator
    at (415) 600-3688.

    Form Information

    Please provide:

    • Title Of Project:

    • Principal Investigator:

    • Sutter Affiliation:

    • Dept.:

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    Protocol Summary Elements

    The following are explanations and/or guidelines of each element of the Protocol Summary, which must be addressed, in the order given, for all protocols that will be reviewed by the IRB. The information should be typed and clearly readable. The intent of requiring a uniform application format is to simplify review by the IRB members, provide maximum information to the members, and thereby facilitate the approval process.

    1. STUDY AIM/PURPOSE: In this section the specific aims of the investigation should be discussed and the problem defined. The specific hypothesis to be tested should be stated. If specific hypotheses are not being tested, then the questions to be answered, data to be tested, description to be made or the information hoped to be gained should be explained. For pilot or exploratory studies, this section should discuss the way in which the information obtained will be used in future studies, so that the potential long-range benefits of the pilot work can be assessed.


    2. BACKGROUND:The background outlines the context of the work by explaining the relation of the proposed research to previous scientific investigation in the field. Relevant laboratory and animal studies should be summarized. This section should present clear justification for participation of human subjects at this stage of the investigation. If the study involves an investigational new drug or device, copies of the Investigator's Brochure/Handbook (obtained from the Sponsor) must be submitted.


    3. SIGNIFICANCE: This section provides the justification for the proposed study, by defining the anticipated benefits and describing to whom they will accrue (e.g., to the individual subject, to science, and/or to society), and explains how these benefits will outweigh the risks involved in the study. Discussion should be included regarding the significance of the knowledge to be generated by the study.


    4. METHODS: Describe the experimental design (i.e., retrospective chart analysis, prospective double-blind, etc.), and the methods and procedures to be used. For behavioral and survey research, attach questionnaire or instrument; or outline types of questions if instrument is to be developed as part of the research. If this is a non-significant risk device study, explain why the risk is non-significant.)

      • General Study Design: A clear, succinct description of the study design should be given in this section.

      • Procedures: Give a detailed explanation of what will be done to each subject, and how this compares with what would be done were the individual not in the study. Describe the frequency and duration of each study procedure, and the total amount of time required for participation in the study. Note the location(s) where study procedures will be carried out. Where will the consent forms be stored (hospital, office etc.)? What steps will be taken to protect patient privacy and confidentiality? Where are the study records archived after the study?

      • Methods of Data Analysis: Methods of data analysis should be presented. If nonstandard types of statistical or other analyses will be used, include a brief explanation.

      • Subject Selection: Per NIH Revitalization Act of 1993 (effective 6/1/94) and FDA regulations, the inclusion of women and racial and ethic minorities must be considered. Who and Why: Subject selection addresses who the proposed subjects are, and what the rationale is for studying this group of individuals. In this section, specify the use of special populations such as minors, pregnant women, those unable to consent for themselves, AIDS patients, those participating in multiple studies, those who are illiterate, those who do not read or speak English, or other vulnerable groups with whom informed and free consent may be compromised. Indicate the gender and racial/ethnic composition of the subject population and include a rationale for excluding any group of individuals. All special recruitment and consent procedures must be discussed in the appropriate sections below. This section should state the total number of subjects proposed for the study, and the number in each group. Statistical rationale should also be presented for use of these numbers. Inclusion/Exclusion Criteria: The specific factors for subject inclusion and exclusion are to be listed, and all screening methods or tests to be used to verify eligibility should be discussed. If subjects are eligible for concurrent research studies, this section should discuss the criteria used to decide which study is most appropriate and how possible conflicts of interest will be avoided.

      • Subject Recruitment: The investigator should detail the sources of prospective subjects, and describe how he/she will gain access to them. If other institutions, agencies or departments are involved, letters of support, indicating knowledge and endorsement of the project, must be submitted from these sites. Initial Contact Method: Discuss how and by whom prospective subjects will be contacted. If recruiting will be done by newspaper advertisement, posted signs, and/or video display on campus, a sample of the recruiting material must be submitted.

    5. HUMAN SUBJECTS:

      • Consent Process and Documentation: The investigator should address how, when and by whom consent will be obtained, along with any special populations that are part of the study. If minors are to be involved in the study, it should be noted whether a separate, simplified consent form will be used for this group, or if there will be one form appropriate for both adult and minor subjects. If the study will include non-English speaking subjects, the participation of translators in the consent process should be discussed, and a copy of the translated consent form should be submitted with the application. If waiver of written, signed consent is requested, justification must be presented here.

      • Risks/Discomforts: This section should discuss all possible risks and discomforts resulting from participation in the study, indicating both severity and likelihood of occurrence for each. Risks may range from the physical to the psychological. Inconvenience, travel or boredom may also be considered risks of participation in the study. The methods that will be used to minimize these risks should also be discussed. Many studies have the potential for loss of privacy and confidentiality. These concerns should be noted in this section, and addressed in the sections on initial contact of prospective subjects and confidentiality.

      • Alternatives: This section should note and briefly describe the alternatives to participation in the study (e.g., no treatment, standard therapy, other experimental treatments) that are available to prospective subjects if they choose not to take part in the study.

    6. QUALIFICATIONS OF INVESTIGATORS: The qualifications and CPMC status of the principal and co-investigators should be noted. For studies employing procedures which require specialized skills on the part of those conducting the study, a brief summary of relevant information on the investigator's background, explaining his/her qualifications to perform these procedures, should be provided.

    7. BIBLIOGRAPHY: If any books, articles or other publications are cited in the protocol, a bibliography should be provided.


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