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    Institutional Review Board (IRB)
    Expedited Review Form

    MS Word Version: Expedited Review Form

    If you have problems using the Word document, provide the IRB with the information below and submit to:
    IRB Office
    2200 Webster Street, Suite 514,
    San Francisco, CA 94115

    For questions and help, please call:
    Human Research Protection Program at (415) 600-3688.

    Form Information

    • Title of Project:

    • Principal Investigator:
      * The Principal Investigator must be a medical staff member or an employee of CPMC. He or she is considered the responsible party for legal and ethical performance of the project.

      • Sutter Affiliation:

      • Dept.:

      • Mailing Address:

      • Phone Number:

      • Fax No:

      • E-mail address:

    • ** If you wish to designate a contact other than the PI to receive correspondence regarding this IRB submission, please include their information.
      • Name of Contact:
      • Contact Phone Number:
      • Contact E-mail address:

    • Sub-INVESTIGATOR (S):

      • Name:

      • Affiliation:

      • Dept.:

    • Anticipated Project Period: (From Date: and To Date: )

    • Total Expected Enrollment Number at this Site:

      • Recruitment Source (s):

      • Subject Payment:

    • Funding agency or sponsor:

    • COSTS: Who will be responsible for costs beyond standard patient care? Check all that apply.

      • Subject

      • Study Sponsor

      • Third Party Insurance

      • Other:

    • Estimated Extent of Potential Financial Liability to Patient as a Result of Participation in this Study: (dollar amount)

    Check affiliate site where research will be conducted:
    Greater Bay Area:

    • Alta Bates Summit Medical Center, Berkeley & Oakland

    • California Pacific Medical Center, San Francisco

    • Eden Medical Center, Castro Valley

    • Marin General Hospital, Greenbrae

    • Mills-Peninsula Health Services, Burlingame/San Mateo

    • Novato Community Hospital, Novato

    • Palo Alto Medical Foundation, Palo Alto

    • Santa Cruz Medical Foundation

    • St. Luke's Hospital, San Francisco

    • Sutter Delta Medical Center, Antioch

    • Sutter Maternity & Surgery Center of Santa Cruz

    • Sutter Medical Center of Santa Rosa

    • Sutter Regional Medical Foundation

    • Sutter Santa Cruz

    • Sutter Solano Medical Center, Vallejo

    • Sutter Tracy Community Hospital, Tracy

    Greater Sacramento Valley/Foothills:
    • Sutter Amador Hospital, Jackson

    • Sutter Auburn Faith Hospital, Auburn

    • Sutter Davis Hospital, Davis

    • Sutter Medical Center, Sacramento

    • Sutter North Medical Foundation, Marysville/Yuba City

    • Sutter Roseville Medical Center, Roseville

    Central Valley:
    • Memorial Hospital, Los Banos

    • Memorial Medical Center, Modesto

    • Sutter Gould Medical Foundation, Modesto

    North Coast:
    • Sutter Coast Hospital, Crescent City

    Clearlake:
    • Sutter Lakeside Hospital, Clearlake

    Other Sutter Affiliates:

    Other Information

    Please provide answers to:

    1. This research qualifies for federal expedited review category number:

      Include justification for chosen federal category number:


    2. Tissue/Blood Banking: Will tissue or serum samples be sent outside of the institution?
      Yes/No.

    3. Does the research protocol involve questionnaire(s)?
      Yes/No. If Yes, please submit questionnaire(s).

      Do questionnaires involve special sensitivity (e.g., drugs/alcohol abuse; sexual behavior)?
      Yes/No. If Yes, please submit questionnaire(s).

    4. Conflict of Interest (COI): Have all CPMC Investigators listed on this application completed the COI form for the current year?
      Yes/No. If No, please submit the COI form with this application. A copy of the form can be requested by sending an email to coi@cpmcri.org

    5. Education of Human Subject Protection:
      Have all CPMC Investigators listed on this application taken a course about Human Subject Protections or Responsible Conduct of Research?
      Yes/No. If No, please refer to “List of Training Options in Human Subjects Protections”, “IRB Submission Requirements Checklist” or please contact the IRB Office at (415)600-3686 or 600-1477.

      Have the research staff (s) taken the same course?
      Yes/No. If No, please refer to “List of Training Options in Human Subjects Protections”, “IRB Submission Requirements Checklist” or please contact the IRB Office at (415)600-3686 or 600-1477.

    Administrative Acknowledgement of the Protocol

    My signature acknowledges that I have reviewed the attached protocol and agree to support its implementation by providing name/signature/date.
    Principal Investigator’s Department Chair’s Signature:
    Date:

    Principal Investigator’s Certification and Assurance

    My signature below constitutes my certification and assurance that:

    1. I certify that the information provided in this application is complete and correct.

    2. I understand that as Principal Investigator, I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and strict adherence to any stipulations imposed by the CPMC IRB.

    3. The consent form will adequately inform the subjects of the nature, scope, and consequences of their participation in the project.

    4. I will adhere to the research protocol as submitted, unless approval for change is granted in advance by CPMC IRB.

    5. I will notify CPMC IRB within 5 working days of any deaths or serious injuries associated with the conduct of the experiment, any unanticipated problems and adverse reactions, and/or any deviations from the protocol.

    6. Appropriate records, including consent forms will be maintained and be available to the CPMC IRB upon request.

    7. I will report on the progress of the study at intervals required by CPMC IRB (at least once per year).

    8. I have disclosed all financial interests that I, the Co-Investigators, Sub-Investigator(s), or any close family members may have in the study sponsor or competing companies, or any benefits that I/we will receive from my participation in this study.

    9. I will adhere to Good Clinical Practice (GCP) and all applicable governmental regulations.

    10. I understand that failure to adhere to these policies and procedures is unlawful and unethical, and that any such action may result in no legal protection from my institution.

    11. I understand that CPMC IRB approval does not indicate institutional authorization to conduct this research study. I will obtain appropriate approval from all institutions involved in this research project.

    12. I understand if I will be unavailable to direct this research personally, I will assure that coverage is available in my absence. Either this person is named as a co-investigator in this application, or I will advise CPMC IRB by letter, in advance of such arrangements.
    Principal Investigator should provide signature/date
    Principal Investigator’s Signature:
    Date:

    Study Contact Information

    The institutional Review Board (IRB) is always looking for ways to promote better communication between our staff and yours. Therefore, we would like to make sure our contact information for your office is as current as possible. Please fill out this form, and anytime thereafter, to report any changes in your contact information.
    Thanks you.

    Please type in the following information:

    • Name of PI

    • Department

    • Address

    • PI’s phone

    • PI’s fax

    • PI’s e-mail

    If you wish to designate a regulatory contact in addition to the PI, please list his/hers information below:
    • Name of Regulatory contact

    • Regulatory contact’s phone

    • Regulatory contact’s fax

    • Regulatory contact’s e-mail

    • Additional comments

    If you wish to designate a clinical coordinator contact in addition to the PI, please list his/hers information below:
    • Name of Clinical coordinator contact

    • Clinical coordinator contact’s phone

    • Clinical coordinator contact’s fax

    • Clinical coordinator contact’s e-mail

    • Additional comments

    • Date prepared

    Categories of Research

    CATEGORIES OF RESEARCH THAT MAY BE REVIEWED
    BY THE INSTITUTIONAL REVIEW BOARD (IRB)
    THROUGH AN EXPEDITED REVIEW PROCEDURE

    Federal Register 11/9/98

    An Expedited Review Procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

    APPLICABILITY

    1. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
    2. The categories in this list apply regardless of the age of subjects, except as noted.
    3. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
    4. The expedited review procedure may not be used for classified research involving human subjects.
    5. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
    6. Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

    RESEARCH CATEGORIES
    1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review).
      2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
    2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
      1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
      2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
      Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.'' 45 CFR 46.402(a).]
    3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylatic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
    4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications). Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
    5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b) (4). This listing refers only to research that is not exempt).
    6. Collection of data from voice, video, digital, or image recordings made for research purposes.
    7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b) (2) and (b) (3). This listing refers only to research that is not exempt).
    8. Continuing review of research previously approved by the convened IRB as follows:
      (a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) Where no subjects have been enrolled and no additional risks have been identified; or (c) Where the remaining research activities are limited to data analysis.
    9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.